MedPath

Tapinarof

Generic Name
Tapinarof
Brand Names
Vtama
Drug Type
Small Molecule
Chemical Formula
C17H18O2
CAS Number
79338-84-4
Unique Ingredient Identifier
84HW7D0V04
Background

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)

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Phase 3
Recruiting
Conditions
Plaque Psoriasis
Interventions
First Posted Date
2021-12-29
Last Posted Date
2024-12-10
Lead Sponsor
Dermavant Sciences, Inc.
Target Recruit Count
100
Registration Number
NCT05172726
Locations
🇨🇦

Dermavant Clinical Trials, Oshawa, Ontario, Canada

🇨🇦

Dermavant Clinical Site, Montréal, Quebec, Canada

Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis

Phase 3
Completed
Conditions
Atopic Dermatitis
Interventions
First Posted Date
2021-12-03
Last Posted Date
2024-07-08
Lead Sponsor
Dermavant Sciences, Inc.
Target Recruit Count
728
Registration Number
NCT05142774
Locations
🇺🇸

Dermavant lnvestigative Site, Greenville, South Carolina, United States

🇨🇦

Dermavant Investigative Site, Montréal, Quebec, Canada

Phase IV Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Psoriasis in Adults

Phase 4
Recruiting
Conditions
Psoriasis
Interventions
First Posted Date
2021-10-01
Last Posted Date
2021-10-01
Lead Sponsor
Peking University People's Hospital
Target Recruit Count
2000
Registration Number
NCT05064748
Locations
🇨🇳

Peking University People's Hospital, Beijing, Beijing, China

Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)

Phase 3
Completed
Conditions
Atopic Dermatitis
Interventions
Drug: vehicle cream
First Posted Date
2021-09-02
Last Posted Date
2024-07-08
Lead Sponsor
Dermavant Sciences, Inc.
Target Recruit Count
406
Registration Number
NCT05032859
Locations
🇺🇸

Dermanvant Investigative Site, Brooklyn, New York, United States

🇨🇦

Dermavant Investigative Site, Windsor, Ontario, Canada

Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults

Phase 3
Completed
Conditions
Atopic Dermatitis
Interventions
Drug: Vehicle cream
First Posted Date
2021-08-20
Last Posted Date
2024-07-08
Lead Sponsor
Dermavant Sciences, Inc.
Target Recruit Count
407
Registration Number
NCT05014568
Locations
🇨🇦

Dermavant Investigative Site, Montréal, Quebec, Canada

Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)

Phase 3
Completed
Conditions
Plaque Psoriasis
Interventions
First Posted Date
2019-08-12
Last Posted Date
2022-09-29
Lead Sponsor
Dermavant Sciences GmbH
Target Recruit Count
763
Registration Number
NCT04053387
Locations
🇨🇦

Dermavant Investigative Site, Montréal, Quebec, Canada

🇨🇦

Dermavant Clinical Site, Markham, Ontario, Canada

🇺🇸

Dermavant Investigational Site, Detroit, Michigan, United States

and more 1 locations

Maximal Use Study of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis

Phase 2
Completed
Conditions
Plaque Psoriasis
Interventions
First Posted Date
2019-08-01
Last Posted Date
2022-05-06
Lead Sponsor
Dermavant Sciences GmbH
Target Recruit Count
21
Registration Number
NCT04042103
Locations
🇺🇸

Dermavant Investigational Site, Spokane, Washington, United States

Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002)

Phase 3
Completed
Conditions
Plaque Psoriasis
Interventions
Drug: Vehicle Cream
First Posted Date
2019-06-12
Last Posted Date
2022-10-13
Lead Sponsor
Dermavant Sciences GmbH
Target Recruit Count
515
Registration Number
NCT03983980
Locations
🇨🇦

Dermavant Investigative Site, Ottawa, Ontario, Canada

Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)

Phase 3
Completed
Conditions
Plaque Psoriasis
Interventions
Drug: Vehicle Cream
First Posted Date
2019-05-20
Last Posted Date
2022-10-13
Lead Sponsor
Dermavant Sciences GmbH
Target Recruit Count
510
Registration Number
NCT03956355
Locations
🇨🇦

Dermavant Investigative Site, Montréal, Quebec, Canada

A Safety/Efficacy Study of a Non-steroid, Topical Cream Treatment of Psoriasis Over 12-weeks

Phase 2
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2010-04-05
Last Posted Date
2012-12-20
Lead Sponsor
Welichem Biotech Inc.
Target Recruit Count
61
Registration Number
NCT01098721
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