The UK MHRA has authorised Eli Lilly’s once-daily oral GLP-1 receptor agonist orforglipron (Foundayo) for weight management and type 2 diabetes.
Written By: Rishabh Sonawane, BPharm
Reviewed By: Pharmacally Editorial Team
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorised orforglipron (Foundayo), making the UK the first country in Europe to authorise the once-daily oral GLP-1 receptor agonist for both weight management and type 2 diabetes. The authorisation was granted to Eli Lilly on 10 August 2026 following regulatory assessment of the medicine’s safety, quality, and effectiveness.
The approval covers weight loss and weight maintenance in adults with a body mass index (BMI) of at least 30, or a BMI of 27 to less than 30 in the presence of at least one weight-related comorbidity. Orforglipron is also authorised to improve glycaemic control in adults with insufficiently controlled type 2 diabetes. Treatment is intended to be used alongside a reduced-calorie diet and increased physical activity.
Julian Beach, MHRA Executive Director of Healthcare Quality and Access, said the agency was pleased to become the first European regulator to authorise the tablet following assessment of its safety, quality, and effectiveness. He added that, as with other GLP-1 receptor agonists, orforglipron will remain subject to close MHRA monitoring of its safety and effectiveness.
Once-Daily Oral Administration and GLP-1 Receptor Agonism
Orforglipron is a GLP-1 receptor agonist that mimics the activity of glucagon-like peptide-1, a hormone naturally released after eating. According to the MHRA, the medicine acts on areas of the brain involved in appetite regulation, helping people feel fuller, reducing hunger and decreasing food cravings. In people with type 2 diabetes, it also lowers elevated blood glucose levels.
The tablet is administered once daily and can be taken at any time of day without food or water restrictions. Treatment starts at 0.8 mg and is escalated through 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg, with a minimum of one month at each dose level. Patients are instructed to follow the approved Patient Information Leaflet.
Safety Profile and Post-Authorisation Monitoring
The MHRA identified nausea, constipation, diarrhoea, vomiting, dyspepsia and abdominal pain among the most common side effects associated with orforglipron. The agency will continue to monitor the medicine’s safety and effectiveness following authorisation, consistent with the regulatory oversight applied to GLP-1 receptor agonists.
Orforglipron remains a prescription-only medicine and can only be obtained through a registered pharmacy with a prescription from a doctor. The MHRA also warned against obtaining GLP-1 medicines from unregulated sellers because of associated health risks. Suspected adverse reactions can be reported through the UK Yellow Card system.
UK Approval Does Not Establish NHS Availability
Although orforglipron has received UK marketing authorisation, it is not currently available through the National Health Service (NHS). Any decision regarding NHS use will follow established processes, including an assessment by the National Institute for Health and Care Excellence (NICE).
This distinction separates regulatory authorisation from subsequent health-technology and reimbursement decisions. The MHRA authorisation establishes that the medicine meets the required standards for quality, safety and effectiveness for its approved uses, while NHS access remains subject to the applicable evaluation process.
Regulatory Status and Expected Product Information
The MHRA granted the authorisation for the new indication to Eli Lilly on 10 August 2026. The MHRA stated that the Summary of Product Characteristics and Patient Information Leaflet would be published on its Products website within seven days of approval.
The UK decision establishes orforglipron as the first GLP-1 tablet authorised in Europe for weight management and type 2 diabetes, while continued post-authorisation surveillance will remain an important part of its regulatory oversight.
Reference
UK first in Europe to authorise orforglipron for weight management and type 2 diabetes
About the Writer
Rishabha Sonawane, B.Pharm (LinkedIn) is healthcare writer with a strong interest in medical writing, regulatory affairs, clinical research, and AI-driven drug discovery. He has completed specialized training from the NIH and ICMR in clinical pharmacology, clinical research, and scientific writing. Passionate about evidence-based healthcare communication, he focuses on translating complex scientific research into clear, accurate, and engaging medical content.