Clinical Trials

Tapinarof has been evaluated across numerous clinical trials, ranging from early Phase 1 through Phase 4, primarily focusing on plaque psoriasis, atopic dermatitis, palmoplantar keratoderma, cutaneous lupus erythematosus, and malaria chemoprevention. Sponsored by pharmaceutical companies and research institutions—including Dermavant Sciences Inc., Sun Pharmaceutical Industries, Organon and Co, Peking University People's Hospital, and the Malaria Consortium—these studies encompass recruitment statuses ranging from completed and actively recruiting to active, not recruiting and enrolling by invitation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07352566 NOT_YET_RECRUITING
Psoriasis; Atopic Dermatitis
University of California, San Francisco
 2026-08-01 PHASE4
NCT06561321 ACTIVE_NOT_RECRUITING
Palmoplantar Keratoderma
Indiana University
 2024-10-30 PHASE2
NCT06661213 ENROLLING_BY_INVITATION
Cutaneous Lupus Erythematosus
Northwestern University
 2025-04-03 EARLY_PHASE1
NCT07265479 ACTIVE_NOT_RECRUITING
Atopic Dermatitis
Organon and Co
 2025-12-29 PHASE3
NCT05981118 ENROLLING_BY_INVITATION
ICD10 Code L40.9 for Psoriasis
Wake Forest University Health Sciences
 2024-07-15 PHASE2; PHASE3
NCT07635043 NOT_YET_RECRUITING
Psoriasis (PsO)
Pakistan Institute of Medical Sciences
 2026-08-01 PHASE4
NCT05172726 ACTIVE_NOT_RECRUITING
Plaque Psoriasis
Organon and Co
 2021-12-02 PHASE3
NCT07546214 COMPLETED
Plaque Psoriasis
Sun Pharmaceutical Industries, Inc.
 2025-10-13 PHASE1
NCT06742957 COMPLETED
Plaque Type Psorisis
Teva Pharmaceuticals USA
 2024-12-17 PHASE3
NCT05142774 COMPLETED
Atopic Dermatitis
Organon and Co
 2021-10-28 PHASE3
NCT06103695 COMPLETED
Psoriasis
Psoriasis Treatment Center of Central New Jersey
 2023-02-27 PHASE4
NCT05979896 Recruiting
Malaria
Malaria Consortium
 2023-07-28 Phase 4
NCT05789576 COMPLETED
Psoriasis
Organon and Co
 2023-03-13 PHASE4
NCT05680740 COMPLETED
Psoriasis
Organon and Co
 2022-12-27 PHASE4
NCT05014568 COMPLETED
Atopic Dermatitis
Organon and Co
 2021-09-01 PHASE3
NCT05032859 COMPLETED
Atopic Dermatitis
Organon and Co
 2021-09-23 PHASE3
NCT05186805 COMPLETED
Atopic Dermatitis
Organon and Co
 2021-11-15 PHASE2
NCT05478954 Active not recruiting
Malaria
Malaria Consortium
 2022-07-15 Phase 4
NCT05471544 Active not recruiting
Malaria
Malaria Consortium
 2022-07-18 Phase 3
NCT05326659 Unknown status
Psoriasis
Peking University People''s Hospital|Zhonghao Pharmaceutical
 2022-04 Not Applicable
NCT05326672 Unknown status
Atopic Dermatitis
Peking University People''s Hospital|Zhonghao Pharmaceutical
 2022-04 Phase 3
NCT05172726 Recruiting
Plaque Psoriasis
Dermavant Sciences Inc.
 2021-12-02 Phase 3
NCT04053387 COMPLETED
Plaque Psoriasis
Organon and Co
 2019-08-13 PHASE3
NCT03956355 COMPLETED
Plaque Psoriasis
Organon and Co
 2019-05-21 PHASE3
NCT03983980 COMPLETED
Plaque Psoriasis
Organon and Co
 2019-06-06 PHASE3
NCT04042103 COMPLETED
Plaque Psoriasis
Organon and Co
 2019-07-23 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-03)

Check the Tapinarof (Benvitimod, WBI-1001) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tapinarof acts as a direct agonist of the aryl hydrocarbon receptor (AhR), inducing nuclear translocation of AhR and modulating gene transcription to inhibit pro-inflammatory cytokine production while selectively inducing cellular apoptosis in T cells. This targeted suppression of cutaneous immune responses restores skin barrier homeostasis and mitigates tissue inflammation, demonstrating clinical utility in treating chronic dermatological disorders such as plaque psoriasis and atopic dermatitis.

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.