Bremelanotide Acetate Clinical Trials

Size	Price	Qty
5mg	USD 90

Clinical Trials

Bremelanotide Acetate has been evaluated across multiple clinical trials spanning Phase 1 through Phase 4 investigations. Primary conditions investigated in these studies include hypoactive sexual desire disorder, female sexual arousal disorder, obesity, diabetic kidney disease, and pharmacokinetics in lactating mothers. Prominent sponsors driving this clinical portfolio include Palatin Technologies, Kwang Dong Pharmaceutical, Cosette Pharmaceuticals, AMAG Pharmaceuticals, and Imperial College Healthcare NHS Trust. Major completed Phase 3 studies, such as NCT02338960 and NCT02333071, established clinical efficacy for hypoactive sexual desire disorder, while Phase 2 trials like NCT06565611 actively investigate emerging indications such as obesity. Additionally, specialized Phase 1 and Phase 4 trials have successfully evaluated tolerability parameters, including nausea incidence and metabolic disposition in healthy female cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06867835	COMPLETED	Lactating Mother	Cosette Pharmaceuticals, Inc.	2025-07-11	PHASE4
NCT06565611	ACTIVE_NOT_RECRUITING	Obesity	Palatin Technologies, Inc	2024-08-05	PHASE2
NCT05709444	COMPLETED	Kidney Disease	Palatin Technologies, Inc	2022-12-26	PHASE2
NCT04943068	COMPLETED	Hypoactive Sexual Desire Disorder	Kwang Dong Pharmaceutical co., ltd.	2021-05-10	PHASE3
NCT04179734	COMPLETED	Hypoactive Sexual Desire Disorder	Imperial College Healthcare NHS Trust	2019-10-07	PHASE4
NCT03973047	COMPLETED	Nausea	AMAG Pharmaceuticals, Inc.	2019-06-17	PHASE1
NCT02338960	COMPLETED	Hypoactive Sexual Desire Disorder	Palatin Technologies, Inc	2015-01	PHASE3
NCT02333071	COMPLETED	Hypoactive Sexual Desire Disorder	Palatin Technologies, Inc	2014-12	PHASE3
NCT01382719	COMPLETED	Female Sexual Arousal Disorder; Hypoactive Sexual Desire Disorder	Palatin Technologies, Inc	2011-06	PHASE2
NCT00425256	COMPLETED	Sexual Arousal Disorder	Palatin Technologies, Inc	2006-02	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-01-13)

Check the Bremelanotide Acetate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bremelanotide Acetate acts as a selective peptide agonist of central melanocortin receptors, predominantly activating MC4R to trigger downstream cyclic adenosine monophosphate intracellular signaling within the central nervous system. This receptor activation modulates neurogenic pathways governing sexual response, thereby restoring central sexual motivation and providing clinical efficacy in the treatment of hypoactive sexual desire disorder.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).