CagriSema
Amylin analogue plus GLP-1 receptor agonist · No brand name. A combination of cagrilintide and semaglutide
- UK status
- Not licensed anywhere
- Availability
- Clinical trials only
- Evidence base
- Phase 3 reported, no approval
- Controlled drug
- No
Sequence
Two separate peptides combined. See the semaglutide record for that sequence; cagrilintide is a modified amylin analogue.
The short version
What it does
Reduces appetite, aiming for more than semaglutide alone by adding a second drug alongside it.
How it does it
Rather than one signal pushed harder, it uses two different fullness signals your body produces, on the theory that two systems beat one.
The catch
A head-to-head trial against Mounjaro went the wrong way for it. Mounjaro produced slightly more weight loss, and Mounjaro is already licensed and available here.
Everything below goes into the detail, with sources.
CagriSema takes a different route to a bigger effect. Rather than adding receptors to one molecule, as tirzepatide and retatrutide do, it combines two separate drugs acting on two separate hormone systems.
At a glance
- Compound type
- Two peptides combined
- Drug class
- Amylin analogue plus GLP-1 receptor agonist
- Components
- Cagrilintide and semaglutide
- Route
- Injection under the skin, in trials
- Frequency
- Weekly, in trials
- Originator
- Novo Nordisk
- Approval status
- None. FDA application submitted December 2025.
- In sport
- Unapproved combination, so would fall under WADA S0. Verify with UKAD.
01What it is
Amylin is a hormone released by the pancreas alongside insulin. Among other things it signals fullness, through a pathway distinct from GLP-1. Cagrilintide is a long-acting synthetic version of it.
CagriSema is cagrilintide and semaglutide together in one weekly injection. The logic is that hitting two independent appetite systems should achieve more than saturating one.
02How it came about
Amylin has been a drug target for a long time. Pramlintide, an amylin analogue, was approved in the US in 2005 but required multiple daily injections and never took off. Cagrilintide is a long-acting version, which makes a weekly combination with semaglutide practical.
The strategic logic was straightforward: pair two appetite systems rather than push one harder. The trial results have complicated that story.
03UK legal and licensing status
CagriSema is not approved in any country. A New Drug Application was submitted to the FDA in December 2025, with a first decision expected during 2026. No MHRA submission had been publicly confirmed as of mid-2026. The only lawful way to receive it is enrolment in an authorised clinical trial.
On the pattern set by Wegovy and Mounjaro, a UK private launch would follow an MHRA approval, with NICE appraisal and NHS commissioning taking a further year or more after that. Anything sold as CagriSema now is grey-market product.
04How it works
- Semaglutide component. GLP-1 receptor. Insulin release, slower gastric emptying, reduced appetite.
- Cagrilintide component. Amylin receptors. A separate satiety signal, plus a further slowing of gastric emptying.
- The rationale. Two independent pathways rather than a larger dose of one. Whether that translates into a clinically meaningful advantage is what the trials are testing.
05What it is not
Claims that attach themselves to this compound and do not hold up.
- Not approved anywhere in the world. An application is under FDA review. No MHRA filing had been publicly confirmed as of mid-2026.
- Not clearly better than what already exists. In the head-to-head REDEFINE 4 trial, tirzepatide produced slightly more weight reduction and CagriSema missed its non-inferiority threshold.
- Not a single drug. Two active components, which for unlicensed product means no way to know the ratio, or whether both are even present.
06What the evidence shows
The REDEFINE programme is the phase 3 evidence base, funded by Novo Nordisk. REDEFINE 4 is the one worth knowing about, because it compared CagriSema directly against tirzepatide.
In REDEFINE 4, tirzepatide produced slightly greater weight reduction than CagriSema, and CagriSema did not meet the non-inferiority threshold the trial had set. Direct comparisons are far more informative than comparing separate trials, and this one did not favour the newer combination.
This is exactly the sort of result that gets lost. Pipeline coverage tends to assume each new drug beats the last. Here a head-to-head trial says otherwise, against a drug already licensed and available in the UK.
No regulator has assessed it. There is no SPC, no approved patient information, and no long-term safety record. Adding a second hormone system also means a second, less well-characterised side effect profile.
07Reported harms
Trial reporting has been dominated by gastrointestinal effects, as across this class. With no licence anywhere there is no authoritative frequency table.
Because the compound is two drugs together, unlicensed product sold under the name has an additional problem beyond the usual ones: there is no way to know the ratio of the two components, or whether both are present at all.
08Interactions and cautions
No licence, so no SPC. The semaglutide component would be expected to carry the class cautions around contraception, surgery and combination with insulin. The amylin component adds a second, less well-characterised profile.
09Stopping
Not established. No approved use exists, so there is no guidance on stopping.
10Monitoring
Trial participants are monitored by clinicians. Nobody else 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 a licensed drug beat this in a head-to-head trial, is there a reason to wait for it?
- Is there a UK trial recruiting?
12Common questions
When will CagriSema be available in the UK?
Unknown. It is not approved anywhere. Based on how Wegovy and Mounjaro reached UK patients, a private launch would follow MHRA approval by some months, with NHS access considerably later after a NICE appraisal.
Is CagriSema better than Mounjaro?
The head-to-head REDEFINE 4 trial says no. Tirzepatide produced slightly greater weight reduction and CagriSema did not meet the non-inferiority threshold it was tested against. A direct comparison carries far more weight than comparing separate trials.
What does amylin actually do?
It is a hormone released by the pancreas alongside insulin. Among other things it signals fullness and slows stomach emptying, through a pathway separate from GLP-1. That separation is the reason for combining the two.
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.
- REDEFINE trial programme recordsClinicalTrials.gov
- REDEFINE 4 head-to-head resultsPubMed
- Cagrilintide, a long-acting amylin analogueCardiology in Review, 2024
- Buying medicines onlineMHRA
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