Survodutide — regulatory status
Authorisation status by jurisdiction, development status, and the distinction between an authorised product and research supply.
§5Regulatory status
§5.1Status by jurisdiction
Table 5. Regulatory status of Survodutide by jurisdiction, as recorded at the assessment date.
| Jurisdiction | Status | Detail |
|---|---|---|
| United States | Investigational | Phase 3 |
| European Union | Investigational | Phase 3 |
| Research-use supply | Not approved | Occasionally offered; sequence documentation generally absent |
| Recorded at the assessment date. Regulatory status changes and this table is re-examined at each review. | ||
§5.2Development status
Phase 3. In confirmatory clinical development; no marketing authorisation.
Table 6. Published trials held by the Institute for this compound, by phase.
| Phase | Trials | Identifiers |
|---|---|---|
| Phase 2 | 2 | SURVO-PH2-OBESITY · SURVO-PH2-MASH |
| Phase 3 | 3 | SYNCHRONIZE-1 · SYNCHRONIZE-2 · SYNCHRONIZE-CVOT |
§5.3Supply outside authorisation
Material offered by research-chemical suppliers is not manufactured under a marketing authorisation, is not subject to the quality system that governs an authorised product, and is not covered by any pharmacovigilance obligation. The distinction matters for this monograph because every efficacy and safety estimate reproduced in §3 and §4 was obtained using material manufactured under such a system. The Institute records supply considerations separately at §8 and analytical characterisation at §6.[1,2]
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
- Sodhi M, Rezaeianzadeh R, Kezouh A, Etminan M. Risk of gastrointestinal adverse events associated with glucagon-like peptide-1 receptor agonists for weight loss. JAMA 2023;330(18):1795–1797. doi:10.1001/jama.2023.19574 · PMID 37796527
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.