The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for orforglipron (marketed as Foundayo), making the United Kingdom the inaugural European nation to endorse this GLP-1 tablet intended for weight management and the treatment of type 2 diabetes as of 10 August 2026.
Regulatory Approval and Conditions for Use
In conjunction with a reduced-calorie diet and increased physical activity, orforglipron has been authorised for weight loss and maintenance in adults with a Body Mass Index (BMI) of 30 or above, or those with a BMI between 27 and 30 who also present at least one weight-related health condition. Additionally, it is indicated for enhancing glycaemic control in patients with inadequately managed type 2 diabetes.
Julian Beach, Executive Director of Healthcare Quality and Access at the MHRA, remarked, “After a thorough evaluation of orforglipron’s safety, quality, and efficacy, we are delighted to be the first regulatory body in Europe to approve this tablet for weight management and type 2 diabetes.” He further noted, “Like all GLP-1 receptor agonists, orforglipron is a prescription-only medication, and the MHRA will continue to monitor its safety and effectiveness closely.”
Administration and Mechanism of Action
The orforglipron tablet is administered once daily and can be taken at any time without restrictions regarding food or water. Initial treatment starts at a dosage of 0.8 mg, gradually increasing through 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and ultimately 17.2 mg, with patients required to maintain each dose level for a minimum of one month. It is essential for patients to adhere to the guidelines outlined in the Patient Information Leaflet.
Orforglipron functions as a GLP-1 receptor agonist by imitating the naturally occurring hormone, glucagon-like peptide (GLP-1), which is secreted by the body post-consumption of food. By acting on specific areas of the brain that govern appetite, orforglipron assists in prolonging the sensation of fullness, curbing hunger, and diminishing food cravings. Consequently, it aids in reducing caloric intake and promoting weight loss alongside suitable dietary and lifestyle modifications. For individuals with type 2 diabetes, orforglipron also lowers blood sugar levels when they are elevated.
Side Effects and Availability
The most frequently reported side effects associated with orforglipron include nausea, constipation, diarrhoea, vomiting, dyspepsia (indigestion), and abdominal discomfort.
Although this tablet has received approval for use within the UK, it is not currently accessible through the National Health Service (NHS). As is customary with new treatments, decisions regarding NHS availability will adhere to established protocols, which include an evaluation by the National Institute for Health and Care Excellence (NICE).
All GLP-1 medications are classified as prescription-only, meaning they can only be sourced from registered pharmacies with a valid prescription from a physician. Purchasing GLP-1 medications from unregulated vendors poses significant health risks.
Legal and Reporting Obligations
It is illegal to market any prescription-only medication directly to the public. Individuals who suspect they are experiencing side effects from orforglipron are encouraged to consult their doctor, pharmacist, or nurse, and to report any adverse effects directly to the Yellow Card scheme, which can be accessed via their website or through the Google Play and Apple App stores by searching for MHRA Yellow Card.
Further Information and Regulatory Oversight
The authorisation for this new indication of orforglipron (Foundayo) was granted to Eli Lilly on 10 August 2026. Additional information will be available in the Summary of Product Characteristics and Patient Information leaflets, which are set to be published on the MHRA Products website within seven days of the approval.
The MHRA is tasked with the regulation of all medicinal products and medical devices in the UK, ensuring their efficacy and safety. All actions undertaken by the agency are supported by meticulous and evidence-based evaluations to ensure that the benefits outweigh any associated risks.
As an executive agency of the Department of Health and Social Care, the MHRA is dedicated to safeguarding public health through rigorous oversight of medicinal products.
For media inquiries, please contact the news centre at 020 3080 7651 or via email at newscentre@mhra.gov.uk.
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