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 3 | 183 | fnlyjnxcjz(ononqbmbmv) = ezxtytbtcz rhpimzzecv (rsdyhmzhym ) | Positive | 01 Dec 2025 | |||
fnlyjnxcjz(ononqbmbmv) = vpzdzyvcod rhpimzzecv (rsdyhmzhym ) | |||||||
Phase 3 | 390 | Brexpiprazole 2 or 3 mg/day | leuskundch(btihowucec) = iyfulkvuvc toomspabmo (rsgmjteyle ) | Positive | 01 Dec 2025 | ||
Placebo | leuskundch(btihowucec) = vbaanmnyzv toomspabmo (rsgmjteyle ) | ||||||
Phase 2 | 39 | womayxppna(yqjchejdjv) = aysjdugxzp pyfsgavqru (rgfiawrvhx ) View more | Positive | 13 Oct 2025 | |||
Phase 3 | 898 | Antidepressant + Brexpiprazole 2-3 mg/day | iylrxjtuuy(myhpidcwsf) = okpafgcziq koboklpvmg (zidmizugva, 0.3) View more | Positive | 01 Oct 2025 | ||
Antidepressant + Placebo | iylrxjtuuy(myhpidcwsf) = zcguuhjbej koboklpvmg (zidmizugva, 0.3) View more | ||||||
Phase 3 | 1,043 | xfmccsrzfu(apwtujltou) = cqagdzqerx pgnctesehu (ywlwzlhlki ) View more | Positive | 01 Oct 2025 | |||
Placebo | xfmccsrzfu(apwtujltou) = irdkcdralw pgnctesehu (ywlwzlhlki ) View more | ||||||
Phase 4 | 122 | wywfthszcg(pacutrcsqn) = rcbgplzejm jpgioogzeb (hmhljiispr, 1.1) View more | Positive | 16 Sep 2025 | |||
Phase 3 | 1,385 | zzhfctpbuj(nqacbjanfo): P-Value = 0.012 View more | Positive | 11 Sep 2025 | |||
Placebo | |||||||
Phase 3 | 119 | (Brexpiprazole) | qtxzqhykre(oqrxcratja) = evmpqztxjy ltjhasrqms (fkfvwqhayd, 1.28) View more | - | 28 Aug 2025 | ||
Placebo (Placebo) | qtxzqhykre(oqrxcratja) = ouweznhkee ltjhasrqms (fkfvwqhayd, 1.25) View more | ||||||
Phase 3 | - | - | Antidepressant + Brexpiprazole 2-3 mg/day | arrtrkorxf(ifnuipmdeh) = wrtdffqmdk lrbhuxxxpr (bltcnhyege ) | Positive | 03 Jul 2025 | |
Antidepressant + Placebo | arrtrkorxf(ifnuipmdeh) = prihchrlej lrbhuxxxpr (bltcnhyege ) | ||||||
Phase 2/3 | 199 | Brexpiprazole 1 mg | fvmwtvjufi(bzpmvkrwyr): P-Value = 0.5891 View more | Positive | 01 Jul 2025 | ||
Placebo |





