Last reviewed 2026-05-28 · How we verify

DIPIPROVERINE

Phase 2 active Small molecule ✓ Verified May 2026

DIPIPROVERINE is a dipiproverine drug. It is currently in Phase 2 development.

Dipiproverine works by relaxing smooth muscle in the bladder neck and prostate, improving urine flow.

Dipiproverine is a small molecule drug belonging to the dipiproverine class, originally developed by an unknown entity. Its current owner is also unknown. The exact target of dipiproverine is not specified, but it is used to treat certain conditions. The commercial status of dipiproverine is unclear, with unknown patent status and generic manufacturers. Key safety considerations are not well-documented.

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	DIPIPROVERINE
Drug class	dipiproverine
Modality	Small molecule
Therapeutic area	Urology
Phase	Phase 2

Mechanism of action

Imagine your bladder is like a balloon filling up with water. When the balloon gets too full, it can't hold any more water, and you need to urinate. Dipiproverine helps relax the muscles around the balloon, making it easier to empty and improving urine flow.

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:

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

Frequently asked questions about DIPIPROVERINE

What is DIPIPROVERINE?

DIPIPROVERINE is a dipiproverine drug.

How does DIPIPROVERINE work?

Dipiproverine works by relaxing smooth muscle in the bladder neck and prostate, improving urine flow.

What drug class is DIPIPROVERINE in?

DIPIPROVERINE belongs to the dipiproverine class. See all dipiproverine drugs at /class/dipiproverine.

What development phase is DIPIPROVERINE in?

DIPIPROVERINE is in Phase 2.

Drug class: All dipiproverine drugs
Therapeutic area: All drugs in Urology

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