Is CagriSema FDA approved?

No. Drugs@FDA holds no approved application for it, checked on 2026-08-28. That check is worth stating precisely because the same query returns six applications for semaglutide, so the absence is a real answer rather than a failed search — about approval only, since Drugs@FDA does not list applications under review. One is: Novo Nordisk submitted a New Drug Application to the FDA on 18 December 2025, based on REDEFINE 1 and REDEFINE 2, and says the FDA is expected to review it in 2026. Until an application is approved there is no legal route to buy it in the United States outside a clinical trial, at any price.

What does CagriSema cost?

Nothing, because it cannot be bought. There is no list price, no cash price and no savings program, and any figure circulating is either a forecast or an invention. When it is approved and sold, it will get a card on this site with the price, its source and the date it was read, the same as everything else here.

Semaglutide is approved. Why can't I just take that with cagrilintide?

Because cagrilintide on its own is not approved either, and a combination is assessed as a new product with its own trials rather than as the sum of two prescriptions. What you can do today is take semaglutide, which is approved, sold, and priced on this site under Wegovy and Ozempic. What the trials are testing is whether the pairing beats it by enough to matter — a question the published results will settle and this page will not pre-empt.

CagriSema: when can you actually buy it?

You cannot: CagriSema holds no approved application in the United States, though one is under FDA review, filed 2025-12-18. It is cagrilintide and semaglutide combined in one weekly injection, pairing an amylin analog with a GLP-1, developed by Novo Nordisk. Every other page on this site carries a price; this one carries the public record there is instead — the filing and the phase 3 trial program.

When will CagriSema be available, and what will it cost?

No approval date has been published by anyone, and no price exists because nothing is for sale. What is public is the filing and the trial program. CagriSema has 12 phase 3 trials in obesity or overweight registered on ClinicalTrials.gov, enrolling 10,594 people between them, the largest of them 3,400. 5 have completed and 6 are still running, and 1 was withdrawn before enrolling anyone, with the last reaching primary completion in March 2030. Those dates do not bound the approval here: Novo Nordisk submitted a New Drug Application to the FDA on 18 December 2025, based on REDEFINE 1 and REDEFINE 2, and says the FDA is expected to review it in 2026. Drugs@FDA was checked on 2026-08-28 and holds no approved application for this molecule, against six for semaglutide — a finding about approval, not about filing, because Drugs@FDA does not list applications still under review.

The trial program

Sponsor	Novo Nordisk
Approved in the US	no — no approved application in Drugs@FDA
Filed with the FDA	2025-12-18, announced by Novo Nordisk
Phase 3 trials in obesity or overweight	12
Completed	5 of 12
Still running	6
Withdrawn before enrolling	1
Participants enrolled across them	10,594
Largest single trial	3,400 participants
Last primary completion	March 2030

Counted from ClinicalTrials.gov on 2026-08-28, restricted to phase 3 studies whose registered condition is obesity, overweight or weight. Approval status checked against Drugs@FDA the same day.

What is worth knowing now

CagriSema is half a drug you can already buy: semaglutide is approved and sold, and it is what Wegovy and Ozempic are. What is not approved is the pairing with cagrilintide, and the combination is regulated as its own product rather than as semaglutide with something added — which is why no part of it can be bought early. It carries the biggest program of the three, twelve phase 3 trials in obesity or overweight registered with 10,594 people enrolled, and also the longest tail: six are still running, one was withdrawn before enrolling anyone, and the last reaches primary completion in March 2030. The tail does not set the date, though. Novo Nordisk filed for FDA approval in December 2025 on the first two trials, REDEFINE 1 and REDEFINE 2, and says the review is expected in 2026 — so this is the one of the three where an approval, or a refusal, can come before its trials are done.

CagriSema, answered

Is CagriSema FDA approved?: No. Drugs@FDA holds no approved application for it, checked on 2026-08-28. That check is worth stating precisely because the same query returns six applications for semaglutide, so the absence is a real answer rather than a failed search — about approval only, since Drugs@FDA does not list applications under review. One is: Novo Nordisk submitted a New Drug Application to the FDA on 18 December 2025, based on REDEFINE 1 and REDEFINE 2, and says the FDA is expected to review it in 2026. Until an application is approved there is no legal route to buy it in the United States outside a clinical trial, at any price.
When will CagriSema be available?: Nobody has published an approval date, but the application exists: Novo Nordisk submitted a New Drug Application to the FDA on 18 December 2025, based on REDEFINE 1 and REDEFINE 2, and says the FDA is expected to review it in 2026. Its remaining trials do not hold that up — 6 of 12 are still running, the last to March 2030, and a sponsor can file on part of a program, which is what happened here. What decides the date now is the FDA's review, and a review can end in a refusal as well as an approval.
What does CagriSema cost?: Nothing, because it cannot be bought. There is no list price, no cash price and no savings program, and any figure circulating is either a forecast or an invention. When it is approved and sold, it will get a card on this site with the price, its source and the date it was read, the same as everything else here.
Semaglutide is approved. Why can't I just take that with cagrilintide?: Because cagrilintide on its own is not approved either, and a combination is assessed as a new product with its own trials rather than as the sum of two prescriptions. What you can do today is take semaglutide, which is approved, sold, and priced on this site under Wegovy and Ozempic. What the trials are testing is whether the pairing beats it by enough to matter — a question the published results will settle and this page will not pre-empt.

What you can buy today

Everything approved for this job, each with the maintenance price, its source and the date it was read.

All three, side by side →Every verified price, ranked →Which drugs are actually GLP-1s →Survodutide →Retatrutide →

Last updated 2026-08-28 — trial registry and Drugs@FDA checked. Read and dated by Alex Seot.