Ethambutol
As of the edition of 20 October 2026, Ethambutol is a small molecule: marketed, first approved in 1967 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1993
- Kind
- Small molecule
- Brand name
- Myambutol
- First approved
- 1 May 1967 (ES)
- Approvals on record
- 10 in 6 regions
- Holder of the most recent approval
- EFISCIENS (MALTE); 6 holders in all
- Registered trials
- 63, 5 stopped early
- Disease areas
- Infections; Lungs and airways; Immune system; Urinary and reproductive; Bones, joints and muscles; Digestive system
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 | 10 | 9 | 0 | 1 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 17 | 8 | 3 | 4 |
| Phase 3 | 22 | 16 | 5 | 0 |
| Phase 4 | 11 | 4 | 3 | 0 |
| All trials | 63 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Labatec Pharma | Applicant | 1967 to now |
| Bausch Health | Acquired holder | 1972 to now |
| Kanchan Healthcare | Acquired holder | 2024 to now |
| Kaken Pharmaceutical | Applicant | |
| Pfizer | Applicant and Lead sponsor of trials |