Misoprostol
As of the edition of 20 October 2026, Misoprostol is a small molecule: marketed, first approved in 1985 (CH); acts on PTGER3.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Cytotec
- First approved
- 21 June 1985 (CH)
- Approvals on record
- 14 in 7 regions
- Holder of the most recent approval
- Linepharma; 4 holders in all
- Registered trials
- 244, 27 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Cancer; Nutrition and metabolism; Skin and connective tissue; Blood and lymph
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Misoprostol.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PTGER3 | Prostaglandin E2 receptor EP3 subtype | P43115 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 94 | 53 | 7 | 8 |
| Phase 1 | 12 | 6 | 4 | 1 |
| Phase 2 | 25 | 13 | 0 | 3 |
| Phase 3 | 50 | 36 | 2 | 4 |
| Phase 4 | 63 | 35 | 3 | 11 |
| All trials | 244 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant | 1985 to now |
| Infan Industria Quimica Farmaceutica Nacional | Applicant | 2001 to now |
| Linepharma | Applicant and Lead sponsor of trials | 2022 to now |