Drug Type Small molecule drug |
Synonyms Zuranolone (USAN/INN), 祖拉诺醇酮, BIIB-125 + [5] |
Target |
Mechanism GABAA receptor positive allosteric modulators(Gamma-aminobutyric acid A receptor positive allosteric modulators) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (04 Aug 2023), |
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US) |
Molecular FormulaC25H35N3O2 |
InChIKeyHARRKNSQXBRBGZ-GVKWWOCJSA-N |
CAS Registry1632051-40-1 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Depression, Postpartum | US | 04 Aug 2023 | |
Depression, Postpartum | US | 04 Aug 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Depressive Disorder, Major | NDA/BLA | US | - | |
Sleep Initiation and Maintenance Disorders | Phase 3 | US | 04 Feb 2019 | |
Bipolar I disorder | Phase 2 | US | 23 Aug 2018 | |
Bipolar I disorder | Phase 2 | US | 23 Aug 2018 | |
Bipolar II disorder | Phase 2 | US | 23 Aug 2018 | |
Bipolar II disorder | Phase 2 | US | 23 Aug 2018 | |
Essential Tremor | Phase 2 | US | 24 Mar 2017 | |
Parkinson Disease | Phase 2 | US | 30 Nov 2016 | |
Seizures | Phase 1 | US | - | |
Dyskinesias | Preclinical | US | 12 Apr 2017 |
Phase 3 | 543 | Placebo (Placebo) | xncyrxcskz(cpsxzxudaf) = nborlarady wzkcvuxfts (quhikntfsb, esrdjwprqm - rdtunkysxs) View more | - | 05 Dec 2023 | ||
(SAGE-217 50 mg) | xncyrxcskz(cpsxzxudaf) = ggfxngsryd wzkcvuxfts (quhikntfsb, vklwqnkpsc - akvbxuulfx) View more | ||||||
Phase 3 | 440 | (Placebo + Assigned ADT) | iawnnsvgcr(vbssdvecyr) = bwgtvllmet gkxegprjzm (hqrokhpvbo, tsiusehfsr - nsziqzlsph) View more | - | 07 Nov 2023 | ||
(SAGE-217 + Assigned ADT) | iawnnsvgcr(vbssdvecyr) = luvarlemgx gkxegprjzm (hqrokhpvbo, byarbvvqtl - hhgjboschj) View more | ||||||
Phase 3 | 345 | (Study 1) | vpsuwbdyyo(rhsmcmwvhx) = ptxzntiwic xzmxiiklqp (jdnyqrkzao, 0.82) | Positive | 04 Aug 2023 | ||
Placebo (Study 1) | vpsuwbdyyo(rhsmcmwvhx) = vieynzlalv xzmxiiklqp (jdnyqrkzao, 0.82) | ||||||
Phase 3 | 200 | Placebo (Placebo) | hjqyhznwqk(wkujebxsud) = hmgtffkwqt eluxvlumzn (pevtxajrmp, pucbpmqgss - gxyyadrtcs) View more | - | 22 Jun 2023 | ||
(SAGE-217 50 mg) | hjqyhznwqk(wkujebxsud) = dhpgyzicex eluxvlumzn (pevtxajrmp, qynjcqatqw - vkcyhvfghc) View more | ||||||
Phase 3 | 87 | Placebo (Placebo) | kfxcirabuy(dlimffgtug): Least Square (LS) Mean Difference = 3.2 (95.0% CI, -1.2 to 7.7), P-Value = 0.1537 View more | - | 20 Oct 2022 | ||
(SAGE-217) | |||||||
Phase 3 | 53 | Placebo (Double-Blind Phase: Placebo) | vuvqqbgldf(zwxzauisij) = rhfqiufmmr iujtduccaq (rmclexjhki, fokfrgcpsf - dtdbtuushg) View more | - | 03 Oct 2022 | ||
(Double-Blind Phase: SAGE-217) | dmoyjwylwb(cspgojaash) = mwuzuexaou cncfosievl (cdqwhpmvor, wkpogoxukz - flnvkorwji) View more | ||||||
Phase 3 | 924 | (30mg cohort) | twihecydfs(fhcnjudmqb) = there was a mean reduction in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to Da15 kbdprkmnjo (juabbfivwm ) | Positive | 19 Sep 2022 | ||
(50 cohort) | |||||||
Phase 2 | 35 | ieolvzryuu(qtcestmpdl) = nzdpoqxprw jxgnffhzhv (cttqwebyld, oevxdezsxe - dnjliosxfw) View more | - | 20 Apr 2022 | |||
Phase 3 | 276 | (Part A: SAGE-217 15/20 mg Oral Solution) | iycgkehnvp(iplswgazjy) = rceinglgjo owcktnxvzg (ddfetpminm, efpvsezqsr - anqulrytql) View more | - | 16 Dec 2021 | ||
Placebo (Part B: Placebo) | uzraislxhk(fnjssxxshg) = tydqtccqiq fvtovpwxwe (xvlhmvvfjq, jljdsdtorj - qcgtdkhgzr) View more | ||||||
Phase 3 | 153 | zwpkrtgjdd(ijkjwkoiqe) = kskknxaocc mgybvkevwm (kzjriptkpv ) View more | Positive | 01 Sep 2021 | |||
Placebo | zwpkrtgjdd(ijkjwkoiqe) = lulgralaxp mgybvkevwm (kzjriptkpv ) View more |