Atosiban
As of the edition of 20 October 2026, Atosiban is a protein: marketed, first approved in 2000 (EU); acts on OXTR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Protein
- Brand name
- Tractocile
- First approved
- 20 January 2000 (EU)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- EVER VALINJECT (AUTRICHE); 4 holders in all
- Registered trials
- 17, 0 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Inherited and neonatal; Nervous system
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| OXTR | Oxytocin receptor | P30559 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 4 | 1 | 0 |
| Phase 1 | 4 | 1 | 2 | 0 |
| Phase 2 | 4 | 2 | 0 | 0 |
| Phase 3 | 1 | 0 | 0 | 0 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ferring Pharmaceuticals | Applicant and Lead sponsor of trials | 2000 to now |