Artesunate
As of the edition of 20 October 2026, Artesunate is a small molecule: marketed, first approved in 2020 (US); US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- First approved
- 26 May 2020 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Amivas; 2 holders in all
- Registered trials
- 137, 5 stopped early
- Disease areas
- Infections; Cancer; Urinary and reproductive; Pregnancy and women's health; Blood and lymph; Lungs and airways
US protection
US protection ends in 2027.
The last listed US exclusivity ends in 2027. The application that gives this date is held by Amivas.
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 product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 15 | 13 | 1 | 0 |
| Phase 1 | 21 | 17 | 3 | 1 |
| Phase 2 | 32 | 20 | 7 | 3 |
| Phase 3 | 34 | 30 | 1 | 1 |
| Phase 4 | 35 | 26 | 1 | 0 |
| All trials | 137 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amivas | Originator, Applicant and Lead sponsor of trials | 2020 to now |