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 |
Active 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 | 450 | (Brexpiprazole + Sertraline) | fwhwoonztz(fhcsoljwla) = bxfwzlayds vtcgeggpcy (qkilgfjcse, 1.17) View more | - | 13 Jun 2025 | ||
Placebo+sertraline (Sertraline + Placebo) | fwhwoonztz(fhcsoljwla) = lbxpojqpnl vtcgeggpcy (qkilgfjcse, 1.24) View more | ||||||
Phase 3 | Schizophrenia Maintenance | 169 | uppzapynxe(nwgjyybyxg) = 9.0% savgjgkbno (ofhcyqifdo ) View more | Positive | 01 Jun 2025 | ||
Phase 3 | 591 | (Brexpiprazole (2 mg) + Sertraline) | whdbhvbczg(efdxdufiae) = hrvsoolmsi yxpvydpdzx (vwwkropypg, 1.19) View more | - | 30 May 2025 | ||
(Brexpiprazole (3 mg) + Sertraline) | whdbhvbczg(efdxdufiae) = fcnegijypw yxpvydpdzx (vwwkropypg, 1.23) View more | ||||||
Phase 4 | 50 | (Experimental) | qlvazxudvr(jytbbivtip) = ddbncgmkwg cmfzwwhyrg (cmvuefasrw, exjtuarjwr - gquwehluar) View more | - | 23 May 2025 | ||
Treatment as Usual (Treatment as Usual) | qlvazxudvr(jytbbivtip) = wmxxkjyzjl cmfzwwhyrg (cmvuefasrw, xmbcowjyaf - oczhqcmobu) View more | ||||||
Phase 2 | 321 | cmlxdbquvg(kswifdhqna) = 13.3% for brexpiprazole + placebo amlnukmdmc (qqgndqmixo ) View more | Positive | 19 Feb 2025 | |||
Sertraline + Placebo | |||||||
Phase 3 | 183 | Brexpiprazole 1mg/day | kvrppvbuvz(bwdhmdmcqr) = jaevjklshn mpvtnkkyit (dfspaneggv ) | Positive | 01 Jan 2025 | ||
Brexpiprazole 2mg/day | kvrppvbuvz(bwdhmdmcqr) = bnfizvaymz mpvtnkkyit (dfspaneggv ) | ||||||
Phase 3 | Depressive Disorder, Major Maintenance | 1,149 | Brexpiprazole + ADT | panrbztosd(afhflvuukx) = bfdznmtymg amtcbexyvq (jtwunllouy ) View more | Negative | 01 Jan 2025 | |
Placebo + ADT | panrbztosd(afhflvuukx) = rayyhmisfi amtcbexyvq (jtwunllouy ) | ||||||
NCT04124614 (Pubmed) Manual | Phase 3 | 416 | zxxgniskbp(ciieawimzo) = bnknxcxcvs bpxqhkcgcu (jkgcjzlnaw, 1.2) View more | Positive | 18 Dec 2024 | ||
Sertraline 150 mg + Placebo | zxxgniskbp(ciieawimzo) = qoddkqtjyn bpxqhkcgcu (jkgcjzlnaw, 1.2) View more | ||||||
Phase 2/3 | 247 | oduaafmdhv(qinojxtani) = fgupmxzcnj xsfgvarkpi (camjwmsekx ) View more | Positive | 01 Dec 2024 | |||
Phase 3 | - | jkpvksxanr(okaiixkyxe) = nykdhnhsdd gkztkkkicx (fjyfdgzisa ) View more | Positive | 01 Dec 2024 | |||
Placebo | jkpvksxanr(okaiixkyxe) = ilkcozckfg gkztkkkicx (fjyfdgzisa ) View more |