Isosorbide
As of the edition of 20 October 2026, Isosorbide is a small molecule: marketed, first approved in 1982 (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 1982
- Kind
- Small molecule
- Brand name
- Ismotic
- First approved
- 1 January 1982 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Alcon
- Registered trials
- 17, 3 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Lungs and airways; Ear, nose and throat; Urinary and reproductive
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 | 1 | 1 | 0 | 0 |
| Phase 1 | 1 | 0 | 0 | 1 |
| Phase 2 | 13 | 10 | 1 | 2 |
| Phase 3 | 1 | 0 | 1 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alcon | Applicant |