Aleniglipron

updated

Aleniglipron (GSBR-1290) is an unapproved oral small-molecule GLP-1 receptor agonist from Structure Therapeutics. In the peer-reviewed phase 2b trial ACCESS (230 adults with obesity or overweight), placebo-adjusted weight change at week 36 was -8.2% to -11.3% across 45, 90 and 120 mg. The 16.3% at 44 weeks figure that sellers quote is a placebo-adjusted company statement dated 16 March 2026 from an 85-person study, and the phase 3 program they describe as starting has already begun.

Oral non-peptide GLP-1 receptor agonist (small molecule)

  • Aleniglipron is PubChem CID 164809721, C49H55FN9O6P, 916.0 g/mol, CAS 2685823-26-9, with GSBR-1290 among its synonyms. The registry sponsor is Gasherbrum Bio, a wholly owned subsidiary of Structure Therapeutics.
  • In ACCESS (230 adults with obesity or overweight, 36 weeks), placebo-adjusted weight change from baseline was -8.2%, -9.8% and -11.3% at 45, 90 and 120 mg (P<0.0001 for all doses). Treatment-related discontinuations were 10.4% across aleniglipron arms.
  • The company reported on 16 March 2026 that ACCESS II (85 adults, 44 weeks) gave a placebo-adjusted -16.3% at 180 mg, which is 15.3% from baseline. That result is not peer reviewed.
  • ACCOMPLISH-1 (estimated 3600) and ACCOMPLISH-2 (estimated 1100) are registered phase 3 studies with registry start dates in July 2026 and a recruiting status, primary completion listed as September 2028 and no results.
  • The company reports no drug-induced liver injury, persistent liver enzyme elevation or QTc prolongation across more than 625 participants. That figure is not peer reviewed.
  • An openFDA Drugs@FDA search and a DailyMed search on 10 October 2026 found no FDA application record and no label. No human pharmacokinetic numbers from a reliable source were found.

What is aleniglipron, and is it approved anywhere?

Aleniglipron (code GSBR-1290) is an oral, non-peptide small-molecule GLP-1 receptor agonist developed by Structure Therapeutics through its subsidiary Gasherbrum Bio. It is not approved: no FDA application record or label turned up on 10 October 2026, and no approval appears in any source reviewed.

Aleniglipron is PubChem CID 164809721, C49H55FN9O6P, 916.0 g/mol, CAS 2685823-26-9. It is listed as an INN and USAN, and GSBR-1290, GSBR1290 and GSBR-1001290 are among its synonyms. It is a phosphorus-containing, non-peptide, orally active small molecule, which the company calls a once-daily nonpeptide GLP-1 receptor agonist. The registry sponsor on every aleniglipron record reviewed is Gasherbrum Bio, Inc., described as a wholly owned subsidiary of Structure Therapeutics.

On 10 October 2026 an openFDA Drugs@FDA search by generic name returned no application records, and a DailyMed search returned 0 labels. No approval appears in any source reviewed.

PubChem: aleniglipron identity and codes

Chemical identity record

National Library of Medicine. PubChem compound record CID 164809721 (aleniglipron).

Aleniglipron is PubChem CID 164809721, C49H55FN9O6P, 916.0 g/mol, CAS 2685823-26-9, listed as an INN and USAN, with GSBR-1290, GSBR1290 and GSBR-1001290 among the synonyms. It is a phosphorus-containing, non-peptide, orally active small molecule (the company calls it a once-daily nonpeptide GLP-1 receptor agonist). The registry sponsor on every aleniglipron record reviewed is Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics (NCT06693843).

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule, oral
Follow-up
Not applicable
Study design
NLM chemical record, with registry sponsor information
Funding
not stated in the source

The code GSBR-1290 maps to this INN. The company description of the molecule and the sponsor relationship come from the registry records summarized in the same entry.

Read the original source
US searches, 10 October 2026: no application records and no labels

Regulatory record

DailyMed, U.S. National Library of Medicine, search for aleniglipron; openFDA Drugs@FDA search by generic name. Both run on 10 October 2026.

An openFDA Drugs@FDA search by generic name aleniglipron returned no application records, and a DailyMed search for aleniglipron returned 0 labels. No FDA approval or label exists in those sources.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Dated regulatory search
Funding
not stated in the source

A search result shows what the databases held on that date.

Read the original source

What did the peer-reviewed phase 2b trial find?

In ACCESS, 230 adults with obesity or overweight had placebo-adjusted body weight changes of -8.2%, -9.8% and -11.3% at week 36 on once-daily oral aleniglipron at 45, 90 and 120 mg (P<0.0001 for all doses), with no apparent plateau.

ACCESS (NCT06693843) randomized 230 adults with obesity or overweight and at least one weight-related comorbidity (mean BMI 39.5 kg/m2, 54% female) to once-daily oral aleniglipron at 45, 90 or 120 mg, or placebo. At week 36 the placebo-adjusted least-squares mean change in body weight from baseline was -8.2% (95% CI -11.1 to -5.3), -9.8% (-12.5 to -7.2) and -11.3% (-13.9 to -8.6), P<0.0001 for all doses, with no apparent plateau.

These are placebo-adjusted changes from baseline in a 36-week trial. The trial was reported in Nature Medicine, and a Publisher Correction exists (PMID 42343118) whose record does not say what changed. The correction should be read before the paper is quoted.

ACCESS phase 2b: 230 adults, 36 weeks, placebo-adjusted -8.2% to -11.3%

Randomized controlled trial

Rosenstock J et al. Nat Med. 2026;32(8):2941-2947. PMID 42249138.

At week 36 the placebo-adjusted least-squares mean body-weight change from baseline was -8.2% (95% CI -11.1 to -5.3) at 45 mg, -9.8% (-12.5 to -7.2) at 90 mg and -11.3% (-13.9 to -8.6) at 120 mg, P<0.0001 for all doses, with no apparent plateau. Gastrointestinal events were generally mild to moderate. Treatment-related discontinuations were 10.4% across aleniglipron arms, with no events of drug-induced liver injury.

Participants / model
230 adults with obesity or overweight and at least one weight-related comorbidity (mean BMI 39.5 kg/m2, 54% female)
Treatment
Aleniglipron 45, 90 or 120 mg orally once daily, or placebo
Follow-up
36 weeks
Study design
Randomized phase 2b trial (NCT06693843)
Funding
not stated in the source

A Publisher Correction exists (PMID 42343118) and its record does not say what changed, so it should be read before the paper is quoted.

Read the original source

What has the company reported beyond the paper?

On 16 March 2026 the company reported ACCESS II in 85 adults: placebo-adjusted -14.7%, -16.3% and -16.0% at week 44 on 120, 180 and 240 mg. It also reported interim extension and body composition results. None of this is peer reviewed.

The company reported on 16 March 2026 that ACCESS II (NCT06703021), a randomized, double-blind, placebo-controlled study, enrolled 85 adults with a BMI above 25 and a weight-related comorbidity for 44 weeks, at target doses of 120, 180 and 240 mg. At week 44 the mean percent change in body weight from baseline was -13.6%, -15.3% and -15.0% versus +1.1% on placebo. The placebo-adjusted change was -14.7%, -16.3% and -16.0% (p<0.0001 for each). One participant (3.7%) who reached 120 mg or higher from week 28 to 44 had an adverse-event-related discontinuation.

The same 16 March 2026 statement gave interim data from the open-label extension of ACCESS (median follow-up 20 weeks, 56 weeks in total): participants previously on aleniglipron lost up to 16.2% from baseline at a maximum of 120 mg, with a 2% overall adverse-event-related discontinuation rate. In a separate body composition study of 71 participants, weight loss was 6.8% at a median 20 weeks, with a 3.4% adverse-event-related discontinuation rate in the aleniglipron arm. The company states that a lower starting dose reduced discontinuations compared with ACCESS and ACCESS II.

These are company results, not peer-reviewed ones. The extension and body composition results are interim and open-label or uncontrolled. The release does not state the arm sizes in ACCESS II and refers to the primary efficacy estimand without defining it, and it says full results will be presented at a medical conference, which was not found.

Company statement, 16 March 2026: ACCESS II, extension, safety, not peer reviewed

Regulatory record

Structure Therapeutics press release, 16 March 2026, read on Nasdaq.com.

ACCESS II (NCT06703021), randomized, double-blind and placebo-controlled, enrolled 85 adults with BMI above 25 and a weight-related comorbidity for 44 weeks. At week 44 the mean percent change in body weight from baseline was -13.6%, -15.3% and -15.0% at target doses of 120, 180 and 240 mg versus +1.1% on placebo, and the placebo-adjusted change was -14.7%, -16.3% and -16.0% (p<0.0001 for each). So 16.3% is the placebo-adjusted result at 180 mg from an 85-person study, and the from-baseline value at 180 mg is 15.3%. In participants who reached 120 mg or higher from week 28 to 44, one (3.7%) had an adverse-event-related discontinuation. In the open-label extension of ACCESS (median follow-up 20 weeks, 56 weeks in total), participants previously on aleniglipron lost up to 16.2% from baseline at a maximum of 120 mg, with an overall adverse-event-related discontinuation rate of 2%. In a separate body composition study of 71 participants, weight loss was 6.8% at a median 20 weeks, with a 3.4% adverse-event-related discontinuation rate in the aleniglipron arm. The company states that a lower starting dose reduced discontinuations compared with ACCESS and ACCESS II. In more than 625 participants across all aleniglipron studies, the company reports no cases of drug-induced liver injury, no persistent liver enzyme elevations and no QTc prolongation to date, and says the most common adverse events were gastrointestinal, with nausea and vomiting the two most common during titration.

Participants / model
85 adults in ACCESS II; participants from ACCESS who rolled over to the extension; 71 adults in the body composition study; more than 625 participants across all studies for safety
Treatment
Aleniglipron 120, 180 or 240 mg orally once daily in ACCESS II; up to 120 mg in the extension
Follow-up
44 weeks (ACCESS II); median 20 weeks of extension follow-up; median 20 weeks (body composition study)
Study design
Company press release; interim and open-label or uncontrolled results are labeled as such; not peer reviewed
Funding
not stated in the source

Arm sizes in ACCESS II are not stated in the release, and the release says full results will be presented at a medical conference, which was not found. The release refers to the primary efficacy estimand without defining it in the text read.

Read the original source

Has the phase 3 program started, and does it have results?

It has started and has no results. ACCOMPLISH-1 (estimated 3600 adults) and ACCOMPLISH-2 (estimated 1100 adults with type 2 diabetes) have registry start dates in July 2026 and are recruiting, and the company said on 6 August 2026 that first patients had been dosed. Primary completion is listed as September 2028.

ACCOMPLISH-1 (NCT07654361) is a pivotal randomized, double-blind, placebo-controlled study of at least 76 weeks in adults with obesity or overweight and a weight-related comorbidity (estimated 3600 participants, registry start 13 July 2026, primary outcome percent change in body weight at week 76). ACCOMPLISH-2 (NCT07654374) enrolls adults with obesity or overweight and type 2 diabetes (estimated 1100 participants, registry start 17 July 2026, same primary outcome). Both list Gasherbrum Bio as sponsor, status Recruiting, and primary completion in September 2028.

A company statement dated 6 August 2026 says the first patients have been dosed in the phase 3 ACCOMPLISH program, with maintenance doses of 45, 90 and 180 mg versus placebo. The release gives no first-dose date. These are registrations and a company statement about a start. They are not outcomes, and there are no phase 3 data.

A PubMed search on 10 October 2026 for aleniglipron or GSBR-1290 returned 3 records and found no peer-reviewed report of ACCESS II, the extension, the body composition study or the earlier phase 1b/2a study (NCT05762471, completed, 142 participants, no posted results).

Registry: ACCOMPLISH-1 and ACCOMPLISH-2, recruiting, no results

Trial registry record

ClinicalTrials.gov record NCT07654361 (ACCOMPLISH-1) and NCT07654374 (ACCOMPLISH-2), read on 10 October 2026.

ACCOMPLISH-1 (NCT07654361) is a pivotal randomized, double-blind, placebo-controlled study of at least 76 weeks in adults with obesity or overweight and a weight-related comorbidity (estimated n=3600, start 2026-07-13, primary outcome percent change in body weight at week 76). ACCOMPLISH-2 (NCT07654374) enrolls adults with obesity or overweight and type 2 diabetes (estimated n=1100, start 2026-07-17, same primary outcome). Both list Gasherbrum Bio as sponsor, status Recruiting, primary completion 2028-09. These are registrations; there are no phase 3 data.

Participants / model
Adults with obesity or overweight, planned
Treatment
Aleniglipron orally once daily versus placebo
Follow-up
At least 76 weeks planned
Study design
Trial registry record; no posted results
Funding
not stated in the source

A registration describes a plan, not a result. Sample sizes are estimates.

Read the original source
Company statement, 6 August 2026: first patients dosed in phase 3

Regulatory record

Structure Therapeutics second-quarter 2026 financial results press release, 6 August 2026, read on Finviz.

The company said the first patients have been dosed in the Phase 3 ACCOMPLISH program. ACCOMPLISH-1 will enroll up to 3,600 patients and ACCOMPLISH-2 up to 1,100. Maintenance doses are 45, 90 and 180 mg versus placebo. The release gives no first-dose date.

Participants / model
Adults with obesity or overweight, planned
Treatment
Aleniglipron 45, 90 or 180 mg orally once daily versus placebo
Follow-up
Statement dated 6 August 2026
Study design
Company press release on phase 3 start and design; not peer reviewed
Funding
not stated in the source

The release reports the start of dosing and the planned design, not data. Combined with the registry start dates in July 2026, the phase 3 program began in July to August 2026.

Read the original source
PubMed search, 10 October 2026: 3 records, only ACCESS reports trial data

PubMed search record

PubMed search for aleniglipron OR GSBR-1290, run on 10 October 2026, with follow-up searches for GSBR-1290 alone and for aleniglipron ACCESS II 44 weeks.

A PubMed search for aleniglipron OR GSBR-1290 returned 3 records: the ACCESS phase 2b paper, its Publisher Correction, and a scoping review of small-molecule GLP-1 agonists. A search for GSBR-1290 alone returned 0 records and a search for aleniglipron ACCESS II 44 weeks returned 0. No peer-reviewed report of ACCESS II, the body composition study, the extension, or the phase 1b/2a study (NCT05762471, completed, 142 participants, no posted results) was found, and no human pharmacokinetic numbers from a reliable source were located.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Search run on 10 October 2026
Study design
Dated literature search
Funding
not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed report exists.

Read the original source

Did aleniglipron produce 16.3% weight loss at 44 weeks, with phase 3 starting this quarter?

The 16.3% is accurate as the company's placebo-adjusted week 44 result at 180 mg in an 85-person study, and the from-baseline value there is 15.3%. The phase 3 claim is out of date: the program began in July to August 2026, not this quarter.

Sellers describe aleniglipron as an oral small-molecule GLP-1 agonist from Structure Therapeutics that produced 16.3% weight loss at 44 weeks, with phase 3 starting this quarter.

The 16.3% is the company's placebo-adjusted change at 180 mg at week 44 in ACCESS II, reported on 16 March 2026 from 85 adults. The from-baseline value at 180 mg is 15.3%. The result is not peer reviewed, and the peer-reviewed phase 2b number is -11.3% placebo-adjusted at 120 mg at week 36.

As of 10 October 2026 the phase 3 claim is out of date. The registry lists ACCOMPLISH-1 and ACCOMPLISH-2 with start dates of 13 and 17 July 2026, and the company said on 6 August 2026 that first patients had been dosed.

Company statement, 16 March 2026: ACCESS II, extension, safety, not peer reviewed

Regulatory record

Structure Therapeutics press release, 16 March 2026, read on Nasdaq.com.

ACCESS II (NCT06703021), randomized, double-blind and placebo-controlled, enrolled 85 adults with BMI above 25 and a weight-related comorbidity for 44 weeks. At week 44 the mean percent change in body weight from baseline was -13.6%, -15.3% and -15.0% at target doses of 120, 180 and 240 mg versus +1.1% on placebo, and the placebo-adjusted change was -14.7%, -16.3% and -16.0% (p<0.0001 for each). So 16.3% is the placebo-adjusted result at 180 mg from an 85-person study, and the from-baseline value at 180 mg is 15.3%. In participants who reached 120 mg or higher from week 28 to 44, one (3.7%) had an adverse-event-related discontinuation. In the open-label extension of ACCESS (median follow-up 20 weeks, 56 weeks in total), participants previously on aleniglipron lost up to 16.2% from baseline at a maximum of 120 mg, with an overall adverse-event-related discontinuation rate of 2%. In a separate body composition study of 71 participants, weight loss was 6.8% at a median 20 weeks, with a 3.4% adverse-event-related discontinuation rate in the aleniglipron arm. The company states that a lower starting dose reduced discontinuations compared with ACCESS and ACCESS II. In more than 625 participants across all aleniglipron studies, the company reports no cases of drug-induced liver injury, no persistent liver enzyme elevations and no QTc prolongation to date, and says the most common adverse events were gastrointestinal, with nausea and vomiting the two most common during titration.

Participants / model
85 adults in ACCESS II; participants from ACCESS who rolled over to the extension; 71 adults in the body composition study; more than 625 participants across all studies for safety
Treatment
Aleniglipron 120, 180 or 240 mg orally once daily in ACCESS II; up to 120 mg in the extension
Follow-up
44 weeks (ACCESS II); median 20 weeks of extension follow-up; median 20 weeks (body composition study)
Study design
Company press release; interim and open-label or uncontrolled results are labeled as such; not peer reviewed
Funding
not stated in the source

Arm sizes in ACCESS II are not stated in the release, and the release says full results will be presented at a medical conference, which was not found. The release refers to the primary efficacy estimand without defining it in the text read.

Read the original source
ACCESS phase 2b: 230 adults, 36 weeks, placebo-adjusted -8.2% to -11.3%

Randomized controlled trial

Rosenstock J et al. Nat Med. 2026;32(8):2941-2947. PMID 42249138.

At week 36 the placebo-adjusted least-squares mean body-weight change from baseline was -8.2% (95% CI -11.1 to -5.3) at 45 mg, -9.8% (-12.5 to -7.2) at 90 mg and -11.3% (-13.9 to -8.6) at 120 mg, P<0.0001 for all doses, with no apparent plateau. Gastrointestinal events were generally mild to moderate. Treatment-related discontinuations were 10.4% across aleniglipron arms, with no events of drug-induced liver injury.

Participants / model
230 adults with obesity or overweight and at least one weight-related comorbidity (mean BMI 39.5 kg/m2, 54% female)
Treatment
Aleniglipron 45, 90 or 120 mg orally once daily, or placebo
Follow-up
36 weeks
Study design
Randomized phase 2b trial (NCT06693843)
Funding
not stated in the source

A Publisher Correction exists (PMID 42343118) and its record does not say what changed, so it should be read before the paper is quoted.

Read the original source
Registry: ACCOMPLISH-1 and ACCOMPLISH-2, recruiting, no results

Trial registry record

ClinicalTrials.gov record NCT07654361 (ACCOMPLISH-1) and NCT07654374 (ACCOMPLISH-2), read on 10 October 2026.

ACCOMPLISH-1 (NCT07654361) is a pivotal randomized, double-blind, placebo-controlled study of at least 76 weeks in adults with obesity or overweight and a weight-related comorbidity (estimated n=3600, start 2026-07-13, primary outcome percent change in body weight at week 76). ACCOMPLISH-2 (NCT07654374) enrolls adults with obesity or overweight and type 2 diabetes (estimated n=1100, start 2026-07-17, same primary outcome). Both list Gasherbrum Bio as sponsor, status Recruiting, primary completion 2028-09. These are registrations; there are no phase 3 data.

Participants / model
Adults with obesity or overweight, planned
Treatment
Aleniglipron orally once daily versus placebo
Follow-up
At least 76 weeks planned
Study design
Trial registry record; no posted results
Funding
not stated in the source

A registration describes a plan, not a result. Sample sizes are estimates.

Read the original source
Company statement, 6 August 2026: first patients dosed in phase 3

Regulatory record

Structure Therapeutics second-quarter 2026 financial results press release, 6 August 2026, read on Finviz.

The company said the first patients have been dosed in the Phase 3 ACCOMPLISH program. ACCOMPLISH-1 will enroll up to 3,600 patients and ACCOMPLISH-2 up to 1,100. Maintenance doses are 45, 90 and 180 mg versus placebo. The release gives no first-dose date.

Participants / model
Adults with obesity or overweight, planned
Treatment
Aleniglipron 45, 90 or 180 mg orally once daily versus placebo
Follow-up
Statement dated 6 August 2026
Study design
Company press release on phase 3 start and design; not peer reviewed
Funding
not stated in the source

The release reports the start of dosing and the planned design, not data. Combined with the registry start dates in July 2026, the phase 3 program began in July to August 2026.

Read the original source

How does aleniglipron work, and what is known about its exposure?

Aleniglipron is an oral, non-peptide small molecule that the company describes as a once-daily GLP-1 receptor agonist. No human pharmacokinetic numbers from a reliable source were found, so half-life and exposure are not established.

The molecule is a phosphorus-containing, non-peptide, orally active small molecule, and the company calls it a once-daily nonpeptide GLP-1 receptor agonist. The weight results in ACCESS and ACCESS II are the evidence for its effect in people.

A PubMed search on 10 October 2026 for aleniglipron or GSBR-1290 returned 3 records and located no human pharmacokinetic numbers from a reliable source. An earlier phase 1b/2a study (NCT05762471, completed, 142 participants) has no posted results.

PubChem: aleniglipron identity and codes

Chemical identity record

National Library of Medicine. PubChem compound record CID 164809721 (aleniglipron).

Aleniglipron is PubChem CID 164809721, C49H55FN9O6P, 916.0 g/mol, CAS 2685823-26-9, listed as an INN and USAN, with GSBR-1290, GSBR1290 and GSBR-1001290 among the synonyms. It is a phosphorus-containing, non-peptide, orally active small molecule (the company calls it a once-daily nonpeptide GLP-1 receptor agonist). The registry sponsor on every aleniglipron record reviewed is Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics (NCT06693843).

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule, oral
Follow-up
Not applicable
Study design
NLM chemical record, with registry sponsor information
Funding
not stated in the source

The code GSBR-1290 maps to this INN. The company description of the molecule and the sponsor relationship come from the registry records summarized in the same entry.

Read the original source
PubMed search, 10 October 2026: 3 records, only ACCESS reports trial data

PubMed search record

PubMed search for aleniglipron OR GSBR-1290, run on 10 October 2026, with follow-up searches for GSBR-1290 alone and for aleniglipron ACCESS II 44 weeks.

A PubMed search for aleniglipron OR GSBR-1290 returned 3 records: the ACCESS phase 2b paper, its Publisher Correction, and a scoping review of small-molecule GLP-1 agonists. A search for GSBR-1290 alone returned 0 records and a search for aleniglipron ACCESS II 44 weeks returned 0. No peer-reviewed report of ACCESS II, the body composition study, the extension, or the phase 1b/2a study (NCT05762471, completed, 142 participants, no posted results) was found, and no human pharmacokinetic numbers from a reliable source were located.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Search run on 10 October 2026
Study design
Dated literature search
Funding
not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed report exists.

Read the original source

What adverse effects have been reported?

Reported adverse events are mostly gastrointestinal. In ACCESS they were generally mild to moderate and treatment-related discontinuations were 10.4% across aleniglipron arms, with no drug-induced liver injury. The company reported on 16 March 2026 no liver injury, persistent liver enzyme elevation or QTc prolongation across more than 625 participants, a figure that is not peer reviewed.

In ACCESS, gastrointestinal events were generally mild to moderate, treatment-related discontinuations were 10.4% across aleniglipron arms, and the abstract reports no events of drug-induced liver injury.

The company reported on 16 March 2026 that across more than 625 participants in all aleniglipron studies there were no cases of drug-induced liver injury, no persistent liver enzyme elevations and no QTc prolongation to date. It said the most common adverse events were gastrointestinal, with nausea and vomiting the two most common during titration. In ACCESS II, one participant (3.7%) who reached 120 mg or higher from week 28 to 44 discontinued for an adverse event. These company figures are not peer reviewed.

No phase 3 safety data exist yet, and the longest follow-up in the sources reviewed is the interim open-label extension (56 weeks in total). Human pharmacokinetics and interactions are not described in the sources reviewed.

ACCESS phase 2b: 230 adults, 36 weeks, placebo-adjusted -8.2% to -11.3%

Randomized controlled trial

Rosenstock J et al. Nat Med. 2026;32(8):2941-2947. PMID 42249138.

At week 36 the placebo-adjusted least-squares mean body-weight change from baseline was -8.2% (95% CI -11.1 to -5.3) at 45 mg, -9.8% (-12.5 to -7.2) at 90 mg and -11.3% (-13.9 to -8.6) at 120 mg, P<0.0001 for all doses, with no apparent plateau. Gastrointestinal events were generally mild to moderate. Treatment-related discontinuations were 10.4% across aleniglipron arms, with no events of drug-induced liver injury.

Participants / model
230 adults with obesity or overweight and at least one weight-related comorbidity (mean BMI 39.5 kg/m2, 54% female)
Treatment
Aleniglipron 45, 90 or 120 mg orally once daily, or placebo
Follow-up
36 weeks
Study design
Randomized phase 2b trial (NCT06693843)
Funding
not stated in the source

A Publisher Correction exists (PMID 42343118) and its record does not say what changed, so it should be read before the paper is quoted.

Read the original source
Company statement, 16 March 2026: ACCESS II, extension, safety, not peer reviewed

Regulatory record

Structure Therapeutics press release, 16 March 2026, read on Nasdaq.com.

ACCESS II (NCT06703021), randomized, double-blind and placebo-controlled, enrolled 85 adults with BMI above 25 and a weight-related comorbidity for 44 weeks. At week 44 the mean percent change in body weight from baseline was -13.6%, -15.3% and -15.0% at target doses of 120, 180 and 240 mg versus +1.1% on placebo, and the placebo-adjusted change was -14.7%, -16.3% and -16.0% (p<0.0001 for each). So 16.3% is the placebo-adjusted result at 180 mg from an 85-person study, and the from-baseline value at 180 mg is 15.3%. In participants who reached 120 mg or higher from week 28 to 44, one (3.7%) had an adverse-event-related discontinuation. In the open-label extension of ACCESS (median follow-up 20 weeks, 56 weeks in total), participants previously on aleniglipron lost up to 16.2% from baseline at a maximum of 120 mg, with an overall adverse-event-related discontinuation rate of 2%. In a separate body composition study of 71 participants, weight loss was 6.8% at a median 20 weeks, with a 3.4% adverse-event-related discontinuation rate in the aleniglipron arm. The company states that a lower starting dose reduced discontinuations compared with ACCESS and ACCESS II. In more than 625 participants across all aleniglipron studies, the company reports no cases of drug-induced liver injury, no persistent liver enzyme elevations and no QTc prolongation to date, and says the most common adverse events were gastrointestinal, with nausea and vomiting the two most common during titration.

Participants / model
85 adults in ACCESS II; participants from ACCESS who rolled over to the extension; 71 adults in the body composition study; more than 625 participants across all studies for safety
Treatment
Aleniglipron 120, 180 or 240 mg orally once daily in ACCESS II; up to 120 mg in the extension
Follow-up
44 weeks (ACCESS II); median 20 weeks of extension follow-up; median 20 weeks (body composition study)
Study design
Company press release; interim and open-label or uncontrolled results are labeled as such; not peer reviewed
Funding
not stated in the source

Arm sizes in ACCESS II are not stated in the release, and the release says full results will be presented at a medical conference, which was not found. The release refers to the primary efficacy estimand without defining it in the text read.

Read the original source

Why does aleniglipron sit in B tier?

B reflects one peer-reviewed phase 2b trial of 230 adults and company-reported higher-dose results from an 85-person study, with a phase 3 program that has only just begun. It is not A because nothing is approved, there are no phase 3 data, and the highest-dose numbers rest on a small unpublished study.

B fits a compound with a published phase 2b trial (230 adults, -11.3% placebo-adjusted at 36 weeks at 120 mg, 10.4% treatment-related discontinuation) and a phase 3 program of two trials that began in July 2026 and will not finish before September 2028 by the registry.

It is not A because aleniglipron is not approved anywhere in the sources reviewed, has no phase 3 data, and its highest-dose numbers (-16.3% placebo-adjusted at 180 mg) come from an 85-person study reported only by the company. The approved oral small molecule orforglipron is graded S on this site.

ACCESS phase 2b: 230 adults, 36 weeks, placebo-adjusted -8.2% to -11.3%

Randomized controlled trial

Rosenstock J et al. Nat Med. 2026;32(8):2941-2947. PMID 42249138.

At week 36 the placebo-adjusted least-squares mean body-weight change from baseline was -8.2% (95% CI -11.1 to -5.3) at 45 mg, -9.8% (-12.5 to -7.2) at 90 mg and -11.3% (-13.9 to -8.6) at 120 mg, P<0.0001 for all doses, with no apparent plateau. Gastrointestinal events were generally mild to moderate. Treatment-related discontinuations were 10.4% across aleniglipron arms, with no events of drug-induced liver injury.

Participants / model
230 adults with obesity or overweight and at least one weight-related comorbidity (mean BMI 39.5 kg/m2, 54% female)
Treatment
Aleniglipron 45, 90 or 120 mg orally once daily, or placebo
Follow-up
36 weeks
Study design
Randomized phase 2b trial (NCT06693843)
Funding
not stated in the source

A Publisher Correction exists (PMID 42343118) and its record does not say what changed, so it should be read before the paper is quoted.

Read the original source
Company statement, 16 March 2026: ACCESS II, extension, safety, not peer reviewed

Regulatory record

Structure Therapeutics press release, 16 March 2026, read on Nasdaq.com.

ACCESS II (NCT06703021), randomized, double-blind and placebo-controlled, enrolled 85 adults with BMI above 25 and a weight-related comorbidity for 44 weeks. At week 44 the mean percent change in body weight from baseline was -13.6%, -15.3% and -15.0% at target doses of 120, 180 and 240 mg versus +1.1% on placebo, and the placebo-adjusted change was -14.7%, -16.3% and -16.0% (p<0.0001 for each). So 16.3% is the placebo-adjusted result at 180 mg from an 85-person study, and the from-baseline value at 180 mg is 15.3%. In participants who reached 120 mg or higher from week 28 to 44, one (3.7%) had an adverse-event-related discontinuation. In the open-label extension of ACCESS (median follow-up 20 weeks, 56 weeks in total), participants previously on aleniglipron lost up to 16.2% from baseline at a maximum of 120 mg, with an overall adverse-event-related discontinuation rate of 2%. In a separate body composition study of 71 participants, weight loss was 6.8% at a median 20 weeks, with a 3.4% adverse-event-related discontinuation rate in the aleniglipron arm. The company states that a lower starting dose reduced discontinuations compared with ACCESS and ACCESS II. In more than 625 participants across all aleniglipron studies, the company reports no cases of drug-induced liver injury, no persistent liver enzyme elevations and no QTc prolongation to date, and says the most common adverse events were gastrointestinal, with nausea and vomiting the two most common during titration.

Participants / model
85 adults in ACCESS II; participants from ACCESS who rolled over to the extension; 71 adults in the body composition study; more than 625 participants across all studies for safety
Treatment
Aleniglipron 120, 180 or 240 mg orally once daily in ACCESS II; up to 120 mg in the extension
Follow-up
44 weeks (ACCESS II); median 20 weeks of extension follow-up; median 20 weeks (body composition study)
Study design
Company press release; interim and open-label or uncontrolled results are labeled as such; not peer reviewed
Funding
not stated in the source

Arm sizes in ACCESS II are not stated in the release, and the release says full results will be presented at a medical conference, which was not found. The release refers to the primary efficacy estimand without defining it in the text read.

Read the original source
Registry: ACCOMPLISH-1 and ACCOMPLISH-2, recruiting, no results

Trial registry record

ClinicalTrials.gov record NCT07654361 (ACCOMPLISH-1) and NCT07654374 (ACCOMPLISH-2), read on 10 October 2026.

ACCOMPLISH-1 (NCT07654361) is a pivotal randomized, double-blind, placebo-controlled study of at least 76 weeks in adults with obesity or overweight and a weight-related comorbidity (estimated n=3600, start 2026-07-13, primary outcome percent change in body weight at week 76). ACCOMPLISH-2 (NCT07654374) enrolls adults with obesity or overweight and type 2 diabetes (estimated n=1100, start 2026-07-17, same primary outcome). Both list Gasherbrum Bio as sponsor, status Recruiting, primary completion 2028-09. These are registrations; there are no phase 3 data.

Participants / model
Adults with obesity or overweight, planned
Treatment
Aleniglipron orally once daily versus placebo
Follow-up
At least 76 weeks planned
Study design
Trial registry record; no posted results
Funding
not stated in the source

A registration describes a plan, not a result. Sample sizes are estimates.

Read the original source
US searches, 10 October 2026: no application records and no labels

Regulatory record

DailyMed, U.S. National Library of Medicine, search for aleniglipron; openFDA Drugs@FDA search by generic name. Both run on 10 October 2026.

An openFDA Drugs@FDA search by generic name aleniglipron returned no application records, and a DailyMed search for aleniglipron returned 0 labels. No FDA approval or label exists in those sources.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Dated regulatory search
Funding
not stated in the source

A search result shows what the databases held on that date.

Read the original source

Studies and sources

PubChem: aleniglipron identity and codes

Chemical identity record

National Library of Medicine. PubChem compound record CID 164809721 (aleniglipron).

Aleniglipron is PubChem CID 164809721, C49H55FN9O6P, 916.0 g/mol, CAS 2685823-26-9, listed as an INN and USAN, with GSBR-1290, GSBR1290 and GSBR-1001290 among the synonyms. It is a phosphorus-containing, non-peptide, orally active small molecule (the company calls it a once-daily nonpeptide GLP-1 receptor agonist). The registry sponsor on every aleniglipron record reviewed is Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics (NCT06693843).

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule, oral
Follow-up
Not applicable
Study design
NLM chemical record, with registry sponsor information
Funding
not stated in the source

The code GSBR-1290 maps to this INN. The company description of the molecule and the sponsor relationship come from the registry records summarized in the same entry.

Read the original source
ACCESS phase 2b: 230 adults, 36 weeks, placebo-adjusted -8.2% to -11.3%

Randomized controlled trial

Rosenstock J et al. Nat Med. 2026;32(8):2941-2947. PMID 42249138.

At week 36 the placebo-adjusted least-squares mean body-weight change from baseline was -8.2% (95% CI -11.1 to -5.3) at 45 mg, -9.8% (-12.5 to -7.2) at 90 mg and -11.3% (-13.9 to -8.6) at 120 mg, P<0.0001 for all doses, with no apparent plateau. Gastrointestinal events were generally mild to moderate. Treatment-related discontinuations were 10.4% across aleniglipron arms, with no events of drug-induced liver injury.

Participants / model
230 adults with obesity or overweight and at least one weight-related comorbidity (mean BMI 39.5 kg/m2, 54% female)
Treatment
Aleniglipron 45, 90 or 120 mg orally once daily, or placebo
Follow-up
36 weeks
Study design
Randomized phase 2b trial (NCT06693843)
Funding
not stated in the source

A Publisher Correction exists (PMID 42343118) and its record does not say what changed, so it should be read before the paper is quoted.

Read the original source
Company statement, 16 March 2026: ACCESS II, extension, safety, not peer reviewed

Regulatory record

Structure Therapeutics press release, 16 March 2026, read on Nasdaq.com.

ACCESS II (NCT06703021), randomized, double-blind and placebo-controlled, enrolled 85 adults with BMI above 25 and a weight-related comorbidity for 44 weeks. At week 44 the mean percent change in body weight from baseline was -13.6%, -15.3% and -15.0% at target doses of 120, 180 and 240 mg versus +1.1% on placebo, and the placebo-adjusted change was -14.7%, -16.3% and -16.0% (p<0.0001 for each). So 16.3% is the placebo-adjusted result at 180 mg from an 85-person study, and the from-baseline value at 180 mg is 15.3%. In participants who reached 120 mg or higher from week 28 to 44, one (3.7%) had an adverse-event-related discontinuation. In the open-label extension of ACCESS (median follow-up 20 weeks, 56 weeks in total), participants previously on aleniglipron lost up to 16.2% from baseline at a maximum of 120 mg, with an overall adverse-event-related discontinuation rate of 2%. In a separate body composition study of 71 participants, weight loss was 6.8% at a median 20 weeks, with a 3.4% adverse-event-related discontinuation rate in the aleniglipron arm. The company states that a lower starting dose reduced discontinuations compared with ACCESS and ACCESS II. In more than 625 participants across all aleniglipron studies, the company reports no cases of drug-induced liver injury, no persistent liver enzyme elevations and no QTc prolongation to date, and says the most common adverse events were gastrointestinal, with nausea and vomiting the two most common during titration.

Participants / model
85 adults in ACCESS II; participants from ACCESS who rolled over to the extension; 71 adults in the body composition study; more than 625 participants across all studies for safety
Treatment
Aleniglipron 120, 180 or 240 mg orally once daily in ACCESS II; up to 120 mg in the extension
Follow-up
44 weeks (ACCESS II); median 20 weeks of extension follow-up; median 20 weeks (body composition study)
Study design
Company press release; interim and open-label or uncontrolled results are labeled as such; not peer reviewed
Funding
not stated in the source

Arm sizes in ACCESS II are not stated in the release, and the release says full results will be presented at a medical conference, which was not found. The release refers to the primary efficacy estimand without defining it in the text read.

Read the original source
Registry: ACCOMPLISH-1 and ACCOMPLISH-2, recruiting, no results

Trial registry record

ClinicalTrials.gov record NCT07654361 (ACCOMPLISH-1) and NCT07654374 (ACCOMPLISH-2), read on 10 October 2026.

ACCOMPLISH-1 (NCT07654361) is a pivotal randomized, double-blind, placebo-controlled study of at least 76 weeks in adults with obesity or overweight and a weight-related comorbidity (estimated n=3600, start 2026-07-13, primary outcome percent change in body weight at week 76). ACCOMPLISH-2 (NCT07654374) enrolls adults with obesity or overweight and type 2 diabetes (estimated n=1100, start 2026-07-17, same primary outcome). Both list Gasherbrum Bio as sponsor, status Recruiting, primary completion 2028-09. These are registrations; there are no phase 3 data.

Participants / model
Adults with obesity or overweight, planned
Treatment
Aleniglipron orally once daily versus placebo
Follow-up
At least 76 weeks planned
Study design
Trial registry record; no posted results
Funding
not stated in the source

A registration describes a plan, not a result. Sample sizes are estimates.

Read the original source
Company statement, 6 August 2026: first patients dosed in phase 3

Regulatory record

Structure Therapeutics second-quarter 2026 financial results press release, 6 August 2026, read on Finviz.

The company said the first patients have been dosed in the Phase 3 ACCOMPLISH program. ACCOMPLISH-1 will enroll up to 3,600 patients and ACCOMPLISH-2 up to 1,100. Maintenance doses are 45, 90 and 180 mg versus placebo. The release gives no first-dose date.

Participants / model
Adults with obesity or overweight, planned
Treatment
Aleniglipron 45, 90 or 180 mg orally once daily versus placebo
Follow-up
Statement dated 6 August 2026
Study design
Company press release on phase 3 start and design; not peer reviewed
Funding
not stated in the source

The release reports the start of dosing and the planned design, not data. Combined with the registry start dates in July 2026, the phase 3 program began in July to August 2026.

Read the original source
PubMed search, 10 October 2026: 3 records, only ACCESS reports trial data

PubMed search record

PubMed search for aleniglipron OR GSBR-1290, run on 10 October 2026, with follow-up searches for GSBR-1290 alone and for aleniglipron ACCESS II 44 weeks.

A PubMed search for aleniglipron OR GSBR-1290 returned 3 records: the ACCESS phase 2b paper, its Publisher Correction, and a scoping review of small-molecule GLP-1 agonists. A search for GSBR-1290 alone returned 0 records and a search for aleniglipron ACCESS II 44 weeks returned 0. No peer-reviewed report of ACCESS II, the body composition study, the extension, or the phase 1b/2a study (NCT05762471, completed, 142 participants, no posted results) was found, and no human pharmacokinetic numbers from a reliable source were located.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Search run on 10 October 2026
Study design
Dated literature search
Funding
not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed report exists.

Read the original source
US searches, 10 October 2026: no application records and no labels

Regulatory record

DailyMed, U.S. National Library of Medicine, search for aleniglipron; openFDA Drugs@FDA search by generic name. Both run on 10 October 2026.

An openFDA Drugs@FDA search by generic name aleniglipron returned no application records, and a DailyMed search for aleniglipron returned 0 labels. No FDA approval or label exists in those sources.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Dated regulatory search
Funding
not stated in the source

A search result shows what the databases held on that date.

Read the original source

Why is Aleniglipron in B tier?

B fits a compound with one peer-reviewed phase 2b trial (230 adults) and company-reported higher-dose results, whose phase 3 program began in July 2026. It is not A because nothing is approved, there are no phase 3 data, and the highest-dose numbers rest on a small unpublished study.