When is the CagriSema PDUFA date and is it FDA approved yet?

The short answer

No PDUFA date for CagriSema has been made public. Novo Nordisk filed the NDA on 18 December 2025 and guides to a US decision in Q4 2026, which fits the standard review clock. CagriSema is not approved anywhere in the US yet — and it is already being sold on the grey market as a "research peptide."

Evidence tier: Tier 1 for the REDEFINE trial results (large phase 3 RCTs, NEJM-published); Tier 2 for regulatory timing, which rests on company guidance rather than a confirmed FDA date. Educational content, not medical advice.

The key points:

• No public PDUFA date exists. Anyone quoting a specific one is guessing.
• NDA filed 18 December 2025; Novo guides to a US decision in Q4 2026.
• REDEFINE 1: 20.4% mean weight loss at 68 weeks vs 14.9% for semaglutide alone.
• The combination is sub-additive, not synergistic — worth understanding before the headlines.
• It is not approved, and unapproved copies are already circulating.

When is the CagriSema PDUFA date?

Evidence tier: 2 — company guidance, no confirmed FDA date.

There isn't one publicly.

Novo Nordisk submitted the New Drug Application to the FDA on 18 December 2025, which started the review clock. Neither the FDA nor Novo Nordisk has publicly confirmed a PDUFA date — the target date by which the agency aims to complete its review.

What Novo has said is that it expects a US decision in Q4 2026. That is consistent with the standard ten-to-twelve-month review clock for a new molecular entity, counted from filing.

So the honest position, as of August 2026, is:

• Filed: 18 December 2025
• Confirmed PDUFA date: none published
• Company guidance: decision expected Q4 2026
• Approval status: not approved

If you see a specific PDUFA date quoted, treat it with suspicion. Several sites publish confident-looking dates that appear to be back-calculated from the filing date rather than sourced from either the FDA or Novo. Back-calculation is a reasonable estimate; it is not the same as a confirmed date, and the distinction matters if you are planning around it.

What is CagriSema?

Evidence tier: 1 — established pharmacology.

CagriSema is a fixed-dose combination of cagrilintide and semaglutide, delivered as a single once-weekly injection. It is the first once-weekly combination of a GLP-1 analogue and an amylin analogue for weight management.

The two components work through separate pathways:

Semaglutide is the GLP-1 receptor agonist already familiar as Ozempic and Wegovy. It slows gastric emptying, acts on hypothalamic appetite circuits, and improves glycaemic control.

Cagrilintide is a long-acting analogue of amylin, a hormone co-secreted with insulin by pancreatic beta cells. Amylin signalling promotes satiety and slows gastric emptying through a mechanism distinct from GLP-1 — which is the rationale for combining them rather than simply raising the semaglutide dose.

The theory is that hitting two separate satiety pathways produces greater weight reduction than saturating either one. The trials tested that theory directly, and the result is more interesting than the headline suggests.

This page focuses on regulatory status and availability. For the full pharmacology, side-effect profile and comparison against tirzepatide and retatrutide, see our CagriSema deep dive and the standalone cagrilintide explainer.

What did the REDEFINE trials show?

Evidence tier: 1 — phase 3, randomised, NEJM-published.

REDEFINE 1 enrolled adults with overweight or obesity without type 2 diabetes, over 68 weeks:

• **CagriSema — Mean weight loss: 20.4%**
• Semaglutide alone — Mean weight loss: 14.9%
• Cagrilintide alone — Mean weight loss: 11.5%
• Placebo — Mean weight loss: 3.0%

Among CagriSema participants, 60% lost at least 20% of body weight and 23% lost 30% or more. Under a full-adherence analysis the mean rose to 22.7%, with 40.4% achieving at least 25% loss.

REDEFINE 2, in adults with type 2 diabetes, produced 13.7% mean weight loss versus 3.4% for placebo (15.7% with full adherence). Glycaemic results were strong: 74% reached HbA1c ≤6.5% versus 15.9% on placebo, and 88% of participants with prediabetes returned to normoglycaemia. Blood pressure, waist circumference and lipids all improved.

These are large, well-run trials with results that would have been implausible a decade ago.

Why does the combination underperform its parts?

Evidence tier: 1 — arithmetic from the trial itself.

This is the part that rarely gets discussed, and it is the most useful thing to understand about CagriSema.

Look at REDEFINE 1 again. Semaglutide alone produced 14.9%. Cagrilintide alone produced 11.5%. If the two mechanisms simply stacked, you would expect something in the region of 26%. The combination delivered 20.4%.

The effect is sub-additive. Adding cagrilintide to semaglutide bought roughly 5.5 additional percentage points — real and clinically meaningful, but well short of what independent pathways would predict. This is entirely normal in obesity pharmacology: appetite regulation is redundant and homeostatically defended, so blocking a second route yields less than the first. It is worth knowing because the marketing narrative of "two mechanisms, therefore much more weight loss" isn't quite what the data shows.

The second thing worth understanding is the two numbers. Headlines mostly quote 22.7%; the trial's primary estimate is 20.4%. The difference is the estimand — 22.7% describes what happens under full adherence, 20.4% includes everyone regardless of whether they stayed on treatment. Real-world results are governed by the second number, and usually fall below even that, because trial participants receive support that ordinary patients do not.

For context, when initial topline results appeared they were widely read as underwhelming relative to expectations of around 25%. That reaction says more about expectation-setting than about the drug, which achieves weight loss approaching bariatric-surgery territory.

Can you buy CagriSema now?

Evidence tier: 3 — search and market observation.

Not legitimately, and this is where it gets concerning.

CagriSema is not approved in the United States. There is no legal prescription route, no pharmacy supply, and no compounding pathway — compounding requires a drug shortage or specific circumstances that do not apply to an unapproved investigational combination.

Despite that, there is visible search demand for buying it: queries for CagriSema "online", "20mg", as a "research peptide", plus requests for cagrilintide certificates of analysis and purity data. That pattern is unmistakable — people are attempting to source an unapproved drug from grey-market suppliers ahead of any regulatory decision.

The risks compound in a way worth spelling out:

• No reference standard exists for finished CagriSema. A COA can attest to a supplier's cagrilintide, but nobody outside Novo Nordisk is producing the validated fixed-dose combination that was trialled.
• The trial results do not transfer. REDEFINE tested a specific formulation at specific doses with a specific titration. A grey-market vial of "cagrilintide + semaglutide" is not that product, and its results are unknown.
• Titration matters here. Amylin analogues carry meaningful gastrointestinal burden, and the trials used structured dose escalation that a self-administered protocol will not replicate.
• You are early, not clever. The plausible upside of taking this now rather than in six to twelve months is small; the downside of an unvalidated combination product is not.

If you are already using a GLP-1 and considering this, the useful comparison is with what is approved and available — covered in our CagriSema deep dive.

Limitations

This is educational content, not medical advice.

• Regulatory timing can change. The FDA can extend a review, request more data, or issue a complete response letter. Q4 2026 is company guidance, not a commitment.
• No confirmed PDUFA date exists, so any timeline here is an estimate.
• REDEFINE trial participants received structured support — dietary counselling, titration supervision, adherence monitoring — that ordinary use does not include.
• Long-term data is limited. REDEFINE 1 ran 68 weeks. Obesity is a chronic condition and durability beyond that is not yet established.
• Cardiovascular outcome data is not yet available for the combination.
• Nothing here describes how to obtain or use unapproved products.
• Marko Maal, MSc Pharmacy reviewed this article. Reviewer attribution does not constitute a doctor-patient relationship.

The bottom line

There is no public PDUFA date for CagriSema. Novo Nordisk filed on 18 December 2025 and expects a US decision in Q4 2026, which is a reasonable estimate from the standard review clock but not a confirmed date — and sites quoting specific dates are, as far as we can tell, back-calculating rather than reporting.

The drug itself is genuinely impressive. Twenty percent mean weight loss at 68 weeks, with 23% of participants losing more than 30%, is a substantial advance. The honest framing is that combining amylin and GLP-1 agonism gains roughly five and a half percentage points over semaglutide alone rather than the additive gain the mechanism story implies, and that the widely-quoted 22.7% is the full-adherence figure rather than the primary result.

What deserves more attention than the approval date is that an unapproved fixed-dose combination is already being sought on the grey market, with people asking for certificates of analysis on a product whose validated form does not exist outside a Novo Nordisk facility. If CagriSema is right for you, it will be available on prescription, properly dosed and titrated, plausibly within a year. That is a short wait for a product that has actually been through the process it is being judged on.

Related on this site

• CagriSema
• Semaglutide
• CagriSema deep dive: the GLP-1 + amylin combo explained
• Cagrilintide: the amylin analog explained
• Peptide legal status by region
• How to verify a peptide vendor
• Our evidence-tier framework

References

• Novo Nordisk NDA submission to FDA for CagriSema, 18 December 2025 — first once-weekly GLP-1 plus amylin analogue combination for weight management; US decision guided to Q4 2026. No PDUFA date publicly confirmed as of August 2026.
• REDEFINE 1, published in NEJM — adults with overweight or obesity without type 2 diabetes, 68 weeks. CagriSema 20.4% mean weight loss (22.7% full adherence) vs semaglutide 14.9%, cagrilintide 11.5%, placebo 3.0%; 60% lost ≥20%, 23% lost ≥30%, 40.4% lost ≥25% under full adherence.
• REDEFINE 2 — adults with type 2 diabetes. CagriSema 13.7% mean weight loss (15.7% full adherence) vs 3.4% placebo; 74% achieved HbA1c ≤6.5% vs 15.9% placebo; 88% of participants with prediabetes returned to normoglycaemia.