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Also known as tapinarof cream, 1%, tapinarof, 1%, Tapinarof cream, 1%, Tapinarof, 1%
Tapinarof · 1 trial · 1 indication
To evaluate the treatment benefit of Tapinarof applied topically to patients affected with palmoplantar keratoderma. Either an overall change in the PGA score to 0 (clear) or 1 (almost clear) or a decrease from baseline of at least 2 points. Higher scores indicate a worse outcome. Title: PHYSICIAN GLOBAL ASSESSMENT Minimum value: 0 Maximum value: 5
| Arm | Type | Description |
|---|---|---|
| Tapinarof Drug Treatment | EXPERIMENTAL | Subjects in this arm will apply Tapinarof 1% cream topically once daily for a 16-week open-label treatment period. Participants who achieve disease clearance after 16 weeks may discontinue treatment and will be monitored for sustained response up to 52 weeks. Those who do not achieve clearance will continue the treatment during an extension period for up to 36 additional weeks or until clearance is achieved, whichever comes first. Regular follow-up visits will assess the duration of disease clearance and monitor for any potential recurrence of keratoderma. |
| Name | Type | Description |
|---|---|---|
| Tapinarof | DRUG | Daily topical Tapinarof use will stop disease advancement and improve the quality of life in patients with palmoplantar keratoderma, through its AhR \& NRF2 agonism properties. |
Inclusion Criteria: * Ability to discern and provide written informed consent and voluntarily adhere to all of the protocol requirements * Male or female subjects in their adult years (≥ 18 years of age), inclusive, from the time of providing written subject-investigator agreement. * Confirmed clin...
Tapinarof is an investigational small molecule cream being studied for dermatologic conditions including atopic dermatitis, plaque psoriasis, and palmoplantar keratoderma. It is currently in Phase 2 clinical development for these indications. Tapinarof is not FDA approved and remains under investigation in clinical trials.
Tapinarof is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The company is conducting clinical trials of tapinarof cream, 1% for the treatment of atopic dermatitis in both pediatric and adult populations.
Tapinarof is in Phase 2 clinical development. While some completed trials for atopic dermatitis were Phase 3 studies, the overall development program for tapinarof across its indications, including plaque psoriasis and palmoplantar keratoderma, is currently at the Phase 2 stage. Tapinarof remains investigational and is not approved.
Tapinarof has been studied in several clinical trials for atopic dermatitis. Completed trials include NCT05032859, a Phase 3 study in children and adults, NCT05142774, a long-term extension study, and NCT05186805, a Phase 2 maximal use study in pediatric subjects. An active Phase 3 trial, NCT07265479, is investigating tapinarof in participants aged 3 months to under 24 months.
Yes, Tapinarof is the same as tapinarof cream, 1%. The drug is referred to by its generic name Tapinarof and by its formulation name tapinarof cream, 1%, which appears in clinical trial titles and descriptions. Both names refer to the same investigational topical medication being developed by Organon & Co.
Tapinarof clinical trials have enrolled a total of 1,867 participants across five trials. The largest completed trial, NCT05142774, enrolled 728 subjects with atopic dermatitis. An active Phase 3 trial, NCT07265479, is enrolling 187 participants aged 3 months to under 24 months with atopic dermatitis.