Sofpironium
As of the edition of 20 October 2026, Sofpironium is a small molecule: marketed, first approved in 2020 (JP); acts on CHRM1, CHRM2 and CHRM3 and 2 more; US protection ends in 2040.
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
- Sofdra
- First approved
- 25 September 2020 (JP)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Botanix Sb; 2 holders in all
- Registered trials
- 8, 0 stopped early
- Disease areas
- Skin and connective tissue
US protection
US protection ends in 2040.
The last listed US drug-substance patent ends in 2040. The application that gives this date is held by Botanix Sb.
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 product5 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
5 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product5 company-target rows are on route B because of Sofpironium.
See the 5 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 4 | 4 | 0 | 0 |
| Phase 3 | 3 | 3 | 0 | 0 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Kaken Pharmaceutical | Applicant | 2020 to now |
| Botanix Sb | Applicant | 2024 to now |