{"id":"pramlintide","name":"Pramlintide","aliases":["Symlin","amylin analogue","AC137"],"url":"https://lyoresearch.com/compounds/pramlintide","class":{"id":"glp-1-agonists","name":"GLP-1 and incretin agonists","url":"https://lyoresearch.com/classes/glp-1-agonists"},"summary":"Pramlintide is a synthetic analogue of amylin, the hormone the pancreas releases with insulin to slow digestion and signal fullness. It is approved in the United States — and nowhere else — as an injection taken with meals alongside insulin in type 1 and type 2 diabetes. In people with obesity but no diabetes, a 12-month trial produced about 6–7 kg of placebo-corrected weight loss at the best doses, with nausea in up to a third at the start. It was never a commercial success, but its mechanism is the one cagrilintide and amycretin have since made weekly.","overall_grade":"A","overall_grade_meaning":"established in humans","human_trials":"Approval programme + 12-month obesity RCT (n=411)","regulatory_status":"Approved (Rx, US only)","molecule":{"formula":"C171H267N51O53S2","molecular_weight":"3949","cas":"151126-32-8","pubchem_cid":70691388,"note":null},"pharmacokinetics":{"basis":"label","route":"Subcutaneous injection, before each major meal","half_life":"About 48 minutes","licensed_regimen":"Type 1: 15 mcg before major meals, increased in 15 mcg steps to 30 or 60 mcg; Type 2: 60 mcg before major meals, increased to 120 mcg","product":"Symlin","source":{"title":"Symlin prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4aea30ff-eb0d-45c1-b114-3127966328ff"}},"outcomes":[{"outcome":"Blood glucose (with insulin)","grade":"A","grade_meaning":"established in humans","effect_size":"small","adverse":false,"human_studies":"Approval programme (type 1 and type 2)","evidence":"Modest HbA1c reductions of a few tenths of a point when added to insulin, with lower post-meal glucose excursions; the licensed indication.","references":[{"citation":"Pramlintide acetate (Symlin) prescribing information.","where":"FDA","url":"https://www.accessdata.fda.gov/scripts/cder/daf/"}]},{"outcome":"Body weight (obesity without diabetes)","grade":"B","grade_meaning":"probable, not settled","effect_size":"moderate","adverse":false,"human_studies":"1 RCT (n=411) with 8-month extension","evidence":"Three-times-daily and higher twice-daily doses produced 3 kg more loss than placebo at four months and 6–7 kg at twelve, with placebo regaining and pramlintide maintaining. Never pursued to approval for obesity.","references":[{"citation":"Smith SR, Aronne LJ, Burns CM, et al. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity.","where":"Diabetes Care, 2008","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Smith+pramlintide+sustained+weight+loss+12-month+lifestyle+intervention+obesity+2008"}],"verbatim":{"text":"Placebo-corrected weight loss with 120 microg t.i.d. and 360 microg b.i.d. averaged 3.2 +/- 1.2 kg (3.1 +/- 1.1% body wt) and 3.3 +/- 1.1 kg (3.1 +/- 1.0% body wt), respectively, at month 4 (both P < 0.01; 4-month evaluable n = 270) and 6.1 +/- 2.1 kg (5.6 +/- 2.1% body wt) and 7.2 +/- 2.3 kg (6.8 +/- 2.3% body wt), respectively, at month 12 (both P < 0.01; 12-month evaluable n = 146).","citation":"Smith SR, Aronne LJ, Burns CM, et al. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity.","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Smith+pramlintide+sustained+weight+loss+12-month+lifestyle+intervention+obesity+2008"}},{"outcome":"Body weight (diabetes, with insulin)","grade":"A","grade_meaning":"established in humans","effect_size":"small","adverse":false,"human_studies":"Approval programme","evidence":"One to two kilograms less than insulin alone — meaningful because insulin usually adds weight.","references":[{"citation":"Pramlintide acetate (Symlin) prescribing information.","where":"FDA","url":"https://www.accessdata.fda.gov/scripts/cder/daf/"}]},{"outcome":"Adverse effects","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":true,"human_studies":"Same trials","evidence":"Nausea in a large minority early on, fading with time; and, when combined with insulin, a risk of severe hypoglycaemia that carries a boxed warning in the US label.","references":[{"citation":"Smith SR, Aronne LJ, Burns CM, et al. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity.","where":"Diabetes Care, 2008","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Smith+pramlintide+sustained+weight+loss+12-month+lifestyle+intervention+obesity+2008"},{"citation":"Pramlintide acetate (Symlin) prescribing information.","where":"FDA","url":"https://www.accessdata.fda.gov/scripts/cder/daf/"}],"verbatim":{"text":"Nausea, the most common adverse event with pramlintide in the 4-month study (9-29% pramlintide vs. 2% placebo), was generally mild to moderate and occurred in <10% of subjects during the extension.","citation":"Smith SR, Aronne LJ, Burns CM, et al. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity.","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Smith+pramlintide+sustained+weight+loss+12-month+lifestyle+intervention+obesity+2008"}}],"regions":[{"region":"European Union","status":"Not authorised","note":"A marketing application was withdrawn; no EU approval."},{"region":"United States","status":"Approved, prescription-only","note":"FDA-approved 2005 (Symlin) for type 1 and type 2 diabetes using mealtime insulin. Boxed warning for insulin-induced severe hypoglycaemia."},{"region":"United Kingdom","status":"Unlicensed medicine","note":"No MHRA licence."},{"region":"Australia","status":"Not registered","note":"Not on the ARTG."},{"region":"Canada","status":"Not authorised","note":"No Health Canada authorisation."},{"region":"Sport (WADA)","status":"Not prohibited","note":"Not on the Prohibited List."}],"faq":[{"q":"Is pramlintide a weight-loss drug?","a":"It causes modest weight loss — about 6–7 kg placebo-corrected over a year in its one obesity trial — but was never approved for that use and is far weaker than GLP-1 drugs. Its descendant cagrilintide, combined with semaglutide, is the modern version."},{"q":"Why is it only approved in the US?","a":"The European application was withdrawn and it was never pursued elsewhere. Three daily injections and a hypoglycaemia warning made it a niche product even in the US."},{"q":"How does it relate to cagrilintide?","a":"Same target — the amylin receptor — but pramlintide lasts hours and needs dosing with each meal, while cagrilintide is engineered to last a week. Pramlintide proved the mechanism; cagrilintide made it practical."}],"references":[{"cite":"Smith SR, Aronne LJ, Burns CM, et al. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity.","where":"Diabetes Care, 2008","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Smith+pramlintide+sustained+weight+loss+12-month+lifestyle+intervention+obesity+2008","note":"411 obese adults without diabetes; 4-month RCT plus 8-month extension."},{"cite":"Pramlintide acetate (Symlin) prescribing information.","where":"FDA","url":"https://www.accessdata.fda.gov/scripts/cder/daf/","note":"Licensed indications, glucose and weight data, boxed warning."}],"last_reviewed":"2026-09-10","literature_searched_to":"2026-09-10","changelog":[{"date":"2026-09-10","note":"Initial publication. Grade A for the licensed diabetes use; B for obesity on a single trial."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}