When Will CagriSema Be Approved? What Novo Has Filed

Novo Nordisk filed its application in December 2025 and expects a decision in the last quarter of 2026.¹ Both of those come from the company, not the FDA.

No PDUFA date exists in public. The FDA does not often publish goal dates while it is still deciding, and none turned up for this one.

Has the FDA decided anything yet?

No, and the clearest statement of that comes from Novo itself.

The company's release of October 20, 2026 states that "CagriSema is not approved for use in the United States." Elsewhere it says "Safety and efficacy are not established," and that "A decision is expected in Q4 2026."² Three days before this page was written, the sponsor was still calling the application pending.

Three database checks agree, each run with a control to prove the search worked.

Separately, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee page for 2026 states "No meetings are currently scheduled."³ So no panel has reviewed CagriSema and none is booked.

What did Novo actually file, and when?

New Drug Application for weight management, filed in December 2025.

The October release gives that date and that indication.² The February 2026 company announcement adds what the application rests on: "the REDEFINE 1 and REDEFINE 2 pivotal trials."⁴

The indication matters. The filing is for weight management, not for type 2 diabetes, even though one of the two trials behind it enrolled only people who had type 2 diabetes.⁵ So a diabetes-population trial is supporting a weight-management application.

Novo's own wording has drifted. That same announcement said the decision was "anticipated by late 2026."⁴ The September and October 2026 releases both say "expected in Q4 2026."²⁶ Quarterly reports put it in a Q4 2026 column instead. They also add that expected timing "may change."⁷⁸ None of those is a date, and the fourth quarter runs to December 31.

What is actually being combined?

Two drugs at the same dose, one of them already approved and one never approved anywhere.

CagriSema is "a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg," given once weekly by subcutaneous injection.⁹ Semaglutide has been approved for years under several brand names. Cagrilintide, an amylin analogue, has never been approved in any country in any form, alone or combined. Our REDEFINE 4 coverage explains what amylin is and what it does.

Splitting them is why REDEFINE 1 ran four arms instead of two. It tested the combination against semaglutide alone, against cagrilintide alone, and against placebo, which is how a trial can show whether the second drug contributes anything. On the adherence-assuming analysis the combination reached 22.7%, semaglutide alone 16.1% and cagrilintide alone 11.8%.¹⁰

So the application asks the FDA to clear a pairing where one half arrives with an approval history and the other half arrives with none.

Which trials is the application built on?

Two of them, and neither is the trial most people remember.

Novo's submission rests on REDEFINE 1 and REDEFINE 2.⁴ Both met their endpoints. REDEFINE 4, the open-label trial where CagriSema lost to tirzepatide, is not part of the filing basis Novo describes.

REDEFINE 3 is a cardiovascular outcomes trial with two separate objectives: "to confirm noninferiority of CagriSema compared with placebo" on a three-part cardiovascular endpoint, and "to confirm the superiority of CagriSema compared with placebo" on a four-part one that adds revascularization.¹¹ No readout date for it is public.

What did REDEFINE 1 show?

A 68-week placebo-controlled trial in 3,417 adults, with two primary endpoints rather than one.

The paper calls them "coprimary end points." One is relative change in body weight. Second is a reduction of 5% or more, both from baseline to week 68.⁵ The design was "a phase 3a, 68-week, multicenter, double-blind, placebo-controlled and active-controlled trial" in adults without diabetes. Randomization ran 21:3:3:7 across CagriSema, semaglutide alone, cagrilintide alone and placebo.⁵

The primary analysis gives "-20.4%" for CagriSema "as compared with -3.0% with placebo."⁵ Between them sits 17.3 percentage points, with a 95% confidence interval of -18.1 to -16.6 and P<0.001.⁵ The sponsor says the trial "achieved its primary endpoint."¹⁰

Gastrointestinal adverse events were far more common on the drug, reported at 79.6% against 39.9% on placebo, and described as mostly transient and mild to moderate.⁵

Why does CagriSema have three different weight-loss numbers?

Because three different analyses are in circulation and they are not interchangeable.

The December 2024 announcement is the one place that prints the first two side by side.¹⁰ Usefully, it gives the single-drug arms too. Assuming adherence, cagrilintide alone reached 11.8% and semaglutide alone 16.1%, against 22.7% for the combination. On the adherence-independent analysis the same three read 11.5%, 14.9% and 20.4%.¹⁰

The placebo value is where this trips people up. Placebo reads 3.0% in both the treatment-policy analysis and the women-only analysis, which makes a cross-estimand comparison look consistent when it is not. Putting 25.0% in women beside 20.4% for the whole trial compares an adherence-assuming analysis with an adherence-independent one and overstates the difference. Matched, the comparison is 25.0% against 22.7%.

Those labels have also been renamed between releases. December 2024 called one the "trial product estimand."¹⁰ February 2026 calls the same thing the "efficacy estimand."⁴ The "treatment policy estimand" became the "treatment-regimen estimand" over the same period.⁴¹⁰

Then October 2026 defines "efficacy estimand" differently again, as an "idealized scenario in which all patients stayed on treatment."² So the label is not stable. The footnote attached to a number is the only reliable guide to what it means.

Does the trial it lost count against the filing?

It is not part of the filing basis, and it was measuring something different.

REDEFINE 4 ran 84 weeks, not the 68 of every other trial in the program. The trial randomized 809 people with obesity and at least one comorbidity, at a mean baseline weight of 114.2 kg. Tirzepatide 15 mg was the comparator, both drugs weekly and subcutaneous. It was fully open-label, so that "all investigators and participants were aware of the specific drug administered."⁹

What it set out to show was not superiority. The announcement says the trial "did not achieve its primary endpoint of demonstrating non-inferiority."⁹ On the efficacy estimand CagriSema reached "23.0%" against "25.5% with tirzepatide 15 mg." On the treatment-regimen estimand the pair is "20.2%" and "23.6%."⁹ So the gap is 2.5 points on one analysis and 3.4 on the other.

No non-inferiority margin was disclosed. The announcement reports the miss and the point estimates and gives no margin and no explanation, so there is no sourced account of how far short it fell.

Nothing about this trial has been peer reviewed. No publication and no conference presentation of REDEFINE 4 could be found, only the sponsor announcement.

Why are there two head-to-heads against tirzepatide?

Two programs ran them, and the names are one letter apart in practice.

REDEFINE is the obesity program. REIMAGINE is the type 2 diabetes program. Both ran open-label head-to-heads against tirzepatide, which is where coverage goes wrong.

REIMAGINE 5 reported in September 2026 with "dual primary endpoints" of "change in HbA1c and relative change in body weight from baseline to week 60," and an "estimated average weight loss of 12.4%, compared with 9.1%" for tirzepatide.⁶ A separate trial, REIMAGINE 4, compared CagriSema 2.4/2.4 against tirzepatide 15 mg over 68 weeks in type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor.⁸

So the high dose lost to the high dose in obesity, and the low dose beat the low dose in diabetes. Both are true and they are not the same experiment.

What happened in the women and menopause analysis?

A post hoc look at REDEFINE 1, reported by the sponsor before the posters were presented.

The October 20, 2026 release covers 2,309 women from REDEFINE 1. The release reports "an average weight loss of 25.0% at week 68, compared with 3.0% with placebo," on the efficacy estimand.² The 2,309 is all four trial arms. The comparison itself is the 1,441 women on CagriSema against the 461 on placebo.

Responder figures are the most concrete numbers in it. Among those women, 93.3% reached at least 10% weight loss and 68.7% reached at least 20%, against 12.7% and 1.8% on placebo, with waist circumference down 20.5 cm against 4.7 cm.²

By menopause stage, the release gives 26.7% against 2.1% in premenopausal women, 24.8% against 1.7% in perimenopausal women, and 23.1% against 2.6% in postmenopausal women.²

Novo states three limits itself. "Menopause status was derived post hoc using age, medical history, and recorded symptoms." The table footnotes say "p values were not adjusted for multiplicity." They also say "formal treatment-by-subgroup interaction testing was not performed." Novo's own summary is that such analyses "are hypothesis-generating."²

Arithmetic is the fourth problem, and it sits in the release itself. Novo describes the stage analysis as covering 1,902 women, but the per-stage counts in its own table add to 1,565, leaving 337 unaccounted for.² Hormone therapy users were "evaluated as a separate group" with no figures given, which may account for some of them, but the release does not say.

No menopause symptom outcome was reported. Symptoms appear only as an input to classifying women by stage, not as something measured. Our perimenopause guide covers what has and has not been tested in that population.

What is still unpublished?

More of this program than you would expect from the coverage.

• REDEFINE 4. Sponsor announcement only, no publication, no presentation.
• REDEFINE 9. The release gives 21.0% against 2.0% for placebo at the 1.0 mg / 1.0 mg dose with the primary superiority endpoint met, and names a 1.7 mg / 1.7 mg arm without giving any figure for it.⁶ The quarterly report says both doses beat placebo, so a number exists and is not public.⁸ Randomized total not stated either.
• The menopause posters. P-50 and P-51, presented October 22, 2026. Titles are listed on Novo's congress page; no abstract text or poster file is publicly available.¹²
• REDEFINE 2's second primary endpoint. The weight result is published; the proportion of patients reaching at least 5% loss is not, and nor is the estimand label for its -13.7% figure.
• REDEFINE 3. Design and baseline paper published, trial ongoing, no readout date public.¹¹
• REDEFINE high-dose. Started, and "expected to read out in the first half of 2028."⁸

Would approval change anything if you are buying cagrilintide now?

Not about the vial in front of you.

Approval would create a licensed product at a fixed dose combination, manufactured and tested to pharmaceutical standards, prescribed and labeled. It would say nothing about the contents of a research-labeled vial sold separately, which is a different supply chain with no connection to the application under review. Our guide to the REDEFINE 4 result covers what that trial does and does not say for anyone buying cagrilintide.

Approval would also leave two questions where they are. The cardiovascular outcomes trial is still running, so the question it was built to answer stays open either way. The head-to-head against tirzepatide in obesity has already been run and reported, so approval would not reverse it.

What would move this?

An FDA action matters most. The rest follows in rough order.

Two of the four are overdue rather than unscheduled. REDEFINE 4 reported in February 2026 and has still not been published or presented anywhere, which is eight months for a phase 3 result on a drug under active review. REDEFINE 9 reported in September 2026 with one of its two dose arms left without a number.

Common questions

Is CagriSema FDA approved?

When will CagriSema be approved?

What is CagriSema's PDUFA date?

When was CagriSema submitted to the FDA?

How much weight did people lose in the trial the FDA is reviewing?

Why do different sources give different CagriSema weight-loss numbers?

Did CagriSema fail its trial against tirzepatide?

Does the tirzepatide result affect the FDA decision?

Has CagriSema beaten tirzepatide in any trial?

Is there an FDA advisory committee meeting for CagriSema?

Does CagriSema work better in women?

Does menopause stage change how well it works?

Did the trial measure menopause symptoms?

Is cagrilintide approved on its own?

What is REDEFINE 3?

Would approval make research-labeled cagrilintide safer to buy?

Sources

1. Novo Nordisk A/S. Press release, "Novo's CagriSema was associated with 25% weight loss on average for women in a post hoc analysis of REDEFINE 1 presented at The Menopause Society Annual Meeting," Plainsboro, New Jersey and Bagsværd, Denmark, October 20, 2026. Read at source on Novo Nordisk's website. Source for the December 2025 filing date and the Q4 2026 decision expectation. Sponsor-reported throughout. ↩1
2. Same press release as footnote 1, read at source. Source for the three statements quoted in the body about approval status, established safety and efficacy, and the expected decision quarter, and for the December 2025 filing date and indication. Also the source for every figure in the women and menopause section: the 2,309 women across all four arms with CagriSema n=1,441, semaglutide n=199, cagrilintide n=208 and placebo n=461; "an average weight loss of 25.0% at week 68, compared with 3.0% with placebo, if all patients adhered to treatment (efficacy estimand)"; the efficacy estimand footnote defining it as "estimated efficacy in an idealized scenario in which all patients stayed on treatment and took no other weight loss therapies"; the responder rates of 93.3% at 10% or more and 68.7% at 20% or more against 12.7% and 1.8%; waist circumference 20.5 cm against 4.7 cm; the per-stage figures of 26.7% against 2.1%, 24.8% against 1.7% and 23.1% against 2.6%; the per-stage counts of 408 and 122, 256 and 81, 530 and 168, which sum to 1,565 against the 1,902 the release states; "Menopause status was derived post hoc using age, medical history, and recorded symptoms"; "p values were not adjusted for multiplicity"; "formal treatment-by-subgroup interaction testing was not performed"; the separate evaluation of hormone therapy users with no figures given; and "Exploratory post hoc analyses are hypothesis-generating, and further work investigating the clinical validity of these results would be of value." The lead author is named in the release as Maria D. Hurtado Andrade, Mayo Clinic Alix School of Medicine. Note that the release was issued on October 20 and the posters were presented on October 22. ↩1 ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8 ↩9
3. US Food and Drug Administration. Three records, all read at source. The openFDA drug label endpoint returns no record for cagrilintide, where a control query for semaglutide returns 18. The openFDA Drugs@FDA endpoint returns no application for cagrilintide, where a control query for tirzepatide returns two, NDA217806 and NDA215866. The agency's Novel Drug Approvals 2026 page lists 47 approvals through October 20, 2026 and includes neither cagrilintide nor CagriSema. The Endocrinologic and Metabolic Drugs Advisory Committee 2026 meeting materials page states that none is scheduled, in the words quoted in the body. Each negative was run with a positive control so that an empty result could be distinguished from a broken query. No complete response letter or review extension could be checked either way, because the FDA does not publish those for pending applications. ↩1
4. Novo Nordisk A/S. Company announcement No 13 / 2026, February 23, 2026, also filed with the US Securities and Exchange Commission as a Form 6-K, accession 0001171843-26-000996. Read at source in both the SEC-filed document and on Novo Nordisk's website, which agree. Source for "CagriSema for weight management was submitted to the US FDA in December 2025 based on the REDEFINE 1 and REDEFINE 2 pivotal trials, and an FDA decision is anticipated by late 2026," and for the February 2026 estimand labels. ↩1 ↩2 ↩3 ↩4 ↩5
5. Garvey WT, et al. "Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity." New England Journal of Medicine 2025;393(7):635-647. Digital object identifier 10.1056/NEJMoa2502081, confirmed at the identifier registry. Read via a reproduction, not at source: the publisher is unreachable from here, so all quoted text comes from the published abstract as deposited and retrieved through bibliographic services. No methods section, results table or supplementary appendix was seen. Source for the "coprimary end points" wording; the design quote; the 21:3:3:7 randomization; "A total of 3417 participants underwent randomization, with 2108 assigned to receive cagrilintide-semaglutide, 302 to receive semaglutide, 302 to receive cagrilintide, and 705 to receive placebo"; the primary result of "-20.4%" against "-3.0% with placebo" with "estimated difference, -17.3 percentage points; 95% confidence interval, -18.1 to -16.6; P<0.001"; the statement that "Effect estimates were assessed with the treatment-policy estimand (consistent with the intention-to-treat principle)"; and the weight-loss targets named as "5% or more, 20% or more, 25% or more, and 30% or more (P<0.001 for all comparisons)." The gastrointestinal adverse event rates of 79.6% against 39.9% are reproduction-level and were not obtained as a verbatim quotation. The 3,417 randomized figure is independently confirmed at source in the filing at footnote 10. A companion trial in type 2 diabetes, Davies MJ, et al., "Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes," New England Journal of Medicine 2025;393(7):648-659, identifier 10.1056/NEJMoa2502082 confirmed at the registry, read via the same reproduction route, gives REDEFINE 2 as a "phase 3a, double-blind, randomized, placebo-controlled trial conducted in 12 countries" over 68 weeks, "A total of 1206 patients underwent randomization to either the cagrilintide-semaglutide group (904 patients) or the placebo group (302 patients)," two primary endpoints of "the percent change in body weight and the percentage of patients with a weight reduction of at least 5%," and a result of "-13.7%" against "-3.4%" with a difference of -10.4 percentage points, 95% confidence interval -11.2 to -9.5, P<0.001. The second primary endpoint result and the estimand label for that pair were not obtained. ↩1 ↩2 ↩3 ↩4 ↩5 ↩6
6. Novo Nordisk A/S. Press release, Bagsværd, September 21, 2026, issued in connection with the company's Capital Markets Day, carrying no company announcement number. Read at source. Source for REDEFINE 9: "REDEFINE 9 was a phase 3 trial investigating once-weekly CagriSema 1.7 mg/1.7 mg and CagriSema 1.0 mg/1.0 mg compared with placebo"; the primary endpoints as "relative change in body weight and the proportion of participants achieving at least 5% body-weight reduction from baseline to week 68"; and "CagriSema 1.0 mg/1.0 mg provided a weight reduction of 21.0% versus 2.0% for placebo, and the primary superiority endpoint was met," labeled "Based on efficacy estimand." No figure is given anywhere in the release for the 1.7 mg / 1.7 mg arm, and no randomized total is stated. Also the source for REIMAGINE 5, whose dual primary endpoints and weight-loss pair against tirzepatide 5 mg are quoted in the body. Note that this release was not filed with the SEC, so regulatory filings alone do not capture Novo's CagriSema news. ↩1 ↩2 ↩3
7. Novo Nordisk A/S. Form 6-K, Q1 2026 financial report, period ending March 31, 2026, filed May 6, 2026, SEC accession 0000353278-26-000018, document caq12026.htm. Read at source. Source for "CagriSema" against "US decision" in the Q4 2026 column of the "Anticipated key R&D milestones in 2026" table, and for the February 2026 REDEFINE 4 summary. ↩1
8. Novo Nordisk A/S. Form 6-K, Q2 2026 financial report, period ending June 30, 2026, filed August 4, 2026, SEC accession 0000353278-26-000023, document caq22026.htm. Read at source. Source for the Q4 2026 US decision entry with the note that expected timing "may change"; for "Novo Nordisk successfully completed the phase 3 trial REDEFINE 9 investigating lower doses of CagriSema for weight management" and that "CagriSema 1.0 mg/1.0 mg and 1.7 mg/1.7 mg achieved a superior weight loss compared to placebo"; for REIMAGINE 4 as an "open-label head-to-head 68-week efficacy and safety trial" of CagriSema 2.4/2.4 mg against tirzepatide 15 mg in type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor; and for the REDEFINE high-dose trial's expected readout, quoted in the body. ↩1 ↩2 ↩3 ↩4
9. Novo Nordisk A/S. REDEFINE 4 headline results, February 23, 2026, read at source in three places that agree: the Form 6-K filed with the US Securities and Exchange Commission, accession 0001171843-26-000996; Novo Nordisk's own website as Company announcement No 13 / 2026; and the wire distribution of the same text. Source for "The trial did not achieve its primary endpoint of demonstrating non-inferiority on weight loss for CagriSema compared to tirzepatide after 84 weeks"; for the design as "an 84-week trial investigating CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to tirzepatide 15 mg, both administered once-weekly and subcutaneously"; for "The trial included 809 randomised people with obesity and one or more comorbidities and with a mean baseline body weight of 114.2 kg"; for "The trial had an open-label design, meaning that all investigators and participants were aware of the specific drug administered throughout the trial"; for "people treated with CagriSema 2.4 mg/2.4 mg achieved a weight loss of 23.0% after 84 weeks compared to 25.5% with tirzepatide 15 mg" on the efficacy estimand and "20.2%" against "23.6%" on the treatment-regimen estimand, with the footnotes "Based on the efficacy estimand according to the trial protocol, regardless of dose modification" and "Based on the treatment-regimen estimand: treatment effect regardless of treatment adherence"; and for "In the trial, CagriSema appeared to have a safe and well-tolerated profile." No non-inferiority margin appears in any of the three copies. No sentence in any of them refers to a scientific conference or a publication. Searches of bibliographic indexes for a REDEFINE 4 primary report, abstract or presentation returned none. ↩1 ↩2 ↩3 ↩4
10. Novo Nordisk A/S. Company announcement of REDEFINE 1 headline results, December 20, 2024, filed with the US Securities and Exchange Commission as a Form 6-K, accession 0001171843-24-007023. Read at source. Source for "The trial included 3,417 randomised people with obesity or overweight"; for "The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 68 with CagriSema versus placebo"; for the trial-product estimand figures, "people treated with CagriSema achieved a superior weight loss of 22.7% after 68 weeks compared to a reduction of 11.8% with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and 2.3% with placebo alone," labeled "Based on the trial product estimand according to the trial protocol, regardless of dose strength"; for the treatment policy estimand figures, "a superior weight loss of 20.4% compared to a reduction of 11.5% with cagrilintide 2.4 mg, 14.9% with semaglutide 2.4 mg and 3.0% with placebo," labeled "treatment effect regardless of treatment adherence"; and for the responder rate, "40.4% of patients who received CagriSema reached a weight loss of 25% or more after 68 weeks compared to 6.0% with cagrilintide 2.4 mg, 16.2% with semaglutide 2.4 mg, and 0.9% with placebo." ↩1 ↩2 ↩3 ↩4 ↩5 ↩6
11. Cavender MA, et al. "Design and baseline characteristics of the CagriSema cardiovascular outcomes trial (REDEFINE 3)." American Heart Journal 2026, article 107626. Read through a bibliographic record only; the publisher is unreachable from here, and the digital object identifier was confirmed at an indexing service rather than at the registry or the journal. Source for "Between 1/2023-12/2024, 7076 adults at 575 sites in 24 countries were randomized"; for the population as participants "with established cardiovascular disease (CVD) and body mass index (BMI) ≥25.0 kg/m2 with/without T2D"; for randomization "to CagriSema 2.4 mg/2.4 mg or placebo, plus standard of care"; and for the two objectives, "to confirm noninferiority of CagriSema compared with placebo on cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke (MACE-3)" and "to confirm the superiority of CagriSema compared with placebo on cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or revascularization (MACE-4)." No expected readout date appears in anything read for this page. ↩1 ↩2
12. Novo Nordisk science communication site, congress listing for The Menopause Society 2026 Annual Meeting. Read at source. Lists two posters presented Thursday, October 22, 2026, 18:15 to 19:15 Pacific time: P-51, "Effect of CagriSema on body weight reduction and cardiometabolic risk factors in women: A post hoc analysis of the REDEFINE 1 trial," and P-50, "Effect of CagriSema on body weight reduction and cardiometabolic risk factors in women by menopause status and hormone therapy use: A post hoc analysis of the REDEFINE 1 trial." Titles only; no abstract text and no poster file are publicly available, and the site gates material behind a healthcare professional prompt. The Menopause Society's own 2026 annual meeting program, read at source and dated as of June 17, 2026, independently confirms a poster session at that time and place but contains no individual poster numbers, titles or authors, and no mention of CagriSema or cagrilintide. ↩1