Thymosin beta-4 — compound monograph
43-residue actin-sequestering polypeptide. Unapproved, research supply. The Institute assesses 2 outcomes for this compound and grades the strongest at low certainty.
§1Identification and status
§1.1Nomenclature
- Preferred name
- Thymosin beta-4
- Compound class
- 43-residue actin-sequestering polypeptide
- Assessment series
- Repair and regeneration
- Synonyms and codes
- Tβ4 · TB4 · thymosin β4 · RGN-352 (investigational formulation)
- Route as evaluated
- Intravenous, subcutaneous or topical in clinical studies
§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
- 77591-33-4
- Molecular formula
- C212H350N56O78S
- Average mass
- 4963.44
- Monoisotopic mass
- 4960.53
- ATC classification
- not assigned
§1.3Sequence and structural notes
A 43-residue N-acetylated polypeptide, one of the most abundant intracellular proteins in mammalian cells. The actin-binding motif LKKTETQ occupies residues 17–23. The single methionine at position 6 is the principal oxidation liability. It is a distinct substance from the TB-500 heptapeptide and the two carry separate monographs in this series.
§1.4Assessment status
The Institute assesses Thymosin beta-4 across 2 indications and grades the strongest of them at low certainty. Supplied as a research chemical; no marketing authorisation for the uses under which it is supplied.
Table 1. Assessed outcomes for Thymosin beta-4, ordered by certainty. Each row links to the per-indication evidence extract.
| Indication | Effect as recorded | Certainty | Trials |
|---|---|---|---|
| Cutaneous wound healing and tissue repair | Phase 2 trials in dry-eye disease, epidermolysis bullosa and venous stasis ulcers reported signals on some secondary endpoints without meeting… | Low | 3 |
| Atherosclerotic cardiovascular disease and cardiovascular risk reduction | Phase 1 safety study completed; no efficacy conclusion | Very low | 1 |
| 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.