Thymosin alpha-1 — compound monograph
28-residue N-acetylated thymic polypeptide. Approved. The Institute assesses 2 outcomes for this compound and grades the strongest at moderate certainty.
§1Identification and status
§1.1Nomenclature
- Preferred name
- Thymosin alpha-1
- Compound class
- 28-residue N-acetylated thymic polypeptide
- Assessment series
- Immune modulators
- Synonyms and codes
- Tα1 · thymalfasin · Zadaxin (trade) · thymosin α1
- Route as evaluated
- Subcutaneous
§1.2Chemistry
Chemical identifiers are reproduced where they are public. Where a structure has not been published the monograph records not disclosed rather than constructing one.[1]
- CAS registry number
- 62304-98-7
- Molecular formula
- C129H215N33O55
- Average mass
- 3108.29
- Monoisotopic mass
- 3106.51
- ATC classification
- L03AX02
§1.3Sequence and structural notes
A 28-residue N-acetylated peptide corresponding to the N-terminal region of prothymosin alpha. It is approved as thymalfasin in more than thirty countries, principally as an adjunct in chronic hepatitis B and C and as an immune adjuvant, which makes it one of only a handful of compounds in the research-peptide category with genuine marketing authorisations.
§1.4Assessment status
The Institute assesses Thymosin alpha-1 across 2 indications and grades the strongest of them at moderate certainty. Holds a marketing authorisation for at least one indication in at least one jurisdiction.
Table 1. Assessed outcomes for Thymosin alpha-1, ordered by certainty. Each row links to the per-indication evidence extract.
| Indication | Effect as recorded | Certainty | Trials |
|---|---|---|---|
| Immune modulation and adjunctive immunotherapy | Meta-analyses of hepatitis B trials report higher sustained virological response with thymosin alpha-1 as monotherapy or adjunct; a large Chinese… | Moderate | 4 |
| Cognitive performance and neuroprotection | No evidence identified | Not rated | 0 |
| Effects are reproduced as the contributing trials reported them. Where a confidence interval is held it appears on the per-indication extract rather than in this summary table. | |||
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
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.