Last reviewed 2026-06-02 · How we verify

CLEBOPRIDE

Phase 2 active Small molecule ✓ Verified Jun 2026

CLEBOPRIDE is a clebopride drug. It is currently in Phase 2 development.

CLEBOPRIDE works by binding to the D(4) dopamine receptor, which helps to regulate gastrointestinal motility.

CLEBOPRIDE is a small molecule. Its exact mechanism of action is not specified in the provided information.

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	CLEBOPRIDE
Drug class	clebopride
Target	D(4) dopamine receptor, Acetylcholinesterase, D(2) dopamine receptor
Modality	Small molecule
Therapeutic area	Gastroenterology
Phase	Phase 2

Mechanism of action

Imagine your digestive system as a highway with cars moving at different speeds. CLEBOPRIDE helps to slow down the cars, allowing food to move through the system more smoothly and reducing symptoms of gastrointestinal disorders.

Approved indications

No approved indications tracked.

Common side effects

Mixed liver injury

Competitive intelligence

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

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

Frequently asked questions about CLEBOPRIDE

What is CLEBOPRIDE?

CLEBOPRIDE is a clebopride drug.

How does CLEBOPRIDE work?

CLEBOPRIDE works by binding to the D(4) dopamine receptor, which helps to regulate gastrointestinal motility.

What drug class is CLEBOPRIDE in?

CLEBOPRIDE belongs to the clebopride class. See all clebopride drugs at /class/clebopride.

What development phase is CLEBOPRIDE in?

CLEBOPRIDE is in Phase 2.

What are the side effects of CLEBOPRIDE?

Common side effects of CLEBOPRIDE include Mixed liver injury.

What does CLEBOPRIDE target?

CLEBOPRIDE targets D(4) dopamine receptor, Acetylcholinesterase, D(2) dopamine receptor and is a clebopride.

Drug class: All clebopride drugs
Target: All drugs targeting D(4) dopamine receptor, Acetylcholinesterase, D(2) dopamine receptor
Therapeutic area: All drugs in Gastroenterology

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