Didanosine
As of the edition of 20 October 2026, Didanosine is a small molecule: marketed, first approved in 1991 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1991
- Kind
- Small molecule
- Brand name
- Videx
- First approved
- 9 October 1991 (US)
- Approvals on record
- 14 in 1 region
- Holder of the most recent approval
- Bristol Myers Squibb; 2 holders in all
- Registered trials
- 130, 5 stopped early
- Disease areas
- Immune system; Infections; Urinary and reproductive; Nervous system; Cancer; Blood and lymph
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 25 | 24 | 0 | 1 |
| Phase 1 | 27 | 27 | 0 | 0 |
| Phase 2 | 50 | 43 | 0 | 4 |
| Phase 3 | 20 | 16 | 0 | 0 |
| Phase 4 | 8 | 7 | 0 | 0 |
| All trials | 130 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Originator, Later holder and Lead sponsor of trials | 1991 to now |