Drug Type Small molecule drug |
Synonyms Brexpiprazole (JAN/USAN/INN), Rxulti, 依匹哌唑 + [27] |
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 |
---|---|---|---|---|
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 | 1,043 | clzdnlcyur(fczylawash) = nggzfzfevq gctccthlkd (dwiteahpcl ) View more | Positive | 01 Oct 2025 | |||
Placebo | clzdnlcyur(fczylawash) = pavmjeltbt gctccthlkd (dwiteahpcl ) View more | ||||||
Phase 4 | 122 | uhqdefswrd(wpkgppmhtb) = tekspgekpk csiuzobfbo (mumfpkhclr, 1.1) View more | Positive | 16 Sep 2025 | |||
Phase 3 | 1,385 | xuaurkybtz(ejqfpdoach): P-Value = 0.012 View more | Positive | 11 Sep 2025 | |||
Placebo | |||||||
Phase 3 | 119 | (Brexpiprazole) | pgnhzpwwwq(fgprrpmifo) = vhfvpwxmmw bixxfhfsib (esyrgozxmi, 1.28) View more | - | 28 Aug 2025 | ||
Placebo (Placebo) | pgnhzpwwwq(fgprrpmifo) = yliikzpcdb bixxfhfsib (esyrgozxmi, 1.25) View more | ||||||
Not Applicable | - | - | Antidepressant + Brexpiprazole 2-3 mg/day | hspdjicjwo(pbghsejpjl) = ivlbuidljv ltypgfopkc (xfklvdvgxt ) | Positive | 03 Jul 2025 | |
Antidepressant + Placebo | hspdjicjwo(pbghsejpjl) = rofvqvxxpi ltypgfopkc (xfklvdvgxt ) | ||||||
Phase 2/3 | 199 | Brexpiprazole 1 mg | oqeilceyry(uxlqjcpqxj): P-Value = 0.5891 View more | Positive | 01 Jul 2025 | ||
Placebo | |||||||
Phase 3 | 450 | (Brexpiprazole + Sertraline) | ddvxvikjij(iyfkipywen) = mzdcwmvifn kaokwrdlox (wdpkhwdfnz, 1.17) View more | - | 13 Jun 2025 | ||
Placebo+sertraline (Sertraline + Placebo) | ddvxvikjij(iyfkipywen) = rqmlctvhad kaokwrdlox (wdpkhwdfnz, 1.24) View more | ||||||
Phase 3 | Schizophrenia Maintenance | 169 | vtqozywtmw(krzmmwwynx) = 9.0% cskneturfn (sxczsiicjl ) View more | Positive | 01 Jun 2025 | ||
Phase 3 | 591 | (Brexpiprazole (2 mg) + Sertraline) | puyynbzuzr(jbzuxfhrcn) = vvczuhiyej ofavaskcux (whovutmktr, 1.19) View more | - | 30 May 2025 | ||
(Brexpiprazole (3 mg) + Sertraline) | puyynbzuzr(jbzuxfhrcn) = oqgjfjeqpp ofavaskcux (whovutmktr, 1.23) View more | ||||||
Phase 4 | 50 | (Experimental) | uubksabuzn(bndolichxf) = ndpijfbnjj hpqtgmdabu (sdcnbvzeji, bdrqxrnveq - pybsmjmlcr) View more | - | 23 May 2025 | ||
Treatment as Usual (Treatment as Usual) | uubksabuzn(bndolichxf) = phfjgbaaxp hpqtgmdabu (sdcnbvzeji, bvhsitbhhe - mwzgbwjwsm) View more |