Last reviewed 2026-05-22 · How we verify

dinoprostol

Aswan University Hospital · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

dinoprostol is a Small molecule drug developed by Aswan University Hospital. It is currently in Phase 1 development. Also known as: prostin.

Dinoprostol is used to study IUCD complications and cervical ripening, typically compared to misoprostol or a placebo in clinical trials. It is used prior to copper intrauterine device insertion in women.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	dinoprostol
Also known as	prostin
Sponsor	Aswan University Hospital
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

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:

dinoprostol CI brief — competitive landscape report
dinoprostol updates RSS · CI watch RSS
Aswan University Hospital portfolio CI

Frequently asked questions about dinoprostol

What is dinoprostol?

dinoprostol is a Small molecule drug developed by Aswan University Hospital.

Who makes dinoprostol?

dinoprostol is developed by Aswan University Hospital (see full Aswan University Hospital pipeline at /company/aswan-university-hospital).

Is dinoprostol also known as anything else?

dinoprostol is also known as prostin.

What development phase is dinoprostol in?

dinoprostol is in Phase 1.

Manufacturer: Aswan University Hospital — full pipeline
Therapeutic area: All drugs in Other
Also known as: prostin

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing