Semax — compound monograph
Synthetic ACTH(4-10) analogue heptapeptide. Approved. The Institute assesses 2 outcomes for this compound and grades the strongest at low certainty.
§1Identification and status
§1.1Nomenclature
- Preferred name
- Semax
- Compound class
- Synthetic ACTH(4-10) analogue heptapeptide
- Assessment series
- Neuroactive peptides
- Synonyms and codes
- Met-Glu-His-Phe-Pro-Gly-Pro · ACTH(4-7)-Pro-Gly-Pro · heptapeptide Semax
- Route as evaluated
- Intranasal in the approved Russian presentations; also supplied for subcutaneous use
§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
- 80714-61-0
- Molecular formula
- C37H51N9O10S
- Average mass
- 813.93
- Monoisotopic mass
- 813.35
- ATC classification
- not assigned
§1.3Sequence and structural notes
A heptapeptide comprising residues 4 to 7 of adrenocorticotropic hormone with a C-terminal Pro-Gly-Pro extension. The tripeptide extension confers marked resistance to enzymatic degradation and abolishes the corticotropic activity of the parent fragment, leaving the reported neurotropic activity.
§1.4Assessment status
The Institute assesses Semax across 2 indications and grades the strongest of them at low certainty. Holds a marketing authorisation for at least one indication in at least one jurisdiction.
Table 1. Assessed outcomes for Semax, ordered by certainty. Each row links to the per-indication evidence extract.
| Indication | Effect as recorded | Certainty | Trials |
|---|---|---|---|
| Cognitive performance and neuroprotection | Russian clinical studies report functional improvement after ischaemic stroke and in cognitive disorders | Very low | 2 |
| Sleep initiation and maintenance disorders | No assessable randomised evidence identified | Very low | 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.