U.S. regulatory status

Cagrilintide

Also known as AM833 · long-acting amylin analog · CagriSema (combination with semaglutide)

RestrictedInvestigational only - no approved form exists anywhere; cannot be compounded; the CagriSema combination is under FDA review

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 the agency is expected to review the application during 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 Sep 22, 2026 (ET) · status held since Dec 18, 2025

Primary source: FDA All 10 sources Reconstitution calculator

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.

Next scheduled dateFDA review of the CagriSema NDA (submitted Dec 18, 2025) expected to run through 2026 - no public action date - Dec 31, 2026 (in 100 days)

What changed last

No recorded changes yet - this entry has held one status since it was added.

Status elsewhere

Cagrilintide: regulatory status by jurisdiction
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

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.

Last verified by a human: Sep 22, 2026 (ET) · how we verify
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