Oxytocin
As of the edition of 20 October 2026, Oxytocin is a protein: marketed, first approved in 1956 (CH); acts on OXTR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Protein
- Brand name
- Pitocin
- First approved
- 12 January 1956 (CH)
- Approvals on record
- 18 in 5 regions
- Holder of the most recent approval
- Ph Health; 10 holders in all
- Registered trials
- 412, 51 stopped early
- Disease areas
- Mental health; Pregnancy and women's health; Urinary and reproductive; Nervous system; Chemically induced; Nutrition and metabolism
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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Oxytocin.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| OXTR | Oxytocin receptor | P30559 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 162 | 97 | 14 | 11 |
| Phase 1 | 70 | 52 | 3 | 7 |
| Phase 2 | 118 | 65 | 15 | 24 |
| Phase 3 | 30 | 14 | 5 | 6 |
| Phase 4 | 32 | 23 | 1 | 3 |
| All trials | 412 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Later holder | 1981 to now |
| Abbott | Acquired holder and Later holder | 1985 to now |
| Fresenius Kabi | Acquired holder | 2013 to now |
| Retrophin | Acquired holder | 2014 to now |
| Hikma Pharmaceuticals | Acquired holder | 2021 to now |
| Ph Health | Acquired holder | 2025 to now |
| Astellas | Later holder | |
| Novartis | Later holder |