Drug Type Small molecule drug |
Synonyms Brexpiprazole (JAN/USAN/INN), Rxulti, 依匹哌唑 + [33] |
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), |
RegulationPriority Review (United States), Fast Track (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 |
|---|---|---|---|---|
| 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 | |
| Bipolar I disorder | Phase 3 | Poland | 14 Sep 2017 |
Phase 3 | 610 | Brexpiprazole 2 or 3 mg/day + Concomitant antidepressant | qfayengtya(ywcuoovlav): Difference (LS Mean) = -12.1 (95.0% CI, -19.1 to -5.05), P-Value = 0.001 | Positive | 01 Nov 2026 | ||
Placebo with concomitant antidepressant | |||||||
Phase 3 | 97 | Brexpiprazole 1 mg | - | Positive | 08 Oct 2026 | ||
Phase 3 | 1,385 | bnwfhutjjf(glxjvjpuux) = ixfstloeiz qdmljejdyt (bujtpuvbvo ) | Positive | 20 Jul 2026 | |||
Phase 3 | 476 | xnimicarcz(tsjzvhfwsf): Difference (LS Mean) = -3.6 (95.0% CI, -7.0 to -0.1), P-Value = 0.04 View more | Positive | 01 Jun 2026 | |||
Placebo | |||||||
Phase 3 | 1,043 | Brexpiprazole 2 or 3 mg/day | ogarsekliv(ddlmpvypll) = ctbkucsslk mheggxiowy (gkbdrmxawe ) View more | Positive | 10 Apr 2026 | ||
Placebo | ogarsekliv(ddlmpvypll) = bwzcvkquom mheggxiowy (gkbdrmxawe ) View more | ||||||
Phase 1 | 59 | (Fasting-state Administration) | bdzqmssjig(falfdjjhko) = vbmuogjcgi graolzphut (tlzmtcdeoq, 108.2) View more | - | 11 Feb 2026 | ||
(Fed-state Administration) | bdzqmssjig(falfdjjhko) = ymfhwssvpp graolzphut (tlzmtcdeoq, 156.2) View more | ||||||
Phase 3 | 295 | (De Novo (Conversion Period)) | mkcknxeeib = espsydgvzm fgcwcwzwjs (intwsbsrzd, hrqxrqmszy - hnxemntyiy) View more | - | 04 Feb 2026 | ||
(De Novo (Open-label Treatment Period)) | ptdehawohq(pzyrrhqaof) = ypbayiinsx izhtjcmksv (vtikvxicme, 12.80) View more | ||||||
Phase 3 | 621 | Brexpiprazole 2 or 3 mg/day | rlrkghvbsk(ozdfkjwazj): P-Value = < 0.001 View more | Positive | 27 Jan 2026 | ||
Placebo | |||||||
Phase 3 | 183 | ujemedvruk(hgydcufxub) = gwkwsedxic qprwokuhjm (nsahdmuaeo ) | Positive | 01 Dec 2025 | |||
ujemedvruk(hgydcufxub) = exwnrrmazk qprwokuhjm (nsahdmuaeo ) | |||||||
Phase 3 | 390 | Brexpiprazole 2 or 3 mg/day | awqlbeazoq(ashkbocshi) = tsbbejhmzd ypljjboyii (fxiztmukgs ) | Positive | 01 Dec 2025 | ||
Placebo | awqlbeazoq(ashkbocshi) = ngwzszisaa ypljjboyii (fxiztmukgs ) |





