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Amylin analogue

Cagrilintide (and CagriSema)

Also called AM833, CagriSema (fixed-dose combination of cagrilintide and semaglutide), Cagrilintide-semaglutide.

Cagrilintide is an experimental drug that copies amylin, a hormone your pancreas makes to help you feel full. It is built to stay in the body for a long time, so in studies it is given once a week. It is not approved anywhere yet. Its maker has asked the US FDA to approve it combined with semaglutide in one product, called CagriSema.

Cagrilintide (and CagriSema) is not an approved medicine for these uses in most countries. This page explains the science and the law; it does not give dosing, sourcing or usage advice.

How strong is the evidence?

AnecdoteAnimalsHuman trialsApproved
Phase 3. Large trials comparing it with placebo or other drugs.Human evidence is from randomised phase 1b, phase 2 and phase 3 trials sponsored by Novo Nordisk. Most phase 3 data test the fixed-dose combination with semaglutide (CagriSema). Cagrilintide-alone phase 3 data come from a comparison arm inside REDEFINE 1, and the dedicated RENEW 1 and RENEW 2 phase 3 trials had not reported at the access date. Cagrilintide is not approved by any regulator. On 2026-09-21 Novo Nordisk still described CagriSema as an investigational product and said an FDA decision on its December 2025 application is expected in Q4 2026.

Last verified 2026-09-29 · how we verify

Rendering of PDB 9BP3: Cagrilintide bound to the Amylin 1 receptor (calcitonin receptor + RAMP1). Experimental structure · cryo-EM 2.2 Å · PDB 9BP3 (2025).
Experimental structure

Experimental structure · cryo-EM 2.2 Å · PDB 9BP3 (2025)RCSB entry ↗

Cagrilintide at the amylin 1 receptor, which is the calcitonin receptor (chain R) paired with receptor activity-modifying protein 1 (RAMP1, chain E). Part of the lipidation (icosanedioic acid, component A1B90) is modelled on the peptide chain. Glycans, lipids and nanobody Nb35 (chain N) omitted. Structure from Cao et al., Nat Commun 2025. Colours are ours, not the molecule's.

Acts on
Amylin receptors (AMY1R, AMY2R, AMY3R), Calcitonin receptor
Taken as
Investigational once-weekly subcutaneous injection in clinical trials, alone or as a fixed-dose combination with semaglutide (CagriSema). There is no approved route because there is no approved product.
Half-life
About 159-195 hours (roughly 6.5-8 days) in a phase 1b trial where cagrilintide was given together with semaglutide[src]
Regulatory status
No approval by any regulator found as of 2026-09-29. FDA states that cagrilintide is not a component of FDA-approved drugs and has not been found safe and effective for any condition.[src]
CagriSema filing
Novo Nordisk announced on 2025-12-18 that it had filed a US New Drug Application for the once-weekly cagrilintide-semaglutide combination for adult weight management, with FDA review expected in 2026.[src]
REDEFINE 1 (68 weeks, adults without diabetes)
Cagrilintide-semaglutide: -20.4% body weight versus -3.0% with placebo (estimated difference -17.3 percentage points; treatment-policy estimand; 3,417 participants).[src]

Inside the body

What Cagrilintide (and CagriSema) does, step by step

Watch the 3D journey →
  1. 01Pancreas

    Copies a hormone from the pancreas

    Your pancreas makes a hormone called amylin that helps you feel full after eating. Cagrilintide is a lab-made copy of amylin.

    For experts

    Native amylin is a pancreatic hormone that induces satiety, but it forms amyloid fibrils readily, which makes it hard to develop as a drug. The earlier analogue pramlintide is approved as an add-on to insulin but needs three injections a day because of its short half-life. Cagrilintide was engineered from the human amylin backbone to be stable and long acting.[src][src]

  2. 02Bloodstream

    Built to stay in the blood for about a week

    The older amylin drug, pramlintide, wears off so fast that it has to be injected three times a day. Cagrilintide has a fatty chain added to it and a few swapped building blocks, so it lasts far longer and is given only once a week in studies.

    For experts

    Structure-activity work at Novo Nordisk combined stabilising amino-acid substitutions with lipidation, per the design paper. The PubChem structure shows a C20 diacid gamma-Glu lipid on the alpha-amino group of the N-terminal lysine. In otherwise healthy adults with overweight or obesity given cagrilintide together with semaglutide, the half-life was 159-195 h, with a median time to peak concentration of 24-72 h.[src][src][src]

  3. 03Brain

    Fits amylin and calcitonin receptors

    Scientists have taken 3D pictures of cagrilintide sitting in its receptors. The peptide fits like a key in a lock and switches the receptor on. The pictures come from lab-made receptors, not from people.

    For experts

    Cryo-EM structures show cagrilintide bound to Gs-coupled human calcitonin receptor and AMY1R, AMY2R and AMY3R. It has an amylin-like binding mode but induces distinct receptor dynamics compared with other peptides. An E14-R17 salt bridge stabilises the helix, Phe23 anchors the peptide near the transmembrane bundle, and Pro37 contacts the extracellular domain. This supports non-selective activation across these receptors. These are structural data on purified proteins, not human tissue measurements.[src][src]

  4. 04Brain

    In mice, amylin receptors 1 and 3 are needed (animal-only)

    In mice, cagrilintide only lowered weight properly when two types of amylin receptor were present. This has been shown in mice, not yet proven the same way in people.

    For experts

    In high-fat-diet mice lacking RAMP1 and RAMP3, cagrilintide's potency for weight loss was impaired, showing dependence on AMY1R and AMY3R. In wild-type mice it reduced early food intake and activated cFos in the dorsal vagal complex and lateral parabrachial nucleus. This is animal-only evidence.[src]

  5. 05Brain

    A brainstem cell group carries the message (animal-only)

    In rats, long-term cagrilintide made a small group of brainstem cells produce more of a chemical messenger called PRLH. Blocking PRLH in that brain area stopped cagrilintide from working, but not semaglutide. So in rats the two drugs seem to use different routes. This has not been tested this way in people.

    For experts

    A cross-species transcriptomic atlas of the caudal brainstem (rat, mouse, macaque) found Calcr-expressing populations regulated by cagrilintide. Long-term treatment in rats increased Prlh expression in nucleus of the solitary tract Calcr/Prlh neurons, and knocking down DVC Prlh abrogated the effects of cagrilintide but not semaglutide. The functional experiments were done in rats; the cell populations are described as conserved in macaques and humans.[src]

  6. 06Fat tissue

    People in trials lose weight

    In studies of adults with overweight or obesity, people given cagrilintide lost more weight than people given a dummy shot. Given together with semaglutide, they lost roughly twice as much as with cagrilintide alone.

    For experts

    In a 26-week phase 2 trial, weight reductions across cagrilintide groups were 6.0%-10.8% versus 3.0% with placebo (trial product estimand). In REDEFINE 1 (68 weeks), cagrilintide alone gave 11.5% versus 3.0% with placebo (treatment-policy estimand), and cagrilintide-semaglutide gave 20.4% versus 3.0%. In REDEFINE 2 (type 2 diabetes), the combination gave 13.7% versus 3.4% with placebo.[src][src][src][src]

  7. 07Gut

    Stomach and gut side effects are the most common

    The most common side effects in trials involve the stomach and gut, such as feeling sick, constipation or diarrhoea. Most were mild to moderate. Some people also had reactions where the injection went in.

    For experts

    In the phase 2 trial, gastrointestinal adverse events occurred in 41%-63% of participants on cagrilintide versus 32% on placebo, mainly nausea (20%-47% versus 18%), and administration-site reactions were also among the most frequent events. In REDEFINE 1, gastrointestinal events affected 79.6% on the combination versus 39.9% on placebo and were mainly transient and mild to moderate.[src][src]

For experts

The detail

Cagrilintide (AM833) is a 37-residue, C-terminally amidated, long-acting amylin analogue from Novo Nordisk. It keeps the human amylin backbone, including the Cys2-Cys7 disulfide, and differs from mature human amylin at six positions (including prolines at 25, 28 and 29 and a Glu14/Arg17 pair); its developers describe it as a stable analogue, in contrast to native amylin's strong tendency to form amyloid fibrils. In the PubChem structure, a C20 fatty diacid is attached through a gamma-glutamic acid linker to the alpha-amino group of the N-terminal lysine; this lipidation is part of what makes it long acting. It is a non-selective agonist of the calcitonin receptor and the three amylin receptors (calcitonin receptor plus RAMP1, RAMP2 or RAMP3). Elimination half-life is about 159-195 h, which supports once-weekly subcutaneous use. In a 26-week phase 2 trial, weight loss across the cagrilintide groups was 6.0%-10.8% versus 3.0% with placebo (trial product estimand). In the phase 3 REDEFINE 1 trial, cagrilintide alone gave 11.5% weight loss at 68 weeks (treatment-policy estimand) versus 3.0% with placebo, and the fixed-dose combination with semaglutide (CagriSema) gave 20.4%. We found no regulatory approval of cagrilintide, alone or combined, as of the access date. Novo Nordisk filed a US NDA for CagriSema on 2025-12-18 and on 2026-09-21 still described CagriSema as investigational, with an FDA decision expected in Q4 2026; and the cagrilintide-alone RENEW phase 3 programme began in November 2025.

Evidence: Human evidence is from randomised phase 1b, phase 2 and phase 3 trials sponsored by Novo Nordisk. Most phase 3 data test the fixed-dose combination with semaglutide (CagriSema). Cagrilintide-alone phase 3 data come from a comparison arm inside REDEFINE 1, and the dedicated RENEW 1 and RENEW 2 phase 3 trials had not reported at the access date. Cagrilintide is not approved by any regulator. On 2026-09-21 Novo Nordisk still described CagriSema as an investigational product and said an FDA decision on its December 2025 application is expected in Q4 2026.[src][src][src][src][src]

Known safety signals

  • Phase 2 trial: gastrointestinal adverse events (mainly nausea, constipation, diarrhoea) occurred in 41%-63% of participants on cagrilintide versus 32% on placebo, and administration-site reactions were also frequent.[src]
  • REDEFINE 1: gastrointestinal adverse events affected 79.6% of people on cagrilintide-semaglutide versus 39.9% on placebo, mainly transient and mild to moderate.[src]
  • Company-reported REDEFINE 1 data: nausea led to permanent discontinuation in 1.0% of people on cagrilintide alone versus 0.1% on placebo.[src]
  • A thorough QT study in 105 healthy adults found no clinically relevant prolongation of the QTcF interval with cagrilintide compared with placebo.[src]
  • Cagrilintide is not approved by FDA and, per FDA, cannot be used in compounding under federal law; it has not been found safe and effective for any condition.[src]
  • Unregulated products: US Customs stated that overseas-made unapproved peptides, with cagrilintide listed among those seized in one 2026 case, could be contaminated with other substances or impurities, and that their authenticity and safety cannot be determined.[src]

Around the world

Is Cagrilintide (and CagriSema) legal where you live?

CountryStatusWhat it meansVerified
AustraliaNot approvedNot approved and not shown as under TGA evaluation. No cagrilintide product is on the ARTG.Details →source2026-09-29
BrazilNot approvedNot registered in Brazil; no filing for cagrilintide or CagriSema was foundDetails →source2026-09-29
CanadaUnder reviewCagrilintide with semaglutide (CagriSema) under review since March 2026; no cagrilintide product is authorisedDetails →source2026-09-29
ChinaNot approvedNot approved in China; CagriSema has been tested in China but only trial-stage filings are visible.Details →source2026-09-29
European UnionNot approvedNo EU marketing authorisation; no application on EMA's September 2026 evaluation listDetails →source2026-09-29
IndiaNot approvedNot approved in India; CagriSema is only in CDSCO-permitted Phase III trialsDetails →source2026-09-29
JapanNot approvedNo marketing approval in Japan; the amylin analogue cagrilintide does not appear in PMDA's approved-drug lists to September 2026Details →source2026-09-29
MexicoNot approvedNot registered in Mexico; CagriSema and cagrilintide are still investigational thereDetails →source2026-09-29
New ZealandNot approvedCagrilintide (alone or in CagriSema) has no Medsafe consent and no data sheet in New ZealandDetails →source2026-09-29
United Arab EmiratesNot approvedNo EDE approval found for cagrilintide or CagriSema; not marketed in the UAEDetails →source2026-09-29
United KingdomNot approvedNo UK licence for cagrilintide or the cagrilintide-semaglutide combination (CagriSema)Details →source2026-09-29
United StatesUnder reviewNot approved alone; Novo Nordisk's CagriSema (cagrilintide plus semaglutide) is under FDA review for obesity, and cagrilintide cannot be compoundedDetails →source2026-09-29

Who makes it

Recent history

  1. 2025-06-22

    REDEFINE 1: CagriSema leads to about 20% weight loss at 68 weeks

Full timeline →

Compare side by side

CagriSema vs tirzepatide

Related molecules

SemaglutidePramlintideAmycretinEloralintideTirzepatide

Sources (56)

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