Novo Nordisk Presses Forward With Oral Semaglutide and Amycretin as CagriSema Nears FDA Verdict

Novo Nordisk awaits FDA decisions on CagriSema and oral Ozempic, expands paediatric GLP-1 approvals, and advances Amycretin for weight maintenance.

Novo Nordisk is navigating one of the most crowded regulatory calendars in its recent history, with decisions due on three different metabolic drug candidates over the next 12 months. While the market’s attention has largely been fixed on the CagriSema filing with the FDA — a fixed-dose combination of semaglutide and cagrilintide — the Danish drugmaker is simultaneously widening its oral GLP-1 franchise and quietly building a pipeline that could eventually dwarf both Wegovy and Ozempic.

The most immediate catalyst is oral Ozempic. The FDA has already cleared the tablet for adults with Type 2 diabetes, and Novo Nordisk is preparing for launch. A supplemental application for a higher 25 mg dose is under review, with a decision due by the end of 2026. The company also plans to file for paediatric approvals of Rybelsus and oral Ozempic in both the US and the EU during the second half of next year — a significant expansion into a patient group that current GLP-1 therapies do not yet address. Across the Atlantic, the EMA is still evaluating the Wegovy pill for obesity, a milestone that would open the European market to Novo Nordisk’s oral weight-loss offering.

The clinical case for the oral portfolio was reinforced at the European Obesity Congress in Istanbul in May 2026, where Novo Nordisk presented fresh data from the OASIS-4 study. Roughly a third of participants responded early, shedding an average of 13.2% of body weight after four months, rising to 21.6% at the end of the trial. An indirect head-to-head analysis — the ORION study — suggested the Wegovy pill outperforms Eli Lilly’s oral GLP-1 candidate Orforglipron on both weight loss and tolerability, with fewer discontinuations due to side effects. Still, Lilly’s Foundayo, which imposes no dietary restrictions, remains a comfort advantage.

Beyond the oral push, Novo Nordisk is building its next generation of injectable therapies. The most advanced is CagriSema, for which a New Drug Application is now under FDA review. In the REDEFINE-1 trial, 91.9% of participants achieved at least 5% weight reduction versus 31.5% on placebo. The agency is expected to rule on the compound later this year. Meanwhile, the larger REDEFINE-11 Phase 3 study for CagriSema is due to report data in the first half of 2027, and a higher-dose version is scheduled to enter Phase 3 in the second half of 2026.

Further out, Novo Nordisk is laying the groundwork for a third pillar: Amycretin. The AMAZE-12 Phase 3 trial, which began recruiting on May 18, 2026, is testing the dual GLP-1/amylin receptor agonist not for initial weight loss but for weight maintenance — a commercially underexplored niche. The clinical rationale is supported by a Phase 1b/2a study showing a 22% weight reduction after 36 weeks with weekly subcutaneous injections, and a Phase 1 oral formulation that delivered 13.1% loss after 12 weeks. The broader AMAZE Phase 3 programme, officially launched according to the Q1 2026 report, also includes AMAZE-1, which measures body weight change after 84 weeks. A mechanistic study of cagrilintide is running in parallel to refine appetite-control profiles for future therapies.

The financial picture reflects both the promise and the pressure. Novo Nordisk raised its full-year guidance after first-quarter results, now expecting a 4% to 12% decline in adjusted sales and operating profit at constant exchange rates — an improvement from the previous forecast of minus 5% to minus 13%. Obesity sales surged 44% internationally in the first quarter, driven by sustained GLP-1 demand. The stock trades at around €38, roughly 45% below its 52-week high of €70, though it has recovered nearly 26% from the March trough. A buyback of up to 15 billion Danish kroner is under way, but the share price’s trajectory will ultimately depend on how quickly pipeline milestones translate into revenue. With six approvals already secured in Q1 2026 and more than ten clinical trials initiated, the next few quarters will determine whether Novo Nordisk can convert regulatory density into durable market leadership.