Isosorbide dinitrate
As of the edition of 20 October 2026, Isosorbide dinitrate is a small molecule: marketed, first approved in 1981 (FR); acts on GUCY1B1 and GUCY1B2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1988
- Kind
- Small molecule
- Brand name
- Isordil
- First approved
- 23 March 1981 (FR)
- Approvals on record
- 21 in 3 regions
- Holder of the most recent approval
- Azurity Pharmaceuticals; 7 holders in all
- Registered trials
- 14, 0 stopped early
- Disease areas
- Heart and blood vessels; Pregnancy and women's health; Urinary and reproductive; Digestive system; Nervous 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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 2 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 2 | 1 | 1 | 0 |
| Phase 3 | 2 | 1 | 0 | 0 |
| Phase 4 | 4 | 4 | 0 | 0 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Earlier holder | 1988 to now |
| UCB | Later holder | 1988 to now |
| AstraZeneca | Later holder | 1996 to now |
| Bausch Health | Acquired holder | 2019 to now |
| Endo | Acquired holder | 2024 to now |