Drugs / Zuranolone
Zuranolone
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ZURZUVAE | — | 2023-08-04 | fda.gov ↗ |
Trials 15 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05655507 | Apr 2023 → Oct 2024 | major depressive disorder | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT03284931 | Sep → Dec 2017 | — | Biogen | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT06759558 | Jan → Jun 2026 overdue | — | Duke University | Recruiting | No outcome recorded |
| Phase 2 | NCT03692910 | Aug 2018 → May 2019 | bipolar I disorder, bipolar II disorder, major depressive disorder | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT02978781 | Mar → Nov 2017 | essential tremor | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT03000530 | Dec 2016 → Oct 2017 | major depressive disorder | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT03000569 | Nov 2016 → Sep 2017 | Parkinson disease | Biogen | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT04476030 | Nov 2020 → Oct 2021 | major depressive disorder | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT04442503 | Jun 2020 → Mar 2022 | postpartum depression | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT04442490 | May 2020 → Mar 2021 | major depressive disorder | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT04007367 | Aug 2019 → Jan 2020 | major depressive disorder | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT03864614 | Feb 2019 → Jun 2023 | major depressive disorder | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT03771664 | Feb → Dec 2019 | insomnia, major depressive disorder | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT03672175 | Nov 2018 → Sep 2019 | major depressive disorder | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT02978326 | Jan 2017 → Nov 2018 | postpartum depression | Biogen | Completed | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zuranolone | “Zuranolone is a neuroactive steroid and positive allosteric modulator of synaptic and extrasynaptic γ-aminobutyric acid (GABA) type A receptors approved as an oral, once-daily,...” PMID 37875578 ↗ Oct 2023 |
| Known as | S-812217 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4105630 ↗ |
| Known as | SAGE 217 | “SAGE 217 30 mg Capsules” NCT02978326 ↗ |
| Known as | SGE-797 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4105630 ↗ |
| Known as | Zurzuvae | ChEMBL registry synonym — accepted as the source's own label CHEMBL4105630 ↗ |
| Action | Activate | “GABAA receptor positive allosteric modulator” PMID 36811520 ↗ Feb 2023 |
| Modality | Small molecule | “zuranolone, a positive allosteric modulator of synaptic and extrasynaptic GABAA receptors and neuroactive steroid” PMID 37491938 ↗ Jul 2023 |
| Route | Oral | “SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.” NCT02978326 ↗ |