Drugs / Tapinarof
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | VTAMA | — | 2024-12-12 | fda.gov ↗ |
| Approved | US (FDA) | VTAMA | — | 2022-05-23 | fda.gov ↗ |
Trials 31 · a red edge is where a trial was stopped
| 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| Phase 1 | NCT03201978 | Dec 2017 → May 2018 | psoriasis | GlaxoSmithKline | Withdrawn | No outcome recorded |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 | ||||||
| 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 | No outcome recorded |
| Phase 311 trials | ||||||
| Phase 3 | NCT07265479 | Dec 2025 → Jan 2028 expected | atopic eczema | Organon and Co | Recruiting | 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 | No outcome recorded |
| Phase 3 | NCT05014568 | Sep 2021 → Mar 2023 | atopic eczema | Organon and Co | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT03956355 | May 2019 → May 2020 | psoriasis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT03202004 | Jan → Sep 2018 | psoriasis | GlaxoSmithKline | Withdrawn | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00837551 Comparator | Mar → Jun 2008 | atopic eczema | Welichem Biotech Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| 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 2/31 trial | ||||||
| Phase 2/3 | NCT05981118 Comparator | Jul 2024 → Jul 2026 overdue | — | Wake Forest University Health Sciences | Enrolling by invitation | No outcome recorded |
Press releases naming this drug 19 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-24 | Organon and Co | 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 ↗ |
| 2026-07-07 | Organon and Co | Organon to Present New Analysis on VTAMA® (tapinarof) cream, 1%, at the 2026 Society for Pediatric Dermatology Annual Meeting organon.com ↗ |
| 2026-04-15 | Organon and Co | Organon’s VTAMA® (tapinarof) cream, 1%, Granted Strong Recommendation in the 2026 American Academy of Dermatology Guidelines for Pediatric Atopic Dermatitis organon.com ↗ |
| 2026-03-27 | Organon and Co | 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 ↗ |
| 2026-02-27 | Organon and Co | 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 ↗ |
| 2025-11-08 | Organon and Co | 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 ↗ |
| 2025-07-07 | Organon and Co | Organon’s VTAMA® (tapinarof) cream, 1%, Granted Strong Recommendation in the American Academy of Dermatology Updated 2025 Guidelines for Adult Atopic Dermatitis organon.com ↗ |
| 2025-03-08 | Organon and Co | 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 ↗ |
| 2024-12-16 | Organon and Co | FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older organon.com ↗ |
| 2024-11-05 | Organon and Co | 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 ↗ |
| 2024-10-28 | Organon and Co | Organon Completes Acquisition of Dermavant, including Innovative Dermatologic Therapy, VTAMA® (tapinarof) Cream, 1% organon.com ↗ |
| 2024-09-18 | Organon and Co | Organon to Acquire Dermavant including its Innovative Dermatologic Therapy, VTAMA® (tapinarof) Cream, 1% organon.com ↗ |
| 2024-04-29 | Organon and Co | [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 ↗ |
| 2024-01-11 | Organon and Co | [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 ↗ |
| 2023-12-06 | Organon and Co | [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 ↗ |
| 2023-05-16 | Organon and Co | [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 ↗ |
| 2023-03-15 | Organon and Co | [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 ↗ |
| 2022-11-08 | Organon and Co | [Dermavant issued release] Dermavant Announces Highly Favorable Results from Pediatric Maximal Usage Study of VTAMA® (tapinarof) cream, 1% in Atopic Dermatitis organon.com ↗ |
| 2022-05-24 | Organon and Co | [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 ↗ |
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 NCT07546214 ↗ |
| Known as | Benvitimod | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05064748 ↗ |
| Known as | Benvitimod Cream | “Drug: Benvitimod Cream” NCT05326659 ↗ |
| Known as | GSK2894512 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02466152 ↗ |
| 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 NCT01098721 ↗ |
| 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 ↗ |