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prostaglandin E1 analogue
prostaglandin E1 analogue is a Small molecule drug developed by Nwali Matthew Igwe. It is currently in Phase 1 development. Also known as: Misoprostol.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | prostaglandin E1 analogue |
|---|---|
| Also known as | Misoprostol |
| Sponsor | Nwali Matthew Igwe |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Laminaria Japonicum Followed by Misoprostol Versus Misoprostol Alone for Mid-Trimester Abortion Induction in Scarred Uterus (PHASE4)
- Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial (NA)
- Significance of Misoprostol-induced Cervical Ripening Prior to Hysteroscopy (NA)
- Comparison of Misoprostol Ripening Efficacy With Dilapan (PHASE4)
- Cri Analog PG1 Effectiveness and Safety in Covid-19 (PHASE2)
- Misoprostol for NASH (PHASE2)
- Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy (PHASE3)
- Induction of Labor in Pregnant Women With Prelabor Rupture of Membranes - Oxytocin or Misoprostol (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:
- prostaglandin E1 analogue CI brief — competitive landscape report
- prostaglandin E1 analogue updates RSS · CI watch RSS
- Nwali Matthew Igwe portfolio CI
Frequently asked questions about prostaglandin E1 analogue
What is prostaglandin E1 analogue?
Who makes prostaglandin E1 analogue?
Is prostaglandin E1 analogue also known as anything else?
What development phase is prostaglandin E1 analogue in?
Related
- Manufacturer: Nwali Matthew Igwe — full pipeline
- Also known as: Misoprostol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing