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OPC-12759

Otsuka Pharmaceutical Co., Ltd. · Phase 3 active Small molecule

OPC-12759 is a Dopamine D2 receptor antagonist Small molecule drug developed by Otsuka Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Treatment of schizophrenia. Also known as: rebamipide.

OPC-12759 is a selective dopamine D2 receptor antagonist.

OPC-12759 is a selective dopamine D2 receptor antagonist. Used for Treatment of schizophrenia.

Likelihood of approval
55.3% 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).
  • CNS / neurology attrition -3.0pp
    CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
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 nameOPC-12759
Also known asrebamipide
SponsorOtsuka Pharmaceutical Co., Ltd.
Drug classDopamine D2 receptor antagonist
TargetD2 receptor
ModalitySmall molecule
Therapeutic areaPsychiatry
PhasePhase 3

Mechanism of action

It works by blocking the action of dopamine at D2 receptors in the brain, which is thought to be involved in the pathophysiology of schizophrenia. This blockade is believed to help alleviate symptoms of psychosis and negative symptoms associated with schizophrenia.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about OPC-12759

What is OPC-12759?

OPC-12759 is a Dopamine D2 receptor antagonist drug developed by Otsuka Pharmaceutical Co., Ltd., indicated for Treatment of schizophrenia.

How does OPC-12759 work?

OPC-12759 is a selective dopamine D2 receptor antagonist.

What is OPC-12759 used for?

OPC-12759 is indicated for Treatment of schizophrenia.

Who makes OPC-12759?

OPC-12759 is developed by Otsuka Pharmaceutical Co., Ltd. (see full Otsuka Pharmaceutical Co., Ltd. pipeline at /company/otsuka).

Is OPC-12759 also known as anything else?

OPC-12759 is also known as rebamipide.

What drug class is OPC-12759 in?

OPC-12759 belongs to the Dopamine D2 receptor antagonist class. See all Dopamine D2 receptor antagonist drugs at /class/dopamine-d2-receptor-antagonist.

What development phase is OPC-12759 in?

OPC-12759 is in Phase 3.

What are the side effects of OPC-12759?

Common side effects of OPC-12759 include Orthostatic hypotension, Somnolence, Dizziness.

What does OPC-12759 target?

OPC-12759 targets D2 receptor and is a Dopamine D2 receptor antagonist.

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