Drugs / Tapinarof
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed atopic eczema 1 milestone | |||||
| Filed | US (FDA) | VTAMA | atopic eczema | 2024-04-29 | “the U.S. Food and Drug Administration (FDA) accepted the company’s Supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) cream, 1%” organon.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | VTAMA | — | 2024-12-12 | fda.gov ↗ |
| Approved | US (FDA) | VTAMA | — | 2022-05-23 | fda.gov ↗ |
Trials 31
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06661213 | Apr 2025 → Nov 2027 expected | cutaneous lupus erythematosus | Northwestern University | Enrolling by invitation | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT07546214 | Oct 2025 → Mar 2026 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03201978 | Dec 2017 → May 2018 | psoriasis | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT02637206 | Oct → Dec 2015 | atopic eczema | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02411162 | Jul → Sep 2015 | atopic eczema | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 1 | NCT02466152 | May → Oct 2015 | atopic eczema | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01984775 | Oct 2013 → Jul 2014 | psoriasis | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT07658924 | Jul 2026 → Oct 2027 expected | mycosis fungoides | Peking University First Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06561321 | Oct 2024 → Dec 2027 expected | palmoplantar keratosis | Indiana University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05186805 | Nov 2021 → Aug 2022 | atopic eczema | Organon and Co | Completed | No outcome recorded |
| Phase 2 | NCT04042103 | Jul 2019 → Jan 2020 | psoriasis | Organon and Co | Completed | No outcome recorded |
| Phase 2 | NCT02564055 | Dec 2015 → Jan 2017 | atopic eczema | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02564042 | Nov 2015 → Oct 2016 | psoriasis | GlaxoSmithKline | Completed | Met primary |
| Phase 311 trials · 4 met primary | ||||||
| Phase 3 | NCT07265479 | Dec 2025 → Aug 2027 | atopic eczema | Organon and Co | Suspended | No outcome recorded |
| Phase 3 | NCT06742957 | Dec 2024 → Oct 2025 | psoriasis | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 3 | NCT05326672 | Apr 2022 → Jun 2023 | atopic eczema | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT05172726 | Dec 2021 → Oct 2026 expected | psoriasis | Organon and Co | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05142774 | Oct 2021 → Feb 2024 | atopic eczema | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT05032859 | Sep 2021 → Feb 2023 | atopic eczema | Organon and Co | Completed | Met primary |
| Phase 3 | NCT05014568 | Sep 2021 → Mar 2023 | atopic eczema | Organon and Co | Completed | Met primary |
| Phase 3 | NCT04053387 | Aug 2019 → Apr 2021 | psoriasis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT03983980 | Jun 2019 → May 2020 | psoriasis | Organon and Co | Completed | Met primary |
| Phase 3 | NCT03956355 | May 2019 → May 2020 | psoriasis | Organon and Co | Completed | Met primary |
| Phase 3 | NCT03202004 | Jan → Sep 2018 | psoriasis | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Business |
| Phase 46 trials | ||||||
| Phase 4 | NCT07635043 | Aug → Oct 2026 expected | psoriasis | Pakistan Institute of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05789576 | Mar → Jun 2023 | psoriasis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT06103695 | Feb → Oct 2023 | psoriasis | Psoriasis Treatment Center of Central New Jersey | Completed | No outcome recorded |
| Phase 4 | NCT05680740 | Dec 2022 → May 2023 | psoriasis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT05064748 | Jun 2021 → Mar 2024 | psoriasis | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05326659 | Apr 2022 → Jun 2023 | psoriasis | Peking University People's Hospital | Unknown | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1/2 | NCT00837551 Comparator | Mar → Jun 2008 | atopic eczema | Welichem Biotech Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01098721 Comparator | Jan → Sep 2010 | psoriasis | Welichem Biotech Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01098734 Comparator | Nov 2009 → Oct 2010 | atopic eczema | Welichem Biotech Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT05981118 Comparator | Jul 2024 → Jul 2026 overdue | — | Wake Forest University Health Sciences | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-07-24 | Organon and Co | Results New Analysis of Phase 3 Pooled Data for Organon’s VTAMA® (tapinarof) cream, 1%, Demonstrates Early, Consistent Improvements in Atopic Dermatitis Patients Across Pediatric Age Groups and in Adults1 organon.com ↗
The findings show that VTAMA cream demonstrated early and consistent improvements in disease severity—as measured by vIGA-AD and EASI75—across three pediatric age groups and adults with moderate to severe atopic dermatitis.1 |
| 2026-03-27 | Organon and Co | Results Organon Debuts New Analysis of VTAMA® (tapinarof) cream, 1%, Phase 3 Pooled Data Demonstrating Early and Consistent Skin Clearance and Itch Improvement in Atopic Dermatitis Patients Down to 2 Years of Age organon.com ↗
The findings demonstrated early and consistent improvement in disease severity, as measured by vIGA-AD and EASI, and itch, as measured by PP-NRS, for patients down to age 2 with moderate to severe AD. |
| 2026-02-27 | Organon and Co | Results New Analysis of Organon’s VTAMA® (tapinarof) cream, 1%, Phase 3 Data Showed Early and Consistent Improvement in Patient-Reported Sleep Subdomains in Pediatric Patients Down to 2 Years of Age with Atopic Dermatitis organon.com ↗
The findings show that VTAMA cream provided early and consistent improvements in the POEM sleep subdomain for pediatric patients down to age 2 with moderate to severe atopic dermatitis (AD) and in the DFI sleep subdomain for family members of patients aged 2-15 years. |
| 2025-11-08 | Organon and Co | Results New Data Show Early and Consistent Response to VTAMA® (tapinarof) Cream, 1%, in Children Aged 2+ with Atopic Dermatitis, Including Those With Associated Comorbidities organon.com ↗
The new data demonstrate that VTAMA cream provided early and consistent response for children aged 2-17 with atopic dermatitis (AD), with or without atopic comorbidities such as asthma, allergic rhinitis and food allergies. |
| 2025-03-08 | Organon and Co | Results New Analysis of Organon’s VTAMA® (tapinarof) cream, 1% Phase 3 Data Shows Atopic Dermatitis Disease Activity Remained Low After Treatment-Free Interval in Adults and Children 2 Years of Age and Older organon.com ↗
The findings demonstrate that AD disease activity remained mild in patients who had achieved treatment success and subsequently entered a treatment-free interval lasting on average 80 days. |
| 2024-12-16 | Organon and Co | Regulatory FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older organon.com ↗
Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025. |
| 2024-11-05 | Organon and Co | Regulatory Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older organon.com ↗
Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) extended by three months the target action date of its review of the supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) cream, 1% as a treatment for atopic dermatitis (AD) in adults and children two years of age and older. |
| 2024-04-29 | Organon and Co | Regulatory [Dermavant issued release] Dermavant Announces FDA Acceptance of Supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older organon.com ↗
The Prescription Drug User Fee Act (“PDUFA”) action date assigned by the Agency is in Q4 2024. |
| 2024-01-11 | Organon and Co | Results [Dermavant issued release] Dermavant Announces Positive Data from the ADORING Phase 3 Development Program in Atopic Dermatitis with VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as 2 Years Old organon.com ↗
Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced new positive efficacy and safety data from analyses of the company’s ADORING Phase 3 development program in atopic dermatitis (AD) with VTAMA® (tapinarof) cream, 1% in adults and children as young as 2 years old. |
| 2023-12-06 | Organon and Co | Results [Dermavant issued release] Dermavant Announces Positive Results from Phase 4 Open-Label Trial of VTAMA® (tapinarof) Cream, 1% for the Treatment of Plaque Psoriasis in the Head and Neck Region in Adults organon.com ↗
today announced positive results from its Phase 4, open-label clinical trial of VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in the head and neck region in adults (N=31). |
| 2023-05-16 | Organon and Co | Results [Dermavant issued release] Dermavant Reports Positive Topline Results from ADORING 1, the Second Atopic Dermatitis Phase 3 Trial of VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as 2 Years Old organon.com ↗
45.4% of subjects receiving VTAMA achieved the primary endpoint of vIGA-ADTM response of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8, versus 13.9% on vehicle (P<0.0001) |
| 2023-03-15 | Organon and Co | Results [Dermavant issued release] Dermavant Reports Positive Topline Results from ADORING 2 Atopic Dermatitis Phase 3 Trial of VTAMA® (tapinarof) Cream, 1% Once Daily in Adults and Children as Young as 2 Years Old organon.com ↗
All secondary endpoints were met with a high degree of statistical significance |
| 2022-11-08 | Organon and Co | Results [Dermavant issued release] Dermavant Announces Highly Favorable Results from Pediatric Maximal Usage Study of VTAMA® (tapinarof) cream, 1% in Atopic Dermatitis organon.com ↗
Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced positive results from its maximal usage study of VTAMA® (tapinarof) cream, 1% in children down to age 2 years old with extensive burden of atopic dermatitis. |
| 2022-05-24 | Organon and Co | Regulatory [Dermavant issued release] FDA Approves Dermavant’s VTAMA® (tapinarof) cream, 1% for the Treatment of Plaque Psoriasis in Adults: First Topical Novel Chemical Entity Launched for Psoriasis in the U.S. in 25 Years organon.com ↗
This approval makes VTAMA cream the first and only FDA-approved steroid-free topical medication in its class. |
All press releases naming this drug 21 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tapinarof | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06561321 ↗ |
| Known as | Benvitimod | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07658924 ↗ |
| Known as | Benvitimod Cream | “Drug: Benvitimod Cream” NCT05326659 ↗ |
| Known as | GSK2894512 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02564055 ↗ |
| Known as | VTAMA | “A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study, Comparing Tapinarof Cream, 1% (Sun Pharma Canada, Inc.) and Vtama® (Tapinarof) Cream, 1% in...” NCT07546214 ↗5“VTAMA (tapinarof) cream, 1% applied topically once daily” NCT05789576 ↗ “Tapinarof cream 1% (VTAMA®; Dermavant Sciences, Inc.)” PMID 37697121 ↗ Sep 2023 “Add on Vtama (tapinarof) to biololgic therapy” NCT06103695 ↗ “reference VTAMA® (Tapinarof Cream 1%)” NCT06742957 ↗ “VTAMA® (tapinarof) Cream 1%” NCT05680740 ↗ |
| Known as | WBI-1001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00837551 ↗ |
| Action | Inhibit | “it affects T-cells through inhibition of T-cell activities including their infiltration processes” NCT00837551 ↗ |
| Modality | Small molecule | “small molecule” NCT00837551 ↗ |
| Route | Topical | “Topical cream application.” NCT00837551 ↗ |
| Target | AHR | “Aryl hydrocarbon receptor (AHR) agonist” NCT06661213 ↗ |