Last reviewed 2026-05-27 · How we verify

Paxapride (CINITAPRIDE)

Phase 3 active Small molecule ✓ Verified May 2026 Quality 24/100

Paxapride (generic name: CINITAPRIDE) is a cinitapride drug. It is currently in Phase 3 development.

Cinitapride works by increasing the release of acetylcholine in the gut, which helps to stimulate muscle contractions and improve digestion.

Paxapride is a small molecule. It is also known by the synonyms Cinitapride, Cinitaprida, and Cinitapride.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	CINITAPRIDE
Drug class	cinitapride
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 3

Mechanism of action

Think of it like a muscle stimulator for your digestive system. When you eat, your gut muscles contract to move food through your digestive tract. Cinitapride helps to make these muscles work better, so food can move through your system more easily and help with symptoms like bloating, nausea, and abdominal pain.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia (PHASE3)

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:

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

Frequently asked questions about Paxapride

What is Paxapride?

Paxapride (CINITAPRIDE) is a cinitapride drug.

How does Paxapride work?

Cinitapride works by increasing the release of acetylcholine in the gut, which helps to stimulate muscle contractions and improve digestion.

What is the generic name of Paxapride?

CINITAPRIDE is the generic (nonproprietary) name of Paxapride.

What drug class is Paxapride in?

Paxapride belongs to the cinitapride class. See all cinitapride drugs at /class/cinitapride.

What development phase is Paxapride in?

Paxapride is in Phase 3.

Drug class: All cinitapride drugs
Therapeutic area: All drugs in Pain

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