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Vagitocin
Vagitocin is a Small molecule drug developed by PepTonic Medical AB. It is currently in Phase 2 development. Also known as: Oxytocin gel 400 International Units.
Vagitocin is a vaginal formulation of oxytocin being studied for the treatment of vaginal atrophy, vulvovaginal atrophy, and atrophy. It is being compared to oxytocin and a placebo in clinical trials.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Vagitocin |
|---|---|
| Also known as | Oxytocin gel 400 International Units |
| Sponsor | PepTonic Medical AB |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms (PHASE2)
- An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy (PHASE2)
- A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin (PHASE2)
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:
- Vagitocin CI brief — competitive landscape report
- Vagitocin updates RSS · CI watch RSS
- PepTonic Medical AB portfolio CI
Frequently asked questions about Vagitocin
What is Vagitocin?
Who makes Vagitocin?
Is Vagitocin also known as anything else?
What development phase is Vagitocin in?
Related
- Manufacturer: PepTonic Medical AB — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Oxytocin gel 400 International Units
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing