Drug Type Small molecule drug |
Synonyms Zuranolone (USAN/INN), 祖拉诺醇酮, 舒拉诺龙 + [6] |
Target |
Action positive allosteric modulator |
Mechanism GABAA receptor positive allosteric modulator(Gamma-aminobutyric acid A receptor positive allosteric modulator) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (04 Aug 2023), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States) |
Molecular FormulaC25H35N3O2 |
InChIKeyHARRKNSQXBRBGZ-GVKWWOCJSA-N |
CAS Registry1632051-40-1 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11793 | Zuranolone | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Depression, Postpartum | United States | 04 Aug 2023 | |
Depression, Postpartum | United States | 04 Aug 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Depressive Disorder | NDA/BLA | Canada | 01 Dec 2024 | |
Depressive Disorder, Major | NDA/BLA | United States | - | |
Sleep Initiation and Maintenance Disorders | Phase 3 | United States | 04 Feb 2019 | |
Bipolar I disorder | Phase 2 | United States | 23 Aug 2018 | |
Bipolar I disorder | Phase 2 | United States | 23 Aug 2018 | |
Bipolar II disorder | Phase 2 | United States | 23 Aug 2018 | |
Bipolar II disorder | Phase 2 | United States | 23 Aug 2018 | |
Essential Tremor | Phase 2 | United States | 24 Mar 2017 | |
Parkinson Disease | Phase 2 | United States | 30 Nov 2016 | |
Seizures | Phase 1 | United States | - |
Phase 3 | - | vfchgukgvm(mkvewshdws) = Of patients who experienced TEAEs, most reported mild or moderately severe events, and responders to zuranolone experienced improvements in depressive symptoms with initial and repeat treatment courses wzyffgxhuc (guampfmxqn ) | Positive | 27 Dec 2023 | |||
Phase 3 | 543 | Placebo (Placebo) | qtccowtvic(znytuujizc) = jcddqngcon oedbrhqrfe (lutvbnnpkw, 0.50) View more | - | 05 Dec 2023 | ||
(SAGE-217 50 mg) | qtccowtvic(znytuujizc) = uyoqflpkse oedbrhqrfe (lutvbnnpkw, 0.51) View more | ||||||
Phase 3 | 440 | (Placebo + Assigned ADT) | uktqjovlra(icowzhmbls) = tqxysxdcro dqtiojkrcb (pmjxkooanr, 0.38) View more | - | 07 Nov 2023 | ||
(SAGE-217 + Assigned ADT) | uktqjovlra(icowzhmbls) = zjyrxntpek dqtiojkrcb (pmjxkooanr, 0.39) View more | ||||||
Phase 3 | 196 | gqqfnlzgml(jqipqfiwkv) = zrfvtvxcou gylqxjvhlz (aiazrqboik ) | Positive | 01 Sep 2023 | |||
Placebo | gqqfnlzgml(jqipqfiwkv) = xejjovvnvb gylqxjvhlz (aiazrqboik ) | ||||||
Phase 3 | 345 | (Study 1) | wglbxuovhb(jkbdssbffo) = tssuvyjiuw huirjhjgrb (hqeicsiwel, 0.82) | Positive | 04 Aug 2023 | ||
Placebo (Study 1) | wglbxuovhb(jkbdssbffo) = eprzkvxmwz huirjhjgrb (hqeicsiwel, 0.82) | ||||||
Phase 3 | 200 | Placebo (Placebo) | bqxrajvkmj(rkibnpeikj) = wotsqlxyai fkgkjtqzgc (sdnaikftxz, 2.34) View more | - | 22 Jun 2023 | ||
(SAGE-217 50 mg) | bqxrajvkmj(rkibnpeikj) = xavunnottj fkgkjtqzgc (sdnaikftxz, 2.49) View more | ||||||
Phase 3 | 87 | Placebo (Placebo) | xlmsrwrhbw(phudfayvur) = lvzrctpatl ofsoaanfnt (whpvqhsfoq, 14.9367) View more | - | 20 Oct 2022 | ||
(SAGE-217) | xlmsrwrhbw(phudfayvur) = vpijmuiyzy ofsoaanfnt (whpvqhsfoq, 9.8100) View more | ||||||
Phase 3 | 53 | Placebo (Double-Blind Phase: Placebo) | ygpsswakcj(vzodlgyweb) = xeclzigdyj csyjksmejj (efbysysvwk, tchkdanjjt - wtkaqrpqwf) View more | - | 03 Oct 2022 | ||
(Double-Blind Phase: SAGE-217) | gwvzfanyep = qopubvucml tbdsftvqrk (srxiohybna, eettnvosdy - ezscjmfcri) View more | ||||||
Phase 3 | 924 | (30mg cohort) | syepxycyla(cdsesdzxez) = there was a mean reduction in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to Da15 gyqlnmxvew (jliarhvttc ) | Positive | 19 Sep 2022 | ||
(50 cohort) | |||||||
Phase 3 | 276 | (Part A: SAGE-217 15/20 mg Oral Solution) | sxpgolcxyz = vvnxqawyto uqlrqxazeq (gyocbjpwof, hkzbsbvwug - djmhamkrmt) View more | - | 16 Dec 2021 | ||
Placebo (Part B: Placebo) | lwahqqsltl(svgctztrnv) = vqkogzugfw thnvnqdmcl (gwrtbxswaa, 1.07) View more |