Last reviewed 2026-05-21 · How we verify

(+/-)-Rosaprostol (ROSAPROSTOL)

Phase 2 active Small molecule ✓ Verified May 2026

(+/-)-Rosaprostol (generic name: ROSAPROSTOL) is a rosaprostol drug. It is currently in Phase 2 development.

Rosaprostol works by mimicking a natural substance in the body to produce a specific effect.

(+/-)-Rosaprostol is a small molecule. It is also known by the synonym ROSAPROSTOL.

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	ROSAPROSTOL
Drug class	rosaprostol
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body has a natural 'brake' system to slow down certain processes. Rosaprostol is a synthetic version of a substance that helps activate this brake system, which can be useful in treating certain conditions. However, the exact details of how it works are not yet fully understood.

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:

(+/-)-Rosaprostol CI brief — competitive landscape report
(+/-)-Rosaprostol updates RSS · CI watch RSS

Frequently asked questions about (+/-)-Rosaprostol

What is (+/-)-Rosaprostol?

(+/-)-Rosaprostol (ROSAPROSTOL) is a rosaprostol drug.

How does (+/-)-Rosaprostol work?

Rosaprostol works by mimicking a natural substance in the body to produce a specific effect.

What is the generic name of (+/-)-Rosaprostol?

ROSAPROSTOL is the generic (nonproprietary) name of (+/-)-Rosaprostol.

What drug class is (+/-)-Rosaprostol in?

(+/-)-Rosaprostol belongs to the rosaprostol class. See all rosaprostol drugs at /class/rosaprostol.

What development phase is (+/-)-Rosaprostol in?

(+/-)-Rosaprostol is in Phase 2.

Drug class: All rosaprostol drugs
Therapeutic area: All drugs in Other

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