Clinical Trials

Multiple clinical trials, supported by industry sponsors including Suzhou Kintor Pharmaceutical Inc and Suzhou Koshine Biomedica, Inc., evaluate the efficacy, safety, and pharmacokinetics of topical pyrilutamide (KX-826) for androgenetic alopecia, male pattern hair loss, and general alopecia. Spanning Phase 1, Phase 2, and Phase 3, these investigations range from completed dose-escalation and Phase 2 studies to Phase 3 and upcoming trials. Overall, these studies focus on determining the local therapeutic activity and safety profile of topical KX-826 solutions and tinctures in patients with androgen-mediated hair loss.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06622824 NOT_YET_RECRUITING
Androgenetic Alopecia (AGA)
Suzhou Kintor Pharmaceutical Inc,
 2024-10-15 PHASE2; PHASE3
NCT06126965 UNKNOWN
Androgenetic Alopecia
Suzhou Kintor Pharmaceutical Inc,
 2021-12-29 PHASE3
NCT05218642 COMPLETED
Alopecia; Male Pattern Hair Loss
Suzhou Kintor Pharmaceutical Inc,
 2022-01-31 PHASE2
NCT06409650 COMPLETED
Alopecia
Suzhou Koshine Biomedica, Inc.
 2021-11-09 PHASE2
NCT05940506 COMPLETED
Androgenetic Alopecia (AGA)
Suzhou Kintor Pharmaceutical Inc,
 2020-09-28 PHASE2
NCT04502901 COMPLETED
Androgenetic Alopecia
Suzhou Kintor Pharmaceutical Inc,
 2020-01-14 PHASE1
NCT04984707 COMPLETED
Androgenetic Alopecia
Suzhou Kintor Pharmaceutical Inc,
 2019-01-28 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-10-21)

Check the Pyrilutamide (KX-826) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pyrilutamide (KX-826) acts as a high-affinity antagonist of the androgen receptor, preventing androgen binding and inhibiting downstream receptor dimerization, nuclear translocation, and gene expression. By locally suppressing androgen signaling within hair follicle epithelial cells, this inhibition counteracts follicular miniaturization, providing direct therapeutic relevance for managing androgenetic alopecia and male pattern hair loss.

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>).

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Note: Technical data last updated: Sep 1, 2026.