Foundayo

Key facts

• FDA approved on 1 April 2026 (NDA 220934, new molecular entity) for chronic weight management in adults with obesity, or overweight with at least one weight-related condition.
• In the US the type 2 diabetes indication is not approved yet: Lilly submitted it in mid-2026 and it was still pending in September 2026.
• The MHRA authorised it on 10 August 2026 for weight management and for type 2 diabetes, the first authorisation in Europe. It was not available on the NHS at authorisation; a NICE appraisal for obesity is in development.
• EU status: under EMA review (EMEA/H/C/006632); no CHMP opinion as of September 2026.
• Can be taken once daily with or without food (US label). The UK SmPC says any time of day without food or water restrictions. This is the main practical difference from Rybelsus and the Wegovy pill.
• Titration: 0.8 mg, then 2.5 mg, then 5.5 mg, each for at least 30 days; the dose can then rise to 9, 14.5 or 17.2 mg (maximum) in steps of at least 30 days.
• Trials used different capsule doses: the 36 mg trial dose corresponds to the 17.2 mg tablet, 12 mg to 9 mg, and 6 mg to 5.5 mg.
• ATTAIN-1 (72 weeks, adults with obesity without diabetes): mean weight change -11.2% at the top dose vs -2.1% with placebo.
• ACHIEVE-3 (52 weeks, head to head vs oral semaglutide in type 2 diabetes on metformin): HbA1c -1.91 points at the top dose vs -1.47 with semaglutide 14 mg, and weight -8.2% vs -5.3%. Gastrointestinal side effects and stopping due to side effects were more common with orforglipron.
• US labelling carries a boxed warning about thyroid C-cell tumours; the UK SmPC has no boxed warning.
• Oral contraceptives: the label advises switching to a non-oral method or adding a barrier method for 30 days after starting and after each dose increase.

Where Foundayo is available