Clascoterone Clinical Trials

Size	Price	Qty
5mg	USD 117

Clinical Trials

Multiple clinical trials have evaluated Clascoterone (Cortexolone 17α-propionate) across Phase 1 and Phase 2 investigations in healthy volunteers and patients with acne vulgaris. Sponsored by industry entities including Cassiopea SpA and Intrepid Therapeutics Inc., all trials on record have reached completed recruitment status. These studies evaluated key parameters including systemic absorption, pharmacokinetics, and potential adrenal suppression.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03665194	Completed	Healthy Volunteers	Cassiopea SpA	2018-06-06	Phase 1
NCT01831960	Completed	Acne Vulgaris	Intrepid Therapeutics Inc.	2013-04	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clascoterone acts as a peripherally selective antagonist that directly binds to the androgen receptor, blocking ligand interaction and suppressing downstream androgenic signaling pathways within target tissues. This inhibition attenuates androgen-stimulated transcription and localized sebum synthesis in cutaneous cells, providing a therapeutic rationale for reducing lesions in dermatological conditions such as acne vulgaris.

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>).