Micafungin
As of the edition of 20 October 2026, Micafungin is a small molecule: marketed, first approved in 2005 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Mycamine
- First approved
- 16 March 2005 (US)
- Approvals on record
- 14 in 3 regions
- Holder of the most recent approval
- Baxter Healthcare; 6 holders in all
- Registered trials
- 50, 11 stopped early
- Disease areas
- Infections; Blood and lymph; Cancer; Mouth and teeth; Digestive system; Immune system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 4 | 0 | 0 |
| Phase 1 | 9 | 7 | 0 | 2 |
| Phase 2 | 11 | 8 | 0 | 2 |
| Phase 3 | 12 | 9 | 0 | 2 |
| Phase 4 | 14 | 6 | 0 | 5 |
| All trials | 50 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Astellas | Originator and Lead sponsor of trials | 1999 to now |
| Sandoz | Applicant | 2008 to now |
| Teva | Later holder | 2021 to now |
| Baxter Healthcare | Applicant and Later holder | 2023 to now |
| Ph Health | Acquired holder | 2025 to now |