Glutathione — 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 Glutathione by jurisdiction, as recorded at the assessment date.
| Jurisdiction | Status | Detail |
|---|---|---|
| Italy and some other jurisdictions | Authorised | Available as an authorised medicinal product in a small number of countries, principally as an adjunct in cisplatin neurotoxicity |
| United States | Not approved as a parenteral | Marketed as a dietary supplement in oral form; parenteral preparations are compounded |
| Philippines and elsewhere | Regulatory warnings issued | Advisories against intravenous glutathione for skin lightening |
| Research-use supply | Variable | Widely available; the material itself is a well-characterised pharmacopoeial-grade chemical, unlike most compounds in this series |
| Recorded at the assessment date. Regulatory status changes and this table is re-examined at each review. | ||
§5.2Development status
Unapproved, research supply. Supplied as a research chemical; no marketing authorisation for the uses under which it is supplied.
Table 6. Published trials held by the Institute for this compound, by phase.
| Phase | Trials | Identifiers |
|---|---|---|
| Phase 2 | 1 | GSH-PD-PH2 |
§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.