Iohexol
As of the edition of 20 October 2026, Iohexol is a small molecule: marketed, first approved in 1985 (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 1998
- Kind
- Small molecule
- Brand name
- Omnipaque 240
- First approved
- 26 December 1985 (US)
- Approvals on record
- 14 in 2 regions
- Holder of the most recent approval
- GE Healthcare; 3 holders in all
- Registered trials
- 60, 9 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Hormones; Nutrition and metabolism; Cancer; Heart and blood vessels
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 | 21 | 10 | 5 | 2 |
| Phase 1 | 19 | 8 | 4 | 6 |
| Phase 2 | 5 | 4 | 1 | 0 |
| Phase 3 | 4 | 4 | 0 | 0 |
| Phase 4 | 11 | 8 | 2 | 1 |
| All trials | 60 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GE Healthcare | Applicant and Lead sponsor of trials | 1985 to now |
| Interpharma Praha | Later holder | 2015 to now |