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.
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.
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.
02UK 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.
03How 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.
04What 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.
05Reported 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.
06Sources
Links go to the primary source. Where a source is behind a paywall or requires registration, the 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
07Change history
Every substantive change to this record is logged here with its date. Corrections are made openly, not quietly.
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