Tirzepatide official document review · version 1
This page preserves this version's findings, scope and source pins. Open the current profile →
Inside the official reviews
Reviewed 2026-09-19 · Preserved version 1
The five trials had different comparisons
EMA’s July 2022 assessment covers SURPASS-1 through SURPASS-5 in type 2 diabetes. Placebo comparisons were blinded, while several active-comparator trials were open-label and used different background therapies. EMA PDF pp. 203 ↗
More findings, study links and document coverage
An effect estimate depends on what happened after discontinuation
The review distinguishes an analysis including treatment changes and nonadherence from an efficacy analysis assuming intended treatment without rescue. These address different questions and should not be merged into one headline estimate. EMA PDF pp. 204 ↗
Comparisons apply to the regimens actually studied
The assessment found greater glycemic and weight improvements than its studied comparators, including the then-studied semaglutide regimen. This does not establish superiority over every formulation, regimen, population or later trial. EMA PDF pp. 203, 204 ↗
Important populations were sparsely represented
EMA noted limited clinical evidence in severe kidney or liver impairment, alongside gastrointestinal adverse effects and treatment discontinuations. This original diabetes assessment is distinct from later weight-management and other indication reviews. EMA PDF pp. 205, 211 ↗
Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.
Document coverage
Selected sections read in 1 of 1 inventoried documents; 0 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.
One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading. EMA inventory source ↗
Inspect documents, application identities and source pins
Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.
Mounjaro : EPAR - Public assessment report ↗
Selected sections reviewed · ema-56782 · Document/feed date: 2022-11-25
Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.
Verified: Mounjaro · EMEA/H/C/005620 · Document dated 2022-07-21. Identity checked on PDF pp. 1.
Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal.
Retrieved 2026-09-19. Read PDF pages: 1, 203, 204, 205, 211 of 212. SHA-256:
dec7c5c0d0692f96f66dff032922f375b9aecb73948c663c4df4bb5d80e10283.Feed-listed application (not a verified association): EMEA/H/C/005620.
Remaining work
- Review later weight-management, sleep-apnea and cardiovascular-outcomes assessments separately from SURPASS.
- Appraise trial publications and statistical plans with their treatment-policy and efficacy estimands preserved.