Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-25. ← Back to Evidence Library

title: "Pramlintide: What the evidence says" slug: pramlintide status: Draft (v1), pending review by Dr. Nova Reyes (Batch F #64) last_checked: 2026-10-25 evidence_verdict: "Diabetes with mealtime insulin (labeled): Strong · Gray-market use: No human data" card_verdict: "Strong (add-on to mealtime insulin) · Gray-market vials: No human data · Boxed warning: severe low blood sugar" related: [cagrilintide, cagrisema, amycretin]

Draft (v1), pending review. Not public. · ← Library · DRAFT · not published · last checked 2026-10-25

Pramlintide: what the evidence says

At a glance

What it is: a 37-amino-acid synthetic analog of amylin, a hormone released with insulin, sold as Symlin for people with type 1 or type 2 diabetes who use mealtime insulin. ^{R1, R2} It is the only amylin-type drug FDA has approved; newer amylin analogs (cagrilintide, amycretin) are still experimental.

What the evidence says: two 1-year trials of about 650 people each found small extra drops in HbA1c (about 0.3 points in type 1, 0.6–0.7 in type 2) and slight weight loss compared with weight gain on placebo. ^{R3, R4}

Biggest risks: boxed warning for severe low blood sugar when used with insulin, especially in type 1 diabetes, usually within 3 hours of an injection. ^R1 Nausea was the most common side effect. ^{R3, R4}

Rating


Human Human evidence	Strong as an add-on to mealtime insulin in type 1 and type 2 diabetes ^{R3, R4}; No human data on gray-market products
Animal Animal / lab evidence	Not reviewed for this page
Regulatory	FDA-approved: Symlin NDA 021332 (Mar 16, 2005); Drugs@FDA lists Symlin products as Discontinued ^R2 · boxed warning ^R1 · WADA: not named on the 2026 List ^R5
Established human dose	For labeled use: on the FDA label ^R1. Study details lists what trials used

Evidence verdict: Diabetes with mealtime insulin (labeled): Strong · Gray-market use: No human data Card verdict: Strong (add-on to mealtime insulin) · Gray-market vials: No human data · Boxed warning: severe low blood sugar Card note: Severe hypoglycemia risk with insulin, see page.

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: both 52-week trials were sponsored by the developer, Amylin Pharmaceuticals. ^{R2, R3}

What is it?

Pramlintide copies amylin: it slows stomach emptying, blunts the after-meal glucagon rise and increases fullness. It is injected before meals alongside insulin. ^{R1, R3} Related pages: Cagrilintide, CagriSema, Amycretin.

Does it work?

Human Type 1 diabetes: 651 adults, 52 weeks: HbA1c −0.29 to −0.34 vs −0.04 on placebo; weight −0.4 kg vs +0.8 kg. ^R3
Human Type 2 diabetes on insulin: 656 adults, 52 weeks: HbA1c −0.62 on the best arm, significantly better than placebo; weight −1.4 vs +0.7 kg. ^R4

Is it safe?

Human Boxed warning: severe hypoglycemia with insulin, mainly type 1; insulin reduction and careful patient selection are required. ^R1
Human Trials: transient mild-to-moderate nausea most common. ^{R3, R4}

Gray-market "research use only" Pramlintide: extra risks

Not the approved product. "Research pramlintide" is not Symlin; identity, strength and sterility are unknown. Unknown Because the main danger is severe low blood sugar, use without supervised insulin adjustment is especially risky.

What we don't know

Unknown Current US availability (Drugs@FDA lists Symlin as Discontinued) ^R2
Unknown Long-term weight outcomes in people without diabetes (Symlin is only approved as an adjunct to mealtime insulin in type 1 and type 2 diabetes)
Unknown Quality of gray-market products

Is it legal?

US: FDA-approved as Symlin (NDA 021332) for type 1 and type 2 diabetes in patients using mealtime insulin. Drugs@FDA lists the Symlin products as Discontinued (checked Oct 25, 2026). ^{R1, R2} Not approved for weight loss. EU, UK and others: UNVERIFIED. WADA: not named on the 2026 Prohibited List. ^R5

Study details

These are amounts researchers used, not recommendations. ### R3 Human RCT: type 1 diabetes (Ratner 2004) | Study | People / model | Route | Amount used | Follow-up | Reported | Side effects / limitations | Citation | |---|---|---|---|---|---|---|---| | Ratner 2004 | 651 adults with type 1 diabetes | Subcutaneous | 60 mcg three or four times daily with meals | 52 weeks | HbA1c −0.29/−0.34 vs −0.04 | Nausea | [PMID 15498087](https://pubmed.ncbi.nlm.nih.gov/15498087/) | ### R4 Human RCT: type 2 diabetes on insulin (Hollander 2003) | Study | People / model | Route | Amount used | Follow-up | Reported | Side effects / limitations | Citation | |---|---|---|---|---|---|---|---| | Hollander 2003 | 656 adults with type 2 diabetes | Subcutaneous | 60 mcg TID, 90 mcg BID or 120 mcg BID | 52 weeks | HbA1c −0.62 (120 mcg BID) vs placebo; weight −1.4 vs +0.7 kg | Nausea | [PMID 12610038](https://pubmed.ncbi.nlm.nih.gov/12610038/) |

Full reference list (PubMed, ClinicalTrials.gov, openFDA and DailyMed entries checked Oct 25, 2026)

^R1 DailyMed. SYMLINPEN (pramlintide) label, AstraZeneca, effective Dec 18, 2019. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4aea30ff-eb0d-45c1-b114-3127966328ff
^R2 FDA. Drugs@FDA data (openFDA drugsfda), NDA 021332 (Symlin), original approval 2005-03-16, marketing status Discontinued, checked Oct 25, 2026. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:pramlintide · https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021332
^R3 Ratner RE, et al. Amylin replacement with pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in Type 1 diabetes mellitus: a 1-year, randomized controlled trial. Diabet Med. 2004. PMID 15498087
^R4 Hollander PA, et al. Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care. 2003. PMID 12610038
^R5 WADA. The 2026 Prohibited List (in force 1 January 2026). https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Pramlintide. Talk to a clinician you trust before using any drug, and report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).

Approved for Adam Greene by Dr. Nova Reyes, 2026-10-25.