Clinical Trials

A clinical trial sponsored by ASLAN Pharmaceuticals is evaluating the safety and efficacy of oral Farudodstat in patients with alopecia areata. Designed as a randomized, double-blind, placebo-controlled Phase 2 investigation, this industry-led study assesses the drug's therapeutic potential for dermatological autoimmune conditions, though its recruitment status is currently listed as unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05865041 UNKNOWN
Alopecia Areata
ASLAN Pharmaceuticals
 2023-04-14 PHASE2

(data from https://clinicaltrials.gov, updated on 2023-12-18)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Farudodstat is a potent and orally active inhibitor of human dihydroorotate dehydrogenase (DHODH) with an IC50 of 35 nM, which blocks de novo pyrimidine synthesis to impair protein synthesis and induce differentiation and apoptosis. By suppressing hyperproliferative and activated immune cell populations through pyrimidine depletion, this mechanism provides the rationale for its clinical evaluation in autoimmune conditions such as alopecia areata.

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.