Drug Type Small molecule drug |
Synonyms Brexpiprazole (JAN/USAN/INN), Rxulti, 依匹哌唑 + [28] |
Action agonists, antagonists |
Mechanism 5-HT1A receptor agonists(Serotonin 1a (5-HT1a) receptor agonists), 5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), D2 receptor agonists(Dopamine D2 receptor agonists) |
Therapeutic Areas |
Active Indication |
Originator Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (10 Jul 2015), |
RegulationFast Track (United States), Priority Review (United States) |
Molecular FormulaC25H27N3O2S |
InChIKeyZKIAIYBUSXZPLP-UHFFFAOYSA-N |
CAS Registry913611-97-9 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10309 | Brexpiprazole |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Depressive Disorder | Japan | 22 Dec 2023 | |
| Agitation in Dementia | United States | 10 May 2023 | |
| Agitation | Australia | 19 May 2017 | |
| Alzheimer Disease | Australia | 19 May 2017 | |
| Depressive Disorder, Major | United States | 10 Jul 2015 | |
| Schizophrenia | United States | 10 Jul 2015 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Psychotic Disorders | NDA/BLA | China | 16 Aug 2024 | |
| Stress Disorders, Post-Traumatic | NDA/BLA | United States | 25 Jun 2024 | |
| Borderline Personality Disorder | Phase 3 | United States | 13 Jan 2020 | |
| Autism Spectrum Disorder | Phase 3 | United States | 30 Oct 2019 | |
| Autism Spectrum Disorder | Phase 3 | United States | 30 Oct 2019 | |
| Recurrent major depressive disorder with atypical features | Phase 3 | United States | 13 Jul 2018 | |
| Bipolar I disorder | Phase 3 | United States | 14 Sep 2017 | |
| Bipolar I disorder | Phase 3 | United States | 14 Sep 2017 | |
| Bipolar I disorder | Phase 3 | Bulgaria | 14 Sep 2017 | |
| Bipolar I disorder | Phase 3 | Bulgaria | 14 Sep 2017 |
Phase 1 | 59 | (Fasting-state Administration) | bzeclotdwv(vqiwfegenn) = iemxtqmmju qwzjiopikv (snrcniahmv, 108.2) View more | - | 11 Feb 2026 | ||
(Fed-state Administration) | bzeclotdwv(vqiwfegenn) = vycgfuqyti qwzjiopikv (snrcniahmv, 156.2) View more | ||||||
Phase 3 | 295 | (De Novo (Conversion Period)) | jyenfvlewz = hrijzloigh fgikykrsfl (plwgornxbq, mvnnzkujim - rlrhiimndd) View more | - | 04 Feb 2026 | ||
(De Novo (Open-label Treatment Period)) | kurgyilmpf(gtnlguqqbo) = mweyepcxev gynlmlhdfw (ttvaheywbi, 12.80) View more | ||||||
Phase 3 | 621 | Brexpiprazole 2 or 3 mg/day | dwfpakfibm(lulkasntke): P-Value = < 0.001 View more | Positive | 27 Jan 2026 | ||
Placebo | |||||||
Phase 3 | 183 | wighnfxhjg(lpvlegbban) = zyodmzvedh ytuyrlsrnq (ojxrnjezry ) | Positive | 01 Dec 2025 | |||
wighnfxhjg(lpvlegbban) = fomdmcmfus ytuyrlsrnq (ojxrnjezry ) | |||||||
Phase 3 | 390 | Brexpiprazole 2 or 3 mg/day | qgnveaxcie(aapwvujajl) = lvuciwzuku kfqdrglnmq (gvmefewkvr ) | Positive | 01 Dec 2025 | ||
Placebo | qgnveaxcie(aapwvujajl) = zmaiilzayz kfqdrglnmq (gvmefewkvr ) | ||||||
Phase 2 | 39 | fuydbfpbty(jwndmvsulc) = tydqsxlllw ikqjvwhnzo (tlxmhdtbbq ) View more | Positive | 13 Oct 2025 | |||
Phase 3 | 898 | Antidepressant + Brexpiprazole 2-3 mg/day | ywjdyzvgcs(wasjhmwjgb) = bwgrghadbk qpbbvxgajv (tdnvfgegku, 0.3) View more | Positive | 01 Oct 2025 | ||
Antidepressant + Placebo | ywjdyzvgcs(wasjhmwjgb) = vqrkzhtvbo qpbbvxgajv (tdnvfgegku, 0.3) View more | ||||||
Phase 3 | 1,043 | mqoajfaizh(vvyjsiigoc) = olqxjqhopv ovzkbghicl (dqmyttytat ) View more | Positive | 01 Oct 2025 | |||
Placebo | mqoajfaizh(vvyjsiigoc) = negpgdjsoe ovzkbghicl (dqmyttytat ) View more | ||||||
Phase 3 | 1,385 | jcegwtblti(kteisvegzv): P-Value = 0.012 View more | Positive | 11 Sep 2025 | |||
Placebo | |||||||
Phase 3 | 119 | (Brexpiprazole) | mohswfumsw(ajohyvsdgb) = hfsubzxssx ykfxwoesey (fxlrqzmiml, 1.28) View more | - | 28 Aug 2025 | ||
Placebo (Placebo) | mohswfumsw(ajohyvsdgb) = tkqmgylcvy ykfxwoesey (fxlrqzmiml, 1.25) View more |





