Home / Compounds / Cagrilintide
Cagrilintide
Long-acting amylin analogue · No brand name. The amylin component of CagriSema
- UK status
- Not licensed anywhere
- Availability
- Clinical trials only
- Evidence base
- Human RCT, phase 3 as part of a combination
- Controlled drug
- No
Sequence
A modified analogue of human amylin.
The short version
What it does
Reduces appetite, through a different route from the GLP-1 drugs. Mostly studied alongside semaglutide rather than alone.
How it does it
Your pancreas releases a second hormone alongside insulin that also tells your brain you have eaten enough. This is a long-lasting copy of that one, so it works on a separate system from the GLP-1 drugs.
The catch
It is not approved anywhere, alone or in combination. And the combination it is famous for lost a head-to-head trial against Mounjaro, which is already licensed here.
Everything below goes into the detail, with sources.
Amylin is the appetite hormone nobody has heard of. Your pancreas releases it alongside insulin every time you eat, and it signals fullness through a pathway entirely separate from GLP-1. Cagrilintide is the long-acting copy, and it is the reason CagriSema exists.
At a glance
- Compound type
- Peptide, a modified amylin analogue
- Drug class
- Amylin receptor agonist
- Originator
- Novo Nordisk
- Route
- Injection under the skin
- Frequency
- Weekly
- Approval status
- None, anywhere, alone or in combination
- Best known as
- The amylin half of CagriSema
- Earlier drug in the class
- Pramlintide, approved in the US in 2005
- In sport
- Unapproved, so would fall under WADA S0. Verify with UKAD.
01What it is
Amylin is co-secreted with insulin from the pancreas. Among other jobs it slows gastric emptying and signals satiety, through receptors in the brainstem rather than the pathways GLP-1 uses.
Native amylin is impractical as a drug: it clumps together and clears quickly. Pramlintide, an earlier analogue, was approved in the US in 2005 but needed multiple daily injections and never took off. Cagrilintide is engineered to last a week, which makes weekly dosing and combination with semaglutide practical.
02How it came about
Cagrilintide has been studied alone and, more prominently, combined with semaglutide as CagriSema. Novo Nordisk submitted the combination to the FDA in December 2025.
Interest in cagrilintide as a standalone has grown partly because of the CagriSema results. In the REDEFINE 4 head-to-head trial, tirzepatide produced slightly greater weight reduction than CagriSema and the combination missed the non-inferiority threshold it was tested against. That raised the obvious question of what each component contributes.
03UK legal and licensing status
Cagrilintide has no marketing authorisation anywhere in the world, alone or in combination. It cannot lawfully be supplied for human use in the UK, and the only lawful route to receiving it is an authorised clinical trial.
It is sold on the grey market, both alone and pre-mixed with semaglutide as counterfeit CagriSema. A pre-mixed product is worse than a single one: you cannot know the ratio of the two components, or whether both are present.
04How it works
It binds amylin and calcitonin receptors, producing satiety signalling and slowed gastric emptying. The argument for combining it with a GLP-1 drug is that two independent appetite systems should achieve more than saturating one.
That argument is reasonable and it is what REDEFINE tested. The result was more complicated than expected.
05What it is not
Claims that attach themselves to this compound and do not hold up.
- Not approved anywhere, alone or as part of CagriSema.
- Not a GLP-1 drug. Different hormone, different receptors, different pathway. It is often lumped in with them.
- Not shown to add to a GLP-1 drug reliably. The combination lost a head-to-head against tirzepatide.
- Not pramlintide. Both are amylin analogues; the earlier one needed multiple daily injections and carried a hypoglycaemia warning with insulin.
06What the evidence shows
The substantive phase 3 evidence is the REDEFINE programme, testing the combination rather than cagrilintide alone. Standalone data exists from earlier phases and reports meaningful weight reduction as monotherapy.
Tirzepatide beat CagriSema, and CagriSema missed its non-inferiority threshold. Two appetite systems did not clearly outperform one drug acting on two incretin receptors.
That is not proof cagrilintide does nothing. It does suggest the "two pathways must beat one" reasoning, which is also the reasoning behind every peptide stack sold online, is not reliable.
Standalone phase 3 data. No approval anywhere means no SPC, no approved patient information and no independent assessment of benefit against risk. Long-term amylin receptor agonism in humans is less well characterised than GLP-1 agonism.
07Reported harms
Trial reporting is dominated by gastrointestinal effects, as with the GLP-1 drugs. With no licence there is no authoritative frequency table.
Nausea appears prominent in amylin analogue reporting generally, and pramlintide's US label carried a warning about severe low blood sugar when used with insulin, which is worth knowing for anyone with diabetes considering an unlicensed amylin analogue.
08Interactions and cautions
No SPC. The pramlintide precedent, severe hypoglycaemia in combination with insulin, is the specific concern for anyone taking insulin. Slowed gastric emptying affects absorption of oral medicines.
09Stopping
Not established outside trial conditions.
10Monitoring
Trial participants are monitored. Nobody buying it online is.
11Questions worth asking
Take these to a doctor or pharmacist. A good clinician will not mind being asked, and the answers are specific to you in a way nothing on this page can be.
- Given the combination lost a head-to-head against a licensed drug, what am I hoping for here?
- Do I take insulin, given the hypoglycaemia precedent with the earlier drug in this class?
- Is there a UK trial recruiting?
12Common questions
What is amylin?
A hormone released by the pancreas alongside insulin. It slows stomach emptying and signals fullness, through a pathway separate from GLP-1. That separation is why combining the two was thought promising.
Is cagrilintide approved anywhere?
No, alone or in combination. CagriSema was submitted to the FDA in December 2025 and no decision had been made public as of mid-2026.
Does cagrilintide work on its own?
Earlier-phase trials reported meaningful weight reduction as monotherapy, but the substantive phase 3 programme tested the combination with semaglutide. There is no standalone approval or completed pivotal programme.
Is it the same as pramlintide?
No, though both are amylin analogues. Pramlintide was approved in the US in 2005 and needed multiple daily injections. Cagrilintide is engineered to last a week.
13Sources
Links go to the authoritative source. Where a document sits behind a paywall or moves around, the full citation is given so you can find it yourself.
- Cagrilintide, a long-acting amylin analogueCardiology in Review, 2024
- REDEFINE trial programme recordsClinicalTrials.gov
- REDEFINE 4 head-to-head resultsPubMed
- CagriSema record/compounds/cagrisema/
- Unlicensed medicines guidanceMHRA
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