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OPC-34712FUM/ Brexpiprazole fumarate — Competitive Intelligence Brief
phase 3
Serotonin-dopamine activity modulator (SDAM); atypical antipsychotic
Dopamine D2 receptor (partial agonist), serotonin 5-HT1A receptor (partial agonist), serotonin 5-HT2A receptor (antagonist)
Psychiatry
Small molecule
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Target snapshot
OPC-34712FUM/ Brexpiprazole fumarate (OPC-34712FUM/ Brexpiprazole fumarate) — Otsuka Pharmaceutical Co., Ltd.. Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors while antagonizing serotonin 5-HT2A receptors.
Comparator set (2 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| OPC-34712FUM/ Brexpiprazole fumarate TARGET | OPC-34712FUM/ Brexpiprazole fumarate | Otsuka Pharmaceutical Co., Ltd. | phase 3 | Serotonin-dopamine activity modulator (SDAM); atypical antipsychotic | Dopamine D2 receptor (partial agonist), serotonin 5-HT1A receptor (partial agonist), serotonin 5-HT2A receptor (antagonist) | |
| Adjunct brexpiprazole | Adjunct brexpiprazole | H. Lundbeck A/S | phase 3 | Serotonin-dopamine activity modulator (SDAM) | Dopamine D2 receptor, Serotonin 5-HT1A receptor | |
| Brexpiprazole (OPC-34712) | Brexpiprazole (OPC-34712) | Otsuka Pharmaceutical Development & Commercialization, Inc. | phase 3 | Atypical antipsychotic; serotonin-dopamine activity modulator (SDAM) | Dopamine D2 receptor (partial agonist); serotonin 5-HT1A receptor (partial agonist); serotonin 5-HT2A receptor (antagonist) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
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Sponsor landscape (Serotonin-dopamine activity modulator (SDAM); atypical antipsychotic class)
- Otsuka Pharmaceutical Co., Ltd. · 1 drug in this class
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Cite this brief
Drug Landscape (2026). OPC-34712FUM/ Brexpiprazole fumarate — Competitive Intelligence Brief. https://druglandscape.com/ci/opc-34712fum-brexpiprazole-fumarate. Accessed 2026-05-17.
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