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Pramlintide

Amylin analog

Status

Withdrawn

FDA-approved in 2005 (Symlin) as an add-on to mealtime insulin in type 1 and type 2 diabetes, but AstraZeneca discontinued SymlinPen in October 2025, leaving no pramlintide product on the US market, so it no longer has a current US or EU approval.

Evidence

Strong

Several 52-week placebo-controlled trials with more than 450 patients each showed modest HbA1c and weight reductions as an add-on to insulin.

Pramlintide is a synthetic analog of amylin, a hormone released with insulin. It was approved in 2005 as a mealtime injection alongside insulin for type 1 and type 2 diabetes, but its only product, Symlin, was discontinued in the US in 2025.

Structure

37 residues

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Sequence as text
H-K-C-N-T-A-T-C-A-T-Q-R-L-A-N-F-L-V-H-S-S-N-N-F-G-P-I-L-P-P-T-N-V-G-S-N-T-Y-NH2

What it is used for

  • Add-on to mealtime insulin in type 1 or type 2 diabetes, US 2005 to 2025 (approved)
  • Weight loss in obesity (studied)

How it works

Amylin is stored and released with insulin by pancreatic beta cells, and people with diabetes release less of it after meals. Pramlintide mimics amylin: it slows stomach emptying, reduces the rise in glucagon after meals and increases fullness, which blunts post-meal glucose spikes and lowers calorie intake. Native human amylin readily forms amyloid fibrils, making it a difficult drug; pramlintide differs from it by prolines at positions 25, 28 and 29. Its short half-life requires injections before each major meal.

How strong the evidence is

StrongSeveral large randomised controlled trials in people.

In a 52-week trial of 656 insulin-treated people with type 2 diabetes, the highest dose tested lowered HbA1c by 0.62 points at 52 weeks and body weight by 1.4 kg (versus a 0.7 kg gain on placebo). A 52-week trial in 651 people with type 1 diabetes found HbA1c falls of 0.29 to 0.34 points versus 0.04 with placebo, with slight weight loss. A 16-week phase 2 trial in 204 people with obesity found 3.7% placebo-adjusted weight loss.

Risks and side effects

  • Boxed warning: severe hypoglycemia with insulin, especially in type 1 diabetes, usually within 3 hours of injection
  • Nausea, especially when starting treatment
  • Mealtime insulin must be reduced when starting; never mix with insulin in the same syringe
  • Contraindicated with confirmed gastroparesis or hypoglycemia unawareness; can delay absorption of oral medicines
  • No longer marketed in the US after 2025

Regulatory status

RegionYearApproved for
USFDA2005Withdrawn 2025Add-on to mealtime insulin in type 1 or type 2 diabetes not controlled despite optimal insulin therapy

Status by country

JurisdictionStatusSource
USUnited StatesWithdrawnSource 3
EUEuropean UnionNo authorised medicineSource 9
UKUnited KingdomNo authorised medicineSource 10
AUAustraliaNo authorised medicineSource 11
CACanadaNo authorised medicineSource 12
Whether a medicine containing it is authorised, checked in each regulator’s records on Oct 1, 2026.

Status of every peptide by country

Timeline

  1. 2025

    1. Withdrawn, US (FDA)Add-on to mealtime insulin in type 1 or type 2 diabetes not controlled despite optimal insulin therapy

  2. 2005

    1. Approved, US (FDA)Add-on to mealtime insulin in type 1 or type 2 diabetes not controlled despite optimal insulin therapy

Sources

  1. 01SymlinPen (pramlintide acetate) injection: prescribing information(opens the source in a new tab) DailyMed, U.S. National Library of Medicine, 2024
  2. 02Pramlintide (D05594): sequence and structure entry(opens the source in a new tab) KEGG DRUG
  3. 03Drugs@FDA: Symlin (NDA 021332) approval history(opens the source in a new tab) U.S. Food and Drug Administration, 2026
  4. 04Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes(opens the source in a new tab) Diabetes Care, 2003
  5. 05Amylin replacement with pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in Type 1 diabetes(opens the source in a new tab) Diabetic Medicine, 2004
  6. 06Progressive reduction in body weight after treatment with the amylin analog pramlintide in obese subjects: a phase 2 trial(opens the source in a new tab) Journal of Clinical Endocrinology & Metabolism, 2007
  7. 07Development of Cagrilintide, a Long-Acting Amylin Analogue(opens the source in a new tab) Journal of Medicinal Chemistry, 2021
  8. 08Washington Pharmacy and Therapeutics Committee drug class review (notes SymlinPen discontinuation, October 2025)(opens the source in a new tab) Washington State Health Care Authority, 2026
  9. 09Find medicine: centrally authorised medicines(opens the source in a new tab) European Medicines Agency, 2026
  10. 10MHRA Products: active substances beginning with P(opens the source in a new tab) Medicines and Healthcare products Regulatory Agency, 2026
  11. 11Australian Register of Therapeutic Goods (ARTG)(opens the source in a new tab) Therapeutic Goods Administration
  12. 12Drug Product Database online query(opens the source in a new tab) Health Canada
  1. In clinical trialsAmycretinUnimolecular GLP-1 and amylin receptor agonistNo single sequence68 WADA banned
  2. Not approvedAOD-9604Modified growth hormone fragment (research peptide)16 WADA banned
  3. In clinical trialsCagrilintideLong-acting amylin analog (amylin and calcitonin receptor agonist)37 WADA banned
  4. ApprovedDulaglutideGLP-1 receptor agonist (Fc fusion protein)31
  5. ApprovedExenatideGLP-1 receptor agonist39

Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.