Thymalin — compound monograph
Thymic peptide extract of undefined composition. Approved. The Institute assesses 2 outcomes for this compound and grades the strongest at very low certainty.
§1Identification and status
§1.1Nomenclature
- Preferred name
- Thymalin
- Compound class
- Thymic peptide extract of undefined composition
- Assessment series
- Immune modulators
- Synonyms and codes
- thymalin · thymus polypeptide extract · Vilon (related dipeptide preparation)
- Route as evaluated
- Intramuscular in the approved Russian presentation
§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
- not applicable (extract)
- Molecular formula
- not applicable
- Average mass
- a mixture of peptides in the approximate range 1000–10,000 Da
- Monoisotopic mass
- not applicable
- ATC classification
- not assigned
§1.3Sequence and structural notes
Thymalin is an extract, not a molecule. It has no sequence, no molecular formula and no single molecular mass. The Institute includes a monograph specifically to record that a compound of undefined composition cannot be characterised by the analytical framework applied to synthetic peptides, and that certificates presenting an HPLC purity percentage for an extract are describing something that has no meaning.
§1.4Assessment status
The Institute assesses Thymalin across 2 indications and grades the strongest of them at very low certainty. Holds a marketing authorisation for at least one indication in at least one jurisdiction.
Table 1. Assessed outcomes for Thymalin, ordered by certainty. Each row links to the per-indication evidence extract.
| Indication | Effect as recorded | Certainty | Trials |
|---|---|---|---|
| Biological ageing and healthspan endpoints | No assessable evidence identified | Very low | 0 |
| Immune modulation and adjunctive immunotherapy | Russian clinical reports describe immunological and clinical effects across a wide range of conditions | 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.