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

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

Biogen Receives European Commission Approval for ZURZUVAE (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe (GlobeNewswire) - "The EC approval of ZURZUVAE is based on the SKYLARK study, which demonstrated rapid relief from depressive symptoms as early as day 3 and sustained through day 45 compared to placebo."

EMA approval • Postpartum Depression

Peripartum Depression Pharmacotherapies Targeting GABA-Glutamate Neurotransmission. (PubMed, J Clin Med) - "Search criteria targeted randomized clinical trials investigating GABA-A-positive allosteric modulators (brexanolone, zuranolone, and ganaxolone) and NMDA receptor antagonists (ketamine and esketamine) in PPD patients. These glutamate-GABA pathway modulators represent novel therapeutic alternatives with rapid onset profiles. Further investigation and research are needed to optimize dosing protocols and patient selection criteria and to establish long-term efficacy before PPD treatment guidelines can be drafted."

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

Epidemiology, pathophysiology, and interventions for postpartum depression: Systematic review. (PubMed, World J Clin Cases) - "Effective PPD management requires integrative, culturally sensitive approaches, prioritizing scalable, personalized non-pharmacological interventions to reduce disparities and enhance maternal mental health equity across diverse populations."

Journal • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Postpartum Depression • Psychiatry • CRP • IL6

Real-world safety profile of zuranolone for postpartum depression: A FAERS analysis. (PubMed, J Affect Disord) - "Our pharmacovigilance study identified a high reporting frequency of psychiatric and neurological ADRs associated with zuranolone use. Given the inherent limitations in establishing causality through FAERS data, we emphasize the need for future clinical monitoring and research to further substantiate the potential causal relationship between zuranolone and these reported AEs."

Journal • Real-world evidence • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Postpartum Depression • Psychiatry

Post marketing safety assessment of the novel postpartum depression drug, Zuranolone: evidence from real-world pharmacovigilance analysis based on the FDA adverse event reporting system. (PubMed, Front Psychiatry) - "Compared to Brexanolone, Zuranolone's adverse reactions were more focused on nervous system diseases, while the latter was primarily associated with psychiatric disorders, General disorders and administration site conditions, and Injury, poisoning and procedural complications. This study revealed potential AEs of Zuranolone, confirming known safety information about Zuranolone, providing comprehensive data for medical practice and public health decision-making, and laying the foundation for further clinical research. It also provides more comprehensive and updated evidence for the clinical safety of Zuranolone."

Adverse events • Journal • P4 data • Real-world evidence • Anesthesia • CNS Disorders • Depression • Fatigue • Insomnia • Mental Retardation • Migraine • Movement Disorders • Otorhinolaryngology • Pain • Postpartum Depression • Psychiatry • Sleep Disorder • Suicidal Ideation • Vertigo

Modeling the efficacy of a novel antidepressant zuranolone for major depressive disorder. (PubMed, J Affect Disord) - "We used changes in rating scale scores from baseline to perform a model-based meta-analysis, characterizing the progression of drug efficacy and placebo response over time and comparing zuranolone's efficacy and safety profiles with those of established antidepressants (escitalopram and amitriptyline). Primary adverse events related to zuranolone included somnolence, headache, dizziness, and sedation, with no severe safety signals observed. Zuranolone demonstrates a safety profile comparable to escitalopram as well as rapid-onset antidepressant action, sustained clinical efficacy, and favorable tolerability, highlighting its potential as a promising therapeutic option for MDD."

Journal • Anesthesia • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Pain • Psychiatry

New and emerging pharmacologic treatments for MDD. (PubMed, Front Psychiatry) - "Furthermore, the combination of dextromethorphan and bupropion has shown promise. Brexanolone, administered via infusion, and zuranolone, available as an oral formulation, both have demonstrated efficacy in clinical settings. Novel treatments targeting opioid pathways, such as esmethadone, and selective kappa receptor antagonists offer new hope for addressing the symptoms of MDD through mechanisms not traditionally associated with antidepressant action."

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

A Call for the Study of Zuranolone as a Novel Treatment for Premenstrual Dysphoric Disorder. (PubMed, J Clin Psychopharmacol) - No abstract available

Journal • CNS Disorders • Depression

MHRA approves zuranolone to treat postnatal depression in adults following childbirth (GOV.UK) - "The MHRA conducted a rigorous assessment of the safety, quality, and efficacy of zuranolone....Zuranolone comes as a capsule and is taken orally, at night with a fat-containing meal for 14 days."

MHRA approval • Postpartum Depression

A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of Their Pregnancy (clinicaltrials.gov) - P=N/A | N=200 | Recruiting | Sponsor: Biogen | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

Overcoming mental health care barriers for postpartum depression in developing countries: Zuranolone as a game changer. (PubMed, J Pak Med Assoc) - No abstract available

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

Supernus Pharmaceuticals Completes Acquisition of Sage Therapeutics (GlobeNewswire) - "Supernus Pharmaceuticals...announced that it has successfully completed its previously announced acquisition of Sage Therapeutics....Strengthens psychiatry portfolio with ZURZUVAE (zuranolone) capsules CIV, the first and only FDA-approved oral medicine indicated for the treatment of postpartum depression in adults....Strong fit with existing Supernus infrastructure is expected to result in cost synergies of up to $200 million on an annual basis. The acquisition is expected to be accretive in 2026."

M&A • Depression • Postpartum Depression