MHRA approves orforglipron weight-loss pill

The Medicines and Healthcare products Regulatory Agency said its approval of orforglipron makes the UK the first country in Europe to authorise the medication.
A woman takes a pill with a glass of water

Eli Lilly’s daily weight-loss pill orforglipron (Foundayo) has been authorised for use in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

In a press release published on 10 August 2026, the MHRA said that the decision makes the UK the first country in Europe to approve the medication.

Orforglipron is authorised for weight loss and weight maintenance in adults in the UK with a BMI of 30 or above, or a BMI of between 27 and 30 and at least one weight-related comorbidity, when used alongside a reduced calorie diet and increased physical activity.

The results of a phase III study, published in the New England Journal of Medicine on 16 September 2025, revealed that patients who received 6mg of orforglipron as an adjunct to healthy diet and physical activity lost an average of 7.5% of their body weight over 72 weeks.

Average weight loss increased with higher doses, the study results showed. Researchers observed 8.4% weight loss in patients who took 12mg of orforglipron and 11.2% weight loss in patients who took 36mg of orforglipron, compared with 2.1% weight loss with placebo.

Orforglipron is also authorised by the MHRA to improve glycaemic control for patients with insufficiently controlled type 2 diabetes mellitus (T2DM). The findings of an ‘ACHIEVE-3‘ study, published in February 2026, showed that orforglipron offered greater weight loss than oral semaglutide in patients with insufficiently controlled T2DM.

The tablet is taken once daily and can be taken at any time of day with no food or water restrictions. 

Julian Beach, executive director of healthcare quality and access at the MHRA, commented: “Following rigorous assessment of orforglipron’s safety, quality and effectiveness, we are pleased to be the first regulator in Europe to authorise this tablet for weight management and T2DM.  

“As with all GLP-1 [glucagon-like peptide-1] receptor agonists, this is a prescription-only medication, and the MHRA will keep the safety and effectiveness of orforglipron under close review.”

The MHRA also confirmed that the tablet is not currently available via the NHS, adding that the decisions on NHS use will follow established processes, including an evaluation by the National Institute for Health and Care Excellence (NICE). 

NICE guidelines on orforglipron for managing overweight and obesity are currently in development and are due to be published on 18 November 2026.

Henry Gregg, chief executive of the National Pharmacy Association, said: “This is another significant day with a second weight-loss pill to be available from some pharmacies in the near future.

“This is particularly significant for patients who cannot or do not want to take an injectable medicine and could make weight-loss treatment available to a wider range of patients.

“However, there must now be a redoubling of efforts within government and the NHS to use pharmacies to make sure more eligible patients in clinical need can get this on the NHS, rather than the current postcode lottery that exists for weight management services via GPs.”

Pharmacy leaders have previously said that commissioning pharmacies to deliver NHS weight-management services would be the ‘most effective way’ to meet demand.

Last updated
Citation
The Pharmaceutical Journal, PJ August 2026, Vol 321, No 8012;321(8012)::DOI:10.1211/PJ.2026.1.423921

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