Amphotericin b
As of the edition of 20 October 2026, Amphotericin b is a small molecule: marketed, first approved in 1958 (CA).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Small molecule
- Brand name
- Fungizone
- First approved
- 31 December 1958 (CA)
- Approvals on record
- 13 in 6 regions
- Holder of the most recent approval
- Astellas; 11 holders in all
- Registered trials
- 121, 12 stopped early
- Disease areas
- Infections; Immune system; Blood and lymph; Urinary and reproductive; Nervous system; Cancer
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 26 | 13 | 11 | 0 |
| Phase 1 | 9 | 7 | 1 | 0 |
| Phase 2 | 33 | 24 | 1 | 4 |
| Phase 3 | 35 | 25 | 5 | 2 |
| Phase 4 | 18 | 8 | 0 | 6 |
| All trials | 121 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Cheplapharm Arzneimittel | Applicant | 1958 to now |
| Liposome | Later holder and Lead sponsor of trials | 1995 to now |
| Sequus Pharmaceuticals | Later holder | 1996 to now |
| Astellas | Later holder and Lead sponsor of trials | 1997 to now |
| Bristol Myers Squibb | Acquired holder, Later holder and Lead sponsor of trials | 2003 to now |
| Alkopharma | Acquired holder | 2011 to now |
| Leadiant Biosciences | Acquired holder | 2018 to now |
| Dainippon Sumitomo Pharma | Applicant |