Peptide dossier, updated Nov 1, 2026

Cagrilintide

Novo Nordisk’s investigational long-acting amylin analogue, developed alone and as CagriSema, a combination with semaglutide. Cagrilintide alone is not approved. Novo Nordisk announced in December 2025 that it had filed a new drug application with FDA for CagriSema. FDA says cagrilintide cannot be used in compounding. This page lays out what each source actually says.

See all 10 verified records for Cagrilintide on the Records page

In plain terms

Approved for: Nothing alone. FDA has not approved cagrilintide or CagriSema. Novo Nordisk announced a CagriSema application in December 2025, and we found no FDA decision as of Nov 1, 2026.

What it is: A lab-made version of amylin, a hormone released with insulin that helps slow stomach emptying and signals fullness. CagriSema pairs it with semaglutide, an approved appetite and blood-sugar drug.

What it is said to do, and by whom:

Novo Nordisk, the developer: in its REDEFINE 1 trial, people taking CagriSema lost 20.4% of body weight over 68 weeks, compared with 3.0% on placebo, counting all participants regardless of whether they stayed on treatment (company press release).
Sellers: cagrilintide is also sold online as a “research” product. We did not collect sellers’ own claims.
FDA: says cagrilintide cannot be used in compounding under federal law.

How strong the evidence is: Strong for the combination in company-sponsored phase 3 trials, with two peer-reviewed NEJM reports (REDEFINE 1 and 2). Weaker for cagrilintide alone, with a smaller literature. Nothing here tests product sold online.

FDA approval

Not approved

Novo Nordisk announced an NDA submission for CagriSema in December 2025. The company release says FDA is expected to review it in 2026. We found no decision as of Nov 1, 2026.

FDA on compounding

Cannot be compounded

FDA’s page (content current Oct 1, 2026) says retatrutide and cagrilintide cannot be used in compounding under federal law.

FDA safety-risk page

Not listed

FDA’s page on bulk substances that may present significant safety risks (content current Apr 22, 2026) does not list cagrilintide.

HHS enforcement, Oct 30

Not covered

The draft policy’s appendix names six covered peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. Cagrilintide is not one of them.

WADA prohibited list

Not named

The 2026 list we read does not name cagrilintide. Its section S0 covers substances with no current approval from any government health authority, including drugs in clinical development. Whether S0 applies is WADA’s call, and we found no WADA statement on it. We read a copy of the list, not WADA’s own file.

Human evidence

Phase 3 completed

ClinicalTrials.gov lists 44 studies. REDEFINE 1 and 2 are published in the New England Journal of Medicine.

Human studies

ClinicalTrials.gov returns 44 studies for cagrilintide as of Nov 1, 2026. We checked three. Registry entries are written by sponsors and are not reviewed for scientific merit.

Study	What it tests	Sponsor	Status (completion)
NCT05669755	REDEFINE 3: CagriSema in people with heart and vascular disease	Novo Nordisk	Active, not recruiting (Oct 2027)
NCT06131437	CagriSema compared with tirzepatide in obesity	Novo Nordisk	Completed (Jan 2026)

We list two of the 44.

FDA statements

FDA has not reviewed cagrilintide for approval. What we read is its page on unapproved GLP-1 drugs (content current Oct 1, 2026), the company’s filing announcement, and the safety-risk page.

What the documents say

FDA’s page says retatrutide and cagrilintide cannot be used in compounding under federal law.
Novo Nordisk’s release (as reposted) announces that it has filed an NDA for CagriSema and that FDA is expected to review it in 2026.
FDA’s safety-risk page does not list cagrilintide.

What we did not find

No FDA briefing document or advisory committee review.
No FDA decision on CagriSema as of Nov 1, 2026.
No NDA number or review date.

Sources: FDA: concerns with unapproved GLP-1 drugs Novo Nordisk release (BioSpace)Pharmaceutical Executive

Published research

PubMed returns 107 results for cagrilintide as of Nov 1, 2026.

What the papers show

Chemistry, 2021. Development of cagrilintide as a long-acting amylin analogue. J Med Chem PubMed
Phase 2, 2021. Once-weekly cagrilintide for weight management in people with overweight and obesity. Lancet PubMed
Phase 1b, 2023. Co-administered cagrilintide and semaglutide. Lancet PubMed
REDEFINE 1, 2025. Coadministered cagrilintide and semaglutide in adults with overweight or obesity. N Engl J Med PubMed
REDEFINE 2, 2025. Cagrilintide-semaglutide in adults with overweight or obesity and type 2 diabetes. N Engl J Med PubMed

Read with care

Trial results are for CagriSema, the combination, under medical supervision. They do not describe cagrilintide alone or product sold online.
We read titles and journal details, not full text.

Timeline

Newest first. Every entry links to the document it comes from.

Government or registry record
Journal

Oct 30, 2026Regulatory
HHS publishes draft policy pausing enforcement on six peptides; cagrilintide is not one of them
The draft policy’s appendix names six peptides: BPC-157, TB-500, epitalon, Semax, KPV and MOTS-c. We read the appendix through a text extraction.
Federal Register HHS policy appendix BakerHostetler summary
Oct 1, 2026Regulatory
FDA page states retatrutide and cagrilintide cannot be used in compounding
Content current as of this date.
FDA page
Dec 18, 2025Sponsor
Novo Nordisk announces it filed an NDA with FDA for CagriSema
The release says FDA is expected to review the application in 2026.
Press release (BioSpace)Pharmaceutical Executive
Aug 2025Literature
REDEFINE 1 and REDEFINE 2 published in N Engl J Med
Coadministered cagrilintide and semaglutide in adults with overweight or obesity, with and without type 2 diabetes.
REDEFINE 1 REDEFINE 2
2021Literature
Cagrilintide described in J Med Chem; phase 2 weight trial in Lancet
The first human efficacy report for weekly cagrilintide.
J Med Chem Lancet

Still not covered

Left off rather than guessed:

CagriSema decision: we found no FDA decision as of Nov 1, 2026. It could change at any time; recheck before relying on this page.
REDEFINE 4 and other results: Novo Nordisk reported a head-to-head trial against tirzepatide in early 2026. We did not read the company release and state no result here.
FDA letter to state boards and warning letters naming cagrilintide: we saw references to them but did not open the documents.
HHS policy: we read the draft policy appendix through a text extraction, not the original PDF layout. It names six covered peptides and not this drug.
Patents, SEC filings and sponsor results releases: not researched for this dossier, except where cited.
Seller claims and independent lab reports: how gray-market product is marketed versus what testing finds. We have not collected testing data.
Unread items: full text of every paper; EU and other non-US regulators; WADA’s own file for the 2026 list; FDA warning letters other than those listed.