Nystatin
As of the edition of 20 October 2026, Nystatin is a drug: marketed, first approved in 1957 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1987
- Kind
- Unknown
- Brand name
- Nilstat
- First approved
- 1 November 1957 (ES)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- GRIMBERG; 9 holders in all
- Registered trials
- 25, 1 stopped early
- Disease areas
- Infections; Mouth and teeth; Urinary and reproductive; Immune system; Lungs and airways; 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 | 7 | 5 | 0 | 0 |
| Phase 1 | 4 | 3 | 1 | 0 |
| Phase 2 | 5 | 3 | 0 | 1 |
| Phase 3 | 5 | 4 | 0 | 0 |
| Phase 4 | 4 | 3 | 0 | 0 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Labatec Pharma | Applicant | 1967 to now |
| Sanofi | Applicant | 1979 to now |
| Bristol Myers Squibb | Later holder and Lead sponsor of trials | 1987 to now |
| Warner Chilcott | Acquired holder | 2011 to now |
| Delcor Asset | Acquired holder | 2017 to now |
| Chartwell Molecules | Acquired holder | 2023 to now |
| Strides Pharma | Acquired holder | 2025 to now |
| Bayer | Applicant and Later holder | |
| Pfizer | Later holder and Lead sponsor of trials | |
| Procter And Gamble | Later holder |