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

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

ZURZUVAE (zuranolone) Receives Positive Opinion from CHMP for the Treatment of Women with Postpartum Depression (Yahoo Finance) - "Biogen Inc...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. If approved by the European Commission (EC), ZURZUVAE will be the first treatment authorized within the European Union specifically indicated to treat depressive symptoms for women with PPD....The CHMP’s recommendation for ZURZUVAE is based on the SKYLARK Study..."

CHMP • Postpartum Depression

EMA OKs Oral Treatment for Postnatal Depression (Medscape) - "The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has adopted a positive opinion on zuranolone (Zurzuvae, Biogen Netherlands BV), the first oral drug to treat postpartum depression in adults. Marketing authorization was granted in recognition of clinical trial results showing a reduction in postpartum depressive symptoms after 2 weeks' treatment...In a multicenter, randomized, double-blind, placebo-controlled study, zuranolone at a 50 mg dose was given for 14 days to women who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode of postpartum depression and whose symptoms started in the third trimester or within 4 weeks of delivery. Compared with placebo, the active group demonstrated significantly greater symptom improvement on days 3,15 (the primary endpoint), and 45, using the standard 17-item Hamilton rating scale for depression."

CHMP • Depression

Neurosteroids Progesterone and Dehydroepiandrosterone: Molecular Mechanisms of Action in Neuroprotection and Neuroinflammation. (PubMed, Pharmaceuticals (Basel)) - "However, only the allopregnanolone analogs brexanolone and zuranolone have been recently approved by the FDA for the treatment of depression. The aspects of their participation in these pathological processes are discussed. New formulations, such as lipophilic emulsions, nanogels, and microneedle array patches, are attractive strategies to overcome the low bioavailability of these neurosteroids for the amelioration and treatment of various nervous disorders."

Journal • Review • CNS Disorders • Depression • Epilepsy • Fragile X Syndrome • Genetic Disorders • Inflammation • Psychiatry • Vascular Neurology • BCL2

Sage Therapeutics Announces Second Quarter 2025 Financial Results (Yahoo Finance) - "Second Quarter 2025 Highlights: ZURZUVAE:...As of the second quarter ended June 30, 2025, the following results had been achieved: (i) Generated $23.2 million in collaboration revenue from ZURZUVAE, representing a 68% increase from the first quarter of 2025. Collaboration revenue represents 50% of the net revenue recorded when Biogen ships ZURZUVAE to the distributors; (ii) Shipped greater than 4,000 prescriptions to women with PPD, representing a 36% increase from the first quarter of 2025, and greater than 13,500 since launch."

Commercial • Depression • Postpartum Depression

Current evidence for the role of rapid-acting antidepressants (RAAD) in bipolar depression? A perspective and plan for action. (PubMed, Biol Psychiatry) - "The following RAAD substance classes have been or are currently being investigated as possible treatments for bipolar depression: NMDA antagonists and indirect AMPA agonists (ketamine, esketamine, riluzole, felbamate), GABAA (gamma-aminobutyric acid A) activators or positive allosteric modulators (zuranolone, pregnenolone, PEA), psychedelics (psilocybin, 5-MeO-DMT), muscarine receptor antagonists (scopolamine), and kappa opioid receptor antagonists (navacaprant). Recent research into RAADs demonstrates the growing field of novel mechanisms of action in the pharmacological treatment of bipolar depression. However, there is an urgent need for well-controlled clinical studies on RAADs in bipolar depression to expand treatment options and improve outcomes for millions of affected individuals worldwide."

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

Neuroactive Steroids as Novel Promising Drugs in Therapy of Postpartum Depression-Focus on Zuranolone. (PubMed, Int J Mol Sci) - "The first rapid-acting neurosteroid approved by the FDA to treat PPD in women is brexanolone, although its use is constrained by pharmacokinetic properties. The first oral neuroactive steroid-based antidepressant approved by the FDA for PPD is zuranolone. This review discusses the molecular mechanism of zuranolone action and the results of preclinical and clinical studies regarding the effectiveness and safety of the drug in treating PPD."

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

A novel fluorescence-based method for the determination of Zuranolone using Tinopal CBS-X in the pharmaceutical formulation and spiked human plasma. (PubMed, Sci Rep) - "The method showed good linearity, precision, and accuracy, and was successfully applied to the quantification of Zuranolone in commercial formulations. These findings suggest potential utility in therapeutic drug monitoring and quality control settings, offering a simple, rapid, and cost-effective tool for ensuring accurate dosing and formulation consistency, ultimately supporting better patient care."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

Zuranolone for Postpartum Depression in Real-World Clinical Practice. (PubMed, J Clin Psychiatry) - No abstract available

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

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 | Not yet recruiting | Sponsor: Biogen

New trial • Real-world evidence • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

Brexanolone, zuranolone and related neurosteroid GABAA receptor positive allosteric modulators for postnatal depression. (PubMed, Cochrane Database Syst Rev) - "This review provides moderate-certainty evidence that zuranolone probably improves depression response and remission but also increases maternal adverse events compared to placebo. There may be little or no difference in depression response and remission and probably little or no difference in maternal adverse events with intravenous neurosteroid GABAA positive allosteric modulators such as brexanolone, compared to placebo. Evidence from this review, alongside current clinical guidelines and reference to evidence from the general adult population, could be used to inform an individualised risk-benefit discussion with women seeking treatment for postnatal depression. However, it is difficult to make recommendations about the use of neurosteroid GABAA receptor positive allosteric modulators for the treatment of postnatal depression as no studies have compared them to active treatment."

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

Zuranolone in Palliative Care: Promise and Practicality for the Rapid Treatment of Depression. (PubMed, Am J Hosp Palliat Care) - "This paper will provide clinicians with an update on a new antidepressant with potential benefits for the palliative care population. The paper will review the pharmacology, pharmacodynamics, safety profile, and clinical studies showing its effectiveness in major depression and how it can potentially be helpful in the palliative care population."

Journal • CNS Disorders • Depression • Insomnia • Major Depressive Disorder • Mood Disorders • Palliative care • Psychiatry • Sleep Disorder

Assessing the utility of zuranolone to modify alcohol-related behaviours (CINP-AsCNP 2025) - "Zuranolone demonstrates sex-dependent effects on binge drinking and locomotor activity. Future research should explore potential benefits of neurosteroid treatments for AUD and their mechanism(s) of action, which may accelerate development of sex-specific treatments. Further, these findings underscore the importance of considering sex as a biological variable in the development of tailored, effective therapies for AUD."

Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Mental Retardation • Postpartum Depression • Psychiatry

Justice Delayed: The Case of Zuranolone and Barriers to Advancing Perinatal Mental Health. (PubMed, Psychiatr Serv) - "By discussing challenges in the development of and access to zuranolone, an innovative oral pharmacological treatment for postpartum depression, this Open Forum examines the systemic exclusion of women's mental health issues from research and advocacy efforts, highlighting how these gaps perpetuate injustice in the health care system. Issues such as inadequate funding for women's mental health research, insurance coverage limitations, and inequities in treatment accessibility represent systemic disparities that violate the foundational principle of justice in medical ethics."

Journal • CNS Disorders • Depression • Postpartum Depression • Psychiatry

Neurosteroid treatment of postpartum depression and beyond. (PubMed, Br J Psychiatry) - "Depression occurring during pregnancy or after delivery is one of the most common complications of childbirth and is associated with maternal morbidity and mortality. Here we review the breakthrough development of the first neuroactive steroid-based antidepressants approved for postpartum depression in the USA and their potential in other psychiatric illnesses."

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

AHA: Allopregnanolone in Post-Stroke Depression (clinicaltrials.gov) - P2 | N=6 | Not yet recruiting | Sponsor: Duke University | Initiation date: Apr 2025 ➔ Jul 2025

Trial initiation date • Cardiovascular • CNS Disorders • Depression • Mood Disorders • Psychiatry

New Agents in the Treatment of Psychiatric Disorders: What Innovations and in What Areas of Psychopathology? (PubMed, Pharmaceuticals (Basel)) - "Our search suggested that a new antipsychotic, lumateperone, and two drug combinations, olanzapine/samidorphan (OLZ/SAM) and xanomeline/trospium (KarXT), were approved for schizophrenia...Two new agents, brexanolone and zuranolone, were approved for treatment of postpartum depression...In summary, some new psychotropic medications have been developed, in particular with the aim to improve the symptoms of resistant patients and to decrease the incidence of adverse effects. It is necessary to continue testing the effectiveness of new compounds in methodologically rigorous studies."

Journal • Review • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Obsessive-Compulsive Disorder • Postpartum Depression • Psychiatry • Schizophrenia • Suicidal Ideation

The Emerging Role of Neurosteroids: Novel Drugs Brexanalone Sepranolone Zuranolone and Ganaxolone in Mood and Neurological Disorders (APA 2025) - "Description This review investigates the potential of neurosteroids, including brexanolone, zuranolone, sepranolone, and ganaxalone, as therapeutic agents for a range of mood and neurological disorders. Their modulation of the GABA system emerges as a central mechanism of action, emphasizing the importance of GABAergic signaling in these conditions. The path forward entails continued investigation and clinical trials to fully unlock the potential of neurosteroids, offering hope for enhanced treatments in these challenging clinical domains."

Alzheimer's Disease • CNS Disorders • Depression • Epilepsy • Major Depressive Disorder • Mood Disorders • Postpartum Depression • Post-traumatic Stress Disorder • Psychiatry