Drugs / Zuranolone
Zuranolone
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed major depressive disorder 1 milestone | |||||
| Filed | US (FDA) | — | major depressive disorder | 2022-05-02 | “initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone” biogen.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | ZURZUVAE | — | 2023-08-04 | fda.gov ↗ |
Trials 15
| 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 · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06759558 | Jan 2026 → Jun 2027 expected | — | 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 | Missed primary |
| Phase 2 | NCT03000530 | Dec 2016 → Oct 2017 | major depressive disorder | Biogen | Completed | Met primary |
| Phase 2 | NCT03000569 | Nov 2016 → Sep 2017 | Parkinson disease | Biogen | Completed | No outcome recorded |
| Phase 38 trials · 4 met primary · 2 missed | ||||||
| Phase 3 | NCT04476030 | Nov 2020 → Oct 2021 | major depressive disorder | Biogen | Completed | Met primary |
| Phase 3 | NCT04442503 | Jun 2020 → Mar 2022 | postpartum depression | Biogen | Completed | Met primary |
| Phase 3 | NCT04442490 | May 2020 → Mar 2021 | major depressive disorder | Biogen | Completed | Met primary |
| 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 | Missed primary |
| Phase 3 | NCT03672175 | Nov 2018 → Sep 2019 | major depressive disorder | Biogen | Completed | Missed primary |
| Phase 3 | NCT02978326 | Jan 2017 → Nov 2018 | postpartum depression | Biogen | Completed | Met primary |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2025-09-17 | Biogen | Regulatory Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE® (zuranolone) to treat post-partum depression (PPD) in adults following childbirth. |
| 2025-07-25 | Biogen | Regulatory ZURZUVAE® (zuranolone) Receives Positive Opinion from CHMP for the Treatment of Women with Postpartum Depression biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for ZURZUVAE ® (zuranolone) for the treatment of postpartum depression (PPD) in adults following childbirth. |
| 2023-08-04 | Biogen | Regulatory FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced the U.S. Food and Drug Administration (FDA) approved ZURZUVAE™ (zuranolone) 50 mg for adults with postpartum depression (PPD). |
| 2023-03-08 | Biogen | Regulatory Biogen and Sage Therapeutics Share Update on FDA Advisory Committee for Zuranolone biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced that the U.S. Food and Drug Administration (FDA) notified the companies that the agency does not currently plan to convene an advisory committee meeting to discuss the New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). |
| 2023-02-06 | Biogen | Regulatory Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression biogen.com ↗
The application has been granted priority review and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 5, 2023. |
| 2022-12-06 | Biogen | Regulatory Biogen and Sage Therapeutics Complete Rolling Submission of New Drug Application for Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics (Nasdaq: SAGE) announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). |
| 2022-10-17 | Biogen | Results Biogen and Sage Therapeutics Present Further Analyses from Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression at the European College of Neuropsychopharmacology (ECNP) Congress biogen.com ↗
Newly presented secondary endpoints offered additional insights on the efficacy profile of zuranolone in postpartum depression observed in the clinical trial |
| 2022-09-19 | Biogen | Results Biogen and Sage Therapeutics Present New Analyses at Psych Congress Further Evaluating the Efficacy and Safety of Zuranolone biogen.com ↗
These data further support zuranolone as a potential episodic treatment for people with MDD. |
| 2022-06-01 | Biogen | Results Sage Therapeutics and Biogen Announce that the Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression Met its Primary and All Key Secondary Endpoints biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) today announced that the Phase 3 SKYLARK Study of zuranolone, an investigational oral drug being evaluated in women with postpartum depression (PPD), met its primary and all key secondary endpoints. |
| 2022-05-02 | Biogen | Regulatory Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD) biogen.com ↗
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). |
| 2022-03-01 | Hopstem Biotechnology Inc. | Results 2022【二月精选】领域最新进展 hopstem.com ↗
2月14日，Biogen/Sage宣布潜在“first-in-class” 口服药物Zuranolone治疗重度抑郁障碍患者的CORAL研究III期临床试验到达主要终点，显示出对抑郁症状快速的改善作用，在2周疗程的第3天即观察到了相比安慰剂更明显的疗效。 |
| 2022-02-16 | Biogen | Results Sage Therapeutics and Biogen Announce the Phase 3 CORAL Study Met its Primary and Key Secondary Endpoints - Comparing Zuranolone 50 mg Co-initiated with Standard of Care Antidepressant vs. Standard of Care Co-initiated with Placebo in People with MDD biogen.com ↗
At the Day 3 primary endpoint, zuranolone 50 mg co-initiated with a standard of care antidepressant showed a statistically significant reduction in depressive symptoms |
| 2021-12-01 | Biogen | Results Sage Therapeutics and Biogen Announce Positive, One-Year Zuranolone 50 mg Data in the Ongoing Open-Label SHORELINE Study in Patients with MDD biogen.com ↗
In the zuranolone 50 mg cohort, the majority of patients who responded to an initial 14-day course received only one two-week course of treatment during the study and nearly 80% received only one or two treatment courses in total |
| 2021-10-04 | Biogen | Results Sage Therapeutics and Biogen Announce Consistent Clinically Meaningful Data for Zuranolone Across the LANDSCAPE and NEST Clinical Development Programs Presented at the European College of Neuropsychopharmacology (ECNP) Congress biogen.com ↗
Collectively, the studies show reductions in depressive symptoms with zuranolone-treated patients such as consistent improvements in depressive mood, as well as rapid onset of significant effect by Day 3. |
| 2021-06-15 | Biogen | Results Sage Therapeutics and Biogen Announce Positive Pivotal Phase 3 Results for Zuranolone, an Investigational Two-Week, Once-Daily Therapeutic Being Evaluated for Major Depressive Disorder biogen.com ↗
At the Day 15 primary endpoint, zuranolone 50 mg showed a statistically significant and clinically meaningful reduction in depressive symptoms as measured by HAMD-17 (p=0.0141) compared to placebo |
All press releases naming this drug 22 releases
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 ↗ |