Isoniazid
As of the edition of 20 October 2026, Isoniazid is a small molecule: marketed, first approved in 1953 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1987
- Kind
- Small molecule
- Brand name
- Rimifon
- First approved
- 1 March 1953 (ES)
- Approvals on record
- 22 in 5 regions
- Holder of the most recent approval
- Sanofi; 10 holders in all
- Registered trials
- 143, 16 stopped early
- Disease areas
- Infections; Lungs and airways; Urinary and reproductive; Immune system; Digestive system; Nutrition and metabolism
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 | 28 | 16 | 0 | 3 |
| Phase 1 | 15 | 12 | 1 | 1 |
| Phase 2 | 30 | 10 | 10 | 6 |
| Phase 3 | 42 | 23 | 9 | 3 |
| Phase 4 | 28 | 15 | 3 | 3 |
| All trials | 143 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder | 1967 to now |
| Sanofi | Applicant | 1975 to now |
| Panray Corp Sub Ormont Drug And Chemical | Acquired holder | 2003 to now |
| Sandoz | Acquired holder | 2004 to now |
| Epic Pharma | Acquired holder | 2022 to now |
| Bristol Myers Squibb | Applicant | |
| Eli Lilly | Later holder | |
| Roche | Later holder | |
| Vitarine Pharmaceuticals | Later holder |