Dinoprostone
As of the edition of 20 October 2026, Dinoprostone is a small molecule: marketed, first approved in 1982 (US); acts on PTGER1, PTGER2 and PTGER3 and 1 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Prostin E2
- First approved
- 1 January 1982 (US)
- Approvals on record
- 10 in 6 regions
- Holder of the most recent approval
- Ferring Pharmaceuticals; 2 holders in all
- Registered trials
- 43, 2 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Nutrition and metabolism; Cancer; Nervous system; Skin and connective tissue
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.
Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Dinoprostone.
See the 3 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 | 13 | 11 | 1 | 0 |
| Phase 2 | 4 | 3 | 0 | 0 |
| Phase 3 | 12 | 7 | 0 | 1 |
| Phase 4 | 14 | 7 | 1 | 1 |
| All trials | 43 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ferring Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2010 to now |
| Pfizer | Applicant |