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misopristol
misopristol is a Small molecule drug developed by Sohag University. It is currently in Phase 2 development. Also known as: Misotac, Foley catheter.
Misoprostol is used to study conditions such as IUD insertion, missed abortion, other abortion, abortion, and cervical ripening in clinical trials. It is administered through various routes, including vaginal and sublingual, and is also compared to placebo and other interventions like evening primrose oil in these 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 | misopristol |
|---|---|
| Also known as | Misotac, Foley catheter |
| Sponsor | Sohag University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Misoprostol in Missed Abortion
- Vaginal Vs Subling Misoprost Before Iud Insertion in Women With Previous CS
- Intrauterine Misoprostol Versus Rectal Misoprostol in Reducing Blood Loss During Cesarean Section (PHASE2)
- Evening Primrose Oil Efficacy in Second Trimester Abortion (PHASE3)
- Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation (PHASE2)
- Misoprostol vs. Sublingual Misoprostol and Laminaria For Second Trimester Termination of Pregnancy (NA)
- Misopristol Versus Pitocin for Second Trimester Abortion (PHASE4)
- Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial (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:
- misopristol CI brief — competitive landscape report
- misopristol updates RSS · CI watch RSS
- Sohag University portfolio CI
Frequently asked questions about misopristol
What is misopristol?
Who makes misopristol?
Is misopristol also known as anything else?
What development phase is misopristol in?
Related
- Manufacturer: Sohag University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Misotac, Foley catheter
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing