MariTide approval cannot be decided until Amgen files, and a search on 5 November 2026 found no filing announcement. BioSpace reported on 4 November 2026 that the first Phase 3 data are expected in 2027. The same report gave no regulatory filing timeline. Amgen’s obesity candidate, maridebart cafraglutide, therefore remains in development.
When will MariTide be approved?
No one outside Amgen can give a date, and Amgen has not given one. The company’s second-quarter 2026 results release, dated 4 August 2026, lists the Phase 3 MARITIME studies. It gives no readout timing and no enrolment totals.
The US review clock offers a fixed reference point. Under the FDA’s PDUFA VII goals letter, the agency aims to act on standard original submissions within 10 months. That period starts at the 60-day filing date. For priority submissions, the goal is six months from that date.
On those goals, MariTide approval would follow a standard filing by about 12 months. A priority review would run about eight months. Neither clock applies yet, because no application exists. Whether MariTide would qualify for priority review is not known.
As at 5 November 2026, Amgen’s disclosures describe MariTide as in Phase 3 development. None of the disclosures reviewed mentions a UK or EU submission.
What has Amgen said about the MariTide Phase 3 programme?
BioSpace reported on 4 November 2026 that the MARITIME programme includes 10 Phase 3 trials. Two more are due to start this year. The report did not name the individual trials. Amgen’s August release describes nine Phase 3 studies. They are MARITIME-1, MARITIME-2, MARITIME-CV, MARITIME-HF, MARITIME-OSA-1, MARITIME-OSA-2 and MARITIME-SWITCH, plus two extension studies.
The two chronic weight management trials
Fierce Biotech described the design of the first two trials. MARITIME-1 enrols about 3,500 adults with obesity or overweight and without type 2 diabetes. MARITIME-2 enrols 999 adults with obesity or overweight and type 2 diabetes. Both run for 72 weeks against placebo, with percentage change in body weight as the primary endpoint.
Fierce Biotech reported that both readouts are expected in 2027. Amgen’s August release describes both studies as ongoing. The registry entries could not be read directly for this article, so the sample sizes rest on Fierce Biotech.
Cardiovascular, heart failure, sleep apnoea and switching trials
The August release describes MARITIME-CV, a cardiovascular outcomes study, as enrolling. It also lists MARITIME-HF, which looks at heart failure events. It lists two sleep apnoea studies, MARITIME-OSA-1 and MARITIME-OSA-2, as enrolling at that date. MARITIME-SWITCH enrols adults moving from weekly tirzepatide or weekly semaglutide to MariTide. It uses an eight-week or quarterly schedule. The release says three Phase 3 studies in type 2 diabetes will begin in 2026.
BioSpace reported that Amgen has since completed enrolment in two sleep apnoea studies and a cardiovascular outcomes trial. It cited the third-quarter earnings release. That release could not be read for this article on 5 November 2026, so the detail rests on BioSpace.
The newest trial tests home self-administration with an autoinjector. BioSpace, citing ClinicalTrials.gov, gave its registry number as NCT07871409. It reported a primary completion date of June 2027. TD Cowen analysts wrote that the study could enable an autoinjector launch.
What did the Phase 2 data show, and how far do they inform MariTide approval?
The Phase 2 trial enrolled 592 adults. Of these, 465 had obesity and 127 had obesity and type 2 diabetes. It was published in the New England Journal of Medicine in 2025 (NCT05669599). Ania Jastreboff was first author.
The obesity cohort tested several regimens. Arms included 140, 280 and 420 mg every four weeks, plus 420 mg every eight weeks. Two further arms gave 420 mg every four weeks with a four-week or 12-week dose escalation.
AJMC summarised the obesity results at 52 weeks. On the treatment-policy estimand, mean weight loss ranged from 12.3 to 16.2 per cent across MariTide arms. Placebo produced 2.5 per cent.
On the efficacy estimand, the range was 16.3 per cent to nearly 20 per cent. Placebo produced 2.6 per cent. The two estimands answer different questions, so the figures should not be mixed. Phase 2 results do not predict Phase 3 outcomes.
The safety record from the same trial is mixed. Gastrointestinal events were the most common side effects. In the obesity cohort, any adverse event occurred in 90 to 99 per cent of treated participants. The placebo figure was 68 per cent.
Discontinuation because of gastrointestinal symptoms ranged from 12 to 27 per cent in groups that started at full dose. It was up to 8 per cent in the dose-escalation groups.
Dosing frequency is another open point. The Phase 2 paper title says once-monthly. Amgen’s August release refers to staying on MariTide with as few as four or six doses per year. The final schedule would depend on Phase 3 results and the regulator’s review of them.
Why does the Phase 3 dosing change matter for MariTide approval?
Fierce Biotech reported in June 2025 that Amgen moved the 72-week Phase 3 studies to a three-step escalation. Patients start at 21 mg, move to 35 mg, then 70 mg over eight weeks. Only then do they reach the target dose. Amgen says the schedule still leads to monthly maintenance therapy.
Fierce Biotech also relayed analyst concerns. Citi Research said the added steps detract from the convenience of a long-acting injection. Mizuho’s Salim Syed questioned whether the steps will reduce vomiting enough. Jefferies was more positive, expecting Phase 3 data to come in “better than expectations”.
The Phase 2 trial did include escalation arms, and they showed lower discontinuation. Phase 3 will show whether that pattern holds at scale. That evidence will shape any MariTide approval decision. Any regulator will weigh those results, together with safety, before deciding.
What do analysts say about MariTide’s prospects?
BMO Capital Markets analysts called differentiation “more of a show-me story”, BioSpace reported. They said management’s comments on monthly dosing and short-lived gastrointestinal symptoms are encouraging. They added that those comments do not replace Phase 3 tolerability data.
Truist Securities analysts said tolerability and maintenance, not weight loss, are driving the debate. Each view is one firm’s note, relayed by BioSpace. Both bear on MariTide approval mainly through tolerability data.
Jay Bradner, Amgen’s executive vice president of research and development, spoke on the earnings call. BioSpace reported that he said Amgen expects to deliver MariTide in a handheld autoinjector. Chief financial officer Thomas Dittrich reaffirmed capital spending of about $2.6 billion this year. BioSpace said the spending is meant partly to prepare for a potential launch.
How does MariTide fit Amgen’s wider finances?
BioSpace reported that Amgen’s third-quarter revenue rose 8 per cent to $10.4 billion. William Blair analysts said key brands such as Repatha, Uplizna, Evenity, Blincyto and Imdelltra continue to outperform. MariTide is not yet generating revenue.
BioSpace also said the Phase 3 readouts will determine how much manufacturing capacity Amgen needs. Chief executive Robert Bradway said Amgen considers all options for capacity. He added that Amgen is confident it can remain a reliable biosimilar supplier.
What would settle the MariTide approval question?
Four events would settle it, in sequence. First, the MARITIME-1 and MARITIME-2 readouts, expected in 2027. Second, an Amgen announcement that it has filed. Third, FDA acceptance of the application, which sets a goal date. Fourth, the regulator’s decision.
The primary endpoint for both weight management trials is percentage change in body weight at 72 weeks. Tolerability and discontinuation rates will matter as much as the headline figure. MARITIME-SWITCH will also show how patients already on weekly drugs respond to a change of treatment.
A UK MariTide approval would need its own application to the MHRA. None has been announced in the disclosures reviewed.
Readers tracking the field can follow the obesity drug news tracker. The guide to late-stage obesity drugs places MariTide alongside its competitors.
