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CagriSema news: Novo Nordisk's trials, filing and approval timeline

Novo Nordisk filed CagriSema with the FDA in December 2025 and expects a decision in the fourth quarter of 2026. Every trial result to date, dated and sourced, and why no price exists yet.

In-depth guide 17 sources Updated

At a glance

Topic
CagriSema
Topic guide
Cagrilintide + semaglutide (CagriSema)
Sources
17 cited, numbered at the bottom; each [n] mark links to its source
Updated

CagriSema is not approved anywhere yet. Novo Nordisk submitted a New Drug Application for once-weekly CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg) to the US Food and Drug Administration in December 2025 [1], and the company's most recent statement, on 20 October 2026, says it expects an FDA decision in the fourth quarter of 2026 [2]. The filing rests on two completed phase 3 trials, REDEFINE 1 and REDEFINE 2 [3].

This page is the dated record behind that answer: every CagriSema trial readout, publication and regulatory step from phase 2 to October 2026, with the source for each. For what CagriSema is and every trial arm in detail, start with the main CagriSema guide. For the doses the trials gave and the escalation steps, see the CagriSema dosing schedule. For how CagriSema fits among the other obesity drugs announced in 2025 and 2026, see new weight-loss drugs.

Compiled from 17 indexed sources, updated . Cited findings carry an evidence tier; passages written from general knowledge are marked editorial synthesis. Nothing here is medical or dosing advice. What changed

Where CagriSema stands in October 2026

Filed in the US, under FDA review, not approved, no price.

The application Novo Nordisk sent to the FDA asks for CagriSema to be approved to reduce excess body weight and maintain that reduction long term, alongside diet and physical activity, in adults with obesity, or with overweight and at least one weight-related condition [1]. If approved it would be the first injectable combination of a GLP-1 receptor agonist and an amylin analogue [1].

The timing has been stated three times. In December 2025 Novo said the FDA was expected to review the application in 2026 [1]. In February 2026 it said a decision was anticipated by late 2026 [3]. On 20 October 2026 it said a decision is expected in Q4 2026, and repeated that CagriSema is not approved in the United States and that its safety and efficacy have not been established [2].

Three things follow from that. There is no approved label, so no approved dose, population or warning list exists yet. There is no price. And the filing covers weight management in adults; the type 2 diabetes trials (REIMAGINE) and the trials in children are separate programmes whose results have not been named as part of this application [3].

CagriSema timeline, 2021 to 2026

Each row is a dated event with its source. Percentages are mean weight change from baseline unless stated.

CagriSema news and trial timeline, from the first cagrilintide trial to the pending FDA decision
DateEventWhat it showed
16 Nov 2021Cagrilintide phase 2 published (alone, 26 weeks, 706 on cagrilintide)Weight down 6.0% to 10.8% across doses vs 3.0% on placebo [4]
23 Jun 2023CagriSema phase 2 in type 2 diabetes published (92 adults, 32 weeks)Weight -15.6% vs -5.1% on semaglutide alone; HbA1c -2.2 vs -1.8 points [5]
20 Dec 2024REDEFINE 1 topline (3,417 adults without diabetes, 68 weeks)22.7% if taken as intended, 20.4% regardless of adherence; semaglutide alone 16.1%, cagrilintide alone 11.8%, placebo 2.3% [6]
10 Mar 2025REDEFINE 2 topline (1,206 adults with type 2 diabetes, 68 weeks)15.7% if taken as intended, 13.7% regardless of adherence, vs 3.1% and 3.4% on placebo [7]
22 Jun 2025REDEFINE 1 and REDEFINE 2 published in full-20.4% vs -3.0% [8]; -13.7% vs -3.4% [9]
16 Sep 2025Cagrilintide-alone arm of REDEFINE 1 presented; RENEW phase 3 announced11.8% vs 2.3% on placebo at 68 weeks if taken as intended [10]
2 Dec 2025Trial in children and adolescents registeredAbout 460 participants from age 8, 68 weeks, as reported [11]
18 Dec 2025New Drug Application submitted to the FDAWeight management in adults, based on REDEFINE 1 and 2 [1]
23 Feb 2026REDEFINE 4 topline: head to head with tirzepatide 15 mg (809 adults, 84 weeks)23.0% vs 25.5%; primary endpoint of non-inferiority not met [3]
17 Apr 2026REDEFINE 5 published (331 adults, Japan and Taiwan)-18.4% vs -11.9% on semaglutide alone [12]
7 Jun 2026REIMAGINE 1, 2 and 3 published (type 2 diabetes)Blood-sugar trials on diet alone, on metformin, and on basal insulin [13][14][15]
20 Oct 2026Post hoc REDEFINE 1 analysis in women25.0% vs 3.0% in 2,309 women if taken as intended; labelled hypothesis-generating [2]
Q4 2026 (expected)FDA decisionCompany guidance, not an FDA date [2]

The CagriSema trial programme and why the numbers differ

Novo Nordisk runs CagriSema through two phase 3 programmes. REDEFINE tests weight management; REIMAGINE tests blood-sugar control in type 2 diabetes. Before both came a phase 2 trial in 92 adults with type 2 diabetes on metformin, which gave the first signal: over 32 weeks the combination lowered weight by 15.6% against 5.1% for semaglutide alone and 8.1% for cagrilintide alone [5]. On HbA1c that trial did not separate the combination from semaglutide alone (-2.2 vs -1.8 points, p=0.075) [5], which is a pattern the later diabetes trials repeated on a smaller scale.

Most of the confusion in CagriSema news comes from two ways of counting the same trial. Novo's announcements lead with the figure that assumes everyone took the drug as intended; the journal papers lead with the figure that counts everyone randomised, whether or not they kept taking it. For REDEFINE 1 that is 22.7% versus 20.4% [6][8]. Neither number is wrong. They answer different questions, and a news story that compares one trial's adherent figure with another drug's intention-to-treat figure is comparing different things.

The other recurring point is the dose actually reached. At week 68 of REDEFINE 1, 57.3% of people on CagriSema were on the top dose, against 70.2% on semaglutide alone [6]. The trial allowed dose reductions for tolerability, so the result reflects how people got on with escalation as well as what the full dose does. The dosing schedule page sets out the escalation the trials used, as trial protocol and not as a regimen to follow.

For the arms that compared CagriSema directly with each component, including REDEFINE 5 against semaglutide alone (18.4% vs 11.9%) [12], see cagrilintide vs semaglutide.

REDEFINE 4: the head-to-head result against tirzepatide

REDEFINE 4 is the CagriSema trial most often cited in news coverage, because it compared CagriSema directly with tirzepatide 15 mg, the highest dose of the active ingredient in Zepbound. It randomised 809 adults with obesity and at least one related condition and ran for 84 weeks, open label, because tirzepatide 15 mg was commercially available only in its own pen [3].

Weight fell 23.0% on CagriSema and 25.5% on tirzepatide among people who took treatment as intended, and 20.2% versus 23.6% counting everyone regardless of adherence [3]. The primary endpoint was non-inferiority, meaning the trial asked whether CagriSema was not meaningfully worse than tirzepatide. It did not meet that endpoint [3]. Novo described CagriSema as appearing safe and well tolerated, with mostly mild-to-moderate gastrointestinal events that diminished over time [3].

REDEFINE 4 is not part of the FDA filing as Novo described it; the filing rests on REDEFINE 1 and 2 [3]. The same announcement listed what comes next in the programme: REDEFINE 11 results in the first half of 2027, and a phase 3 trial of a higher-dose CagriSema (cagrilintide 2.4 mg with semaglutide 7.2 mg) planned to start in the second half of 2026 [3].

When will CagriSema be available?

The honest answer is a range, not a date.

The earliest point at which CagriSema could be prescribed in the United States is after an FDA approval, and Novo expects the FDA's decision in the fourth quarter of 2026 [2]. That is company guidance, not a date published by the FDA, and a regulatory decision is not necessarily an approval. Any specific launch month circulating online is an inference from that guidance, not an announcement.

Approval and availability are also two different events. When Novo's Wegovy pill was approved on 22 December 2025, the company said it expected to launch in early January 2026 [16], and it announced broad availability on 5 January 2026 [17]. CagriSema's launch timing after any approval will be set by Novo and announced by Novo.

Outside the US, the Novo announcements cited on this page describe only the US filing [1][2]. Until a filing elsewhere is announced, no date for Europe, the UK, Canada or anywhere else can be stated. Products sold online as "CagriSema" or as cagrilintide before approval are not the trial product; the cagrilintide record explains why their identity is unknown.

CagriSema cost and price: why there is no number yet

No price for CagriSema has been published. A manufacturer sets a list price at or after approval; Novo's filing announcement and its October 2026 announcement contain no pricing information [1][2]. Any CagriSema price or monthly cost quoted before approval is an estimate by whoever wrote it.

The only Novo prices on record for this drug class are for products already approved. At the Wegovy pill's US launch on 5 January 2026, Novo listed self-pay prices of $149 a month for the 1.5 mg starting dose and $149 for 4 mg through 15 April 2026 [17]. Those figures describe a different product and say nothing about what CagriSema will cost or how insurers will cover it. This page will add a CagriSema price when Novo publishes one, with its date.

What to watch for next in CagriSema news

  • The FDA decision, expected by Novo in Q4 2026 [2]. If approved, the label will fix the approved population, dose steps and warnings, which no source can state today.
  • REDEFINE 11, with results expected in the first half of 2027 [3].
  • Higher-dose CagriSema: cagrilintide 2.4 mg with semaglutide 7.2 mg, in a phase 3 trial planned from the second half of 2026 [3].
  • Children and adolescents: a 68-week trial in about 460 young people from age 8, with arms for CagriSema, each component alone and placebo, as reported in December 2025 [11].
  • Cagrilintide on its own, which Novo moved into its own phase 3 programme, RENEW, after the cagrilintide-alone arm of REDEFINE 1 showed 11.8% weight loss [10].

Post hoc analyses, such as the October 2026 figure of 25.0% in women, will keep appearing as conference news. Novo itself calls that analysis hypothesis-generating and notes its p-values were not adjusted for multiple comparisons [2]; it does not replace the trial's primary result.

More in this topic

This guide is part of Cagrilintide + semaglutide (CagriSema).

Questions people ask

Is CagriSema FDA approved?

No. Novo Nordisk filed for FDA approval in December 2025 [1] and, as of 20 October 2026, said CagriSema is not approved in the United States and a decision is expected in Q4 2026 [2].

When will CagriSema be available?

Not before an FDA approval, which Novo expects to be decided in the fourth quarter of 2026 [2]. Launch timing after any approval is set by Novo; no launch date has been announced.

How much will CagriSema cost?

No price exists yet. Novo's filing and October 2026 announcements contain no pricing [1][2]. A list price is normally set at or after approval.

What did the CagriSema phase 3 trial show?

In REDEFINE 1, 3,417 adults without diabetes lost 20.4% of body weight over 68 weeks on CagriSema against 3.0% on placebo, counting everyone randomised [8]. Novo's adherent-only figure for the same trial is 22.7% [6].

Did CagriSema beat tirzepatide?

No. In REDEFINE 4, CagriSema produced 23.0% weight loss against 25.5% for tirzepatide 15 mg over 84 weeks and did not meet its non-inferiority endpoint [3].

What were the CagriSema phase 2 results?

In 92 adults with type 2 diabetes over 32 weeks, weight fell 15.6% on CagriSema against 5.1% on semaglutide alone and 8.1% on cagrilintide alone; HbA1c fell 2.2 points against 1.8 on semaglutide [5].

Sources

Numbered in the order they are first cited. The bracketed numbers in the text link straight to these.

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    Novo Nordisk to test next-gen obesity drug CagriSema in children
    reuters-cagrisema-children · · other
  12. 12
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Last reviewed and what changed

  1. · Written: CagriSema news and dated timeline from phase 2 to the pending FDA decision (Q4 2026 per Novo), REDEFINE 4 head-to-head, availability and the price boundary.