What is CagriSema?
CagriSema is Novo Nordisk’s answer to tirzepatide: a single weekly injection combining cagrilintide, a long-acting amylin analogue, with semaglutide, the GLP-1 in Ozempic and Wegovy. Two different appetite pathways in one pen.
Novo submitted a New Drug Application to the FDA on December 18, 2025, based on the phase 3 REDEFINE 1 trial. The company has said a US decision is expected in the fourth quarter of 2026. No public PDUFA date has been confirmed.
Expectations have been trimmed along the way. REDEFINE 1 delivered 20.4% average weight loss — strong, but below the 25% figure analysts had anticipated — and the REDEFINE 4 head-to-head against tirzepatide, reported in February 2026, came in slightly behind rather than ahead.
It is not approved and cannot be prescribed today.
How it works
Semaglutide does the familiar GLP-1 work: slower gastric emptying, better insulin response, and reduced appetite signalling in the brain.
Cagrilintide targets amylin, a separate hormone co-secreted with insulin that promotes satiety through a different set of brain receptors. Because the two pathways are independent, the combination suppresses appetite more than either alone — and, in trials, does so at a semaglutide dose no higher than Wegovy uses.
Dosing schedule
There is no approved dosing schedule yet. The phase 3 program titrated both components together over roughly 16 weeks to the target combination:
| Dose | When |
|---|---|
| 0.25 mg + 0.25 mg / week | Starting dose in trials (cagrilintide + semaglutide) |
| 0.5 mg + 0.5 mg / week | Titration step |
| 1.0 mg + 1.0 mg / week | Titration step |
| 1.7 mg + 1.7 mg / week | Titration step |
| 2.4 mg + 2.4 mg / week | Target maintenance dose studied |
Results in clinical trials
REDEFINE 1 enrolled 3,417 adults with obesity and found a mean body weight reduction of 20.4% at 68 weeks versus 3.0% on placebo. REDEFINE 4, a head-to-head against tirzepatide reported in February 2026, showed CagriSema producing slightly less weight loss than tirzepatide at 84 weeks — short of the superiority Novo Nordisk had hoped to demonstrate.
Side effects
Common
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Decreased appetite
- Injection site reactions
Serious (rare)
- Pancreatitis (class risk)
- Gallbladder disease (class risk)
- Kidney injury from dehydration
- Full profile pending FDA review
How much does CagriSema cost?
No US price exists yet. Pricing will be set at launch if the FDA approves it:
| Route | Typical cost |
|---|---|
| Current US price | Not available — under FDA review |
| Expected decision | Q4 2026 (no confirmed PDUFA date) |
| Likely comparison point | Wegovy cash-pay, ~$499 / month |
| Available alternative today | Wegovy or Zepbound, both FDA-approved |
No US price exists until the FDA approves a drug. For what clinics charge for approved GLP-1s today, see our clinic pricing study.
Frequently asked questions
When will CagriSema be approved?
Novo Nordisk submitted its application in December 2025 and expects a US decision in the fourth quarter of 2026. No public PDUFA date has been confirmed, and the FDA can extend a review, so treat the timing as guidance rather than a commitment.
Is CagriSema better than Zepbound?
The head-to-head says no. REDEFINE 4 compared CagriSema directly to tirzepatide over 84 weeks and CagriSema produced slightly less weight loss, missing the superiority Novo was targeting. It remains a strong drug — roughly 20.4% average loss in REDEFINE 1 — just not the tirzepatide-beater the market expected.
What is cagrilintide?
A long-acting synthetic version of amylin, a hormone released with insulin that signals fullness through brain receptors distinct from the GLP-1 pathway. On its own it produces modest weight loss; the point of CagriSema is stacking it with semaglutide so two independent satiety systems are engaged at once.
Can I get CagriSema now?
No. It is under FDA review and cannot be legally prescribed or dispensed in the United States. If you want treatment now, Wegovy and Zepbound are the approved options to discuss with a provider.
Related medications
Guides
Primary sources
- Novo Nordisk submits NDA to the FDA for CagriSema — Novo Nordisk
- CagriSema NDA submission and REDEFINE 1 results — Pharmaceutical Executive
This page is for educational purposes only and is not medical advice. CagriSema is an investigational drug that has not been approved by the FDA and cannot be legally prescribed or dispensed in the United States. Products sold online under this name are unregulated. GLPFinders is a directory service and does not prescribe, sell, or dispense medications.