Isosorbide mononitrate
As of the edition of 20 October 2026, Isosorbide mononitrate is a small molecule: marketed, first approved in 1986 (ES); acts on GUCY1B1 and GUCY1B2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1994
- Kind
- Small molecule
- Brand name
- Ismo
- First approved
- 1 January 1986 (ES)
- Approvals on record
- 8 in 3 regions
- Holder of the most recent approval
- Merck & Co.; 5 holders in all
- Registered trials
- 30, 5 stopped early
- Disease areas
- Heart and blood vessels; Digestive system; Pregnancy and women's health; Urinary and reproductive; Nervous system; Cancer
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.
Companies that need a new molecule because of this drug
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Isosorbide mononitrate.
See the 4 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 2 | 2 | 1 |
| Phase 1 | 6 | 4 | 0 | 2 |
| Phase 2 | 4 | 1 | 1 | 1 |
| Phase 3 | 5 | 2 | 1 | 0 |
| Phase 4 | 9 | 5 | 0 | 1 |
| All trials | 30 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Earlier holder | 1991 to now |
| UCB | Later holder and Lead sponsor of trials | 1993 to now |
| Merck & Co. | Later holder and Lead sponsor of trials | 1993 to now |
| Dr. Reddy's | Acquired holder | 2008 to now |
| Omnivium Pharmaceuticals | Acquired holder | 2024 to now |