Overview
Tapinarof is a novel, first-in-class, small-molecule AhR agonist that is indicated for the treatment of adult psoriasis. It is available as a topical cream to be applied to the affected area once daily. Tapiranof was first discovered as a metabolite (3,5-dihydroxy-4-isopropylstilbene) produced in Photorhabdus luminescens, a gram-negative bacillus that lives symbiotically with the Heterorhabditis nematodes. In 1959, it was noticed that Heterorhabditis with a high amount of 3,5-dihydroxy-4-isopropylstilbene did not putrefy once dead, thus suggesting its potential anti-inflammatory activity. Tapinarof received initial approval from the FDA in 2022.
Indication
Tapinarof is indicated for the topical treatment of plaque psoriasis in adults.
Associated Conditions
- Psoriasis Vulgaris (Plaque Psoriasis)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/19 | Phase 3 | Recruiting | |||
2024/10/28 | Early Phase 1 | ENROLLING_BY_INVITATION | |||
2024/08/20 | Phase 2 | Recruiting | |||
2023/10/27 | Phase 4 | Completed | Psoriasis Treatment Center of Central New Jersey | ||
2023/08/08 | Phase 2 | ENROLLING_BY_INVITATION | |||
2023/03/29 | Phase 4 | Completed | |||
2023/01/11 | Phase 4 | Completed | |||
2022/04/13 | Not Applicable | UNKNOWN | |||
2022/04/13 | Phase 3 | UNKNOWN | |||
2022/01/11 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Dermavant Sciences, Inc. | 81672-5051 | TOPICAL | 10 mg in 1 g | 12/22/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Benvitimod Cream | 国药准字H20190026 | 化学药品 | 乳膏剂 | 5/29/2019 | |
| Benvitimod Cream | 国药准字H20240040 | 化学药品 | 乳膏剂 | 11/22/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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