Nitrofurantoin
As of the edition of 20 October 2026, Nitrofurantoin is a small molecule: marketed, first approved in 1955 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Furadantin
- First approved
- 1 March 1955 (ES)
- Approvals on record
- 13 in 5 regions
- Holder of the most recent approval
- Casper Pharma; 7 holders in all
- Registered trials
- 22, 3 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Infections; Mouth and teeth; 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 | 3 | 1 | 0 | 2 |
| Phase 1 | 5 | 1 | 2 | 0 |
| Phase 4 | 14 | 8 | 4 | 1 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Casper Pharma | Acquired holder | 2016 to now |
| Almatica Pharma | Acquired holder | 2020 to now |
| Procter And Gamble | Later holder |