Last reviewed 2026-05-25 · How we verify

PIPOXOLAN

Phase 2 active Small molecule ✓ Verified May 2026

PIPOXOLAN is a pipoxolan drug. It is currently in Phase 2 development.

PIPOXOLAN is a small molecule that works by interacting with a specific target to produce a therapeutic effect.

Pipoxolan is a drug used in a clinical trial for the treatment of Irritable Bowel Syndrome (IBS) via a colonoscopic probiotics spray. The exact mechanism of action of Pipoxolan is not specified in the provided information, but it is being compared to oral administration of probiotics in the treatment of IBS.

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	PIPOXOLAN
Drug class	pipoxolan
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and PIPOXOLAN is a key that fits into one of those locks. When it binds to the lock, it triggers a series of events that ultimately lead to a therapeutic effect, such as reducing symptoms of a particular disease. However, the exact lock that PIPOXOLAN binds to and the events that follow are not well understood.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Colonoscopic Probiotics Spray in Irritable Bowel Syndrome (NA)

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:

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

Frequently asked questions about PIPOXOLAN

What is PIPOXOLAN?

PIPOXOLAN is a pipoxolan drug.

How does PIPOXOLAN work?

PIPOXOLAN is a small molecule that works by interacting with a specific target to produce a therapeutic effect.

What drug class is PIPOXOLAN in?

PIPOXOLAN belongs to the pipoxolan class. See all pipoxolan drugs at /class/pipoxolan.

What development phase is PIPOXOLAN in?

PIPOXOLAN is in Phase 2.

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

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