Last reviewed 2026-05-27 · How we verify

Ronoprost (ORNOPROSTIL)

Phase 2 active Small molecule ✓ Verified May 2026

Ronoprost (generic name: ORNOPROSTIL) is a ornoprostil drug. It is currently in Phase 2 development.

Ornoprostil works by inhibiting the production of stomach acid.

Ronoprost is a small molecule. It is also known by the synonyms ORNOPROSTIL, ORNOPROSTILO, and RONOK.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	ORNOPROSTIL
Drug class	ornoprostil
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

Think of stomach acid like a strong cleaning solution that helps break down food in your stomach. Ornoprostil helps reduce the amount of this acid, which can help with conditions like heartburn and ulcers. By doing so, it can help alleviate symptoms and promote healing in the stomach lining.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Ronoprost CI brief — competitive landscape report
Ronoprost updates RSS · CI watch RSS

Frequently asked questions about Ronoprost

What is Ronoprost?

Ronoprost (ORNOPROSTIL) is a ornoprostil drug.

How does Ronoprost work?

Ornoprostil works by inhibiting the production of stomach acid.

What is the generic name of Ronoprost?

ORNOPROSTIL is the generic (nonproprietary) name of Ronoprost.

What drug class is Ronoprost in?

Ronoprost belongs to the ornoprostil class. See all ornoprostil drugs at /class/ornoprostil.

What development phase is Ronoprost in?

Ronoprost is in Phase 2.

Drug class: All ornoprostil drugs
Therapeutic area: All drugs in Metabolic

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