Synthetic amylin analog (amylinomimetic)
Pramlintide
Approvedaka Symlin, SymlinPen
Pramlintide is a prescription mealtime injection used alongside insulin in adults with type 1 or type 2 diabetes who have not reached their glucose targets. In year-long randomized controlled trials it produced modest reductions in HbA1c, roughly 0.3 to 0.7 percentage points, together with small weight loss, compared with placebo added to insulin. It is marketed only in the United States and carries a boxed warning for severe insulin-induced hypoglycemia.
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Mechanism
In plain terms, pramlintide mimics amylin, a hormone the pancreas normally releases together with insulin at meals. Technically it is a synthetic analog of human amylin that slows gastric emptying, suppresses post-meal glucagon secretion and increases satiety, which blunts the rise in blood glucose after eating.
Regulatory Status by Region
- United States (FDA)Approved. Initial U.S. approval 2005 (Symlin, NDA 021332) as an adjunct to mealtime insulin in adults with type 1 or type 2 diabetes who have failed to achieve glycemic control despite optimal insulin therapy. The label carries a boxed warning for insulin-induced severe hypoglycemia.
- Australia (TGA)Not registered on the Australian Register of Therapeutic Goods (ARTG); pramlintide is not marketed as a registered medicine in Australia.
- European Union (EMA)Not authorized. Pramlintide does not hold an EMA marketing authorisation and is not marketed in the European Union.
- WADANot listed on the WADA Prohibited List and not in the 2026 Monitoring Program. An amylin analog is not prohibited in or out of competition.
Key Studies
- Pramlintide adjunct to insulin in type 1 diabetes, 1-year RCT (Ratner et al.) (opens in a new tab) (Diabet Med 2004;21(11):1204-1212; DOI 10.1111/j.1464-5491.2004.01319.x; PMID 15498087)
- Pramlintide adjunct to insulin in type 2 diabetes, 1-year RCT (Hollander et al.) (opens in a new tab) (Diabetes Care 2003;26(3):784-790; DOI 10.2337/diacare.26.3.784; PMID 12610038)
- SYMLIN (pramlintide acetate) FDA prescribing information (DailyMed) (opens in a new tab) (Initial U.S. Approval 2005; amylin analog indicated adjunct to mealtime insulin in type 1 or type 2 diabetes)
Related Clinical Trials
- Postprandial Regulation of Bone Perfusion in Healthy IndividualsN/A · Not Yet Recruiting
- Pancreatic Polypeptide as a Modulator of Amylin- Induced Satiety in Healthy HumansN/A · Recruiting
- Amylin-Induced Migraine Attacks Without AuraN/A · Not Yet Recruiting
- Hypersensitivity to Amylin in Post-Traumatic HeadacheN/A · Not Yet Recruiting
- Tailoring Obesity Treatment TrialPhase 2/Phase 3 · Withdrawn
- Two Way Crossover Closed Loop Study Insulin vs Insulin and PramlintideN/A · Completed
- The Role of Amylin in Bone MetabolismN/A · Unknown
- A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 DiabetesPhase 2/Phase 3 · Unknown
Latest research
- Metal-tuned antimicrobial peptides and zincophore pathways: from coordination chemistry to targeted therapeutics. (opens in a new tab)
Journal of inorganic biochemistry · Jul 1, 2026
Common Questions
- What is Pramlintide?
- Pramlintide (Symlin) is a synthetic analog of the pancreatic hormone amylin, FDA-approved in 2005 as a mealtime injectable adjunct to insulin for adults with type 1 or type 2 diabetes who have not reached glucose targets despite optimal insulin therapy. It is marketed only in the United States, is not authorized by the EMA, and is not registered by the Australian TGA.
- Is Pramlintide approved for medical use?
- Pramlintide is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Approved. Initial U.S. approval 2005 (Symlin, NDA 021332) as an adjunct to mealtime insulin in adults with type 1 or type 2 diabetes who have failed to achieve glycemic control despite optimal insulin therapy. The label carries a boxed warning for insulin-induced severe hypoglycemia. European Union (EMA): Not authorized. Pramlintide does not hold an EMA marketing authorisation and is not marketed in the European Union. Australia (TGA): Not registered on the Australian Register of Therapeutic Goods (ARTG); pramlintide is not marketed as a registered medicine in Australia.
- How does Pramlintide work?
- In plain terms, pramlintide mimics amylin, a hormone the pancreas normally releases together with insulin at meals. Technically it is a synthetic analog of human amylin that slows gastric emptying, suppresses post-meal glucagon secretion and increases satiety, which blunts the rise in blood glucose after eating.
- Is Pramlintide legal in Australia?
- Pramlintide in Australia (TGA): Not registered on the Australian Register of Therapeutic Goods (ARTG); pramlintide is not marketed as a registered medicine in Australia.
- Is Pramlintide banned in sport?
- Pramlintide under the World Anti-Doping Agency (WADA) code: Not listed on the WADA Prohibited List and not in the 2026 Monitoring Program. An amylin analog is not prohibited in or out of competition.