The orforglipron UK approval date is 10 August 2026. On that day the MHRA, the UK medicines regulator, granted Foundayo (Eli Lilly's once-daily orforglipron tablet) a marketing authorisation for weight management and for type 2 diabetes, making the UK the first country in Europe to license it. Private prescribing followed on 24 August 2026. The NHS question runs separately: NICE is still appraising it, with guidance expected on 27 January 2027.
Below are the dates in order, the official document behind each, and what "approved" means for a UK patient as of 14 October 2026. It is information, not medical advice: Foundayo is a prescription-only medicine, and a qualified prescriber decides whether it suits anyone.
Orforglipron UK approval date: what happened on 10 August 2026
The MHRA announced it under the headline "UK first in Europe to authorise orforglipron for weight management and type 2 diabetes", and its notes to editors record the authorisation as granted on 10 August 2026 to Eli Lilly. Julian Beach, the agency's Executive Director of Healthcare Quality and Access, said the decision followed "rigorous assessment of orforglipron's safety, quality, and effectiveness".
The document behind the headline is the Summary of Product Characteristics (SmPC), now on the electronic medicines compendium for all six strengths. The 0.8 mg entry gives the licence number PL 14895/0369 and a date of first authorisation of 10 August 2026. It also carries the black triangle for additional monitoring, which is why every suspected side effect should be reported through the Yellow Card scheme.
What the UK licence covers
The authorisation has two indications.
- Weight management: as an adjunct to a reduced-calorie diet and increased physical activity, in adults with a starting BMI of 30 or more, or 27 to under 30 with at least one weight-related comorbidity. It covers weight loss and weight maintenance.
- Type 2 diabetes: to improve glycaemic control in adults whose type 2 diabetes is insufficiently controlled, alongside diet and exercise, alone or with other diabetes medicines.
Lilly's UK announcement says the licence rests on six phase 3 trials: ATTAIN-1 and ATTAIN-2 for weight management, and ACHIEVE-1, -2, -3 and -5 for type 2 diabetes. Those studies used capsules; the licensed tablet comes in six strengths from 0.8 mg to 17.2 mg, and Table 2 in section 5.1 of the SmPC states which capsule dose each matches (they are not interchangeable milligram for milligram). See our dosage page and trial results summary.
24 August 2026: private prescribing begins
A fortnight after the licence, Eli Lilly and Company Limited issued a press release from Basingstoke, dated 24 August 2026, saying orforglipron was now available to be prescribed for eligible adults "via private prescription". The same release says Lilly is working with NICE on the assessment for potential NHS use in England.
That is all the launch date settles: it does not put the medicine on the NHS, and it fixes no cost. Private prices vary between regulated providers; this site names no providers and quotes no figures.
The timeline at a glance
| Date | What happened |
|---|---|
| 14 November 2024 | NICE selects orforglipron for appraisal (ID6516) |
| 1 April 2026 | US FDA approves Foundayo for weight management |
| 14 July 2026 | First NICE committee meeting |
| 10 August 2026 | MHRA authorises orforglipron, the first regulator in Europe to do so |
| 24 August 2026 | Lilly UK announces private-prescription availability |
| 10 November 2026 | Second NICE committee meeting (provisional) |
| 27 January 2027 | NICE guidance expected to publish (provisional) |
The US approval date, checked: 1 April 2026
The Food and Drug Administration's press announcement is dated 1 April 2026 and describes Foundayo as approved to reduce excess body weight, and keep it off, in adults with obesity or with overweight and at least one weight-related comorbid condition. It was the first new molecular entity approved under the FDA's National Priority Voucher pilot; see our development page.
Two differences stand out: the FDA describes the approved use in terms of weight management, whereas the UK licence also covers type 2 diabetes, and the UK decision came just over four months later.
NICE: in progress, guidance expected 27 January 2027
NICE's project page for "Orforglipron for managing overweight and obesity [ID6516]", reference GID-TA11650, shows the status "In progress" and an expected publication date of 27 January 2027. NICE's timeline records a first committee meeting on 14 July 2026 and a note added on 5 August 2026 saying the committee needed more information from the company before it could conclude; the provisional schedule lists a second meeting on 10 November 2026.
The MHRA's announcement is plain about today: the tablet "is not available currently via the NHS", and NHS decisions will follow established processes, including a NICE evaluation. How the appraisal works and what a yes would mean are covered in our article on whether Foundayo will be available on the NHS.
What "approved" does and does not mean for a patient
- The MHRA accepted the evidence. A marketing authorisation means the regulator judged the medicine's quality, safety and effectiveness acceptable for the licensed uses. It is a judgement about the medicine, not about you.
- It is still prescription-only. The MHRA's release says GLP-1 medicines can only be obtained from a registered pharmacy with a prescription, and that unregulated sellers carry serious health risks.
- A prescriber decides. Approval entitles nobody to the medicine; a qualified prescriber judges whether it is appropriate and may conclude that it is not.
- It is not on the NHS yet. Private prescription is the only current route, and NICE's timetable is provisional.
- Monitoring continues. If you suspect a side effect from any medicine, tell your doctor, pharmacist or nurse and report it through the MHRA Yellow Card scheme. Our side effects page covers what the label and trials report.
For a one-page summary kept current as the dates move, see our UK availability page and FAQ.
Frequently asked questions
What is the orforglipron UK approval date?
10 August 2026. The MHRA granted Foundayo (orforglipron) a UK marketing authorisation for weight management and type 2 diabetes, the first in Europe; the Summary of Product Characteristics gives the same date of first authorisation.
Can orforglipron be prescribed in the UK now?
Yes, privately. Lilly UK announced on 24 August 2026 that Foundayo could be prescribed for eligible adults via private prescription. It is prescription-only, so a qualified prescriber must assess you first, and it is not available on the NHS.
When was orforglipron approved in the United States?
On 1 April 2026. The FDA's announcement describes the approved use as reducing excess body weight, and maintaining the reduction, in adults with obesity or with overweight plus a weight-related condition.
Is Foundayo licensed for type 2 diabetes in the UK?
Yes. The UK marketing authorisation covers weight management in adults meeting the BMI criteria and glycaemic control in adults with insufficiently controlled type 2 diabetes. NICE's current appraisal (ID6516) concerns the weight-management use.
When will NICE decide whether the NHS can use it?
NICE's project page gives an expected publication date of 27 January 2027, with a second committee meeting listed for 10 November 2026. Both are provisional. Until NICE publishes, the medicine is not routinely available on the NHS.
Is this article medical advice?
No. It is general information drawn from the MHRA, Lilly UK, the FDA and NICE. A qualified prescriber decides whether Foundayo is suitable. Private prices vary between regulated providers; this site names no providers and quotes no prices.
Sources
- MHRA. UK first in Europe to authorise orforglipron for weight management and type 2 diabetes, 10 August 2026. gov.uk
- Foundayo — Summary of Product Characteristics (sections 4.1, 5.1, 8 and 9). emc. medicines.org.uk
- Eli Lilly and Company Limited. Orforglipron (Foundayo▼) launched in the UK following recent authorisation for weight management and type 2 diabetes mellitus in adults. Press release, Basingstoke, 24 August 2026. lilly.com/uk
- NICE. Orforglipron for managing overweight and obesity [ID6516], GID-TA11650, checked 14 October 2026. nice.org.uk
- US FDA. FDA approves first new molecular entity under National Priority Voucher program, 1 April 2026. fda.gov
- MHRA Yellow Card scheme. yellowcard.mhra.gov.uk