Romania: peptide approval and availability

Recent changes

• 2026-07-15

  EU approval: Wegovy pill (oral semaglutide)

  15 July 2026: the European Commission approved the Wegovy pill (oral semaglutide) as the first oral GLP-1 receptor agonist for weight management in the EU. A single ready-to-use 7.2 mg higher-dose pen was approved at the same time.

• 2026-05-21

  CHMP: positive opinion for oral Wegovy (semaglutide)

  21 May 2026: EMA's CHMP adopted a positive opinion for a new pharmaceutical form of Wegovy — oral tablets (1.5 / 4 / 9 / 25 mg) for weight management. The first oral GLP-1 receptor agonist for this indication. In the OASIS 4 trial, 25 mg once daily showed 16.6% mean weight loss.

• 2026-03-19

  Retatrutide: TRIUMPH-4 published — 28.7% weight loss

  March 2026: full Phase 3 TRIUMPH-4 results from Eli Lilly were published, showing 28.7% average body weight loss — the highest ever recorded in an obesity clinical trial. Seven additional TRIUMPH trials are expected throughout 2026, with NDA filing to the FDA expected in late 2026.

• 2026-03-26

  EMA CHMP March 2026: 5 new medicines + 13 indication extensions

  At the 23-26 March 2026 meeting, EMA's CHMP recommended approval of 5 new medicines and 13 extensions of therapeutic indications for existing marketing authorisations — including metabolic/endocrine indications.

• 2026-01-29

  EMA CHMP January 2026: 6 new approvals + 9 extensions

  At the 26-29 January 2026 meeting, CHMP recommended 6 new medicine approvals and 9 indication extensions — the first major EMA-level regulatory decision of 2026.

• 2025-12-11

  EMA CHMP: positive opinion on Mounjaro® marketing authorisation variation

  On 11 December 2025 EMA's CHMP adopted a positive opinion recommending a change to the marketing authorisation terms for Mounjaro® (tirzepatide) at EU level.

• 2025-09-03

  EMA warning: sharp rise in illegal GLP-1 medicines sold in the EU

  EMA and the HMA issued a joint warning about illegal medicines sold as GLP-1 receptor agonists for weight loss and diabetes, posing serious health risks.

• 2025-03-21

  FDA: semaglutide & tirzepatide shortages officially resolved — stricter compounding rules

  FDA confirmed that semaglutide and tirzepatide shortages are officially resolved, triggering restrictions on 503A/503B pharmacy compounding in the US — with downstream effects on the global market.

• 2025-05-12

  EASO: semaglutide & tirzepatide as first-line obesity treatment

  The European Association for the Study of Obesity (EASO) issued new framework recommending semaglutide and tirzepatide as first-line pharmacotherapy for obesity and most of its complications.

• 2025-08-15

  Retatrutide: remains investigational — Phase 3 ongoing

  Retatrutide (Eli Lilly, LY3437943) remains unapproved by FDA/EMA. TRIUMPH (obesity) and TRANSCEND (cardiovascular) Phase 3 programs are ongoing with regulatory submission expected from 2026 onwards.

• 2024-11-20

  EMA notice: prolonged Ozempic® shortage

  EMA confirmed ongoing shortage until Q2 2025 across 0.25mg, 0.5mg and 1mg pens.

• 2024-10-08

  Retatrutide: Phase III interim data published

  Eli Lilly published Phase III interim showing average -24% body weight at 48 weeks.

• 2024-05-10

  WADA: TB-500 confirmed as prohibited substance

  WADA updated the 2024 list keeping thymosin β4 fragment as S2 anabolic agent.