Last reviewed 2026-05-23 · How we verify

Propess,SYNPITAN FORT

Erzincan Military Hospital · Phase 3 active Small molecule ✓ Verified May 2026

Propess,SYNPITAN FORT is a Prostaglandin E2 analog Small molecule drug developed by Erzincan Military Hospital. It is currently in Phase 3 development for Cervical ripening and labor induction in pregnant women at or near term with a medical indication for labor induction.

Propess is a sustained-release dinoprostone (prostaglandin E2) vaginal insert that promotes cervical ripening and uterine contractions to induce labor.

Propess, also known as SYNPITAN FORT, is a small molecule used to induce labor and treat premature rupture of membranes. It works by acting as an external insecticide, although its exact mechanism in this context is not specified.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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,SYNPITAN FORT
Sponsor	Erzincan Military Hospital
Drug class	Prostaglandin E2 analog
Target	Prostaglandin E receptor (EP receptor)
Modality	Small molecule
Therapeutic area	Obstetrics
Phase	Phase 3

Mechanism of action

Dinoprostone is a naturally occurring prostaglandin E2 analog that binds to prostaglandin receptors on the cervix and uterus, promoting cervical softening, effacement, and dilation while simultaneously stimulating uterine contractions. The sustained-release formulation allows controlled delivery over 12-24 hours, reducing the need for repeated dosing compared to intravenous or intracervical formulations.

Approved indications

Cervical ripening and labor induction in pregnant women at or near term with a medical indication for labor induction

Common side effects

Uterine hyperstimulation
Vaginal irritation or discomfort
Fever
Diarrhea
Nausea

Key clinical trials

Induction of Labor in Term Premature Rupture of Membranes: A Comparison Between Oxytocin and Dinoprostone Followed Six Hours Later by Oxytocin (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,SYNPITAN FORT CI brief — competitive landscape report
Propess,SYNPITAN FORT updates RSS · CI watch RSS
Erzincan Military Hospital portfolio CI

Frequently asked questions about Propess,SYNPITAN FORT

What is Propess,SYNPITAN FORT?

Propess,SYNPITAN FORT is a Prostaglandin E2 analog drug developed by Erzincan Military Hospital, indicated for Cervical ripening and labor induction in pregnant women at or near term with a medical indication for labor induction.

How does Propess,SYNPITAN FORT work?

Propess is a sustained-release dinoprostone (prostaglandin E2) vaginal insert that promotes cervical ripening and uterine contractions to induce labor.

What is Propess,SYNPITAN FORT used for?

Propess,SYNPITAN FORT is indicated for Cervical ripening and labor induction in pregnant women at or near term with a medical indication for labor induction.

Who makes Propess,SYNPITAN FORT?

Propess,SYNPITAN FORT is developed by Erzincan Military Hospital (see full Erzincan Military Hospital pipeline at /company/erzincan-military-hospital).

What drug class is Propess,SYNPITAN FORT in?

Propess,SYNPITAN FORT belongs to the Prostaglandin E2 analog class. See all Prostaglandin E2 analog drugs at /class/prostaglandin-e2-analog.

What development phase is Propess,SYNPITAN FORT in?

Propess,SYNPITAN FORT is in Phase 3.

What are the side effects of Propess,SYNPITAN FORT?

Common side effects of Propess,SYNPITAN FORT include Uterine hyperstimulation, Vaginal irritation or discomfort, Fever, Diarrhea, Nausea.

What does Propess,SYNPITAN FORT target?

Propess,SYNPITAN FORT targets Prostaglandin E receptor (EP receptor) and is a Prostaglandin E2 analog.

Drug class: All Prostaglandin E2 analog drugs
Target: All drugs targeting Prostaglandin E receptor (EP receptor)
Manufacturer: Erzincan Military Hospital — full pipeline
Therapeutic area: All drugs in Obstetrics
Indication: Drugs for Cervical ripening and labor induction in pregnant women at or near term with a medical indication for labor induction

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