Pramlintide

updated

Pramlintide is a synthetic analog of human amylin, FDA-approved in 2005 as SYMLIN, an add-on for people with type 1 or type 2 diabetes who use mealtime insulin. AstraZeneca AB reported discontinuing manufacture, and the FDA shortage database and Drugs@FDA list the pens as discontinued. Weight loss in trials was modest, a placebo-corrected 3.7% over 16 weeks in obese adult completers, and it never led to an obesity approval.

Amylin analog peptide

  • FDA approved SYMLIN under NDA 021332 on 16 March 2005 as a Type 1 new molecular entity. The label (text effective 18 December 2019) covers people with type 1 or type 2 diabetes who use mealtime insulin and have not reached glucose goals.
  • The FDA drug shortages database lists pramlintide acetate injection as Discontinuation: AstraZeneca AB reported discontinuing manufacture of SymlinPen 60 and SymlinPen 120, posted 27 October 2025.
  • The SYMLIN boxed warning says use with insulin increases the risk of severe hypoglycemia, particularly in type 1 diabetes.
  • In 52-week trials with insulin, HbA1c fell 0.29% and 0.34% versus 0.04% on placebo in type 1 diabetes (651 adults), and 0.62% at week 52 in insulin-treated type 2 diabetes (656 adults).
  • In 204 obese adults with no lifestyle program, 16 weeks of pramlintide gave completers a placebo-corrected weight loss of 3.7% (3.6 kg).
  • In pooled long-term trials, nausea occurred in 48% versus 17% on placebo (type 1) and 28% versus 12% (type 2).

What is pramlintide approved to do?

FDA labels SYMLIN as an adjunct for people with type 1 or type 2 diabetes who use mealtime insulin and have not reached glucose goals despite optimal insulin therapy. Pramlintide is a synthetic analog of human amylin, and the label does not include weight loss or obesity.

SYMLIN is labeled as an adjunct for people with type 1 or type 2 diabetes who use mealtime insulin and have not reached glucose goals despite optimal insulin therapy. It was supplied as SymlinPen 60 and SymlinPen 120 subcutaneous pen-injectors. The label text used here took effect on 18 December 2019 (DailyMed version 18, published 20 August 2024). The labeled use does not include weight loss or obesity.

The label describes pramlintide as a synthetic 37-amino-acid analog of human amylin with proline in place of alanine 25, serine 28 and serine 29, supplied as the acetate salt (C171H267N51O53S2 with 3 to 8 acetates, molecular weight 3949.4 for the peptide). PubChem lists pramlintide as CID 70691388 (C171H267N51O53S2, molecular weight 3949, CAS 151126-32-8) and pramlintide acetate as CID 118984456, with two CAS-style numbers (196078-30-5 and 187887-46-3).

FDA approved SYMLIN under NDA 021332 on 16 March 2005 as a Type 1 new molecular entity. The current holder is AstraZeneca AB, and the last labeling supplement was approved on 18 December 2019. The US product has since been discontinued, as the next section sets out.

SYMLIN label, text effective 18 December 2019: indication, boxed warning, PK, adverse reactions

FDA prescribing information

DailyMed, U.S. National Library of Medicine. SYMLIN (pramlintide acetate) injection, SymlinPen 60 and SymlinPen 120 pen-injectors, prescribing information, label text effective 18 December 2019 (DailyMed version 18, published 20 August 2024). Set ID 4aea30ff-eb0d-45c1-b114-3127966328ff.

The label approves SYMLIN as an adjunct for people with type 1 or type 2 diabetes who use mealtime insulin and have not reached glucose goals despite optimal insulin therapy. There is a boxed warning: use with insulin increases the risk of severe hypoglycemia, particularly in type 1 diabetes, seen within 3 hours of an injection. It is contraindicated with serious hypersensitivity, hypoglycemia unawareness or confirmed gastroparesis. The label describes pramlintide as a synthetic 37-amino-acid analog of human amylin with proline in place of alanine 25, serine 28 and serine 29, supplied as the acetate salt (C171H267N51O53S2 with 3 to 8 acetates, molecular weight 3949.4 for the peptide). Absolute subcutaneous bioavailability is about 30 to 40%, about 40% circulates unbound, and the half-life in healthy people is about 48 minutes. The main metabolite (2-37 pramlintide) is active in vitro, and there is no accumulation. In pooled long-term placebo-controlled trials, nausea occurred in 48% versus 17% (type 1, 30 or 60 mcg three times daily) and 28% versus 12% (type 2, 120 mcg twice daily), and anorexia in 17% versus 2% and 9% versus 2%.

Participants / model
People with type 1 or type 2 diabetes using mealtime insulin; label PK participants; insulin-using adults in pooled long-term trials
Treatment
SymlinPen 60 and SymlinPen 120 subcutaneous pen-injectors
Follow-up
Label text effective 18 December 2019
Study design
FDA prescribing information
Funding
not stated in the source

The label's severe hypoglycemia incidence figures are not given on this page. The US product is discontinued.

Read the original source
PubChem: pramlintide identity

Chemical identity record

National Library of Medicine. PubChem compound records CID 70691388 (pramlintide) and CID 118984456 (pramlintide acetate).

PubChem lists pramlintide as CID 70691388 (C171H267N51O53S2, molecular weight 3949, CAS 151126-32-8) and pramlintide acetate as CID 118984456, with two CAS-style numbers (196078-30-5 and 187887-46-3).

Participants / model
Chemical identity, not a clinical population
Treatment
Defined peptide and acetate salt
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source
Drugs@FDA: SYMLIN approved 16 March 2005 as a Type 1 new molecular entity

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for NDA 021332 (SYMLIN). Dates read from the openFDA Drugs@FDA record on 10 October 2026.

FDA approved SYMLIN under NDA 021332 on 16 March 2005 as a Type 1 new molecular entity. The current holder is AstraZeneca AB, and the last labeling supplement was approved on 18 December 2019.

Participants / model
Not a clinical population
Treatment
New drug application
Follow-up
Approved in 2005; last labeling supplement 2019
Study design
FDA application record
Funding
not stated in the source

The record gives approval and labeling dates. Status outside the United States is not covered here.

Read the original source

Is SYMLIN still on the market in the US?

No. The FDA drug shortages database lists pramlintide acetate injection as Discontinuation: AstraZeneca AB reported discontinuing manufacture of SymlinPen 60 and SymlinPen 120, posted 27 October 2025. Drugs@FDA lists all three SYMLIN products as Discontinued.

The FDA drug shortages database lists pramlintide acetate injection with status Discontinuation. AstraZeneca AB reported SymlinPen 60 (NDC 0310-6615-02) and SymlinPen 120 (NDC 0310-6627-02), posted 27 October 2025, as discontinuation of the manufacture of the drug. The openFDA Drugs@FDA record (data updated 9 October 2026) lists all three SYMLIN products under NDA 021332, the vial and both pens, as Discontinued.

The DailyMed SPL records a marketing end date of 31 January 2027 for both pen NDCs, which likely reflects the last lot's expiry. That reading is an inference. No AstraZeneca press release or dear-doctor letter was found, so the discontinuation rests on the FDA shortage listing, the Drugs@FDA status and the SPL end date. Status outside the United States is not covered here.

FDA shortages database: AstraZeneca AB reported discontinuing manufacture, posted 27 October 2025

Regulatory record

U.S. Food and Drug Administration. Drug shortages database entry for pramlintide acetate injection (status Discontinuation), with the openFDA Drugs@FDA record for NDA 021332 (data updated 9 October 2026) and DailyMed SPL marketing end dates.

The FDA drug shortages database lists pramlintide acetate injection with status Discontinuation: AstraZeneca AB reported SymlinPen 60 (NDC 0310-6615-02) and SymlinPen 120 (NDC 0310-6627-02), posted 27 October 2025, as Discontinuation of the manufacture of the drug. The openFDA Drugs@FDA record (data updated 9 October 2026) lists all three SYMLIN products under NDA 021332, the vial and both pens, as Discontinued, and the DailyMed SPL records a marketing end date of 31 January 2027 for both pen NDCs, which likely reflects the last lot's expiry. No AstraZeneca press release was found.

Participants / model
Not a clinical population
Treatment
SymlinPen 60 and SymlinPen 120
Follow-up
Posted 27 October 2025; marketing end date 31 January 2027
Study design
Official FDA record and sponsor-submitted label data
Funding
not stated in the source

The discontinuation rests on the FDA shortage listing, the Drugs@FDA status and the SPL end date. The reading of 31 January 2027 as the last lot's expiry is an inference. Status outside the United States is not covered here.

Read the original source
Drugs@FDA: SYMLIN approved 16 March 2005 as a Type 1 new molecular entity

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for NDA 021332 (SYMLIN). Dates read from the openFDA Drugs@FDA record on 10 October 2026.

FDA approved SYMLIN under NDA 021332 on 16 March 2005 as a Type 1 new molecular entity. The current holder is AstraZeneca AB, and the last labeling supplement was approved on 18 December 2019.

Participants / model
Not a clinical population
Treatment
New drug application
Follow-up
Approved in 2005; last labeling supplement 2019
Study design
FDA application record
Funding
not stated in the source

The record gives approval and labeling dates. Status outside the United States is not covered here.

Read the original source

What did the diabetes trials find?

In 52-week double-blind trials with insulin, HbA1c fell 0.29% and 0.34% versus 0.04% on placebo in 651 adults with type 1 diabetes, and 0.62% at week 52 on the top regimen in 656 insulin-treated adults with type 2 diabetes. The effects on HbA1c were small.

The type 1 trial was a 52-week double-blind trial in 651 adults (age 41 on average, HbA1c 8.9%) on insulin, randomized to placebo or pramlintide. HbA1c fell 0.29% on 60 mcg three times daily and 0.34% on 60 mcg four times daily versus 0.04% on placebo, and weight fell 0.4 kg on both versus a 0.8 kg gain on placebo. Transient mild-to-moderate nausea was the most common adverse event.

The type 2 trial was a 52-week double-blind trial in 656 insulin-treated adults (BMI 34.0, HbA1c 9.1%), with or without sulfonylurea or metformin, randomized to placebo or pramlintide at 60 mcg three times daily, 90 mcg twice daily or 120 mcg twice daily. On 120 mcg twice daily, HbA1c fell 0.68% at week 26 and 0.62% at week 52, more than placebo, and weight changed -1.4 kg versus +0.7 kg at week 52, with no overall rise in the severe hypoglycemia event rate.

A meta-analysis of 8 randomized trials found pramlintide lowered HbA1c by 0.33% (95% CI -0.51 to -0.14) in insulin-treated type 2 diabetes (4 trials, 930 patients). The authors called the HbA1c effect small and the weight effect modest, with no long-term outcome data.

Type 1 diabetes: 651 patients, 52 weeks, HbA1c fell 0.29% and 0.34% versus 0.04% on placebo

Randomized controlled trial

Ratner RE et al. Diabet Med. 2004;21(11):1204-12. PMID 15498087.

HbA1c fell 0.29% on 60 mcg three times daily and 0.34% on 60 mcg four times daily versus 0.04% on placebo, and weight fell 0.4 kg on both versus a 0.8 kg gain on placebo. Transient mild-to-moderate nausea was the most common adverse event.

Participants / model
651 adults with type 1 diabetes (age 41 on average, HbA1c 8.9%) on insulin
Treatment
Subcutaneous pramlintide 60 mcg three or four times daily plus insulin, or placebo plus insulin
Follow-up
52 weeks
Study design
Randomized double-blind placebo-controlled trial
Funding
not stated in the source

Weight was a secondary result: a small loss on pramlintide against a gain on placebo.

Read the original source
Type 2 diabetes on insulin: 656 patients, 52 weeks, HbA1c -0.62% and weight -1.4 kg versus +0.7 kg

Randomized controlled trial

Hollander PA et al. Diabetes Care. 2003;26(3):784-90. PMID 12610038.

On 120 mcg twice daily, HbA1c fell 0.68% at week 26 and 0.62% at week 52, more than placebo, and weight changed -1.4 kg versus +0.7 kg at week 52, with no overall rise in the severe hypoglycemia event rate.

Participants / model
656 insulin-treated adults with type 2 diabetes (BMI 34.0, HbA1c 9.1%), with or without sulfonylurea or metformin
Treatment
Subcutaneous pramlintide 60 mcg three times daily, 90 mcg twice daily or 120 mcg twice daily plus insulin, or placebo plus insulin
Follow-up
52 weeks
Study design
Randomized double-blind placebo-controlled trial
Funding
not stated in the source

The figures given are for the 120 mcg twice-daily regimen.

Read the original source
Meta-analysis of 8 trials: HbA1c -0.33%, weight -2.57 kg in type 2 diabetes, -2.27 kg in obesity

Systematic review and meta-analysis

Singh-Franco D et al. Diabetes Obes Metab. 2011;13(2):169-80. PMID 21199269.

In 8 randomized trials, pramlintide lowered HbA1c by 0.33% (95% CI -0.51 to -0.14) and weight by 2.57 kg (95% CI -3.44 to -1.70) in insulin-treated type 2 diabetes (4 trials, 930 patients), and weight by 2.27 kg (95% CI -2.88 to -1.66) in obese people without diabetes (4 trials, 686 patients, 6 to 24 weeks). Nausea was 1.8 times as likely as on control. The authors called the HbA1c effect small and the weight effect modest, with no long-term outcome data.

Participants / model
Insulin-treated adults with type 2 diabetes (930 patients); obese adults without diabetes (686 patients)
Treatment
Subcutaneous pramlintide, 120 to 360 mcg two or three times daily
Follow-up
6 to 24 weeks in the obesity trials
Study design
Systematic review and meta-analysis of 8 randomized trials
Funding
not stated in the source

Outcomes pooled were HbA1c, weight, nausea and hypoglycaemia. The authors reported no long-term outcome data.

Read the original source

How much weight did pramlintide take off?

Modestly. In 204 obese adults without a lifestyle program, completers lost a placebo-corrected 3.7% (3.6 kg) over 16 weeks. In a 411-adult lifestyle trial, placebo-corrected loss at month 12 was 6.1 kg and 7.2 kg on two regimens, but only 146 participants were evaluable. It never led to an obesity approval.

In 204 obese adults (80% women, BMI 37.8), with and without type 2 diabetes, randomized to pramlintide escalated up to 240 mcg three times daily or placebo for 16 weeks with no lifestyle program, completers lost a placebo-corrected 3.7% of body weight (3.6 kg), and about 31% versus 2% lost at least 5%. Withdrawal was 29% on pramlintide and 25% on placebo. Mild, transient nausea was most common.

In 411 obese adults without diabetes in a lifestyle program, randomized to six pramlintide regimens (120 to 360 mcg two or three times daily) or placebo for 4 months with an 8-month single-blind extension, placebo-corrected weight loss at month 12 was 6.1 kg (5.6%) on 120 mcg three times daily and 7.2 kg (6.8%) on 360 mcg twice daily. Only 146 participants were evaluable at month 12, so those figures rest on about a third of the enrolled group.

In the pooled analysis of 8 randomized trials, pramlintide lowered weight by 2.57 kg (95% CI -3.44 to -1.70) in insulin-treated type 2 diabetes (4 trials, 930 patients) and by 2.27 kg (95% CI -2.88 to -1.66) in obese people without diabetes (4 trials, 686 patients, 6 to 24 weeks). The authors called the weight effect modest and reported no long-term outcome data. In the 52-week type 2 trial, weight changed -1.4 kg versus +0.7 kg on placebo.

Obesity without insulin: 204 adults, 16 weeks, placebo-corrected 3.7% weight loss in completers

Randomized controlled trial

Aronne L et al. J Clin Endocrinol Metab. 2007;92(8):2977-83. PMID 17504894.

Completers lost a placebo-corrected 3.7% of body weight (3.6 kg), and about 31% versus 2% lost at least 5%. Withdrawal was 29% on pramlintide and 25% on placebo. Mild, transient nausea was most common.

Participants / model
204 obese adults (80% women, BMI 37.8), with and without type 2 diabetes
Treatment
Subcutaneous pramlintide escalated up to 240 mcg three times daily, or placebo, with no lifestyle program
Follow-up
16 weeks
Study design
Randomized phase 2 trial
Funding
not stated in the source

The weight figure is for completers and is placebo-corrected. The trial used no lifestyle program.

Read the original source
Obesity with lifestyle program: 411 adults, 4 months plus 8-month extension, only 146 evaluable at month 12

Randomized controlled trial

Smith SR et al. Diabetes Care. 2008;31(9):1816-23. PMID 18753666.

Placebo-corrected weight loss at month 12 was 6.1 kg (5.6%) on 120 mcg three times daily and 7.2 kg (6.8%) on 360 mcg twice daily, but only 146 participants were evaluable at month 12. Nausea in the first 4 months was 9 to 29% on pramlintide versus 2% on placebo.

Participants / model
411 obese adults without diabetes in a lifestyle program
Treatment
Six subcutaneous pramlintide regimens (120 to 360 mcg two or three times daily) or placebo
Follow-up
4 months, with an 8-month single-blind extension
Study design
Randomized dose-ranging trial
Funding
not stated in the source

Only 146 of the 411 participants were evaluable at month 12, so the month-12 figures rest on about a third of the enrolled group.

Read the original source
Meta-analysis of 8 trials: HbA1c -0.33%, weight -2.57 kg in type 2 diabetes, -2.27 kg in obesity

Systematic review and meta-analysis

Singh-Franco D et al. Diabetes Obes Metab. 2011;13(2):169-80. PMID 21199269.

In 8 randomized trials, pramlintide lowered HbA1c by 0.33% (95% CI -0.51 to -0.14) and weight by 2.57 kg (95% CI -3.44 to -1.70) in insulin-treated type 2 diabetes (4 trials, 930 patients), and weight by 2.27 kg (95% CI -2.88 to -1.66) in obese people without diabetes (4 trials, 686 patients, 6 to 24 weeks). Nausea was 1.8 times as likely as on control. The authors called the HbA1c effect small and the weight effect modest, with no long-term outcome data.

Participants / model
Insulin-treated adults with type 2 diabetes (930 patients); obese adults without diabetes (686 patients)
Treatment
Subcutaneous pramlintide, 120 to 360 mcg two or three times daily
Follow-up
6 to 24 weeks in the obesity trials
Study design
Systematic review and meta-analysis of 8 randomized trials
Funding
not stated in the source

Outcomes pooled were HbA1c, weight, nausea and hypoglycaemia. The authors reported no long-term outcome data.

Read the original source
Type 2 diabetes on insulin: 656 patients, 52 weeks, HbA1c -0.62% and weight -1.4 kg versus +0.7 kg

Randomized controlled trial

Hollander PA et al. Diabetes Care. 2003;26(3):784-90. PMID 12610038.

On 120 mcg twice daily, HbA1c fell 0.68% at week 26 and 0.62% at week 52, more than placebo, and weight changed -1.4 kg versus +0.7 kg at week 52, with no overall rise in the severe hypoglycemia event rate.

Participants / model
656 insulin-treated adults with type 2 diabetes (BMI 34.0, HbA1c 9.1%), with or without sulfonylurea or metformin
Treatment
Subcutaneous pramlintide 60 mcg three times daily, 90 mcg twice daily or 120 mcg twice daily plus insulin, or placebo plus insulin
Follow-up
52 weeks
Study design
Randomized double-blind placebo-controlled trial
Funding
not stated in the source

The figures given are for the 120 mcg twice-daily regimen.

Read the original source

Is pramlintide an approved weight-loss drug?

No. Calling it the FDA-approved amylin analog is accurate as history, but the US product is discontinued, its approved role is an add-on to mealtime insulin, and the weight data are modest and never led to an obesity approval.

Sellers describe pramlintide as the FDA-approved amylin analog (SYMLIN) used with mealtime insulin and also discussed for appetite and weight loss. The approval part is accurate as history: FDA approved it in 2005, and the labeled role is an add-on for people who use mealtime insulin.

Two corrections apply. The US product is discontinued: the FDA shortage listing and Drugs@FDA record AstraZeneca AB's discontinuation of manufacture. And the weight data are modest: a placebo-corrected loss of 3.7% over 16 weeks in completers in one obesity trial, and placebo-corrected losses of 6.1 kg and 7.2 kg on two regimens at month 12 in a lifestyle trial where only 146 of 411 participants were evaluable. The weight data never led to an obesity approval. The obesity program, including pramlintide with metreleptin, and why it stopped is not established here.

SYMLIN label, text effective 18 December 2019: indication, boxed warning, PK, adverse reactions

FDA prescribing information

DailyMed, U.S. National Library of Medicine. SYMLIN (pramlintide acetate) injection, SymlinPen 60 and SymlinPen 120 pen-injectors, prescribing information, label text effective 18 December 2019 (DailyMed version 18, published 20 August 2024). Set ID 4aea30ff-eb0d-45c1-b114-3127966328ff.

The label approves SYMLIN as an adjunct for people with type 1 or type 2 diabetes who use mealtime insulin and have not reached glucose goals despite optimal insulin therapy. There is a boxed warning: use with insulin increases the risk of severe hypoglycemia, particularly in type 1 diabetes, seen within 3 hours of an injection. It is contraindicated with serious hypersensitivity, hypoglycemia unawareness or confirmed gastroparesis. The label describes pramlintide as a synthetic 37-amino-acid analog of human amylin with proline in place of alanine 25, serine 28 and serine 29, supplied as the acetate salt (C171H267N51O53S2 with 3 to 8 acetates, molecular weight 3949.4 for the peptide). Absolute subcutaneous bioavailability is about 30 to 40%, about 40% circulates unbound, and the half-life in healthy people is about 48 minutes. The main metabolite (2-37 pramlintide) is active in vitro, and there is no accumulation. In pooled long-term placebo-controlled trials, nausea occurred in 48% versus 17% (type 1, 30 or 60 mcg three times daily) and 28% versus 12% (type 2, 120 mcg twice daily), and anorexia in 17% versus 2% and 9% versus 2%.

Participants / model
People with type 1 or type 2 diabetes using mealtime insulin; label PK participants; insulin-using adults in pooled long-term trials
Treatment
SymlinPen 60 and SymlinPen 120 subcutaneous pen-injectors
Follow-up
Label text effective 18 December 2019
Study design
FDA prescribing information
Funding
not stated in the source

The label's severe hypoglycemia incidence figures are not given on this page. The US product is discontinued.

Read the original source
Drugs@FDA: SYMLIN approved 16 March 2005 as a Type 1 new molecular entity

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for NDA 021332 (SYMLIN). Dates read from the openFDA Drugs@FDA record on 10 October 2026.

FDA approved SYMLIN under NDA 021332 on 16 March 2005 as a Type 1 new molecular entity. The current holder is AstraZeneca AB, and the last labeling supplement was approved on 18 December 2019.

Participants / model
Not a clinical population
Treatment
New drug application
Follow-up
Approved in 2005; last labeling supplement 2019
Study design
FDA application record
Funding
not stated in the source

The record gives approval and labeling dates. Status outside the United States is not covered here.

Read the original source
FDA shortages database: AstraZeneca AB reported discontinuing manufacture, posted 27 October 2025

Regulatory record

U.S. Food and Drug Administration. Drug shortages database entry for pramlintide acetate injection (status Discontinuation), with the openFDA Drugs@FDA record for NDA 021332 (data updated 9 October 2026) and DailyMed SPL marketing end dates.

The FDA drug shortages database lists pramlintide acetate injection with status Discontinuation: AstraZeneca AB reported SymlinPen 60 (NDC 0310-6615-02) and SymlinPen 120 (NDC 0310-6627-02), posted 27 October 2025, as Discontinuation of the manufacture of the drug. The openFDA Drugs@FDA record (data updated 9 October 2026) lists all three SYMLIN products under NDA 021332, the vial and both pens, as Discontinued, and the DailyMed SPL records a marketing end date of 31 January 2027 for both pen NDCs, which likely reflects the last lot's expiry. No AstraZeneca press release was found.

Participants / model
Not a clinical population
Treatment
SymlinPen 60 and SymlinPen 120
Follow-up
Posted 27 October 2025; marketing end date 31 January 2027
Study design
Official FDA record and sponsor-submitted label data
Funding
not stated in the source

The discontinuation rests on the FDA shortage listing, the Drugs@FDA status and the SPL end date. The reading of 31 January 2027 as the last lot's expiry is an inference. Status outside the United States is not covered here.

Read the original source
Obesity without insulin: 204 adults, 16 weeks, placebo-corrected 3.7% weight loss in completers

Randomized controlled trial

Aronne L et al. J Clin Endocrinol Metab. 2007;92(8):2977-83. PMID 17504894.

Completers lost a placebo-corrected 3.7% of body weight (3.6 kg), and about 31% versus 2% lost at least 5%. Withdrawal was 29% on pramlintide and 25% on placebo. Mild, transient nausea was most common.

Participants / model
204 obese adults (80% women, BMI 37.8), with and without type 2 diabetes
Treatment
Subcutaneous pramlintide escalated up to 240 mcg three times daily, or placebo, with no lifestyle program
Follow-up
16 weeks
Study design
Randomized phase 2 trial
Funding
not stated in the source

The weight figure is for completers and is placebo-corrected. The trial used no lifestyle program.

Read the original source
Obesity with lifestyle program: 411 adults, 4 months plus 8-month extension, only 146 evaluable at month 12

Randomized controlled trial

Smith SR et al. Diabetes Care. 2008;31(9):1816-23. PMID 18753666.

Placebo-corrected weight loss at month 12 was 6.1 kg (5.6%) on 120 mcg three times daily and 7.2 kg (6.8%) on 360 mcg twice daily, but only 146 participants were evaluable at month 12. Nausea in the first 4 months was 9 to 29% on pramlintide versus 2% on placebo.

Participants / model
411 obese adults without diabetes in a lifestyle program
Treatment
Six subcutaneous pramlintide regimens (120 to 360 mcg two or three times daily) or placebo
Follow-up
4 months, with an 8-month single-blind extension
Study design
Randomized dose-ranging trial
Funding
not stated in the source

Only 146 of the 411 participants were evaluable at month 12, so the month-12 figures rest on about a third of the enrolled group.

Read the original source
Meta-analysis of 8 trials: HbA1c -0.33%, weight -2.57 kg in type 2 diabetes, -2.27 kg in obesity

Systematic review and meta-analysis

Singh-Franco D et al. Diabetes Obes Metab. 2011;13(2):169-80. PMID 21199269.

In 8 randomized trials, pramlintide lowered HbA1c by 0.33% (95% CI -0.51 to -0.14) and weight by 2.57 kg (95% CI -3.44 to -1.70) in insulin-treated type 2 diabetes (4 trials, 930 patients), and weight by 2.27 kg (95% CI -2.88 to -1.66) in obese people without diabetes (4 trials, 686 patients, 6 to 24 weeks). Nausea was 1.8 times as likely as on control. The authors called the HbA1c effect small and the weight effect modest, with no long-term outcome data.

Participants / model
Insulin-treated adults with type 2 diabetes (930 patients); obese adults without diabetes (686 patients)
Treatment
Subcutaneous pramlintide, 120 to 360 mcg two or three times daily
Follow-up
6 to 24 weeks in the obesity trials
Study design
Systematic review and meta-analysis of 8 randomized trials
Funding
not stated in the source

Outcomes pooled were HbA1c, weight, nausea and hypoglycaemia. The authors reported no long-term outcome data.

Read the original source

How does pramlintide work, and how long does it last in the body?

Pramlintide is a synthetic analog of human amylin. After subcutaneous injection, absolute bioavailability is about 30 to 40%, about 40% circulates unbound, and the half-life in healthy people is about 48 minutes.

Pramlintide is a synthetic 37-amino-acid analog of human amylin with three proline substitutions (in place of alanine 25, serine 28 and serine 29). The sources reviewed for this page do not set out how amylin receptor activation produces the glucose and weight effects seen in the trials.

Absolute subcutaneous bioavailability is about 30 to 40%, and about 40% circulates unbound. The half-life in healthy people is about 48 minutes. The main metabolite (2-37 pramlintide) is active in vitro, and there is no accumulation. Tmax is not given in the sources reviewed.

SYMLIN label, text effective 18 December 2019: indication, boxed warning, PK, adverse reactions

FDA prescribing information

DailyMed, U.S. National Library of Medicine. SYMLIN (pramlintide acetate) injection, SymlinPen 60 and SymlinPen 120 pen-injectors, prescribing information, label text effective 18 December 2019 (DailyMed version 18, published 20 August 2024). Set ID 4aea30ff-eb0d-45c1-b114-3127966328ff.

The label approves SYMLIN as an adjunct for people with type 1 or type 2 diabetes who use mealtime insulin and have not reached glucose goals despite optimal insulin therapy. There is a boxed warning: use with insulin increases the risk of severe hypoglycemia, particularly in type 1 diabetes, seen within 3 hours of an injection. It is contraindicated with serious hypersensitivity, hypoglycemia unawareness or confirmed gastroparesis. The label describes pramlintide as a synthetic 37-amino-acid analog of human amylin with proline in place of alanine 25, serine 28 and serine 29, supplied as the acetate salt (C171H267N51O53S2 with 3 to 8 acetates, molecular weight 3949.4 for the peptide). Absolute subcutaneous bioavailability is about 30 to 40%, about 40% circulates unbound, and the half-life in healthy people is about 48 minutes. The main metabolite (2-37 pramlintide) is active in vitro, and there is no accumulation. In pooled long-term placebo-controlled trials, nausea occurred in 48% versus 17% (type 1, 30 or 60 mcg three times daily) and 28% versus 12% (type 2, 120 mcg twice daily), and anorexia in 17% versus 2% and 9% versus 2%.

Participants / model
People with type 1 or type 2 diabetes using mealtime insulin; label PK participants; insulin-using adults in pooled long-term trials
Treatment
SymlinPen 60 and SymlinPen 120 subcutaneous pen-injectors
Follow-up
Label text effective 18 December 2019
Study design
FDA prescribing information
Funding
not stated in the source

The label's severe hypoglycemia incidence figures are not given on this page. The US product is discontinued.

Read the original source
PubChem: pramlintide identity

Chemical identity record

National Library of Medicine. PubChem compound records CID 70691388 (pramlintide) and CID 118984456 (pramlintide acetate).

PubChem lists pramlintide as CID 70691388 (C171H267N51O53S2, molecular weight 3949, CAS 151126-32-8) and pramlintide acetate as CID 118984456, with two CAS-style numbers (196078-30-5 and 187887-46-3).

Participants / model
Chemical identity, not a clinical population
Treatment
Defined peptide and acetate salt
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source

What warnings and adverse reactions are reported?

SYMLIN carries a boxed warning: use with insulin increases the risk of severe hypoglycemia, particularly in type 1 diabetes, seen within 3 hours of an injection. It is contraindicated with serious hypersensitivity, hypoglycemia unawareness or confirmed gastroparesis. In pooled long-term trials, nausea occurred in 48% versus 17% on placebo (type 1) and 28% versus 12% (type 2).

The boxed warning says use with insulin increases the risk of severe hypoglycemia, particularly in type 1 diabetes, seen within 3 hours of an injection. SYMLIN is contraindicated with serious hypersensitivity, hypoglycemia unawareness or confirmed gastroparesis. The label's severe hypoglycemia incidence figures are not given here.

In pooled long-term placebo-controlled trials, nausea occurred in 48% versus 17% on placebo (type 1, 30 or 60 mcg three times daily) and 28% versus 12% (type 2, 120 mcg twice daily), and anorexia in 17% versus 2% and 9% versus 2%.

In the type 1 trial, transient mild-to-moderate nausea was the most common adverse event. In the type 2 trial, the severe hypoglycemia event rate did not rise overall. In the 16-week obesity trial, withdrawal was 29% on pramlintide versus 25% on placebo and nausea was mild and transient. In the lifestyle trial, nausea in the first 4 months was 9 to 29% on pramlintide versus 2% on placebo. In the meta-analysis, nausea was 1.8 times as likely as on control.

SYMLIN label, text effective 18 December 2019: indication, boxed warning, PK, adverse reactions

FDA prescribing information

DailyMed, U.S. National Library of Medicine. SYMLIN (pramlintide acetate) injection, SymlinPen 60 and SymlinPen 120 pen-injectors, prescribing information, label text effective 18 December 2019 (DailyMed version 18, published 20 August 2024). Set ID 4aea30ff-eb0d-45c1-b114-3127966328ff.

The label approves SYMLIN as an adjunct for people with type 1 or type 2 diabetes who use mealtime insulin and have not reached glucose goals despite optimal insulin therapy. There is a boxed warning: use with insulin increases the risk of severe hypoglycemia, particularly in type 1 diabetes, seen within 3 hours of an injection. It is contraindicated with serious hypersensitivity, hypoglycemia unawareness or confirmed gastroparesis. The label describes pramlintide as a synthetic 37-amino-acid analog of human amylin with proline in place of alanine 25, serine 28 and serine 29, supplied as the acetate salt (C171H267N51O53S2 with 3 to 8 acetates, molecular weight 3949.4 for the peptide). Absolute subcutaneous bioavailability is about 30 to 40%, about 40% circulates unbound, and the half-life in healthy people is about 48 minutes. The main metabolite (2-37 pramlintide) is active in vitro, and there is no accumulation. In pooled long-term placebo-controlled trials, nausea occurred in 48% versus 17% (type 1, 30 or 60 mcg three times daily) and 28% versus 12% (type 2, 120 mcg twice daily), and anorexia in 17% versus 2% and 9% versus 2%.

Participants / model
People with type 1 or type 2 diabetes using mealtime insulin; label PK participants; insulin-using adults in pooled long-term trials
Treatment
SymlinPen 60 and SymlinPen 120 subcutaneous pen-injectors
Follow-up
Label text effective 18 December 2019
Study design
FDA prescribing information
Funding
not stated in the source

The label's severe hypoglycemia incidence figures are not given on this page. The US product is discontinued.

Read the original source
Type 1 diabetes: 651 patients, 52 weeks, HbA1c fell 0.29% and 0.34% versus 0.04% on placebo

Randomized controlled trial

Ratner RE et al. Diabet Med. 2004;21(11):1204-12. PMID 15498087.

HbA1c fell 0.29% on 60 mcg three times daily and 0.34% on 60 mcg four times daily versus 0.04% on placebo, and weight fell 0.4 kg on both versus a 0.8 kg gain on placebo. Transient mild-to-moderate nausea was the most common adverse event.

Participants / model
651 adults with type 1 diabetes (age 41 on average, HbA1c 8.9%) on insulin
Treatment
Subcutaneous pramlintide 60 mcg three or four times daily plus insulin, or placebo plus insulin
Follow-up
52 weeks
Study design
Randomized double-blind placebo-controlled trial
Funding
not stated in the source

Weight was a secondary result: a small loss on pramlintide against a gain on placebo.

Read the original source
Type 2 diabetes on insulin: 656 patients, 52 weeks, HbA1c -0.62% and weight -1.4 kg versus +0.7 kg

Randomized controlled trial

Hollander PA et al. Diabetes Care. 2003;26(3):784-90. PMID 12610038.

On 120 mcg twice daily, HbA1c fell 0.68% at week 26 and 0.62% at week 52, more than placebo, and weight changed -1.4 kg versus +0.7 kg at week 52, with no overall rise in the severe hypoglycemia event rate.

Participants / model
656 insulin-treated adults with type 2 diabetes (BMI 34.0, HbA1c 9.1%), with or without sulfonylurea or metformin
Treatment
Subcutaneous pramlintide 60 mcg three times daily, 90 mcg twice daily or 120 mcg twice daily plus insulin, or placebo plus insulin
Follow-up
52 weeks
Study design
Randomized double-blind placebo-controlled trial
Funding
not stated in the source

The figures given are for the 120 mcg twice-daily regimen.

Read the original source
Obesity without insulin: 204 adults, 16 weeks, placebo-corrected 3.7% weight loss in completers

Randomized controlled trial

Aronne L et al. J Clin Endocrinol Metab. 2007;92(8):2977-83. PMID 17504894.

Completers lost a placebo-corrected 3.7% of body weight (3.6 kg), and about 31% versus 2% lost at least 5%. Withdrawal was 29% on pramlintide and 25% on placebo. Mild, transient nausea was most common.

Participants / model
204 obese adults (80% women, BMI 37.8), with and without type 2 diabetes
Treatment
Subcutaneous pramlintide escalated up to 240 mcg three times daily, or placebo, with no lifestyle program
Follow-up
16 weeks
Study design
Randomized phase 2 trial
Funding
not stated in the source

The weight figure is for completers and is placebo-corrected. The trial used no lifestyle program.

Read the original source
Obesity with lifestyle program: 411 adults, 4 months plus 8-month extension, only 146 evaluable at month 12

Randomized controlled trial

Smith SR et al. Diabetes Care. 2008;31(9):1816-23. PMID 18753666.

Placebo-corrected weight loss at month 12 was 6.1 kg (5.6%) on 120 mcg three times daily and 7.2 kg (6.8%) on 360 mcg twice daily, but only 146 participants were evaluable at month 12. Nausea in the first 4 months was 9 to 29% on pramlintide versus 2% on placebo.

Participants / model
411 obese adults without diabetes in a lifestyle program
Treatment
Six subcutaneous pramlintide regimens (120 to 360 mcg two or three times daily) or placebo
Follow-up
4 months, with an 8-month single-blind extension
Study design
Randomized dose-ranging trial
Funding
not stated in the source

Only 146 of the 411 participants were evaluable at month 12, so the month-12 figures rest on about a third of the enrolled group.

Read the original source
Meta-analysis of 8 trials: HbA1c -0.33%, weight -2.57 kg in type 2 diabetes, -2.27 kg in obesity

Systematic review and meta-analysis

Singh-Franco D et al. Diabetes Obes Metab. 2011;13(2):169-80. PMID 21199269.

In 8 randomized trials, pramlintide lowered HbA1c by 0.33% (95% CI -0.51 to -0.14) and weight by 2.57 kg (95% CI -3.44 to -1.70) in insulin-treated type 2 diabetes (4 trials, 930 patients), and weight by 2.27 kg (95% CI -2.88 to -1.66) in obese people without diabetes (4 trials, 686 patients, 6 to 24 weeks). Nausea was 1.8 times as likely as on control. The authors called the HbA1c effect small and the weight effect modest, with no long-term outcome data.

Participants / model
Insulin-treated adults with type 2 diabetes (930 patients); obese adults without diabetes (686 patients)
Treatment
Subcutaneous pramlintide, 120 to 360 mcg two or three times daily
Follow-up
6 to 24 weeks in the obesity trials
Study design
Systematic review and meta-analysis of 8 randomized trials
Funding
not stated in the source

Outcomes pooled were HbA1c, weight, nausea and hypoglycaemia. The authors reported no long-term outcome data.

Read the original source

Why does pramlintide sit in A tier?

SYMLIN was FDA-approved in 2005 with 52-week randomized trials in both diabetes types. The A does not extend to weight loss: the approved role is narrow, the effects are small, the label carries a boxed severe-hypoglycemia warning, and AstraZeneca has reported discontinuing manufacture.

A fits an approved drug promoted for an off-label use. The approval is real, and the 52-week trials in both diabetes types are randomized and double-blind. But the approved role is narrow (an add-on to mealtime insulin), and the effects are small: HbA1c down 0.3 to 0.7 points and weight down 1 to 3 kg in most trials.

The weight-loss use sellers describe never led to an approval, the label carries a boxed warning for severe hypoglycemia, and AstraZeneca has reported discontinuing manufacture of the US product.

SYMLIN label, text effective 18 December 2019: indication, boxed warning, PK, adverse reactions

FDA prescribing information

DailyMed, U.S. National Library of Medicine. SYMLIN (pramlintide acetate) injection, SymlinPen 60 and SymlinPen 120 pen-injectors, prescribing information, label text effective 18 December 2019 (DailyMed version 18, published 20 August 2024). Set ID 4aea30ff-eb0d-45c1-b114-3127966328ff.

The label approves SYMLIN as an adjunct for people with type 1 or type 2 diabetes who use mealtime insulin and have not reached glucose goals despite optimal insulin therapy. There is a boxed warning: use with insulin increases the risk of severe hypoglycemia, particularly in type 1 diabetes, seen within 3 hours of an injection. It is contraindicated with serious hypersensitivity, hypoglycemia unawareness or confirmed gastroparesis. The label describes pramlintide as a synthetic 37-amino-acid analog of human amylin with proline in place of alanine 25, serine 28 and serine 29, supplied as the acetate salt (C171H267N51O53S2 with 3 to 8 acetates, molecular weight 3949.4 for the peptide). Absolute subcutaneous bioavailability is about 30 to 40%, about 40% circulates unbound, and the half-life in healthy people is about 48 minutes. The main metabolite (2-37 pramlintide) is active in vitro, and there is no accumulation. In pooled long-term placebo-controlled trials, nausea occurred in 48% versus 17% (type 1, 30 or 60 mcg three times daily) and 28% versus 12% (type 2, 120 mcg twice daily), and anorexia in 17% versus 2% and 9% versus 2%.

Participants / model
People with type 1 or type 2 diabetes using mealtime insulin; label PK participants; insulin-using adults in pooled long-term trials
Treatment
SymlinPen 60 and SymlinPen 120 subcutaneous pen-injectors
Follow-up
Label text effective 18 December 2019
Study design
FDA prescribing information
Funding
not stated in the source

The label's severe hypoglycemia incidence figures are not given on this page. The US product is discontinued.

Read the original source
Drugs@FDA: SYMLIN approved 16 March 2005 as a Type 1 new molecular entity

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for NDA 021332 (SYMLIN). Dates read from the openFDA Drugs@FDA record on 10 October 2026.

FDA approved SYMLIN under NDA 021332 on 16 March 2005 as a Type 1 new molecular entity. The current holder is AstraZeneca AB, and the last labeling supplement was approved on 18 December 2019.

Participants / model
Not a clinical population
Treatment
New drug application
Follow-up
Approved in 2005; last labeling supplement 2019
Study design
FDA application record
Funding
not stated in the source

The record gives approval and labeling dates. Status outside the United States is not covered here.

Read the original source
FDA shortages database: AstraZeneca AB reported discontinuing manufacture, posted 27 October 2025

Regulatory record

U.S. Food and Drug Administration. Drug shortages database entry for pramlintide acetate injection (status Discontinuation), with the openFDA Drugs@FDA record for NDA 021332 (data updated 9 October 2026) and DailyMed SPL marketing end dates.

The FDA drug shortages database lists pramlintide acetate injection with status Discontinuation: AstraZeneca AB reported SymlinPen 60 (NDC 0310-6615-02) and SymlinPen 120 (NDC 0310-6627-02), posted 27 October 2025, as Discontinuation of the manufacture of the drug. The openFDA Drugs@FDA record (data updated 9 October 2026) lists all three SYMLIN products under NDA 021332, the vial and both pens, as Discontinued, and the DailyMed SPL records a marketing end date of 31 January 2027 for both pen NDCs, which likely reflects the last lot's expiry. No AstraZeneca press release was found.

Participants / model
Not a clinical population
Treatment
SymlinPen 60 and SymlinPen 120
Follow-up
Posted 27 October 2025; marketing end date 31 January 2027
Study design
Official FDA record and sponsor-submitted label data
Funding
not stated in the source

The discontinuation rests on the FDA shortage listing, the Drugs@FDA status and the SPL end date. The reading of 31 January 2027 as the last lot's expiry is an inference. Status outside the United States is not covered here.

Read the original source
Type 1 diabetes: 651 patients, 52 weeks, HbA1c fell 0.29% and 0.34% versus 0.04% on placebo

Randomized controlled trial

Ratner RE et al. Diabet Med. 2004;21(11):1204-12. PMID 15498087.

HbA1c fell 0.29% on 60 mcg three times daily and 0.34% on 60 mcg four times daily versus 0.04% on placebo, and weight fell 0.4 kg on both versus a 0.8 kg gain on placebo. Transient mild-to-moderate nausea was the most common adverse event.

Participants / model
651 adults with type 1 diabetes (age 41 on average, HbA1c 8.9%) on insulin
Treatment
Subcutaneous pramlintide 60 mcg three or four times daily plus insulin, or placebo plus insulin
Follow-up
52 weeks
Study design
Randomized double-blind placebo-controlled trial
Funding
not stated in the source

Weight was a secondary result: a small loss on pramlintide against a gain on placebo.

Read the original source
Type 2 diabetes on insulin: 656 patients, 52 weeks, HbA1c -0.62% and weight -1.4 kg versus +0.7 kg

Randomized controlled trial

Hollander PA et al. Diabetes Care. 2003;26(3):784-90. PMID 12610038.

On 120 mcg twice daily, HbA1c fell 0.68% at week 26 and 0.62% at week 52, more than placebo, and weight changed -1.4 kg versus +0.7 kg at week 52, with no overall rise in the severe hypoglycemia event rate.

Participants / model
656 insulin-treated adults with type 2 diabetes (BMI 34.0, HbA1c 9.1%), with or without sulfonylurea or metformin
Treatment
Subcutaneous pramlintide 60 mcg three times daily, 90 mcg twice daily or 120 mcg twice daily plus insulin, or placebo plus insulin
Follow-up
52 weeks
Study design
Randomized double-blind placebo-controlled trial
Funding
not stated in the source

The figures given are for the 120 mcg twice-daily regimen.

Read the original source
Meta-analysis of 8 trials: HbA1c -0.33%, weight -2.57 kg in type 2 diabetes, -2.27 kg in obesity

Systematic review and meta-analysis

Singh-Franco D et al. Diabetes Obes Metab. 2011;13(2):169-80. PMID 21199269.

In 8 randomized trials, pramlintide lowered HbA1c by 0.33% (95% CI -0.51 to -0.14) and weight by 2.57 kg (95% CI -3.44 to -1.70) in insulin-treated type 2 diabetes (4 trials, 930 patients), and weight by 2.27 kg (95% CI -2.88 to -1.66) in obese people without diabetes (4 trials, 686 patients, 6 to 24 weeks). Nausea was 1.8 times as likely as on control. The authors called the HbA1c effect small and the weight effect modest, with no long-term outcome data.

Participants / model
Insulin-treated adults with type 2 diabetes (930 patients); obese adults without diabetes (686 patients)
Treatment
Subcutaneous pramlintide, 120 to 360 mcg two or three times daily
Follow-up
6 to 24 weeks in the obesity trials
Study design
Systematic review and meta-analysis of 8 randomized trials
Funding
not stated in the source

Outcomes pooled were HbA1c, weight, nausea and hypoglycaemia. The authors reported no long-term outcome data.

Read the original source

Studies and sources

SYMLIN label, text effective 18 December 2019: indication, boxed warning, PK, adverse reactions

FDA prescribing information

DailyMed, U.S. National Library of Medicine. SYMLIN (pramlintide acetate) injection, SymlinPen 60 and SymlinPen 120 pen-injectors, prescribing information, label text effective 18 December 2019 (DailyMed version 18, published 20 August 2024). Set ID 4aea30ff-eb0d-45c1-b114-3127966328ff.

The label approves SYMLIN as an adjunct for people with type 1 or type 2 diabetes who use mealtime insulin and have not reached glucose goals despite optimal insulin therapy. There is a boxed warning: use with insulin increases the risk of severe hypoglycemia, particularly in type 1 diabetes, seen within 3 hours of an injection. It is contraindicated with serious hypersensitivity, hypoglycemia unawareness or confirmed gastroparesis. The label describes pramlintide as a synthetic 37-amino-acid analog of human amylin with proline in place of alanine 25, serine 28 and serine 29, supplied as the acetate salt (C171H267N51O53S2 with 3 to 8 acetates, molecular weight 3949.4 for the peptide). Absolute subcutaneous bioavailability is about 30 to 40%, about 40% circulates unbound, and the half-life in healthy people is about 48 minutes. The main metabolite (2-37 pramlintide) is active in vitro, and there is no accumulation. In pooled long-term placebo-controlled trials, nausea occurred in 48% versus 17% (type 1, 30 or 60 mcg three times daily) and 28% versus 12% (type 2, 120 mcg twice daily), and anorexia in 17% versus 2% and 9% versus 2%.

Participants / model
People with type 1 or type 2 diabetes using mealtime insulin; label PK participants; insulin-using adults in pooled long-term trials
Treatment
SymlinPen 60 and SymlinPen 120 subcutaneous pen-injectors
Follow-up
Label text effective 18 December 2019
Study design
FDA prescribing information
Funding
not stated in the source

The label's severe hypoglycemia incidence figures are not given on this page. The US product is discontinued.

Read the original source
PubChem: pramlintide identity

Chemical identity record

National Library of Medicine. PubChem compound records CID 70691388 (pramlintide) and CID 118984456 (pramlintide acetate).

PubChem lists pramlintide as CID 70691388 (C171H267N51O53S2, molecular weight 3949, CAS 151126-32-8) and pramlintide acetate as CID 118984456, with two CAS-style numbers (196078-30-5 and 187887-46-3).

Participants / model
Chemical identity, not a clinical population
Treatment
Defined peptide and acetate salt
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source
Drugs@FDA: SYMLIN approved 16 March 2005 as a Type 1 new molecular entity

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for NDA 021332 (SYMLIN). Dates read from the openFDA Drugs@FDA record on 10 October 2026.

FDA approved SYMLIN under NDA 021332 on 16 March 2005 as a Type 1 new molecular entity. The current holder is AstraZeneca AB, and the last labeling supplement was approved on 18 December 2019.

Participants / model
Not a clinical population
Treatment
New drug application
Follow-up
Approved in 2005; last labeling supplement 2019
Study design
FDA application record
Funding
not stated in the source

The record gives approval and labeling dates. Status outside the United States is not covered here.

Read the original source
FDA shortages database: AstraZeneca AB reported discontinuing manufacture, posted 27 October 2025

Regulatory record

U.S. Food and Drug Administration. Drug shortages database entry for pramlintide acetate injection (status Discontinuation), with the openFDA Drugs@FDA record for NDA 021332 (data updated 9 October 2026) and DailyMed SPL marketing end dates.

The FDA drug shortages database lists pramlintide acetate injection with status Discontinuation: AstraZeneca AB reported SymlinPen 60 (NDC 0310-6615-02) and SymlinPen 120 (NDC 0310-6627-02), posted 27 October 2025, as Discontinuation of the manufacture of the drug. The openFDA Drugs@FDA record (data updated 9 October 2026) lists all three SYMLIN products under NDA 021332, the vial and both pens, as Discontinued, and the DailyMed SPL records a marketing end date of 31 January 2027 for both pen NDCs, which likely reflects the last lot's expiry. No AstraZeneca press release was found.

Participants / model
Not a clinical population
Treatment
SymlinPen 60 and SymlinPen 120
Follow-up
Posted 27 October 2025; marketing end date 31 January 2027
Study design
Official FDA record and sponsor-submitted label data
Funding
not stated in the source

The discontinuation rests on the FDA shortage listing, the Drugs@FDA status and the SPL end date. The reading of 31 January 2027 as the last lot's expiry is an inference. Status outside the United States is not covered here.

Read the original source
Type 1 diabetes: 651 patients, 52 weeks, HbA1c fell 0.29% and 0.34% versus 0.04% on placebo

Randomized controlled trial

Ratner RE et al. Diabet Med. 2004;21(11):1204-12. PMID 15498087.

HbA1c fell 0.29% on 60 mcg three times daily and 0.34% on 60 mcg four times daily versus 0.04% on placebo, and weight fell 0.4 kg on both versus a 0.8 kg gain on placebo. Transient mild-to-moderate nausea was the most common adverse event.

Participants / model
651 adults with type 1 diabetes (age 41 on average, HbA1c 8.9%) on insulin
Treatment
Subcutaneous pramlintide 60 mcg three or four times daily plus insulin, or placebo plus insulin
Follow-up
52 weeks
Study design
Randomized double-blind placebo-controlled trial
Funding
not stated in the source

Weight was a secondary result: a small loss on pramlintide against a gain on placebo.

Read the original source
Type 2 diabetes on insulin: 656 patients, 52 weeks, HbA1c -0.62% and weight -1.4 kg versus +0.7 kg

Randomized controlled trial

Hollander PA et al. Diabetes Care. 2003;26(3):784-90. PMID 12610038.

On 120 mcg twice daily, HbA1c fell 0.68% at week 26 and 0.62% at week 52, more than placebo, and weight changed -1.4 kg versus +0.7 kg at week 52, with no overall rise in the severe hypoglycemia event rate.

Participants / model
656 insulin-treated adults with type 2 diabetes (BMI 34.0, HbA1c 9.1%), with or without sulfonylurea or metformin
Treatment
Subcutaneous pramlintide 60 mcg three times daily, 90 mcg twice daily or 120 mcg twice daily plus insulin, or placebo plus insulin
Follow-up
52 weeks
Study design
Randomized double-blind placebo-controlled trial
Funding
not stated in the source

The figures given are for the 120 mcg twice-daily regimen.

Read the original source
Obesity without insulin: 204 adults, 16 weeks, placebo-corrected 3.7% weight loss in completers

Randomized controlled trial

Aronne L et al. J Clin Endocrinol Metab. 2007;92(8):2977-83. PMID 17504894.

Completers lost a placebo-corrected 3.7% of body weight (3.6 kg), and about 31% versus 2% lost at least 5%. Withdrawal was 29% on pramlintide and 25% on placebo. Mild, transient nausea was most common.

Participants / model
204 obese adults (80% women, BMI 37.8), with and without type 2 diabetes
Treatment
Subcutaneous pramlintide escalated up to 240 mcg three times daily, or placebo, with no lifestyle program
Follow-up
16 weeks
Study design
Randomized phase 2 trial
Funding
not stated in the source

The weight figure is for completers and is placebo-corrected. The trial used no lifestyle program.

Read the original source
Obesity with lifestyle program: 411 adults, 4 months plus 8-month extension, only 146 evaluable at month 12

Randomized controlled trial

Smith SR et al. Diabetes Care. 2008;31(9):1816-23. PMID 18753666.

Placebo-corrected weight loss at month 12 was 6.1 kg (5.6%) on 120 mcg three times daily and 7.2 kg (6.8%) on 360 mcg twice daily, but only 146 participants were evaluable at month 12. Nausea in the first 4 months was 9 to 29% on pramlintide versus 2% on placebo.

Participants / model
411 obese adults without diabetes in a lifestyle program
Treatment
Six subcutaneous pramlintide regimens (120 to 360 mcg two or three times daily) or placebo
Follow-up
4 months, with an 8-month single-blind extension
Study design
Randomized dose-ranging trial
Funding
not stated in the source

Only 146 of the 411 participants were evaluable at month 12, so the month-12 figures rest on about a third of the enrolled group.

Read the original source
Meta-analysis of 8 trials: HbA1c -0.33%, weight -2.57 kg in type 2 diabetes, -2.27 kg in obesity

Systematic review and meta-analysis

Singh-Franco D et al. Diabetes Obes Metab. 2011;13(2):169-80. PMID 21199269.

In 8 randomized trials, pramlintide lowered HbA1c by 0.33% (95% CI -0.51 to -0.14) and weight by 2.57 kg (95% CI -3.44 to -1.70) in insulin-treated type 2 diabetes (4 trials, 930 patients), and weight by 2.27 kg (95% CI -2.88 to -1.66) in obese people without diabetes (4 trials, 686 patients, 6 to 24 weeks). Nausea was 1.8 times as likely as on control. The authors called the HbA1c effect small and the weight effect modest, with no long-term outcome data.

Participants / model
Insulin-treated adults with type 2 diabetes (930 patients); obese adults without diabetes (686 patients)
Treatment
Subcutaneous pramlintide, 120 to 360 mcg two or three times daily
Follow-up
6 to 24 weeks in the obesity trials
Study design
Systematic review and meta-analysis of 8 randomized trials
Funding
not stated in the source

Outcomes pooled were HbA1c, weight, nausea and hypoglycaemia. The authors reported no long-term outcome data.

Read the original source

Why is Pramlintide in A tier?

A fits an approved drug promoted for an off-label use. SYMLIN was FDA-approved in 2005 with 52-week randomized trials in both diabetes types, but its approved role is narrow, the effects are small, it carries a boxed severe-hypoglycemia warning, and AstraZeneca has reported discontinuing manufacture. The weight-loss use sellers describe never led to an approval.