PT-141 (bremelanotide) — compound monograph
Melanocortin receptor agonist (cyclic heptapeptide). Approved. The Institute assesses 1 outcome for this compound and grades the strongest at moderate certainty.
§1Identification and status
§1.1Nomenclature
- Preferred name
- PT-141 (bremelanotide)
- Compound class
- Melanocortin receptor agonist (cyclic heptapeptide)
- Assessment series
- Melanocortin receptor agonists
- Synonyms and codes
- bremelanotide · PT-141 · Vyleesi (trade)
- Route as evaluated
- Subcutaneous, on demand
§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
- 189691-06-3
- Molecular formula
- C50H68N14O10
- Average mass
- 1025.16
- Monoisotopic mass
- 1024.52
- ATC classification
- G02CX05
§1.3Sequence and structural notes
A cyclic heptapeptide analogue of alpha-melanocyte-stimulating hormone, formed by a lactam bridge between the Asp side chain and the Lys side chain. It is the deaminated metabolite of melanotan-II and, unlike melanotan-II, holds a marketing authorisation. The cyclic constraint is essential to the pharmacology and its integrity is a critical quality attribute.
§1.4Assessment status
The Institute assesses PT-141 (bremelanotide) across 1 indication 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 PT-141 (bremelanotide), ordered by certainty. Each row links to the per-indication evidence extract.
| Indication | Effect as recorded | Certainty | Trials |
|---|---|---|---|
| Hypoactive sexual desire and erectile dysfunction | Change in Female Sexual Function Index desire domain of +0.30 versus +0.06 with placebo, and improvement in the Female Sexual Distress Scale item 13… | Moderate | 2 |
| 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.