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Misoprostol vaginal insert
Misoprostol vaginal insert is a Small molecule drug developed by Asklepios Kliniken Hamburg GmbH. It is currently in Phase 2 development.
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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 | Misoprostol vaginal insert |
|---|---|
| Sponsor | Asklepios Kliniken Hamburg GmbH |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening (PHASE3)
- IntraCERvical Balloon Catheter in the Setting of Induction of Labor for Fetal Loss or Abortion (NA)
- Misoprostol Versus Dinoprostone in Induction of Labor (NA)
- Comparison Between Vaginal Misoprostol Gel and Oral Misoprostol Solution in Induction of Labor (EARLY_PHASE1)
- Elective Induction of Nulliparous Labor (NA)
- Comparison of the Effectiveness, Safety, and Satisfaction of Different Methods for Labor Induction (PHASE4)
- Termination Of Anembryonic Pregnancy (PHASE2)
- Comparison of Misoprostol Ripening Efficacy With Dilapan (PHASE4)
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:
- Misoprostol vaginal insert CI brief — competitive landscape report
- Misoprostol vaginal insert updates RSS · CI watch RSS
- Asklepios Kliniken Hamburg GmbH portfolio CI
Frequently asked questions about Misoprostol vaginal insert
What is Misoprostol vaginal insert?
Who makes Misoprostol vaginal insert?
What development phase is Misoprostol vaginal insert in?
Related
- Manufacturer: Asklepios Kliniken Hamburg GmbH — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing