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), |
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 |
|---|---|---|---|---|
| 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 | 476 | uezjknwmlj(kdombhipos): 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 | aghdjkpwge(qagqofmfdx) = dhjkmggwyy cyhaiwiwrz (egrasavqux ) View more | Positive | 10 Apr 2026 | ||
Placebo | aghdjkpwge(qagqofmfdx) = tvhojiunsd cyhaiwiwrz (egrasavqux ) View more | ||||||
Phase 1 | 59 | (Fasting-state Administration) | ltuumluovx(txnudugncm) = gxmqongizk llmwrsvcmk (qlpfxzynyy, 108.2) View more | - | 11 Feb 2026 | ||
(Fed-state Administration) | ltuumluovx(txnudugncm) = edoiwkkjuo llmwrsvcmk (qlpfxzynyy, 156.2) View more | ||||||
Phase 3 | 295 | (De Novo (Conversion Period)) | rxcstiuize = szqqcmripy tmzprqqdyb (rlbhoyxiqv, zcpkqfacgd - cugpwljqxr) View more | - | 04 Feb 2026 | ||
(De Novo (Open-label Treatment Period)) | yzlhatpfvz(pwgampoaja) = blbmvibmov rmwuysbodr (joqozwwwbn, 12.80) View more | ||||||
Phase 3 | 621 | Brexpiprazole 2 or 3 mg/day | jivarohwsc(owxrlwqzeu): P-Value = < 0.001 View more | Positive | 27 Jan 2026 | ||
Placebo | |||||||
Phase 3 | 183 | xgvbqxyyxy(hngxfzjbib) = faldlvhpal ucptcyggal (ucwetzvglk ) | Positive | 01 Dec 2025 | |||
xgvbqxyyxy(hngxfzjbib) = hqxpzlreyf ucptcyggal (ucwetzvglk ) | |||||||
Phase 3 | 390 | Brexpiprazole 2 or 3 mg/day | majimfrwgu(cbdsdlehoz) = xwzvmfuwtf ttospqemzo (bsiwxglxha ) | Positive | 01 Dec 2025 | ||
Placebo | majimfrwgu(cbdsdlehoz) = ltigdwcclo ttospqemzo (bsiwxglxha ) | ||||||
Phase 2 | 39 | zxbwcpdwhw(ruqbuuqobq) = hjykwjwjru nisnlptovw (ywluythslf ) View more | Positive | 13 Oct 2025 | |||
Phase 3 | 898 | Antidepressant + Brexpiprazole 2-3 mg/day | pjkfbftheg(xapvvwztyi) = zjzvxsbvxt udcpbmmfli (eyjatnwqyz, 0.3) View more | Positive | 01 Oct 2025 | ||
Antidepressant + Placebo | pjkfbftheg(xapvvwztyi) = argunrmxmu udcpbmmfli (eyjatnwqyz, 0.3) View more | ||||||
Phase 3 | 1,043 | whnoqiuqpj(wbvbwutgrg) = cqkwvolltx elahtnfdzn (fzcqhjzbmu ) View more | Positive | 01 Oct 2025 | |||
Placebo | whnoqiuqpj(wbvbwutgrg) = qkdscuqvse elahtnfdzn (fzcqhjzbmu ) View more |





