EU regulator committee recommends authorising oral orforglipron (Foundayo) for weight management and type 2 diabetes

The European Medicines Agency's human medicines committee (CHMP) adopted a positive opinion at its October 12-15, 2026 meeting recommending that the European Union grant a marketing authorisation for Foundayo (orforglipron), an oral GLP-1 receptor agonist, for weight management and for the treatment of type 2 diabetes in adults.

For weight management, the recommended use is alongside a healthy diet and physical activity in adults with obesity, or adults with overweight who have at least one weight-related health problem. For type 2 diabetes, it is recommended alongside diet and physical activity for adults whose blood glucose is not sufficiently controlled; it can be used alone when metformin is not appropriate or together with other diabetes medicines.

Foundayo would be available as a prescription-only tablet taken once daily, at any time of day, with or without food, starting at a low dose that is gradually increased based on response and tolerability. The EMA notes it provides an alternative to injectable and other oral GLP-1 receptor agonists.

Orforglipron is a small, non-peptide molecule that activates the GLP-1 receptor, a hormone pathway involved in appetite and blood-glucose control. Because it is not a peptide, it can be absorbed when taken by mouth. The EMA said the recommendation is supported by studies involving 4,740 adults with obesity or overweight and 3,765 adults with type 2 diabetes whose glucose was not adequately controlled.

The most common side effects reported were nausea, vomiting and diarrhoea, which occurred more often while the dose was being increased and became less frequent over time. The CHMP opinion is an intermediary step: the European Commission will now decide on an EU-wide marketing authorisation, so the medicine is not yet authorised or marketed in the EU.

In the United States, the FDA approved Foundayo on April 1, 2026 for chronic weight management only; it is not FDA-approved for type 2 diabetes. This brief summarises regulator documents and is not treatment guidance; medication decisions belong with the treating clinician.