U.S. regulatory status
Cagrilintide
Also known as AM833, long-acting amylin analog, CagriSema (combination with semaglutide)
Is Cagrilintide legal right now?
Cagrilintide is an investigational drug - Novo Nordisk’s long-acting amylin analog - with no approved form anywhere in the world.
It is furthest along as half of CagriSema, a fixed-dose weekly combination with semaglutide: Novo Nordisk submitted a New Drug Application to the FDA on December 18, 2025 on the strength of the Phase 3 REDEFINE trials, and on September 30, 2026 Novo Nordisk said a decision is expected in the fourth quarter of 2026. Until that decision lands there is no legal commercial product containing cagrilintide, and compounding is not an option either: cagrilintide is not a component of any approved drug and is not an eligible bulk substance, so the FDA states plainly that it cannot be used in compounding.
The agency has backed that with enforcement - a March 2026 warning letter names ‘Cagrilintide’ among unapproved new drugs a seller offered online, alongside coded product names, treating ‘research use’ framing as immaterial when products are aimed at human use. Note this entry sits outside the 503A pipeline entirely: no advisory-committee review of cagrilintide is scheduled or on record - and even an approval of CagriSema would legalize that finished product, not gray-market cagrilintide powder.
Restricted: Prescription-only, banned, controlled, or under active FDA enforcement.
Verified Oct 9, 2026 (ET) · status held since Dec 18, 2025
Primary source: FDA All 11 sources Reconstitution calculator CagriSema decision watch
Where it sits in the process
- Nominated (stalled here - not advancing)
- Under review (not reached)
- Rulemaking (not reached)
- Compounding-legal (not reached)
Not on a path to the 503A list right now. The process stalled or reversed at this stage - read the status above. Sitting at an earlier step is not a sign it will advance.
What changed last
No recorded changes yet - this entry has held one status since it was added.
Status elsewhere
| Jurisdiction | Status | Note |
|---|---|---|
| United States (FDA) | Restricted | Investigational; not approved, not compoundable (not a component of an approved drug, not an eligible bulk substance). The CagriSema NDA is under FDA review; warning letters to sellers, including products sold under coded names. |
| Australia (TGA) | Unscheduled | Not individually named or scheduled in the Poisons Standard. |
| United Kingdom (MHRA) | Restricted | No UK marketing authorisation; supply for human use treated as an unlicensed medicine. |
| European Union (EMA) | Restricted | No EU marketing authorisation; not on EMA’s August 2026 list of applications under CHMP evaluation; sale as a medicine unlawful EU-wide, with enforcement at member-state level. |
| Canada (Health Canada) | Under review | Cagrilintide/semaglutide new drug submission (Novo Nordisk) accepted into Health Canada review in March 2026; no cagrilintide product yet authorized in the Drug Product Database. |
| Sport / anti-doping (WADA) | Restricted | Prohibited at all times, but not listed by name - captured by the S0 catch-all for substances with no regulatory approval for human use. |
The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it
FDA warning letters
5 FDA warning letters mention cagrilintide, from Dec 10, 2024 to Mar 31, 2026.
A warning letter is the FDA telling one company it believes the company broke federal law. It does not change the status above. All warning letters, by compound
Sources & transparency
Sources for this entry
- FDA - FDA’s concerns with unapproved GLP-1 drugs used for weight loss FDA · primaryStates that cagrilintide (and retatrutide) are not components of FDA-approved drugs and cannot be used in compounding.
- FDA - warning letter, Prime Sciences (Mar 31, 2026) FDA · primaryNames ‘Cagrilintide’ among unapproved new drugs offered for sale online, alongside coded product names (GLP1-R, GLP1-S, GLP1-T).
- FDA - press announcement: 30 telehealth companies warned over compounded GLP-1 marketing FDA · primaryThe broader enforcement wave around unapproved and compounded GLP-1 products.
- MHRA Products database (search: cagrilintide) UK gov · primaryBasis for the United Kingdom (MHRA) status row.
- Health Canada - New drug submissions under review (SUR list) Health Canada · primaryBasis for the Canada (Health Canada) status row.
- EMA - Applications for new human medicines under evaluation: August 2026 EU · primaryBasis for the European Union (EMA) status row.
- Therapeutic Goods (Poisons Standard - June 2026) Instrument 2026 Government · primaryBasis for the Australia (TGA) status row.
- Novo Nordisk - company announcement: CagriSema NDA filed with the FDA (Dec 18, 2025) AnalysisConfirms the NDA submission for once-weekly CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg) and that the FDA is expected to review the application in 2026.
- Drugs.com - CagriSema FDA approval status tracker AnalysisIndependent tracker of the CagriSema application; confirms it is not approved in the US or EU as of the last verification.
- USADA - the WADA Prohibited List (S0: non-approved substances) AnalysisS0 prohibits substances with no regulatory approval for human therapeutic use at all times.
- Novo Nordisk - CagriSema at EASD 2026 (Sep 30, 2026) Analysis”A decision is expected in Q4 2026.” NDA submitted to the FDA and Health Canada in December 2025.
- Last verified by a human
- Oct 9, 2026 (ET) · how we verify
- Who runs this
- Peptlas Research Team - independent. About us.
- What we sell
- Nothing. No products, no affiliates, no sponsored placements.
This page reports publicly available regulatory status for information only. It is not medical or legal advice and makes no health claim. See our full disclaimer.
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