Zurzuvae (zuranolone) / Shionogi, Biogen, Supernus Pharma - LARVOL DELTA

Zuranolone as a Novel Therapy for Postpartum Depression: A Narrative Review of Current Evidence and Future Directions. (PubMed, Cureus) - "This narrative review outlines the evolving evidence base for zuranolone, including current understanding of its efficacy and tolerability, and explores practical considerations for its use. The potential role of zuranolone within the broader treatment landscape is discussed, alongside key uncertainties regarding duration of effect, longer-term outcomes and accessibility. By synthesising available literature and identifying key knowledge gaps, this review aims to clarify the evolving role of zuranolone in the treatment of PPD, while highlighting priorities for future research and clinical practice."

Journal • Review • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

Biogen reports strong fourth quarter and full year 2025 results and provides full year 2026 financial guidance (Biogen Press Release) - "LEQEMBI fourth quarter global in-market sales of approximately $134 million, up 54% year-over-year, with U.S. in-market sales of approximately $78 million, representing continued growth; SKYCLARYS grew global patients on therapy by approximately 30% in 2025; fourth quarter U.S. revenue of approximately $89 million driven by demand growth, with ex-U.S. revenue of approximately $44 million reflecting continued demand growth, also impacted by a one-time reimbursement true-up; ZURZUVAE fourth quarter revenue of approximately $66 million showed strong continued demand growth; VUMERITY grew 3% year-over-year in the fourth quarter; SPINRAZA fourth quarter revenue declined 15% year-over-year, impacted by timing of shipments outside the U.S., with full year revenue down 2% year-over-year."

Commercial • Alzheimer's Disease • Depression • Friedreich ataxia • Multiple Sclerosis • Muscular Atrophy • Ocular Inflammation • Pain • Parkinson's Disease

Zuranolone: A case study in (regulatory) rush to judgement? (PubMed, Br J Clin Pharmacol) - "We examine the clinical trial data submitted by the manufacturer for zuranolone and discuss how regulatory bodies may be failing in their role as gatekeepers. The approval of zuranolone for PPD can thus be seen as a case study for recent developments in drug regulatory sciences."

Journal • Review • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Postpartum Depression • Psychiatry

A systematic safety assessment of zuranolone: real-world adverse event analysis from the FAERS database. (PubMed, Arch Womens Ment Health) - "Enhanced monitoring for AEs related to nervous system disorders and psychiatric disorders is required during the clinical use of Zuranolone."

Adverse events • Journal • Real-world evidence • Anesthesia • CNS Disorders • Depression • Insomnia • Mental Retardation • Mood Disorders • Movement Disorders • Postpartum Depression • Psychiatry • Sleep Disorder • Suicidal Ideation

Addressing the Global Mental Health Crisis: How a Human Rights Approach Can Help End the Search for Pharmaceutical Magic Bullets. (PubMed, Health Hum Rights) - "I discuss the marketing of postpartum distress (PPD) as a disorder of the hypothalamic-pituitary-adrenal axis and the "first ever" pill to treat PPD, zuranolone, as a case illustration of medicalization. I conclude by offering solutions for reform that are embedded in a human rights framework."

Journal • Psychiatry

Current treatment options for perinatal depression. (PubMed, Curr Opin Obstet Gynecol) - "Timely diagnosis and individualized treatment of PND are essential for optimizing maternal and neonatal outcomes. Individualized, evidence-based treatment, including pharmacologic and nonpharmacologic options, can improve outcomes for both the parent and fetus or infant. New therapies and digital innovations hold promise but require careful integration into practice."

Journal • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

Assessing the utility of the neurosteroid zuranolone to modify alcohol-related behaviours. (PubMed, Neuropharmacology) - "Overall, our data do not show robust reductions in alcohol intake following zuranolone administration across dosing schedules in either sex in preclinical models of binge drinking. Future studies are required to explore its potential relevance in comorbid AUD and affective disorders."

Journal • Addiction (Opioid and Alcohol) • Anesthesia • CNS Disorders • Depression • Postpartum Depression • Psychiatry

Molecular Mechanisms of Emerging Antidepressant Strategies: From Ketamine to Neuromodulation. (PubMed, Int J Mol Sci) - "We then focus on emerging therapies targeting the glutamatergic, GABAergic, and dopaminergic systems, including ketamine, esketamine, (R)-ketamine, the dextromethorphan-bupropion combination (DMX-BUP), neurosteroids (zuranolone, brexanolone), as well as selective serotonin receptor modulators (gepirone ER) and dopaminergic modulators (cariprazine). The review is complemented by a discussion of non-pharmacological neuromodulatory approaches, such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and photobiomodulation. Rather than providing another summary of clinical response indicators, this article integrates the molecular underpinnings of novel antidepressant agents and neuromodulation techniques with current concepts of depression pathophysiology, highlighting their relevance for the development of precise, mechanistically targeted, and multimodal treatment strategies."

Journal • Review • CNS Disorders • Depression • Inflammation • Major Depressive Disorder • Mental Retardation • Metabolic Disorders • Mood Disorders • Psychiatry

Health Canada approves first drug specifically made to treat moderate to severe postpartum depression (MSN News) - "Patients with ZURZUVAE showed an average reduction of 17.8 points while those with a placebo showed an average reduction of 13.2 points in the 17-item Hamilton Rating Scale, both in day 15 of treatment."

Canada approval • Postpartum Depression

Durability of zuranolone in postpartum depression versus major depressive disorder. (PubMed, Psychiatry Clin Neurosci) - "The antidepressant effect of zuranolone appears to be sustained beyond the treatment period in postpartum depression, whereas in major depressive disorder it may not persist after treatment discontinuation."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Postpartum Depression • Psychiatry

Shionogi has received Japanese regulatory approval to manufacture and market ZURZUVAE Capsules 30 mg (zuranolone) for the treatment of depression and depressive states, following positive Phase 3 trial results in adults with major depressive disorder. (TipRanks)

Japan approval • Major Depressive Disorder

Comparison of Zuranolone, Brexanolone, and Sertraline in the Treatment of Postpartum Depression (ASHP 2025) - No abstract available

CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

Sustainable Spectrofluorometric Method for the Determination of Zuranolone in Pharmaceutical Formulations Using Propidium Iodide Ion-Pair Complex. (PubMed, Luminescence) - "Application to Zurzuvae capsules demonstrated excellent accuracy and reliable analytical performance. Furthermore, high Analytical GREEnness and favorable Green Analytical Procedure Index scores highlighted the method's environmental sustainability, positioning it as a robust, eco-friendly tool for routine analysis."

Journal

Health Canada has granted a Notice of Compliance (NOC) to Biogen for its drug Zurzuvae, which is classified as a New Active Substance (NAS). (GeneOnline) - "The approval designates Zurzuvae as a treatment option for women experiencing moderate or severe postpartum depression (PPD)."

Canada approval • Postpartum Depression

Postpartum depression pill gets approval in a 1st for Canada (Global News) - "Zuranolone, sold under the brand name Zurzuvae, is a pill taken once a day for 14 days and can start relieving depressive symptoms in as few as three days."

Canada approval • Postpartum Depression

Editorial: Enhancing therapeutic strategies: a focus on pharmacovigilance in new wave antidepressants and antipsychotics. (PubMed, Front Psychiatry) - No abstract available

Adverse events • Journal • CNS Disorders

Efficacy and safety of zuranolone in Japanese adults with major depressive disorder: A double-blind, randomized, placebo-controlled, Phase 3 clinical trial. (PubMed, Psychiatry Clin Neurosci) - "Zuranolone improved depressive symptoms on Day 15, compared with placebo, in Japanese patients with MDD. No new safety signals were observed."

Clinical • Journal • P3 data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

LEQEMBI global in-market sales of approximately $121 million represents year-over-year growth of 82%; U.S. in-market sales of approximately $69 million shows continued steady growth; ex-U.S. in-market sales of approximately $52 million reflects continued demand growth, offset by a partial drawdown of the previously disclosed Q2 inventory build in China (Biogen Press Release) - "SKYCLARYS global revenue of approximately $133 million represents 30% year-over-year growth; U.S. revenue of approximately $75 million impacted by a Medicare true up...ZURZUVAE revenue of approximately $55 million showed strong continued growth; now approved in the European Union"

Commercial • Alzheimer's Disease • Depression • Friedreich ataxia • Pain • Parkinson's Disease

Real-World Outcomes of Brexanolone to Treat Postpartum Depression. (PubMed, Womens Health Rep (New Rochelle)) - "Importantly, 15 participants had a diagnosis of bipolar depression and were prescribed an antipsychotic or mood stabilizer at the time of treatment, there were no episodes of mania or hypomania reported during the follow-up period. Given the shared mechanism of action between brexanolone and the recently approved oral medication for PPD, zuranolone, the applicability of findings and relevance to the more accessible oral drug, zuranolone, are explored."

Journal • Real-world evidence • Bipolar Disorder • CNS Disorders • Depression • Long-acting Reversible Contraceptives • Mood Disorders • Postpartum Depression • Psychiatry

Rapid-acting NMDA and GABAergic Modulators in Mood Disorders: From Synaptic Mechanisms to Clinical Practice. (PubMed, Clin Psychopharmacol Neurosci) - "Two rapid-acting therapeutic classes, NMDA receptor modulators (ketamine, esketamine) and neuroactive-steroid GABA-A positive allosteric modulators (brexanolone, zuranolone), offer complementary approaches to restore circuit function. Robust efficacy/tolerability predictors remain limited, though early symptomatic change is clinically informative. In conclusion, NMDA receptor modulators and neuroactive-steroid GABA-A positive allosteric modulators have improved the treatment for mood disorders and accelerated a transition to mechanism-driven care."

Journal • Review • Anesthesia • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Postpartum Depression • Psychiatry • Suicidal Ideation

Allopregnanolone (Zuranolone) in Post-stroke Depression (clinicaltrials.gov) - P2 | N=6 | Recruiting | Sponsor: Duke University | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • CNS Disorders • Depression • Mood Disorders • Psychiatry

Navigating Therapies, Challenges, and Recommendations for Treatment-Resistant Peripartum Depression: A Comprehensive Review. (PubMed, Healthcare (Basel)) - "According to related research, pharmacological treatments such as SSRIs or brexanolone and zuranolone can be effective in addressing TRPD challenges, but they carry concerns regarding fetal and neonatal risk. Our findings imply that innovative therapeutics and integration of these interventions personalized to individual needs are the optimal clinical approach that may help in balancing maternal symptom control and perinatal safety. Also, expanded mental health infrastructure with enhanced research is essential for advancing TRPD care."

Journal • Review • CNS Disorders • Depression • Mood Disorders • Psychiatry

Zuranolone, a GABAA receptor positive allosteric modulator: safety from SKYLARK, a phase 3 placebo-controlled study in adults with postpartum depression​ (ECNP 2025) - P3 | "All somnolence events were resolved in both groups. Conclusions In SKYLARK, most participants who experienced AEs had mild-to-moderate AEs."

Clinical • P3 data • CNS Disorders • Depression • Mood Disorders • Psychiatry

Two heartbeats, one molecule: The role of zuranolone in postpartum depression (ECNP 2025) - "It has emerged as an alternative to brexanolone – an earlier neuroactive steroid with a similar GABA-A receptor modulation which requires continuous intravenous infusion over a 60-hour period [3]. Zuranolone appears to be a promising approach in the treatment of PPD, given the evidence of its efficacy, short treatment duration, and rapid onset of action compared to conventional antidepressants, particularly selective serotonin reuptake inhibitors. These features may enhance accessibility and help overcome barriers to treatment adherence in the postpartum population. Nevertheless, further studies are required to fully evaluate its long-term safety profile—particularly in breastfed children of women taking zuranolone—and to determine the durability of its therapeutic effects."

CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Zuranolone and Brexanolone for the Treatment of Postpartum Depression. (PubMed, Obstet Gynecol) - "This document is a focused update of related content in Clinical Practice Guideline No. 5, Treatment and Management of Mental Health Conditions During Pregnancy and Postpartum (Obstet Gynecol 2023;141:1262-88) and replaces the August 2023 Practice Advisory, Zuranolone for the Treatment of Postpartum Depression."

Journal • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry