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Propess
Propess is a Small molecule drug developed by Ain Shams University. It is currently in Phase 3 development. Also known as: Intravaginal PGE2 insert.
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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 | Propess |
|---|---|
| Also known as | Intravaginal PGE2 insert |
| Sponsor | Ain Shams University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM) (NA)
- Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies (PHASE3)
- Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening (PHASE3)
- Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter (PHASE4)
- Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess (PHASE3)
- IV PAPAVERINE Prior to Propess for Labor Induction (PHASE4)
- The Effect of Labour Hopscotch Based Midwifery Care in Labor (NA)
- Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term? (PHASE3)
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:
- Propess CI brief — competitive landscape report
- Propess updates RSS · CI watch RSS
- Ain Shams University portfolio CI
Frequently asked questions about Propess
What is Propess?
Who makes Propess?
Is Propess also known as anything else?
What development phase is Propess in?
Related
- Manufacturer: Ain Shams University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Intravaginal PGE2 insert
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing