Isavuconazonium
As of the edition of 20 October 2026, Isavuconazonium is a small molecule: marketed, first approved in 2015 (US); US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Cresemba
- First approved
- 6 March 2015 (US)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- Asahi Kasei Therapeutics; 2 holders in all
- Registered trials
- 7, 1 stopped early
- Disease areas
- Infections; Blood and lymph; Cancer; Lungs and airways
US protection
US protection ends in 2031.
The last listed US exclusivity ends in 2031. The application that gives this date is held by Astellas.
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 product36 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 36 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 2 | 1 | 0 | 1 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Astellas | Originator and Lead sponsor of trials | 2013 to now |
| Asahi Kasei Therapeutics | Applicant and Lead sponsor of trials | 2018 to now |