Cagrilintide and CagriSema: Trial Results, FDA Status, and Timeline

Cagrilintide is Novo Nordisk's once-weekly amylin analogue, best known as half of CagriSema, an investigational obesity combination. Here is what the REDEFINE Phase 3 trials showed and where the FDA filing stands as of July 2026.

The short answer

Cagrilintide is a once-weekly amylin analogue from Novo Nordisk; its flagship is CagriSema, a fixed-dose combination of cagrilintide 2.4 mg plus semaglutide 2.4 mg. As of July 10, 2026 it is investigational and NOT FDA-approved or available. Novo Nordisk filed its U.S. New Drug Application on December 18, 2025, and an FDA decision is anticipated by late 2026, with a possible launch in late 2026 or early 2027 if approved.

Molecule / mechanism	Cagrilintide is a long-acting amylin analogue (once-weekly). Its flagship is CagriSema, a fixed-dose combination of cagrilintide 2.4 mg + semaglutide 2.4 mg (a GLP-1 receptor agonist) that curbs hunger and increases fullness (Novo Nordisk, Dec 18, 2025).
Developer	Novo Nordisk (Bagsvaerd, Denmark).
Route & frequency	Subcutaneous injection, once weekly.
Trial program	REDEFINE (obesity) and REIMAGINE (type 2 diabetes) Phase 3 programs; roughly 4,600 adults across the two pivotal REDEFINE trials (Novo Nordisk).
Headline efficacy — REDEFINE 1	68-week Phase 3 (3,417 adults, obesity without diabetes): CagriSema achieved 22.7% weight loss if all stayed on treatment (trial-product estimand) vs 16.1% semaglutide, 11.8% cagrilintide alone, 2.3% placebo; 20.4% under the treatment-policy estimand. Only 57% reached the top dose (Novo Nordisk, Dec 20, 2024).
Headline efficacy — REDEFINE 2	68-week Phase 3 (1,206 adults with type 2 diabetes + obesity/overweight): CagriSema 15.7% weight loss vs 3.1% placebo if all adhered; 89.7% lost at least 5% of body weight (Novo Nordisk, Mar 10, 2025).
Head-to-head — REDEFINE 4	84-week open-label Phase 3 (809 adults) vs tirzepatide 15 mg: CagriSema 23.0% vs tirzepatide 25.5% if all adhered (20.2% vs 23.6% treatment-regimen estimand). CagriSema did NOT meet its non-inferiority primary endpoint (Novo Nordisk, Feb 23, 2026).
Regulatory status (as of July 2026)	Investigational — NOT FDA-approved and not commercially available. Novo Nordisk submitted the U.S. NDA for chronic weight management on Dec 18, 2025, based on REDEFINE 1 and REDEFINE 2. No public PDUFA date confirmed.
Expected approval / launch	FDA decision anticipated by late 2026 (Q4 2026 per Novo's Q1 2026 investor materials); if approved on that timeline, commercial launch most likely late 2026 or early 2027. Not guaranteed.
Vs tirzepatide / semaglutide	Beats semaglutide 2.4 mg (Wegovy) head-to-head in REDEFINE 1 (22.7% vs 16.1%). Trails tirzepatide 15 mg (Zepbound) in the head-to-head REDEFINE 4 (23.0% vs 25.5%), missing non-inferiority.

What cagrilintide and CagriSema are

Cagrilintide is a long-acting amylin analogue developed by Novo Nordisk and given as a once-weekly subcutaneous injection. Amylin is a hormone released with insulin that signals fullness and slows how fast the stomach empties, so an amylin analogue is designed to reduce appetite through a pathway that is different from GLP-1 medicines.

Cagrilintide's flagship is CagriSema, a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, the same GLP-1 receptor agonist used in Wegovy and Ozempic. The idea is that pairing an amylin analogue with a GLP-1 agonist hits two complementary appetite pathways at once. If approved, Novo Nordisk says CagriSema would be the first injectable combination of a GLP-1 receptor agonist and an amylin analogue (Novo Nordisk, December 18, 2025).

Important: as of July 10, 2026, both cagrilintide alone and CagriSema are investigational. They are not FDA-approved and are not available by prescription in the United States.

What the REDEFINE trials showed

REDEFINE 1 was a 68-week Phase 3 trial in 3,417 adults with obesity, or overweight with a weight-related complication, and without diabetes. CagriSema produced 22.7% average weight loss at 68 weeks if all participants stayed on treatment (the trial-product estimand), compared with 16.1% for semaglutide 2.4 mg alone, 11.8% for cagrilintide 2.4 mg alone, and 2.3% for placebo. Under the treatment-policy estimand, which counts everyone regardless of whether they stopped, CagriSema reached 20.4% versus 3.0% for placebo. Notably, only about 57% of participants reached the highest CagriSema dose (Novo Nordisk, December 20, 2024).

REDEFINE 2 was a 68-week Phase 3 trial in 1,206 adults with type 2 diabetes plus obesity or overweight. CagriSema produced 15.7% weight loss versus 3.1% for placebo if all adhered, and 89.7% of those on CagriSema lost at least 5% of their body weight (Novo Nordisk, March 10, 2025). Weight loss is typically smaller in people with type 2 diabetes, which is consistent with what other obesity drugs have shown.

Estimand matters here: the higher percentages describe an idealized scenario in which everyone takes the drug as directed, while the treatment-policy figures reflect real-world dropout. Both are reported so the numbers are not overstated.

How CagriSema compares to tirzepatide and semaglutide

Against semaglutide, CagriSema looks stronger. In REDEFINE 1 the combination beat semaglutide 2.4 mg head-to-head, 22.7% versus 16.1% at 68 weeks, indicating that adding cagrilintide delivered additional weight loss beyond semaglutide on its own (Novo Nordisk, December 20, 2024).

Against tirzepatide, the picture is less favorable. In the head-to-head REDEFINE 4 trial, an 84-week open-label study in 809 adults, CagriSema achieved 23.0% weight loss versus 25.5% for tirzepatide 15 mg if all adhered (20.2% versus 23.6% under the treatment-regimen estimand). CagriSema did not meet its primary endpoint of proving non-inferiority to tirzepatide, so on this direct comparison tirzepatide came out ahead (Novo Nordisk, February 23, 2026).

In short: current data suggest CagriSema may outperform semaglutide but trails tirzepatide (Zepbound) on head-to-head weight loss. Novo Nordisk is studying higher-dose combinations to try to close that gap.

Regulatory timeline as of July 2026

Novo Nordisk submitted its U.S. New Drug Application for CagriSema for chronic weight management on December 18, 2025, based on the REDEFINE 1 and REDEFINE 2 pivotal trials. A filing is a request for approval, not an approval (Novo Nordisk, December 18, 2025).

Novo Nordisk's Q1 2026 investor materials point to an FDA decision in Q4 2026, roughly October through December. As of mid-2026 no public PDUFA target date or priority-review status had been confirmed. If approved on the expected timeline, Novo has guided toward a commercial launch in late 2026 or early 2027. None of these dates are guaranteed.

Development continues in parallel. The REDEFINE 11 trial, exploring CagriSema's fuller weight-loss potential over a longer duration, is expected to read out in the first half of 2027, and a higher-dose CagriSema (2.4 mg/7.2 mg) Phase 3 trial is planned to start in the second half of 2026 (Novo Nordisk, February 23, 2026).

What this means for patients right now

You cannot get cagrilintide or CagriSema today. Neither is FDA-approved, and there is no legitimate way to buy either one in the United States as of July 2026. Products marketed online as 'compounded CagriSema,' 'research cagrilintide,' or peptide vials are not FDA-approved for safety, effectiveness, or quality, and they are not a legal or safe workaround. Because CagriSema is investigational, no approved compounded version can exist.

If you are looking for weight-management treatment now, FDA-approved options such as semaglutide and tirzepatide are already available through licensed clinicians. In the REDEFINE 1 trial, reported side effects with CagriSema were mostly gastrointestinal, including nausea, vomiting, diarrhea, constipation, and abdominal pain. This page is general information, not medical advice; decisions about any medication should be made with a licensed healthcare professional.

We update this page when CagriSema's regulatory status materially changes.

References(1)

Our sourcing standards →

REDEFINE 1 — CagriSema phase 3 obesity trial (22.7% weight loss, fully adherent) — ClinicalTrials.gov

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Common questions about Cagrilintide (CagriSema)

Is cagrilintide (CagriSema) FDA approved?

No. As of July 10, 2026, neither cagrilintide nor CagriSema is FDA-approved or commercially available in the United States. Novo Nordisk submitted its New Drug Application to the FDA on December 18, 2025, for chronic weight management, but a filing is not an approval. The FDA decision is anticipated by late 2026 (Novo Nordisk; Novo Q1 2026 investor materials).

When will CagriSema be available?

Novo Nordisk's Q1 2026 investor materials point to an FDA decision in Q4 2026 (roughly October-December 2026). If approved on that timeline, a commercial launch would most likely follow in late 2026 or early 2027. Widespread pharmacy stocking and insurance coverage usually lag the launch. None of these dates are guaranteed.

How much weight did people lose with CagriSema?

In the 68-week REDEFINE 1 trial (3,417 adults with obesity, no diabetes), CagriSema produced 22.7% average weight loss if all participants stayed on treatment, or 20.4% under the treatment-policy estimand (which counts people regardless of whether they stopped). In REDEFINE 2 (68 weeks, adults with type 2 diabetes), the figure was 15.7% versus 3.1% for placebo (Novo Nordisk, Dec 2024 and Mar 2025).

CagriSema vs tirzepatide (Zepbound) — which works better?

In the head-to-head REDEFINE 4 trial (84 weeks, 809 adults), CagriSema achieved 23.0% weight loss versus 25.5% for tirzepatide 15 mg if all adhered (20.2% vs 23.6% under the treatment-regimen estimand). CagriSema did not meet its goal of proving non-inferiority to tirzepatide, so on this direct comparison tirzepatide came out ahead (Novo Nordisk, Feb 23, 2026).

CagriSema vs semaglutide (Wegovy) — which is stronger?

In REDEFINE 1, CagriSema outperformed semaglutide 2.4 mg head-to-head: 22.7% versus 16.1% weight loss at 68 weeks (trial-product estimand). Adding the amylin analogue cagrilintide to semaglutide produced meaningfully more weight loss than semaglutide alone (Novo Nordisk, Dec 20, 2024).

Can I buy compounded cagrilintide or CagriSema now?

No legitimate compounded version exists. Cagrilintide and CagriSema are investigational and not FDA-approved, so any product sold as 'compounded CagriSema' or 'research cagrilintide' is not a legal or safe workaround. Compounded products are not FDA-approved for safety, effectiveness, or quality. Talk to a licensed clinician about approved options.

What are the side effects of CagriSema?

In the REDEFINE 1 trial, the most common side effects were gastrointestinal. Gastrointestinal adverse events were reported by 79.6% of people on CagriSema versus 39.9% on placebo, and included nausea, vomiting, diarrhea, constipation, and abdominal pain. The trial investigators reported these events were mostly mild to moderate and transient, consistent with the GLP-1 drug class. This is general information, not medical advice, and side effects can vary from person to person (REDEFINE 1, New England Journal of Medicine, June 22, 2025).

What is cagrilintide on its own?

Cagrilintide is a long-acting amylin analogue given once weekly. In REDEFINE 1, cagrilintide 2.4 mg used alone produced 11.8% weight loss at 68 weeks. Its main development is as one half of CagriSema, where it is paired with semaglutide to target complementary weight-related pathways (Novo Nordisk, Dec 20, 2024).

Sources

Novo Nordisk — Files for FDA approval of CagriSema (NDA submission) (2025-12-18); Novo Nordisk / GlobeNewswire — REDEFINE 4 head-to-head vs tirzepatide; primary endpoint not met (2026-02-23); Novo Nordisk / GlobeNewswire — REDEFINE 1 headline results (2024-12-20); REDEFINE 1 primary results — Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (New England Journal of Medicine; safety/adverse-event data) (2025-06-22); Novo Nordisk / Nasdaq — REDEFINE 2 headline results (type 2 diabetes) (2025-03-10); PR Newswire (Novo Nordisk Inc.) — CagriSema NDA filing details and efficacy/safety data (2025-12-18); The RX Index — CagriSema FDA Approval Status (Q4 2026 decision window, not approved) (2026-05-22); Drugs.com — CagriSema: What is it and is it FDA approved? (2026-02-23); REDEFINE 1 blood pressure analysis (Hypertension / PMC) — trial design and NCT05567796 (2026-02-01). Trial data, regulatory status, and timelines for investigational drugs change frequently — confirm before acting. Educational information, not medical advice. Last reviewed 2026-07-10.