Four GLP-1 FDA decisions line up for late 2026

Pharmacy benefit manager Prime Therapeutics, in its August 2026 GLP-1 pipeline update, listed four pending US Food and Drug Administration decisions clustered in the back half of the year: a cardiovascular indication for Mounjaro (tirzepatide) in the third quarter, Foundayo (orforglipron) for type 2 diabetes and a 25 mg Ozempic (semaglutide) tablet in the fourth quarter, and CagriSema for weight management in December ^[1].

The list is a forecast prepared for health plans and employers, not an FDA announcement. Prime publishes monthly "FDA decisions expected" and pipeline roundups so its clients can budget for coverage changes before they land ^[1]. The exact target action dates behind each of the four items are not spelled out in the sources available here, and companies do not always disclose them.

What each decision covers

The CagriSema application is the biggest single item left on the 2026 calendar. CagriSema is Novo Nordisk's once-weekly combination of a GLP-1 analogue and an amylin analogue. The company filed for FDA approval in weight management in December 2025 and has guided to a decision by late 2026 ^[2]. Prime's list places that decision specifically in December ^[1].

CagriSema's data have been mixed. In the 68-week REIMAGINE 4 trial, an open-label study in about 1,000 adults with type 2 diabetes inadequately controlled on metformin, CagriSema produced 15.2% weight loss and a 1.9 percentage point drop in HbA1c on the efficacy estimand, against 15.8% and 2.2 percentage points for tirzepatide 15 mg ^[2]. The combination met non-inferiority on weight loss but missed it on HbA1c, and because both were part of a dual primary endpoint, the trial did not succeed on its stated terms ^[2]. Those figures came out in Novo Nordisk's second-quarter financial report rather than a standalone data release ^[2]. That trial was in diabetes; the pending US application is for weight management ^[2].

Foundayo is orforglipron, a once-daily small-molecule GLP-1 pill from Eli Lilly. The FDA approved it for obesity in April 2026, and Lilly submitted it for type 2 diabetes in the US during the second quarter of 2026 ^[2]. Prime expects that second decision in the fourth quarter ^[1]. In the UK, where the Medicines and Healthcare products Regulatory Agency authorised the tablet on 10 August 2026 for both weight management and type 2 diabetes, dosing starts at 0.8 mg and steps up through five further levels to 17.2 mg, with at least one month at each level, and no food or water restrictions ^[2]. US labeling details are set by the FDA and are not covered in these sources.

The Ozempic 25 mg tablet would be a higher-dose oral form of semaglutide ^[1]. The Mounjaro item is a cardiovascular indication for tirzepatide ^[1]. The underlying trial evidence for both is not described in the sources here.

Why it matters for patients

Labels drive coverage. Insurers and PBMs frequently tie prior authorization rules to an FDA-approved indication, so a new indication can change who qualifies for a drug and on what terms. A cardiovascular indication for Mounjaro, for example, would give prescribers and plans a formal basis for using tirzepatide beyond glucose control — though whether any given plan follows is a separate decision that is not addressed in these sources.

An oral option matters for a different reason. Orforglipron is a small molecule rather than a peptide, so it survives digestion and does not require injection or the fasting window that oral semaglutide needs ^[2]. The most common side effects reported in the UK authorisation were nausea, constipation, diarrhoea, vomiting, dyspepsia and abdominal pain ^[2].

CagriSema would be the first once-weekly GLP-1 and amylin combination for weight management if approved ^[2]. A rejection or a narrow label would reset expectations for the whole amylin class ^[2].

US pricing and formulary placement for any of these are not addressed in the sources.

What happens next

• Third quarter 2026: Prime expects the Mounjaro cardiovascular decision ^[1].
• Fourth quarter 2026: Foundayo for type 2 diabetes and the 25 mg Ozempic tablet ^[1].
• December 2026: CagriSema for weight management, per Prime ^[1]; Novo Nordisk has said only "late 2026" ^[2].
• First quarter 2027: Lilly plans to submit retatrutide, a separate triple agonist, to the FDA ^[2].