Tapinarof
As of the edition of 20 October 2026, Tapinarof is a small molecule: marketed, first approved in 2022 (US); acts on AHR; US protection ends in 2038.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Vtama
- First approved
- 23 May 2022 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Japan Tobacco; 2 holders in all
- Registered trials
- 31, 2 stopped early
- Disease areas
- Skin and connective tissue; Immune system; Inherited and neonatal; Blood and lymph; Cancer
US protection
US protection ends in 2038.
The last listed US drug-substance patent ends in 2038. The application that gives this date is held by Organon.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product4 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Tapinarof.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| AHR | Aryl hydrocarbon receptor | P35869 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 7 | 5 | 1 | 1 |
| Phase 2 | 6 | 4 | 2 | 0 |
| Phase 3 | 11 | 7 | 2 | 1 |
| Phase 4 | 6 | 3 | 2 | 0 |
| All trials | 31 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Organon | Originator, Applicant and Lead sponsor of trials | 2019 to now |
| Japan Tobacco | Applicant | 2024 to now |