Delamanid
As of the edition of 20 October 2026, Delamanid is a small molecule: marketed, first approved in 2014 (EU).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Deltyba
- First approved
- 27 April 2014 (EU)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Otsuka; 2 holders in all
- Registered trials
- 33, 3 stopped early
- Disease areas
- Infections; Lungs and airways; Immune system; Urinary and reproductive
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 | 2 | 1 | 1 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 20 | 13 | 4 | 2 |
| Phase 3 | 9 | 3 | 5 | 1 |
| Phase 4 | 1 | 0 | 0 | 0 |
| All trials | 33 |