GLP1 Europe

GLP1 Europe › Molecules › Tirzepatide

Is tirzepatide approved in Europe?

Last checked 16 August 2026 · Sources listed at the end

Short answer

Yes. Tirzepatide is authorised in the European Union and the United Kingdom under one brand name, Mounjaro, for two things: type 2 diabetes and weight management. Unlike semaglutide, the weight version does not get a separate name in Europe.

It hits two receptors rather than one, GLP-1 and GIP, and in the only head-to-head trial against semaglutide it produced more weight loss. That trial was run in the United States, not Europe.

Tirzepatide authorisations in Europe. Verified 16 August 2026.
Indication European Union United Kingdom
Type 2 diabetesadults Authorised 15 Sep 2022 Authorised 2022
Type 2 diabeteschildren and adolescents from 10 Added after Dec 2025 opinion Not verified
Weight managementBMI 30, or 27 with a related condition Authorised Authorised Nov 2023
Obstructive sleep apnoeaas a separate indication Refused as separate Not verified
Heart failure, preserved ejection fractionas a separate indication Refused 30 Jan 2026 Not verified
Cardiovascular risk reductionas a separate indication Refused 25 Jun 2026 Not verified

Those three refusals need explaining, because "refused" sounds worse than it is. In each case the EU committee accepted the evidence and added it to the product information, but declined to create a new standalone indication, on the view that the benefit was already covered by the weight-management licence. The data is on the label. The separate claim is not.

What changed in 2026

  1. Heart failure indication refused

    The EU committee assessed the SUMMIT trial in heart failure with preserved ejection fraction and declined a separate indication, saying the benefit was already covered by weight management. The trial data went onto the label instead.

    30 January 2026

  2. Netherlands widens diabetes reimbursement

    Reimbursement extended to diabetes patients at very high cardiovascular risk, on advice issued 19 March 2026.

    1 May 2026

  3. Spain declines public funding

    The interministerial pricing commission refused public financing, citing budget impact. Semaglutide products kept their funding, at reduced prices. Talks were reported to be continuing.

    Reported 5 February 2026

  4. France starts paying for the weight indication

    Mounjaro became reimbursable for obesity alongside Wegovy. Eligibility is BMI 40 and above after failed nutritional management, or BMI 35 and above with at least one weight-related condition. The first prescription must come from an obesity specialist.

    15 June 2026

  5. Cardiovascular indication refused

    The EU committee assessed SURPASS-CVOT and again declined a new indication, adding the data to the product information instead.

    25 June 2026

What the big trials actually found

Major tirzepatide outcome trials read out in 2025 and 2026.
TrialWhat it testedResult
SURMOUNT-5 Head to head against semaglutide for weight, 72 weeks, 751 people, run in the United States and Puerto Rico Tirzepatide 20.2 percent average weight loss against semaglutide 13.7 percent. A gap of 6.5 percentage points. Published 11 May 2025.
SURPASS-CVOT Cardiovascular outcomes against dulaglutide, more than 13,000 people, around four years Major cardiac events 12.2 percent against 13.1 percent. Non-inferiority met, superiority not. Weight loss 11.6 percent against 4.5 percent. Published December 2025.
SUMMIT Heart failure with preserved ejection fraction in people with obesity Fewer worsening heart-failure events and better quality-of-life scores. Not enough for the EU regulator to grant a separate indication.

The honest reading of SURMOUNT-5 is that tirzepatide beat semaglutide on weight in one open-label trial of 751 people. That is a real result and it is a single trial, against the injectable semaglutide dose available at the time, in a non-European population.

Public funding for tirzepatide. Verified 16 August 2026.
CountryDiabetesWeightDetail
FranceYesFrom 15 Jun 202665 percent. Specialist must start it, a support form goes with every dispensing, including for people already on treatment.
United KingdomYesPhasedNHS primary-care rollout began 23 June 2025 and runs in cohorts over several years. The first group is BMI 40 and above with at least four qualifying conditions. Later groups start in 2026/27 and beyond.
GermanyYesNoListed as a lifestyle medicine and excluded from statutory insurance for the weight indication.
ItalyYesNoFunded for type 2 diabetes only, under AIFA Note 100 since 23 February 2025, with an electronic assessment form. Weight patients pay in full.
NetherlandsYesUnder reviewDiabetes cover widened on 1 May 2026 to very high cardiovascular risk. The obesity file was received in March 2026, with the advisory committee due to discuss it in October 2026.
SpainNoNoPublic financing refused. Semaglutide products remained funded, at cut prices.

Sources

  1. European Medicines Agency, Mounjaro EPAR and product information, checked 16 August 2026.
  2. EMA, CHMP meeting highlights 26 to 29 January 2026, and the accompanying questions and answers on heart failure with preserved ejection fraction.
  3. EMA, CHMP meeting highlights 22 to 25 June 2026, on the cardiovascular risk application.
  4. EMA, CHMP meeting highlights 8 to 11 December 2025, paediatric type 2 diabetes opinion.
  5. EMA, questions and answers on the assessment of Mounjaro for obstructive sleep apnoea, 13 December 2024.
  6. New England Journal of Medicine, SURMOUNT-5, published 11 May 2025, and SURPASS-CVOT, December 2025.
  7. NICE technology appraisal TA1026, published 23 December 2024, and NHS England interim commissioning guidance, last reviewed April 2026.
  8. Vidal and Ameli, French reimbursement conditions from 15 June 2026.
  9. Zorginstituut Nederland, advice of 19 March 2026 and the open obesity assessment, page updated 21 July 2026.
  10. AIFA Note 100, in force 23 February 2025, on Italian reimbursement conditions.

Some items here rest on secondary reporting rather than a document we could open directly: the exact original UK authorisation date, the Spanish funding refusal, the current Italian position, and the status of the German exclusion. They are described as reported rather than verified. The EU regulatory decisions are all taken from published EMA committee minutes.

This page is background information, not medical advice. Tirzepatide is a prescription medicine everywhere in Europe. Whether it is appropriate for you is a question for a doctor or a pharmacist.