Pramlintide

Pramlintide is best known as Symlin, the only FDA-approved amylin-class medicine — a synthetic version of amylin, a hormone the pancreas releases alongside insulin, used as an injection before meals to help control blood sugar in people with type 1 or type 2 diabetes who also use mealtime insulin. AstraZeneca discontinued Symlin/SymlinPen in the US on 2025-10-27 (a commercial discontinuation, not an FDA safety or efficacy withdrawal), so it is no longer marketed and no generic exists.

Pramlintide (Symlin) is used alongside insulin for blood-sugar control, an FDA-approved amylin analog. Per its label, it slows gastric emptying, suppresses post-meal glucagon, and increases satiety, acting as an adjunct to mealtime insulin. It is short-acting (about a 48-minute half-life), and the label requires reducing mealtime insulin when starting it because of hypoglycemia risk.

FDA-approved — Symlin / SymlinPen (NDA 021332, originally approved March 16, 2005). ⚠️ Marketing discontinued — AstraZeneca discontinued all Symlin/SymlinPen formulations effective 2025-10-27; no longer marketed / not available in the US, and no generic exists. The discontinuation was commercial/manufacturing, not an FDA safety/efficacy withdrawal; the approval and label remain on record. Indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin and have not achieved desired glucose control. Carries an FDA boxed warning for severe hypoglycemia (see below). Prescription-only, not DEA-scheduled. WADA: not named on the 2026 Prohibited List per the local archive check (amylin analogs are not a listed class) — confirm against current edition before competition.

Pramlintide is a prescription-only medication and carries an FDA boxed warning for severe hypoglycemia when used with insulin, particularly in type 1 diabetes; it is given as a separate injection from insulin and never mixed in the same syringe. It is not on the WADA Prohibited List. VialWise is a research and educational reference, not medical advice — consult a licensed professional.

⚠️ For research and educational purposes only. Pramlintide (Symlin) is an FDA-approved prescription drug with an FDA boxed warning for severe hypoglycemia. Information in this entry is informational, not medical advice. Always confirm dose calculations with the in-app calculator and consult appropriate professional guidance before any protocol decisions.

⚠️ Not currently marketed. AstraZeneca discontinued all Symlin/SymlinPen formulations in the US effective 2025-10-27 (a commercial discontinuation, not an FDA safety/efficacy withdrawal). No generic is available. The molecule remains FDA-approved on paper (NDA 021332 was not withdrawn), and every clinical/pharmacology fact below is still label-accurate — but the product is no longer manufactured or sold. Information below reflects the product as it was approved and labeled; it remains a research/educational reference for the amylin-analog class.

⚠️ FDA boxed warning — severe hypoglycemia. Per the FDA label (verbatim): *"SYMLIN use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes."* Severe hypoglycemia from pramlintide+insulin usually occurs within 3 hours of injection and can impair the ability to drive or operate machinery. The label mandates an insulin-dose reduction when starting pramlintide. This is the single most important safety fact about this compound.

⚠️ Dosed in micrograms; never mix with insulin in one syringe. Pramlintide is dialed in mcg on its own pen and is given as a separate subcutaneous injection from insulin (different injection site, never the same syringe — mixing changes the pharmacokinetics of both). ⚠️ Precision matters: a small mis-dial is a large percentage error. Confirm against the pen's dose window.

⚠️ Pramlintide ≠ cagrilintide. Both are amylin analogs, but pramlintide is the short-acting (~48 min half-life), FDA-approved, mealtime adjunct; cagrilintide is the long-acting (~7 day), once-weekly, investigational analog ([cagrilintide.md](./cagrilintide.md)). Different molecules, different dosing schedules, different regulatory status.

Pramlintide is an FDA-approved synthetic analog of human amylin (islet amyloid polypeptide, IAPP) — the hormone co-secreted with insulin by pancreatic beta cells. It was the first and only FDA-approved amylin-class drug, marketed as Symlin/SymlinPen; AstraZeneca discontinued it in the US on 2025-10-27 (a commercial/manufacturing discontinuation, not an FDA safety/efficacy withdrawal). It remains FDA-approved on paper but is no longer manufactured or sold, and no generic exists.

Mechanism. Native human amylin aggregates and is insoluble, which is why it can't be used as a drug directly; pramlintide substitutes proline at positions 25, 28, and 29 ("tripro-amylin") to keep it soluble and stable while retaining amylin receptor agonism. Amylin complements insulin through three actions: it slows gastric emptying (blunting the post-meal glucose spike), suppresses post-prandial glucagon (which is inappropriately high in diabetes), and increases satiety (centrally). It does not replace insulin — it's a mealtime adjunct to it.

Clinical use. Approved March 2005 as an adjunct to mealtime insulin for type 1 and type 2 diabetes patients who haven't reached glucose goals on insulin alone. Because it shares insulin's hypoglycemia risk and amplifies it, the label requires a 50% mealtime-insulin reduction at initiation and carries a boxed warning.

Research-community interest. Outside its labeled diabetes use, amylin agonism is of interest for weight management (satiety + slowed gastric emptying), which is why the *long-acting* analog cagrilintide is in late-stage obesity development (often paired with semaglutide as CagriSema). Pramlintide itself is short-acting and mealtime-bound, making it less convenient for weight-focused use than the once-weekly analogs — but it is the FDA-approved (though now discontinued), well-characterized reference member of the class.[⁴]

Regulatory status. FDA-approved (NDA 021332), prescription-only, not DEA-scheduled. Marketing discontinued in the US effective 2025-10-27 — AstraZeneca discontinued all Symlin/SymlinPen formulations (a commercial/manufacturing discontinuation, not an FDA safety/efficacy withdrawal); the approval and label remain on record and no generic is available.[³] Boxed warning for severe hypoglycemia. Not on the WADA 2026 Prohibited List (amylin analogs aren't a listed class; verify current edition before competition).[²]

Commonly reported

• Nausea (most common, dose-dependent, usually attenuates with titration)
• Hypoglycemia (especially with insulin — see boxed warning)
• Anorexia, vomiting
• Headache, fatigue, dizziness
• Injection-site reactions

Serious

• Severe hypoglycemia (boxed warning) — especially within 3 hours of dosing in type 1 diabetes; can impair driving/operating machinery
• Signs of severe persistent vomiting/dehydration
• Severe allergic reaction

Confirmed hypoglycemia unawareness — contraindicated (can't safely detect the boxed-warning risk).

Confirmed gastroparesis — contraindicated (pramlintide further slows gastric emptying).

Hypersensitivity to pramlintide or metacresol.

Poor compliance with insulin/glucose monitoring — the label advises against initiation.

Boxed warning: severe hypoglycemia with insulin, particularly in type 1 diabetes.

Pregnancy/lactation: limited data; per label/clinical judgment.

Regulatory: prescription-only, not DEA-scheduled; not WADA-listed (verify current edition).

Amylin analogue

A lab-made copy of amylin, a natural hormone released with insulin that slows digestion and increases fullness.

Subcutaneous

An injection into the fatty layer just under the skin, rather than into a muscle or vein.

Half-life

Roughly how long the body takes to clear half of a dose. A long half-life is why some compounds can be taken only once a week.

Boxed warning

The FDA's strongest warning on a drug label, highlighting a serious or life-threatening risk.

1. Amylin/AstraZeneca. Symlin / SymlinPen (pramlintide acetate) injection — prescribing information. US FDA, NDA 021332 (approved 2005-03-16; product discontinued 2025-10-27 — label retained on record).
2. WADA 2026 Prohibited List — pramlintide / amylin analogs not listed.(PMID 41702251)
3. Drugs.com. Generic Symlin Availability (FDA availability record, updated 2026-05-07). https://www.drugs.com/availability/generic-symlin.html — "All of the above formulations have been discontinued." Corroborated by the Drugs.com pramlintide-acetate injection discontinuation notice (https://www.drugs.com/drug-shortages/pramlintide-acetate-injection-193; SymlinPen 60/120, AstraZeneca, update dated 2025-10-27).
4. Alhazmi A, le Roux CW. "Amylin Analogs: The Next Major Class of Weight Loss Therapy: A Review of Experimental Data and Early-Phase Clinical Trials." Diabetes Obes Metab 2026 (published 2026-07-14). PMID 42452898.(PMID 42452898)

• Cagrilintide — same mechanism class
• Adipotide — shared research area
• Amycretin — shared research area
• AOD-9604 — shared research area
• CagriSema — shared research area
• Dulaglutide — shared research area