Flibanserin Clinical Trials

Size	Price	Qty
10mg	USD 97

Clinical Trials

Several clinical trials sponsored by industry and academic entities, including Sprout Pharmaceuticals and Memorial Sloan Kettering Cancer Center, evaluate flibanserin across Phase 1, Phase 3, and feasibility designs. These investigations target conditions such as hypoactive sexual desire disorder, psychological sexual dysfunctions, and breast cancer. Completed studies have evaluated single-dose and steady-state pharmacokinetics as well as sustained efficacy, while an active, non-recruiting trial assesses flibanserin feasibility in breast cancer survivors receiving tamoxifen or aromatase inhibitor therapy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03707340	Active not recruiting	Breast Cancer\|Hyposexual Desire Disorder	Memorial Sloan Kettering Cancer Center	2018-09-14	--
NCT01188603	Completed	Sexual Dysfunctions Psychological	Sprout Pharmaceuticals Inc	2010-07	Phase 1
NCT00277914	Completed	Sexual Dysfunctions Psychological	Sprout Pharmaceuticals Inc	2006-01	Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Flibanserin functions as a selective agonist at postsynaptic 5-HT1A receptors and an antagonist at 5-HT2A receptors, thereby modulating central serotonergic neurotransmission and downstream neurotransmitter release in the central nervous system. By rebalancing monoaminergic signaling within key neural pathways, this pharmacological profile restores sexual drive and function, offering therapeutic relevance for hypoactive sexual desire disorder and sexual dysfunctions in affected populations, including breast cancer survivors.

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>).