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IV Oxytocin
IV Oxytocin is a Oxytocin receptor agonist Small molecule drug developed by Stony Brook University. It is currently in Phase 3 development for Labor induction, Labor augmentation, Prevention and treatment of postpartum hemorrhage.
IV oxytocin is a synthetic form of the naturally occurring hormone oxytocin that binds to oxytocin receptors to stimulate uterine contractions and promote milk letdown.
IV oxytocin is a synthetic form of the naturally occurring hormone oxytocin that binds to oxytocin receptors to stimulate uterine contractions and promote milk letdown. Used for Labor induction, Labor augmentation, Prevention and treatment of postpartum hemorrhage.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | IV Oxytocin |
|---|---|
| Sponsor | Stony Brook University |
| Drug class | Oxytocin receptor agonist |
| Target | Oxytocin receptor (OXTR) |
| Modality | Small molecule |
| Therapeutic area | Obstetrics/Gynecology |
| Phase | Phase 3 |
Mechanism of action
Oxytocin acts as a neurohypophyseal hormone that binds to G-protein coupled oxytocin receptors on uterine smooth muscle and mammary gland myoepithelial cells. This receptor activation triggers calcium influx and muscle contraction, facilitating labor induction, augmentation of labor, and postpartum hemorrhage control. It also stimulates milk ejection during lactation through similar receptor-mediated mechanisms.
Approved indications
- Labor induction
- Labor augmentation
- Prevention and treatment of postpartum hemorrhage
Common side effects
- Uterine hyperstimulation
- Maternal hypertension
- Tachycardia
- Nausea and vomiting
- Water intoxication/hyponatremia
- Fetal bradycardia
Key clinical trials
- Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage (PHASE4)
- Efficacy of Intravenous Oxytocin to Speed Recovery After THA (PHASE2)
- Effects Of Intravenous Oxytocin On Peripheral Sensory Afferents Using Microneurography (PHASE2)
- Cooling the Uterus in C-section After Dysfunctional Labor (NA)
- Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain (PHASE2)
- Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor (PHASE4)
- Use of Papaverine to Shorten the Second Stage/Duration of Labor in Pregnant Women After Cervical Ripening by Double-balloon Catheter (NA)
- The Role of Oxytocin in the Second Stage of Labor (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IV Oxytocin CI brief — competitive landscape report
- IV Oxytocin updates RSS · CI watch RSS
- Stony Brook University portfolio CI
Frequently asked questions about IV Oxytocin
What is IV Oxytocin?
How does IV Oxytocin work?
What is IV Oxytocin used for?
Who makes IV Oxytocin?
What drug class is IV Oxytocin in?
What development phase is IV Oxytocin in?
What are the side effects of IV Oxytocin?
What does IV Oxytocin target?
Related
- Drug class: All Oxytocin receptor agonist drugs
- Target: All drugs targeting Oxytocin receptor (OXTR)
- Manufacturer: Stony Brook University — full pipeline
- Therapeutic area: All drugs in Obstetrics/Gynecology
- Indication: Drugs for Labor induction
- Indication: Drugs for Labor augmentation
- Indication: Drugs for Prevention and treatment of postpartum hemorrhage
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing