Clinical Trials

Numerous clinical trials spanning Phase 1, Phase 2, and Phase 3 have evaluated peficitinib (ASP015K) primarily in rheumatoid arthritis, psoriasis, and specialized clinical pharmacology cohorts, including healthy volunteers and populations with hepatic or renal impairment. Sponsored by industry partners such as Astellas Pharma and Janssen Research & Development, these completed studies investigated therapeutic efficacy, safety, bioequivalence, and drug-drug interactions. Overall, this research reflects advanced clinical development aimed at establishing therapeutic benefit in inflammatory disease management.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03660059 COMPLETED
Rheumatoid Arthritis (RA)
Astellas Pharma China, Inc.
 2018-09-27 PHASE3
NCT04143477 COMPLETED
Healthy Volunteers
Astellas Pharma China, Inc.
 2019-12-05 PHASE1
NCT01638013 COMPLETED
Arthritis, Rheumatoid
Astellas Pharma Inc
 2012-06-13 PHASE3
NCT02305849 COMPLETED
Rheumatoid Arthritis
Astellas Pharma Inc
 2014-07-25 PHASE3
NCT02308163 COMPLETED
Rheumatoid Arthritis
Astellas Pharma Inc
 2014-08-08 PHASE3
NCT02760342 COMPLETED
Healthy Subjects
Astellas Pharma Inc
 2016-05-15 PHASE1
NCT02760342 Completed
Healthy Subjects
Astellas Pharma Inc
 2016-05-15 Phase 1
NCT01711814 COMPLETED
Arthritis, Rheumatoid
Astellas Pharma Global Development, Inc.
 2012-09-26 PHASE2
NCT02586194 Completed
Patients With Impaired Hepatic Function
Astellas Pharma Inc
 2015-12-28 Phase 1
NCT02603497 Completed
Patients With Impaired Renal Function
Astellas Pharma Inc
 2015-11-24 Phase 1
NCT02531191 COMPLETED
Healthy Volunteers
Astellas Pharma Inc
 2015-06-21 PHASE1
NCT02531191 Completed
Healthy Volunteers
Astellas Pharma Inc
 2015-06-21 Phase 1
NCT02117505 Completed
Healthy
Janssen Research & Development LLC
 2014-04 Phase 1
NCT01554696 COMPLETED
Arthritis, Rheumatoid
Astellas Pharma Inc
 2012-07-06 PHASE2
NCT01565655 COMPLETED
Arthritis, Rheumatoid
Astellas Pharma Global Development, Inc.
 2012-06-19 PHASE2
NCT01649999 COMPLETED
Arthritis, Rheumatoid
Astellas Pharma Inc
 2012-03-01 PHASE2
NCT01096862 COMPLETED
Psoriasis
Astellas Pharma Inc
 2010-03-23 PHASE2
NCT01754805 COMPLETED
Rheumatoid Arthritis
Astellas Pharma Inc
 2010-01-22 PHASE1
NCT01225224 COMPLETED
Pharmacokinetics of ASP015K; Healthy Volunteer
Astellas Pharma Inc
 2009-11-18 PHASE1

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

Check the Peficitinib (ASP015K) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Peficitinib selectively binds to and inhibits Janus kinases (JAK), thereby blocking downstream STAT protein phosphorylation and suppressing signaling cascades crucial for pro-inflammatory cytokine production in immune cells. By inhibiting cytokine-mediated immune signaling, peficitinib reduces systemic inflammation, providing clinical relevance in the treatment of autoimmune disorders such as rheumatoid arthritis and psoriasis studied in clinical trials.

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.