Last reviewed 2026-04-20 · How we verify

Centbutindole (BIRIPERONE)

Phase 2 active Small molecule

Centbutindole (generic name: BIRIPERONE) is a biriperone drug. It is currently in Phase 2 development.

Centbutindole works by binding to the D(3) dopamine receptor, which is involved in regulating movement and other functions in the brain.

Centbutindole, also known as biriperone, is a small molecule targeting the D(3) dopamine receptor. It is a biriperone drug class, but its current status and indications are unknown. As a small molecule, it is likely to have a specific mechanism of action, but its commercial status and safety considerations are not well-documented. Further research is needed to understand its potential therapeutic applications and risks. Its exact pharmacokinetic properties, such as half-life and bioavailability, are also unknown.

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	BIRIPERONE
Drug class	biriperone
Target	D(3) dopamine receptor, 5-hydroxytryptamine receptor 2A, D(1A) dopamine receptor
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your brain has a system for controlling movement and emotions, and dopamine is a key chemical that helps it work. Centbutindole blocks the D(3) dopamine receptor, which can affect how this system functions. This can potentially help with conditions related to abnormal movement or dopamine imbalances.

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:

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

Frequently asked questions about Centbutindole

What is Centbutindole?

Centbutindole (BIRIPERONE) is a biriperone drug.

How does Centbutindole work?

Centbutindole works by binding to the D(3) dopamine receptor, which is involved in regulating movement and other functions in the brain.

What is the generic name of Centbutindole?

BIRIPERONE is the generic (nonproprietary) name of Centbutindole.

What drug class is Centbutindole in?

Centbutindole belongs to the biriperone class. See all biriperone drugs at /class/biriperone.

What development phase is Centbutindole in?

Centbutindole is in Phase 2.

What does Centbutindole target?

Centbutindole targets D(3) dopamine receptor, 5-hydroxytryptamine receptor 2A, D(1A) dopamine receptor and is a biriperone.

Drug class: All biriperone drugs
Target: All drugs targeting D(3) dopamine receptor, 5-hydroxytryptamine receptor 2A, D(1A) dopamine receptor
Therapeutic area: All drugs in Other

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