Ribupatide

updated

Ribupatide (HRS9531, KAI-9531) is an investigational synthetic peptide that the WHO describes as a dual agonist of the GIP and GLP-1 receptors, developed by Hengrui and licensed to Kailera outside Greater China. Its only peer-reviewed human result is a phase 1 study in 90 healthy Chinese participants, and the efficacy results are company statements, such as weight change at week 48 of -10.7% to -17.7% across three doses versus -1.4% on placebo in a 567-person China phase 3 trial (treatment policy estimand). The global phase 3 program is no longer recruiting, and Kailera describes a pending NDA in China with no decision found.

GIP and GLP-1 receptor dual agonist peptide (investigational)

  • Ribupatide is a WHO Proposed INN (List 133, 2025; structure revised in List 134) for a dual GIP and GLP-1 receptor agonist, formula C229H346N48O71, CAS 2940971-65-1. Kailera's filings give HRS9531 (Hengrui) and KAI-9531 as other names for the same molecule.
  • In a phase 1 study of 90 healthy Chinese participants, the mean half-life in the multiple-dose part was 7 to 8 days, all treatment-emergent adverse events were mild to moderate, and no serious events or deaths occurred. It is the only peer-reviewed human report found.
  • Kailera's April 2026 prospectus describes a China phase 3 trial of 567 adults without diabetes: mean weight change at week 48 was -10.7% (2 mg), -16.4% (4 mg) and -17.7% (6 mg) versus -1.4% on placebo by the treatment policy estimand, and -11.2%, -17.4% and -19.2% by the efficacy estimand. These are each arm's change, not placebo-adjusted, and are company statements.
  • In a China phase 3 trial in type 2 diabetes, Kailera reported HbA1c falls of 2.78% (4 mg) and 2.34% (2 mg) versus 2.29% with semaglutide 1 mg at week 36, meeting non-inferiority for both doses. This is a company statement.
  • The three global KaiNETIC phase 3 trials (5,070 enrolled in all) are Active, not recruiting per the registry as of the 6 October 2026 update, with 76-week primary endpoints and primary completion in 2028. None has posted results.
  • No FDA approval exists: on 10 October 2026 openFDA Drugs@FDA returned no application records and DailyMed returned no labels. Kailera's filings describe a pending NDA in China submitted by Hengrui, and no decision was found.

What is ribupatide, and is it approved anywhere?

Ribupatide is the WHO Proposed INN for a synthetic peptide described as a dual GIP and GLP-1 receptor agonist, one molecule with HRS9531 and KAI-9531. No FDA approval exists, and Kailera's filings describe a pending NDA in China submitted by Hengrui, with no decision found.

Ribupatide is a WHO Proposed INN (List 133, WHO Drug Information Vol. 39 No. 2, 2025; structure revised in List 134, Vol. 39 No. 4, 2025), described as a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, antidiabetic. The entry lists the formula C229H346N48O71 and CAS 2940971-65-1. WHO INN entries carry no company codes. A PubChem name search for ribupatide, HRS9531 and HRS-9531 returned no compound record on 10 October 2026.

Ribupatide, HRS9531 and KAI-9531 are one molecule. Kailera's 10-Q filed on 12 August 2026 states ribupatide injection (also known as KAI-9531) and ribupatide injection (being developed as HRS9531 by Hengrui). Kailera licensed it from Jiangsu Hengrui Pharmaceuticals under a May 2024 agreement that gives Kailera rights outside Greater China (China, Hong Kong, Macau, Taiwan) and leaves Hengrui responsible within Greater China. ClinicalTrials.gov lists ribupatide with the other name KAI-9531 under sponsor Kailera (NCT07284875), and lists HRS9531 injection under sponsor Fujian Shengdi Pharmaceutical for the China phase 3 trial NCT06396429. The records read do not state Fujian Shengdi's relationship to Hengrui.

No FDA approval exists. On 10 October 2026 openFDA Drugs@FDA returned no application records for ribupatide and a DailyMed search returned no labels. Kailera's 10-Q filed on 12 August 2026 and its IPO prospectus filed on 17 April 2026 state that ribupatide injection (as HRS9531) is the subject of a pending NDA in China submitted by Hengrui. That is a company statement by the licensee, and no decision from the Chinese regulator was found, so this page does not describe the compound as approved or accepted for review.

WHO Proposed INN List 133 (2025): dual GIP and GLP-1 receptor agonist

Chemical identity record

World Health Organization. Proposed International Nonproprietary Names: List 133. WHO Drug Information, Vol. 39, No. 2, 2025. Structure revised in List 134, Vol. 39, No. 4, 2025.

Ribupatide is described as a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, antidiabetic. The entry lists the formula C229H346N48O71 and CAS 2940971-65-1. WHO INN entries carry no company codes. A PubChem name search for ribupatide, HRS9531 and HRS-9531 returned no compound record on 10 October 2026.

Participants / model
Molecular identity, not a clinical population
Treatment
Synthetic peptide, subcutaneous
Follow-up
Not applicable
Study design
Official WHO nomenclature record (Proposed INN list)
Funding
not stated in the source

The link between the INN and the codes HRS9531 and KAI-9531 rests on Kailera's filings and the registry, because the WHO list carries no codes.

Read the original source
Company filing, 12 August 2026: names, Hengrui license, pending China NDA; no FDA approval found

Regulatory record

Kailera Therapeutics Form 10-Q for the quarter ended 30 June 2026, filed 12 August 2026, U.S. Securities and Exchange Commission. openFDA Drugs@FDA and DailyMed searches run on 10 October 2026. ClinicalTrials.gov records NCT07284875 and NCT06396429.

The filing states ribupatide injection (also known as KAI-9531) and ribupatide injection (being developed as HRS9531 by Hengrui). Kailera licensed it from Jiangsu Hengrui Pharmaceuticals under a May 2024 agreement giving Kailera rights outside Greater China (China, Hong Kong, Macau, Taiwan) and leaving Hengrui responsible within Greater China. ClinicalTrials.gov lists ribupatide with other name KAI-9531 under sponsor Kailera (NCT07284875), and HRS9531 injection under sponsor Fujian Shengdi Pharmaceutical for the China phase 3 trial NCT06396429. No FDA approval exists: on 10 October 2026 openFDA Drugs@FDA returned no application records for ribupatide and a DailyMed search returned no labels. The 10-Q, and Kailera's IPO prospectus filed on 17 April 2026, state that ribupatide injection (as HRS9531) is the subject of a pending NDA in China submitted by Hengrui (company statement by the licensee; no decision found).

Participants / model
Sponsor and code identity, not a clinical population
Treatment
Not applicable
Follow-up
Filing dated 12 August 2026; searches run on 10 October 2026
Study design
Company filing, trial registry records and US regulator database searches
Funding
not stated in the source

The China NDA is described only in Kailera's filings. No regulator record or approval decision was retrieved, so the NDA is described as pending per Kailera and not as approved or accepted for review. The records read do not state the relationship between Fujian Shengdi Pharmaceutical and Hengrui.

Read the original source

What has been published, and what did the phase 1 study find?

One peer-reviewed report exists: a phase 1 study in 90 healthy Chinese participants. The mean half-life in the multiple-dose part was 7 to 8 days, all adverse events were mild to moderate, and weight change after four weekly doses ranged from -4.3 kg (-6.7%) to -7.7 kg (-9.6%) versus -1.2 kg (-1.4%) on placebo.

The phase 1 trial (NCT05152277), published on 20 September 2026, gave subcutaneous ribupatide as single-ascending doses of 0.1 to 8.1 mg and as four once-weekly multiple doses (0.9, 2.7 and 5.4 mg), or placebo, to 90 healthy Chinese participants. 87 (96.7%) completed it. All treatment-emergent adverse events were mild to moderate, and no serious events or deaths occurred. In the multiple-dose part the mean half-life was 7 to 8 days.

After four weekly doses, mean weight change in the ribupatide groups ranged from -4.3 kg (-6.7%) to -7.7 kg (-9.6%) versus -1.2 kg (-1.4%) on placebo. These are changes in healthy participants over four weeks, each group against placebo's own change, not placebo-adjusted differences, and the study was not an efficacy trial in people with obesity. The same paper includes preclinical work in rats, monkeys and diet-induced obese mice; the sources reviewed give no doses or routes for it.

A PubMed search on 10 October 2026 for ribupatide OR HRS9531 OR HRS-9531 OR KAI-9531 returned 1 record, the phase 1 paper (PMID 42764407). A ClinicalTrials.gov search for HRS9531 OR ribupatide OR KAI-9531 OR HRS-9531 returned 40 records (16 phase 1, 11 phase 2, 13 phase 3), with no posted results on any. No peer-reviewed report of any ribupatide phase 2 or phase 3 efficacy trial was found; the obesity, diabetes and oral results are company statements.

Phase 1: 90 healthy Chinese adults, half-life 7 to 8 days, mild to moderate adverse events

Clinical trial

He K et al. Diabetes Obes Metab. 2026. PMID 42764407.

Single-ascending doses of 0.1 to 8.1 mg and four once-weekly multiple doses (0.9, 2.7 and 5.4 mg) or placebo were given to 90 healthy Chinese participants, 87 (96.7%) completing. All treatment-emergent adverse events were mild to moderate and no serious events or deaths occurred. In the multiple-dose part the mean half-life was 7 to 8 days. After four weekly doses, mean weight change in the ribupatide groups ranged from -4.3 kg (-6.7%) to -7.7 kg (-9.6%) versus -1.2 kg (-1.4%) on placebo. Preclinical work in rats, monkeys and diet-induced obese mice is in the same paper.

Participants / model
90 healthy Chinese adults; rats, monkeys and diet-induced obese mice (preclinical)
Treatment
Subcutaneous ribupatide, single doses and four once-weekly doses, or placebo
Follow-up
Single doses; four weekly doses
Study design
Phase 1 single- and multiple-ascending-dose trial with preclinical data (NCT05152277)
Funding
not stated in the source

The weight figures are from healthy participants over four weeks and are not placebo-adjusted. The sources reviewed give no doses or routes for the animal work.

Read the original source
Searches, 10 October 2026: 1 PubMed record, no posted registry results

PubMed search record

PubMed search for ribupatide OR HRS9531 OR HRS-9531 OR KAI-9531, run on 10 October 2026 (1 record). ClinicalTrials.gov search for HRS9531 OR ribupatide OR KAI-9531 OR HRS-9531 run the same day (40 records).

PubMed returned 1 record, the phase 1 paper (PMID 42764407). ClinicalTrials.gov returned 40 records (16 phase 1, 11 phase 2, 13 phase 3), with no posted results on any. In the records reviewed there is no peer-reviewed report of any ribupatide phase 2 or phase 3 efficacy trial; the obesity, diabetes and oral results are company statements.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature and registry searches
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source

What has Kailera reported from the China obesity phase 2 and phase 3 studies?

In Kailera's April 2026 prospectus, a 567-person China phase 3 trial gave weight change at week 48 of -10.7% (2 mg), -16.4% (4 mg) and -17.7% (6 mg) versus -1.4% on placebo (treatment policy estimand). Neither China trial has a peer-reviewed report.

Kailera's IPO prospectus, filed on 17 April 2026, describes two Hengrui trials in adults with overweight or obesity without diabetes in China (mean age about 34 years), given weekly subcutaneous ribupatide. The 48-week phase 3 trial enrolled 567 and matches NCT06396429 by size and endpoint, although the passage read does not cite the NCT number. By the treatment policy estimand, weight change at week 48 was -10.7% (2 mg), -16.4% (4 mg) and -17.7% (6 mg) versus -1.4% on placebo. By the efficacy estimand it was -11.2%, -17.4% and -19.2%. These are each arm's change in body weight, not placebo-adjusted differences.

At 6 mg, 75.4% lost at least 10%, 63.8% at least 15% and 44.4% at least 20% of body weight, versus 9.2%, 7.1% and 3.5% on placebo. The passage read does not name the estimand for these thresholds.

The phase 2 trial enrolled 249, with 240 completing 24 weeks, and matches NCT05881837. At week 24 by the treatment policy estimand, weight change was 5.4% (1 mg), 13.4% (3 mg), 14.0% (4.5 mg) and 16.8% (6 mg) versus 0.1% on placebo. Kailera says the most common adverse events were gastrointestinal and mostly mild or moderate, and the passage read gives no incidence.

These are company statements by the licensee, read from an SEC prospectus. A prospectus is a company document, and no peer-reviewed report of either trial was found.

Company statement, 17 April 2026: China phase 3 -10.7% to -17.7% at week 48, not peer reviewed

Regulatory record

Kailera Therapeutics prospectus (Form 424B4) filed 17 April 2026, U.S. Securities and Exchange Commission.

The prospectus describes Hengrui's China phase 2 (249 enrolled, 240 completing 24 weeks; matches NCT05881837) and 48-week phase 3 (567 enrolled; matches NCT06396429 by size and endpoint, although the passage read does not cite the NCT number). In phase 3, by the treatment policy estimand, weight change at week 48 was -10.7% (2 mg), -16.4% (4 mg) and -17.7% (6 mg) versus -1.4% on placebo, and by the efficacy estimand -11.2%, -17.4% and -19.2%. At 6 mg, 75.4% lost at least 10%, 63.8% at least 15% and 44.4% at least 20% versus 9.2%, 7.1% and 3.5% on placebo (the passage does not name the estimand for these thresholds). Phase 2 at week 24 (treatment policy estimand): 5.4% (1 mg), 13.4% (3 mg), 14.0% (4.5 mg) and 16.8% (6 mg) versus 0.1% on placebo. Kailera says the most common adverse events were gastrointestinal and mostly mild or moderate, and gives no incidence in the passage read. No peer-reviewed report of either trial was found.

Participants / model
Adults with overweight or obesity without diabetes in China (mean age about 34 years)
Treatment
Weekly subcutaneous ribupatide, 24 and 48 weeks
Follow-up
24 weeks (phase 2) and 48 weeks (phase 3)
Study design
Company prospectus describing Hengrui phase 2 and phase 3 trials; not peer reviewed
Funding
not stated in the source

The figures are each arm's mean percent change in body weight, not placebo-adjusted differences. No safety incidence table was read.

Read the original source

What has Kailera reported in type 2 diabetes and for the oral tablet?

In China phase 3 trials in type 2 diabetes, HbA1c fell by up to a mean 2.67% (efficacy estimand), and 2.78% on 4 mg versus 2.29% on semaglutide 1 mg at week 36. An oral tablet reached up to 12.1% weight loss at week 26 in a 166-person phase 2 trial. All are company statements, and no oral phase 3 has started.

Kailera's press release filed on 12 August 2026 reports Hengrui topline results in adults with type 2 diabetes in China. In a phase 3 trial (NCT06650007), ribupatide 4 mg and 2 mg lowered HbA1c by up to a mean 2.67% (efficacy estimand). In a second phase 3 trial (NCT06649344), HbA1c fell 2.78% (4 mg) and 2.34% (2 mg) versus 2.29% with semaglutide 1 mg at week 36, meeting non-inferiority for both doses, with 4 mg statistically superior. The estimand for the second trial is not stated in the sources reviewed. Kailera reports tolerability consistent with other GLP-1 treatments, mostly mild to moderate gastrointestinal events.

Oral ribupatide (HRS9531 tablet, KAI-9531-T) is at an earlier stage. In Hengrui's phase 2 obesity trial (NCT06841445, 166 enrolled per the registry), the same release reports mean weight loss at week 26 of up to 12.1% on 25 mg and 50 mg once daily (efficacy estimand), with vomiting in 11.4% and 7.5% across the two doses. Kailera has an active US IND and says global oral phase 3 trials would begin as early as the first half of 2027, so no oral phase 3 has started.

Company statement, 12 August 2026: type 2 diabetes HbA1c, oral phase 2, phase 3 on track

Regulatory record

Kailera Therapeutics press release filed 12 August 2026 as an exhibit with the U.S. Securities and Exchange Commission.

In a China phase 3 trial in type 2 diabetes (NCT06650007), ribupatide 4 mg and 2 mg lowered HbA1c by up to a mean 2.67% (efficacy estimand). In a second China phase 3 trial (NCT06649344), HbA1c fell 2.78% (4 mg) and 2.34% (2 mg) versus 2.29% with semaglutide 1 mg at week 36, meeting non-inferiority for both doses, with 4 mg statistically superior. Kailera reports tolerability consistent with other GLP-1 treatments, mostly mild to moderate gastrointestinal events. In Hengrui's phase 2 obesity trial of the oral tablet (NCT06841445, 166 enrolled per the registry), mean weight loss at week 26 was up to 12.1% on 25 mg and 50 mg (efficacy estimand) with vomiting in 11.4% and 7.5%. Kailera has an active US IND and says global oral phase 3 trials would begin as early as the first half of 2027. The release says enrollment is on track for more than 4,700 participants in the global phase 3 program, with data in 2028.

Participants / model
Adults with type 2 diabetes in China; adults with obesity in China (oral phase 2)
Treatment
Weekly subcutaneous ribupatide 2 and 4 mg (36 weeks); once-daily oral ribupatide tablet (26 weeks)
Follow-up
36 weeks (type 2 diabetes) and 26 weeks (oral phase 2)
Study design
Company press release on Hengrui topline results; not peer reviewed
Funding
not stated in the source

Company statements by the licensee. No oral phase 3 has started. The estimand for the second type 2 diabetes trial is not stated in the sources reviewed.

Read the original source

Is the global phase 3 recruiting, and does it have results?

Per the registry on 10 October 2026, no longer recruiting, and no results. KaiNETIC-1 (2,530 adults without diabetes), KaiNETIC-2 (1,270 with diabetes) and KaiNETIC-3 (1,270, versus semaglutide and placebo) are all Active, not recruiting with 76-week primary endpoints and primary completion in 2028.

KaiNETIC-1 (NCT07284875, adults without diabetes, 2,530 enrolled), KaiNETIC-2 (NCT07284901, with diabetes, 1,270 enrolled) and KaiNETIC-3 (NCT07284979, versus semaglutide and placebo, 1,270 enrolled) all show the status Active, not recruiting, with actual enrollment as of the 6 October 2026 update, 76-week primary endpoints and primary completion in 2028. That totals 5,070 enrolled. The trials give weekly subcutaneous ribupatide versus placebo or semaglutide.

Kailera's 12 August 2026 release says enrollment is on track for more than 4,700 participants and data in 2028 (company statement). None of the three records has posted results. A registration without posted results is not an outcome.

Registry: KaiNETIC-1, -2 and -3, Active not recruiting, 5,070 enrolled, no posted results

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Record NCT07284875 (KaiNETIC-1), with NCT07284901 (KaiNETIC-2) and NCT07284979 (KaiNETIC-3). Read on 10 October 2026, showing the 6 October 2026 update.

KaiNETIC-1 (NCT07284875, adults without diabetes, 2,530 enrolled), KaiNETIC-2 (NCT07284901, with diabetes, 1,270 enrolled) and KaiNETIC-3 (NCT07284979, versus semaglutide and placebo, 1,270 enrolled) all show status Active, not recruiting with actual enrollment as of the 6 October 2026 update, 76-week primary endpoints and primary completion in 2028. None of the three records has posted results. The claim that the global phase 3 is recruiting is not supported by the registry as of 10 October 2026.

Participants / model
Adults with obesity or overweight, without and with diabetes
Treatment
Weekly subcutaneous ribupatide versus placebo or semaglutide, 76 weeks
Follow-up
76 weeks per participant; primary completion in 2028
Study design
Registered phase 3 design and status only
Funding
Kailera is the sponsor of KaiNETIC-1 (NCT07284875)

Registry design and status only. No efficacy or safety result from any KaiNETIC trial is public.

Read the original source
Company statement, 12 August 2026: type 2 diabetes HbA1c, oral phase 2, phase 3 on track

Regulatory record

Kailera Therapeutics press release filed 12 August 2026 as an exhibit with the U.S. Securities and Exchange Commission.

In a China phase 3 trial in type 2 diabetes (NCT06650007), ribupatide 4 mg and 2 mg lowered HbA1c by up to a mean 2.67% (efficacy estimand). In a second China phase 3 trial (NCT06649344), HbA1c fell 2.78% (4 mg) and 2.34% (2 mg) versus 2.29% with semaglutide 1 mg at week 36, meeting non-inferiority for both doses, with 4 mg statistically superior. Kailera reports tolerability consistent with other GLP-1 treatments, mostly mild to moderate gastrointestinal events. In Hengrui's phase 2 obesity trial of the oral tablet (NCT06841445, 166 enrolled per the registry), mean weight loss at week 26 was up to 12.1% on 25 mg and 50 mg (efficacy estimand) with vomiting in 11.4% and 7.5%. Kailera has an active US IND and says global oral phase 3 trials would begin as early as the first half of 2027. The release says enrollment is on track for more than 4,700 participants in the global phase 3 program, with data in 2028.

Participants / model
Adults with type 2 diabetes in China; adults with obesity in China (oral phase 2)
Treatment
Weekly subcutaneous ribupatide 2 and 4 mg (36 weeks); once-daily oral ribupatide tablet (26 weeks)
Follow-up
36 weeks (type 2 diabetes) and 26 weeks (oral phase 2)
Study design
Company press release on Hengrui topline results; not peer reviewed
Funding
not stated in the source

Company statements by the licensee. No oral phase 3 has started. The estimand for the second type 2 diabetes trial is not stated in the sources reviewed.

Read the original source

Is ribupatide a GLP-1/GIP dual agonist in a global phase 3 program that is recruiting?

The first two parts hold and the third is out of date. The WHO describes ribupatide as a dual GIP and GLP-1 receptor agonist, and the Hengrui and Kailera partnership is confirmed. But all three global KaiNETIC trials were Active, not recruiting on 10 October 2026, and none has results.

The claim is that ribupatide (HRS9531, Hengrui, partnered with Kailera) is a GLP-1/GIP dual agonist in a global phase 3 program that is recruiting. The WHO record describes a dual GIP and GLP-1 receptor agonist. Kailera's 10-Q confirms the molecule, the Hengrui origin and the licensing partnership.

The recruiting part is not supported by the registry as of 10 October 2026: KaiNETIC-1, KaiNETIC-2 and KaiNETIC-3 all show Active, not recruiting with 5,070 actual participants, while Kailera's 12 August 2026 release still describes enrollment as on track. Primary completion is in 2028, so no global phase 3 result is expected before then.

WHO Proposed INN List 133 (2025): dual GIP and GLP-1 receptor agonist

Chemical identity record

World Health Organization. Proposed International Nonproprietary Names: List 133. WHO Drug Information, Vol. 39, No. 2, 2025. Structure revised in List 134, Vol. 39, No. 4, 2025.

Ribupatide is described as a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, antidiabetic. The entry lists the formula C229H346N48O71 and CAS 2940971-65-1. WHO INN entries carry no company codes. A PubChem name search for ribupatide, HRS9531 and HRS-9531 returned no compound record on 10 October 2026.

Participants / model
Molecular identity, not a clinical population
Treatment
Synthetic peptide, subcutaneous
Follow-up
Not applicable
Study design
Official WHO nomenclature record (Proposed INN list)
Funding
not stated in the source

The link between the INN and the codes HRS9531 and KAI-9531 rests on Kailera's filings and the registry, because the WHO list carries no codes.

Read the original source
Company filing, 12 August 2026: names, Hengrui license, pending China NDA; no FDA approval found

Regulatory record

Kailera Therapeutics Form 10-Q for the quarter ended 30 June 2026, filed 12 August 2026, U.S. Securities and Exchange Commission. openFDA Drugs@FDA and DailyMed searches run on 10 October 2026. ClinicalTrials.gov records NCT07284875 and NCT06396429.

The filing states ribupatide injection (also known as KAI-9531) and ribupatide injection (being developed as HRS9531 by Hengrui). Kailera licensed it from Jiangsu Hengrui Pharmaceuticals under a May 2024 agreement giving Kailera rights outside Greater China (China, Hong Kong, Macau, Taiwan) and leaving Hengrui responsible within Greater China. ClinicalTrials.gov lists ribupatide with other name KAI-9531 under sponsor Kailera (NCT07284875), and HRS9531 injection under sponsor Fujian Shengdi Pharmaceutical for the China phase 3 trial NCT06396429. No FDA approval exists: on 10 October 2026 openFDA Drugs@FDA returned no application records for ribupatide and a DailyMed search returned no labels. The 10-Q, and Kailera's IPO prospectus filed on 17 April 2026, state that ribupatide injection (as HRS9531) is the subject of a pending NDA in China submitted by Hengrui (company statement by the licensee; no decision found).

Participants / model
Sponsor and code identity, not a clinical population
Treatment
Not applicable
Follow-up
Filing dated 12 August 2026; searches run on 10 October 2026
Study design
Company filing, trial registry records and US regulator database searches
Funding
not stated in the source

The China NDA is described only in Kailera's filings. No regulator record or approval decision was retrieved, so the NDA is described as pending per Kailera and not as approved or accepted for review. The records read do not state the relationship between Fujian Shengdi Pharmaceutical and Hengrui.

Read the original source
Registry: KaiNETIC-1, -2 and -3, Active not recruiting, 5,070 enrolled, no posted results

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Record NCT07284875 (KaiNETIC-1), with NCT07284901 (KaiNETIC-2) and NCT07284979 (KaiNETIC-3). Read on 10 October 2026, showing the 6 October 2026 update.

KaiNETIC-1 (NCT07284875, adults without diabetes, 2,530 enrolled), KaiNETIC-2 (NCT07284901, with diabetes, 1,270 enrolled) and KaiNETIC-3 (NCT07284979, versus semaglutide and placebo, 1,270 enrolled) all show status Active, not recruiting with actual enrollment as of the 6 October 2026 update, 76-week primary endpoints and primary completion in 2028. None of the three records has posted results. The claim that the global phase 3 is recruiting is not supported by the registry as of 10 October 2026.

Participants / model
Adults with obesity or overweight, without and with diabetes
Treatment
Weekly subcutaneous ribupatide versus placebo or semaglutide, 76 weeks
Follow-up
76 weeks per participant; primary completion in 2028
Study design
Registered phase 3 design and status only
Funding
Kailera is the sponsor of KaiNETIC-1 (NCT07284875)

Registry design and status only. No efficacy or safety result from any KaiNETIC trial is public.

Read the original source
Company statement, 12 August 2026: type 2 diabetes HbA1c, oral phase 2, phase 3 on track

Regulatory record

Kailera Therapeutics press release filed 12 August 2026 as an exhibit with the U.S. Securities and Exchange Commission.

In a China phase 3 trial in type 2 diabetes (NCT06650007), ribupatide 4 mg and 2 mg lowered HbA1c by up to a mean 2.67% (efficacy estimand). In a second China phase 3 trial (NCT06649344), HbA1c fell 2.78% (4 mg) and 2.34% (2 mg) versus 2.29% with semaglutide 1 mg at week 36, meeting non-inferiority for both doses, with 4 mg statistically superior. Kailera reports tolerability consistent with other GLP-1 treatments, mostly mild to moderate gastrointestinal events. In Hengrui's phase 2 obesity trial of the oral tablet (NCT06841445, 166 enrolled per the registry), mean weight loss at week 26 was up to 12.1% on 25 mg and 50 mg (efficacy estimand) with vomiting in 11.4% and 7.5%. Kailera has an active US IND and says global oral phase 3 trials would begin as early as the first half of 2027. The release says enrollment is on track for more than 4,700 participants in the global phase 3 program, with data in 2028.

Participants / model
Adults with type 2 diabetes in China; adults with obesity in China (oral phase 2)
Treatment
Weekly subcutaneous ribupatide 2 and 4 mg (36 weeks); once-daily oral ribupatide tablet (26 weeks)
Follow-up
36 weeks (type 2 diabetes) and 26 weeks (oral phase 2)
Study design
Company press release on Hengrui topline results; not peer reviewed
Funding
not stated in the source

Company statements by the licensee. No oral phase 3 has started. The estimand for the second type 2 diabetes trial is not stated in the sources reviewed.

Read the original source

How does ribupatide work, and how long does it last?

The WHO describes ribupatide as a dual agonist of the GIP and GLP-1 receptors. In the multiple-dose part of the phase 1 study in healthy Chinese participants, the mean half-life was 7 to 8 days.

The WHO entry describes a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, antidiabetic, and lists a synthetic peptide with the formula C229H346N48O71. The sources reviewed give no receptor-binding or cell data, so nothing further about the mechanism is stated here.

In the phase 1 study in 90 healthy Chinese participants, the mean half-life in the multiple-dose part (four once-weekly doses) was 7 to 8 days. The phase 2 and phase 3 trials used weekly subcutaneous dosing, and the oral tablet is dosed once daily in its phase 2 trial.

WHO Proposed INN List 133 (2025): dual GIP and GLP-1 receptor agonist

Chemical identity record

World Health Organization. Proposed International Nonproprietary Names: List 133. WHO Drug Information, Vol. 39, No. 2, 2025. Structure revised in List 134, Vol. 39, No. 4, 2025.

Ribupatide is described as a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, antidiabetic. The entry lists the formula C229H346N48O71 and CAS 2940971-65-1. WHO INN entries carry no company codes. A PubChem name search for ribupatide, HRS9531 and HRS-9531 returned no compound record on 10 October 2026.

Participants / model
Molecular identity, not a clinical population
Treatment
Synthetic peptide, subcutaneous
Follow-up
Not applicable
Study design
Official WHO nomenclature record (Proposed INN list)
Funding
not stated in the source

The link between the INN and the codes HRS9531 and KAI-9531 rests on Kailera's filings and the registry, because the WHO list carries no codes.

Read the original source
Phase 1: 90 healthy Chinese adults, half-life 7 to 8 days, mild to moderate adverse events

Clinical trial

He K et al. Diabetes Obes Metab. 2026. PMID 42764407.

Single-ascending doses of 0.1 to 8.1 mg and four once-weekly multiple doses (0.9, 2.7 and 5.4 mg) or placebo were given to 90 healthy Chinese participants, 87 (96.7%) completing. All treatment-emergent adverse events were mild to moderate and no serious events or deaths occurred. In the multiple-dose part the mean half-life was 7 to 8 days. After four weekly doses, mean weight change in the ribupatide groups ranged from -4.3 kg (-6.7%) to -7.7 kg (-9.6%) versus -1.2 kg (-1.4%) on placebo. Preclinical work in rats, monkeys and diet-induced obese mice is in the same paper.

Participants / model
90 healthy Chinese adults; rats, monkeys and diet-induced obese mice (preclinical)
Treatment
Subcutaneous ribupatide, single doses and four once-weekly doses, or placebo
Follow-up
Single doses; four weekly doses
Study design
Phase 1 single- and multiple-ascending-dose trial with preclinical data (NCT05152277)
Funding
not stated in the source

The weight figures are from healthy participants over four weeks and are not placebo-adjusted. The sources reviewed give no doses or routes for the animal work.

Read the original source

What adverse events were reported?

In the phase 1 study, all treatment-emergent adverse events were mild to moderate, and no serious events or deaths occurred. Kailera says adverse events in its China trials were mostly gastrointestinal and mild to moderate, and gives no incidence for the obesity phase 3 trial.

In the phase 1 study in 90 healthy Chinese participants, all treatment-emergent adverse events were mild to moderate, and no serious events or deaths occurred. 87 (96.7%) completed the study.

Kailera's prospectus says the most common adverse events in the China obesity trials were gastrointestinal and mostly mild or moderate, with no incidence in the passage read. Its 12 August 2026 release reports tolerability in type 2 diabetes consistent with other GLP-1 treatments, mostly mild to moderate gastrointestinal events, and vomiting in 11.4% and 7.5% across the two oral doses in the oral phase 2 trial. These are company statements.

No safety incidence table from the China phase 3 obesity trial was read, no peer-reviewed safety report of a phase 2 or phase 3 trial was found, and no global phase 3 safety data are public.

Phase 1: 90 healthy Chinese adults, half-life 7 to 8 days, mild to moderate adverse events

Clinical trial

He K et al. Diabetes Obes Metab. 2026. PMID 42764407.

Single-ascending doses of 0.1 to 8.1 mg and four once-weekly multiple doses (0.9, 2.7 and 5.4 mg) or placebo were given to 90 healthy Chinese participants, 87 (96.7%) completing. All treatment-emergent adverse events were mild to moderate and no serious events or deaths occurred. In the multiple-dose part the mean half-life was 7 to 8 days. After four weekly doses, mean weight change in the ribupatide groups ranged from -4.3 kg (-6.7%) to -7.7 kg (-9.6%) versus -1.2 kg (-1.4%) on placebo. Preclinical work in rats, monkeys and diet-induced obese mice is in the same paper.

Participants / model
90 healthy Chinese adults; rats, monkeys and diet-induced obese mice (preclinical)
Treatment
Subcutaneous ribupatide, single doses and four once-weekly doses, or placebo
Follow-up
Single doses; four weekly doses
Study design
Phase 1 single- and multiple-ascending-dose trial with preclinical data (NCT05152277)
Funding
not stated in the source

The weight figures are from healthy participants over four weeks and are not placebo-adjusted. The sources reviewed give no doses or routes for the animal work.

Read the original source
Company statement, 17 April 2026: China phase 3 -10.7% to -17.7% at week 48, not peer reviewed

Regulatory record

Kailera Therapeutics prospectus (Form 424B4) filed 17 April 2026, U.S. Securities and Exchange Commission.

The prospectus describes Hengrui's China phase 2 (249 enrolled, 240 completing 24 weeks; matches NCT05881837) and 48-week phase 3 (567 enrolled; matches NCT06396429 by size and endpoint, although the passage read does not cite the NCT number). In phase 3, by the treatment policy estimand, weight change at week 48 was -10.7% (2 mg), -16.4% (4 mg) and -17.7% (6 mg) versus -1.4% on placebo, and by the efficacy estimand -11.2%, -17.4% and -19.2%. At 6 mg, 75.4% lost at least 10%, 63.8% at least 15% and 44.4% at least 20% versus 9.2%, 7.1% and 3.5% on placebo (the passage does not name the estimand for these thresholds). Phase 2 at week 24 (treatment policy estimand): 5.4% (1 mg), 13.4% (3 mg), 14.0% (4.5 mg) and 16.8% (6 mg) versus 0.1% on placebo. Kailera says the most common adverse events were gastrointestinal and mostly mild or moderate, and gives no incidence in the passage read. No peer-reviewed report of either trial was found.

Participants / model
Adults with overweight or obesity without diabetes in China (mean age about 34 years)
Treatment
Weekly subcutaneous ribupatide, 24 and 48 weeks
Follow-up
24 weeks (phase 2) and 48 weeks (phase 3)
Study design
Company prospectus describing Hengrui phase 2 and phase 3 trials; not peer reviewed
Funding
not stated in the source

The figures are each arm's mean percent change in body weight, not placebo-adjusted differences. No safety incidence table was read.

Read the original source
Company statement, 12 August 2026: type 2 diabetes HbA1c, oral phase 2, phase 3 on track

Regulatory record

Kailera Therapeutics press release filed 12 August 2026 as an exhibit with the U.S. Securities and Exchange Commission.

In a China phase 3 trial in type 2 diabetes (NCT06650007), ribupatide 4 mg and 2 mg lowered HbA1c by up to a mean 2.67% (efficacy estimand). In a second China phase 3 trial (NCT06649344), HbA1c fell 2.78% (4 mg) and 2.34% (2 mg) versus 2.29% with semaglutide 1 mg at week 36, meeting non-inferiority for both doses, with 4 mg statistically superior. Kailera reports tolerability consistent with other GLP-1 treatments, mostly mild to moderate gastrointestinal events. In Hengrui's phase 2 obesity trial of the oral tablet (NCT06841445, 166 enrolled per the registry), mean weight loss at week 26 was up to 12.1% on 25 mg and 50 mg (efficacy estimand) with vomiting in 11.4% and 7.5%. Kailera has an active US IND and says global oral phase 3 trials would begin as early as the first half of 2027. The release says enrollment is on track for more than 4,700 participants in the global phase 3 program, with data in 2028.

Participants / model
Adults with type 2 diabetes in China; adults with obesity in China (oral phase 2)
Treatment
Weekly subcutaneous ribupatide 2 and 4 mg (36 weeks); once-daily oral ribupatide tablet (26 weeks)
Follow-up
36 weeks (type 2 diabetes) and 26 weeks (oral phase 2)
Study design
Company press release on Hengrui topline results; not peer reviewed
Funding
not stated in the source

Company statements by the licensee. No oral phase 3 has started. The estimand for the second type 2 diabetes trial is not stated in the sources reviewed.

Read the original source

Why does ribupatide sit in B tier?

Ribupatide has a pending NDA in China (per its licensee), a published phase 1 study and company-reported efficacy results, and a 5,070-person global phase 3 that will not report before 2028. There is no peer-reviewed efficacy report.

The efficacy evidence is company-reported: weight change at week 48 of -10.7% to -17.7% across three doses versus -1.4% on placebo in a 567-person China phase 3 trial (treatment policy estimand, not placebo-adjusted), and an HbA1c result that met non-inferiority to semaglutide 1 mg in type 2 diabetes. The only peer-reviewed human report is a four-week phase 1 study in 90 healthy adults.

The global phase 3 program (5,070 enrolled) will not report before 2028. The NDA in China is described only in Kailera's filings, and no decision from the Chinese regulator was found.

Company filing, 12 August 2026: names, Hengrui license, pending China NDA; no FDA approval found

Regulatory record

Kailera Therapeutics Form 10-Q for the quarter ended 30 June 2026, filed 12 August 2026, U.S. Securities and Exchange Commission. openFDA Drugs@FDA and DailyMed searches run on 10 October 2026. ClinicalTrials.gov records NCT07284875 and NCT06396429.

The filing states ribupatide injection (also known as KAI-9531) and ribupatide injection (being developed as HRS9531 by Hengrui). Kailera licensed it from Jiangsu Hengrui Pharmaceuticals under a May 2024 agreement giving Kailera rights outside Greater China (China, Hong Kong, Macau, Taiwan) and leaving Hengrui responsible within Greater China. ClinicalTrials.gov lists ribupatide with other name KAI-9531 under sponsor Kailera (NCT07284875), and HRS9531 injection under sponsor Fujian Shengdi Pharmaceutical for the China phase 3 trial NCT06396429. No FDA approval exists: on 10 October 2026 openFDA Drugs@FDA returned no application records for ribupatide and a DailyMed search returned no labels. The 10-Q, and Kailera's IPO prospectus filed on 17 April 2026, state that ribupatide injection (as HRS9531) is the subject of a pending NDA in China submitted by Hengrui (company statement by the licensee; no decision found).

Participants / model
Sponsor and code identity, not a clinical population
Treatment
Not applicable
Follow-up
Filing dated 12 August 2026; searches run on 10 October 2026
Study design
Company filing, trial registry records and US regulator database searches
Funding
not stated in the source

The China NDA is described only in Kailera's filings. No regulator record or approval decision was retrieved, so the NDA is described as pending per Kailera and not as approved or accepted for review. The records read do not state the relationship between Fujian Shengdi Pharmaceutical and Hengrui.

Read the original source
Company statement, 17 April 2026: China phase 3 -10.7% to -17.7% at week 48, not peer reviewed

Regulatory record

Kailera Therapeutics prospectus (Form 424B4) filed 17 April 2026, U.S. Securities and Exchange Commission.

The prospectus describes Hengrui's China phase 2 (249 enrolled, 240 completing 24 weeks; matches NCT05881837) and 48-week phase 3 (567 enrolled; matches NCT06396429 by size and endpoint, although the passage read does not cite the NCT number). In phase 3, by the treatment policy estimand, weight change at week 48 was -10.7% (2 mg), -16.4% (4 mg) and -17.7% (6 mg) versus -1.4% on placebo, and by the efficacy estimand -11.2%, -17.4% and -19.2%. At 6 mg, 75.4% lost at least 10%, 63.8% at least 15% and 44.4% at least 20% versus 9.2%, 7.1% and 3.5% on placebo (the passage does not name the estimand for these thresholds). Phase 2 at week 24 (treatment policy estimand): 5.4% (1 mg), 13.4% (3 mg), 14.0% (4.5 mg) and 16.8% (6 mg) versus 0.1% on placebo. Kailera says the most common adverse events were gastrointestinal and mostly mild or moderate, and gives no incidence in the passage read. No peer-reviewed report of either trial was found.

Participants / model
Adults with overweight or obesity without diabetes in China (mean age about 34 years)
Treatment
Weekly subcutaneous ribupatide, 24 and 48 weeks
Follow-up
24 weeks (phase 2) and 48 weeks (phase 3)
Study design
Company prospectus describing Hengrui phase 2 and phase 3 trials; not peer reviewed
Funding
not stated in the source

The figures are each arm's mean percent change in body weight, not placebo-adjusted differences. No safety incidence table was read.

Read the original source
Company statement, 12 August 2026: type 2 diabetes HbA1c, oral phase 2, phase 3 on track

Regulatory record

Kailera Therapeutics press release filed 12 August 2026 as an exhibit with the U.S. Securities and Exchange Commission.

In a China phase 3 trial in type 2 diabetes (NCT06650007), ribupatide 4 mg and 2 mg lowered HbA1c by up to a mean 2.67% (efficacy estimand). In a second China phase 3 trial (NCT06649344), HbA1c fell 2.78% (4 mg) and 2.34% (2 mg) versus 2.29% with semaglutide 1 mg at week 36, meeting non-inferiority for both doses, with 4 mg statistically superior. Kailera reports tolerability consistent with other GLP-1 treatments, mostly mild to moderate gastrointestinal events. In Hengrui's phase 2 obesity trial of the oral tablet (NCT06841445, 166 enrolled per the registry), mean weight loss at week 26 was up to 12.1% on 25 mg and 50 mg (efficacy estimand) with vomiting in 11.4% and 7.5%. Kailera has an active US IND and says global oral phase 3 trials would begin as early as the first half of 2027. The release says enrollment is on track for more than 4,700 participants in the global phase 3 program, with data in 2028.

Participants / model
Adults with type 2 diabetes in China; adults with obesity in China (oral phase 2)
Treatment
Weekly subcutaneous ribupatide 2 and 4 mg (36 weeks); once-daily oral ribupatide tablet (26 weeks)
Follow-up
36 weeks (type 2 diabetes) and 26 weeks (oral phase 2)
Study design
Company press release on Hengrui topline results; not peer reviewed
Funding
not stated in the source

Company statements by the licensee. No oral phase 3 has started. The estimand for the second type 2 diabetes trial is not stated in the sources reviewed.

Read the original source
Registry: KaiNETIC-1, -2 and -3, Active not recruiting, 5,070 enrolled, no posted results

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Record NCT07284875 (KaiNETIC-1), with NCT07284901 (KaiNETIC-2) and NCT07284979 (KaiNETIC-3). Read on 10 October 2026, showing the 6 October 2026 update.

KaiNETIC-1 (NCT07284875, adults without diabetes, 2,530 enrolled), KaiNETIC-2 (NCT07284901, with diabetes, 1,270 enrolled) and KaiNETIC-3 (NCT07284979, versus semaglutide and placebo, 1,270 enrolled) all show status Active, not recruiting with actual enrollment as of the 6 October 2026 update, 76-week primary endpoints and primary completion in 2028. None of the three records has posted results. The claim that the global phase 3 is recruiting is not supported by the registry as of 10 October 2026.

Participants / model
Adults with obesity or overweight, without and with diabetes
Treatment
Weekly subcutaneous ribupatide versus placebo or semaglutide, 76 weeks
Follow-up
76 weeks per participant; primary completion in 2028
Study design
Registered phase 3 design and status only
Funding
Kailera is the sponsor of KaiNETIC-1 (NCT07284875)

Registry design and status only. No efficacy or safety result from any KaiNETIC trial is public.

Read the original source
Phase 1: 90 healthy Chinese adults, half-life 7 to 8 days, mild to moderate adverse events

Clinical trial

He K et al. Diabetes Obes Metab. 2026. PMID 42764407.

Single-ascending doses of 0.1 to 8.1 mg and four once-weekly multiple doses (0.9, 2.7 and 5.4 mg) or placebo were given to 90 healthy Chinese participants, 87 (96.7%) completing. All treatment-emergent adverse events were mild to moderate and no serious events or deaths occurred. In the multiple-dose part the mean half-life was 7 to 8 days. After four weekly doses, mean weight change in the ribupatide groups ranged from -4.3 kg (-6.7%) to -7.7 kg (-9.6%) versus -1.2 kg (-1.4%) on placebo. Preclinical work in rats, monkeys and diet-induced obese mice is in the same paper.

Participants / model
90 healthy Chinese adults; rats, monkeys and diet-induced obese mice (preclinical)
Treatment
Subcutaneous ribupatide, single doses and four once-weekly doses, or placebo
Follow-up
Single doses; four weekly doses
Study design
Phase 1 single- and multiple-ascending-dose trial with preclinical data (NCT05152277)
Funding
not stated in the source

The weight figures are from healthy participants over four weeks and are not placebo-adjusted. The sources reviewed give no doses or routes for the animal work.

Read the original source
Searches, 10 October 2026: 1 PubMed record, no posted registry results

PubMed search record

PubMed search for ribupatide OR HRS9531 OR HRS-9531 OR KAI-9531, run on 10 October 2026 (1 record). ClinicalTrials.gov search for HRS9531 OR ribupatide OR KAI-9531 OR HRS-9531 run the same day (40 records).

PubMed returned 1 record, the phase 1 paper (PMID 42764407). ClinicalTrials.gov returned 40 records (16 phase 1, 11 phase 2, 13 phase 3), with no posted results on any. In the records reviewed there is no peer-reviewed report of any ribupatide phase 2 or phase 3 efficacy trial; the obesity, diabetes and oral results are company statements.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature and registry searches
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source

Studies and sources

WHO Proposed INN List 133 (2025): dual GIP and GLP-1 receptor agonist

Chemical identity record

World Health Organization. Proposed International Nonproprietary Names: List 133. WHO Drug Information, Vol. 39, No. 2, 2025. Structure revised in List 134, Vol. 39, No. 4, 2025.

Ribupatide is described as a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, antidiabetic. The entry lists the formula C229H346N48O71 and CAS 2940971-65-1. WHO INN entries carry no company codes. A PubChem name search for ribupatide, HRS9531 and HRS-9531 returned no compound record on 10 October 2026.

Participants / model
Molecular identity, not a clinical population
Treatment
Synthetic peptide, subcutaneous
Follow-up
Not applicable
Study design
Official WHO nomenclature record (Proposed INN list)
Funding
not stated in the source

The link between the INN and the codes HRS9531 and KAI-9531 rests on Kailera's filings and the registry, because the WHO list carries no codes.

Read the original source
Company filing, 12 August 2026: names, Hengrui license, pending China NDA; no FDA approval found

Regulatory record

Kailera Therapeutics Form 10-Q for the quarter ended 30 June 2026, filed 12 August 2026, U.S. Securities and Exchange Commission. openFDA Drugs@FDA and DailyMed searches run on 10 October 2026. ClinicalTrials.gov records NCT07284875 and NCT06396429.

The filing states ribupatide injection (also known as KAI-9531) and ribupatide injection (being developed as HRS9531 by Hengrui). Kailera licensed it from Jiangsu Hengrui Pharmaceuticals under a May 2024 agreement giving Kailera rights outside Greater China (China, Hong Kong, Macau, Taiwan) and leaving Hengrui responsible within Greater China. ClinicalTrials.gov lists ribupatide with other name KAI-9531 under sponsor Kailera (NCT07284875), and HRS9531 injection under sponsor Fujian Shengdi Pharmaceutical for the China phase 3 trial NCT06396429. No FDA approval exists: on 10 October 2026 openFDA Drugs@FDA returned no application records for ribupatide and a DailyMed search returned no labels. The 10-Q, and Kailera's IPO prospectus filed on 17 April 2026, state that ribupatide injection (as HRS9531) is the subject of a pending NDA in China submitted by Hengrui (company statement by the licensee; no decision found).

Participants / model
Sponsor and code identity, not a clinical population
Treatment
Not applicable
Follow-up
Filing dated 12 August 2026; searches run on 10 October 2026
Study design
Company filing, trial registry records and US regulator database searches
Funding
not stated in the source

The China NDA is described only in Kailera's filings. No regulator record or approval decision was retrieved, so the NDA is described as pending per Kailera and not as approved or accepted for review. The records read do not state the relationship between Fujian Shengdi Pharmaceutical and Hengrui.

Read the original source
Phase 1: 90 healthy Chinese adults, half-life 7 to 8 days, mild to moderate adverse events

Clinical trial

He K et al. Diabetes Obes Metab. 2026. PMID 42764407.

Single-ascending doses of 0.1 to 8.1 mg and four once-weekly multiple doses (0.9, 2.7 and 5.4 mg) or placebo were given to 90 healthy Chinese participants, 87 (96.7%) completing. All treatment-emergent adverse events were mild to moderate and no serious events or deaths occurred. In the multiple-dose part the mean half-life was 7 to 8 days. After four weekly doses, mean weight change in the ribupatide groups ranged from -4.3 kg (-6.7%) to -7.7 kg (-9.6%) versus -1.2 kg (-1.4%) on placebo. Preclinical work in rats, monkeys and diet-induced obese mice is in the same paper.

Participants / model
90 healthy Chinese adults; rats, monkeys and diet-induced obese mice (preclinical)
Treatment
Subcutaneous ribupatide, single doses and four once-weekly doses, or placebo
Follow-up
Single doses; four weekly doses
Study design
Phase 1 single- and multiple-ascending-dose trial with preclinical data (NCT05152277)
Funding
not stated in the source

The weight figures are from healthy participants over four weeks and are not placebo-adjusted. The sources reviewed give no doses or routes for the animal work.

Read the original source
Company statement, 17 April 2026: China phase 3 -10.7% to -17.7% at week 48, not peer reviewed

Regulatory record

Kailera Therapeutics prospectus (Form 424B4) filed 17 April 2026, U.S. Securities and Exchange Commission.

The prospectus describes Hengrui's China phase 2 (249 enrolled, 240 completing 24 weeks; matches NCT05881837) and 48-week phase 3 (567 enrolled; matches NCT06396429 by size and endpoint, although the passage read does not cite the NCT number). In phase 3, by the treatment policy estimand, weight change at week 48 was -10.7% (2 mg), -16.4% (4 mg) and -17.7% (6 mg) versus -1.4% on placebo, and by the efficacy estimand -11.2%, -17.4% and -19.2%. At 6 mg, 75.4% lost at least 10%, 63.8% at least 15% and 44.4% at least 20% versus 9.2%, 7.1% and 3.5% on placebo (the passage does not name the estimand for these thresholds). Phase 2 at week 24 (treatment policy estimand): 5.4% (1 mg), 13.4% (3 mg), 14.0% (4.5 mg) and 16.8% (6 mg) versus 0.1% on placebo. Kailera says the most common adverse events were gastrointestinal and mostly mild or moderate, and gives no incidence in the passage read. No peer-reviewed report of either trial was found.

Participants / model
Adults with overweight or obesity without diabetes in China (mean age about 34 years)
Treatment
Weekly subcutaneous ribupatide, 24 and 48 weeks
Follow-up
24 weeks (phase 2) and 48 weeks (phase 3)
Study design
Company prospectus describing Hengrui phase 2 and phase 3 trials; not peer reviewed
Funding
not stated in the source

The figures are each arm's mean percent change in body weight, not placebo-adjusted differences. No safety incidence table was read.

Read the original source
Company statement, 12 August 2026: type 2 diabetes HbA1c, oral phase 2, phase 3 on track

Regulatory record

Kailera Therapeutics press release filed 12 August 2026 as an exhibit with the U.S. Securities and Exchange Commission.

In a China phase 3 trial in type 2 diabetes (NCT06650007), ribupatide 4 mg and 2 mg lowered HbA1c by up to a mean 2.67% (efficacy estimand). In a second China phase 3 trial (NCT06649344), HbA1c fell 2.78% (4 mg) and 2.34% (2 mg) versus 2.29% with semaglutide 1 mg at week 36, meeting non-inferiority for both doses, with 4 mg statistically superior. Kailera reports tolerability consistent with other GLP-1 treatments, mostly mild to moderate gastrointestinal events. In Hengrui's phase 2 obesity trial of the oral tablet (NCT06841445, 166 enrolled per the registry), mean weight loss at week 26 was up to 12.1% on 25 mg and 50 mg (efficacy estimand) with vomiting in 11.4% and 7.5%. Kailera has an active US IND and says global oral phase 3 trials would begin as early as the first half of 2027. The release says enrollment is on track for more than 4,700 participants in the global phase 3 program, with data in 2028.

Participants / model
Adults with type 2 diabetes in China; adults with obesity in China (oral phase 2)
Treatment
Weekly subcutaneous ribupatide 2 and 4 mg (36 weeks); once-daily oral ribupatide tablet (26 weeks)
Follow-up
36 weeks (type 2 diabetes) and 26 weeks (oral phase 2)
Study design
Company press release on Hengrui topline results; not peer reviewed
Funding
not stated in the source

Company statements by the licensee. No oral phase 3 has started. The estimand for the second type 2 diabetes trial is not stated in the sources reviewed.

Read the original source
Registry: KaiNETIC-1, -2 and -3, Active not recruiting, 5,070 enrolled, no posted results

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Record NCT07284875 (KaiNETIC-1), with NCT07284901 (KaiNETIC-2) and NCT07284979 (KaiNETIC-3). Read on 10 October 2026, showing the 6 October 2026 update.

KaiNETIC-1 (NCT07284875, adults without diabetes, 2,530 enrolled), KaiNETIC-2 (NCT07284901, with diabetes, 1,270 enrolled) and KaiNETIC-3 (NCT07284979, versus semaglutide and placebo, 1,270 enrolled) all show status Active, not recruiting with actual enrollment as of the 6 October 2026 update, 76-week primary endpoints and primary completion in 2028. None of the three records has posted results. The claim that the global phase 3 is recruiting is not supported by the registry as of 10 October 2026.

Participants / model
Adults with obesity or overweight, without and with diabetes
Treatment
Weekly subcutaneous ribupatide versus placebo or semaglutide, 76 weeks
Follow-up
76 weeks per participant; primary completion in 2028
Study design
Registered phase 3 design and status only
Funding
Kailera is the sponsor of KaiNETIC-1 (NCT07284875)

Registry design and status only. No efficacy or safety result from any KaiNETIC trial is public.

Read the original source
Searches, 10 October 2026: 1 PubMed record, no posted registry results

PubMed search record

PubMed search for ribupatide OR HRS9531 OR HRS-9531 OR KAI-9531, run on 10 October 2026 (1 record). ClinicalTrials.gov search for HRS9531 OR ribupatide OR KAI-9531 OR HRS-9531 run the same day (40 records).

PubMed returned 1 record, the phase 1 paper (PMID 42764407). ClinicalTrials.gov returned 40 records (16 phase 1, 11 phase 2, 13 phase 3), with no posted results on any. In the records reviewed there is no peer-reviewed report of any ribupatide phase 2 or phase 3 efficacy trial; the obesity, diabetes and oral results are company statements.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature and registry searches
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source

Why is Ribupatide in B tier?

B fits a compound with a pending NDA in China (as described by its licensee), a published phase 1 study, company-reported efficacy results from Chinese phase 2 and phase 3 trials, and a global phase 3 program of 5,070 enrolled participants that will not report before 2028. There is no peer-reviewed efficacy report and no approval decision was found, so the efficacy numbers rest on company statements.