Zurzuvae (zuranolone) / Sage Therapeutics, Shionogi, Biogen - LARVOL DELTA

Racial and ethnic diversity in zuranolone and brexanolone clinical trials for postpartum depression: A cross-sectional analysis of ClinicalTrials.gov. (PubMed, Eur Neuropsychopharmacol) - No abstract available

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

Comment on the study "the efficacy and safety of zuranolone for treatment of depression: a systematic review and meta-analysis". (PubMed, Psychopharmacology (Berl)) - No abstract available

Journal • Retrospective data • CNS Disorders • Depression • Mood Disorders • Psychiatry

Pharmacology of novel, fast-acting, non-monoaminergic antidepressants (PubMed, Neuropsychopharmacol Hung) - "Two glutamatergic drugs, esketamine and dextromethorphan-bupropion (AXS-05), have already been approved for the treatment of treatment-resistant depression. The GABAergic drugs brexanolone and zuranolone are approved for the treatment of postpartum depression. These novel treatment options pave the way for novel avenues for further research and new targets in the treatment of depression. Keywords: depression, antidepressant, glutamate, fast-acting antidepressant, non- monoaminergic antidepressant."

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

New Directions in Neurosteroid Therapeutics in Neuropsychiatry. (PubMed, Neurosci Biobehav Rev) - "In recent years three neuroactive steroids (NAS), brexanolone (allopregnanolone, AlloP), ganaxolone and zuranolone, have been approved for the treatment of neuropsychiatric illnesses including postpartum depression and seizures in a neurodevelopmental syndrome. In this review, we explore GABAergic and other cellular effects of pregnane steroids including novel molecules that have potential therapeutic importance. This work discusses the complex chemical nature of NAS and what is being learned at cellular, molecular, synaptic and brain network levels about key sites of action including GABAARs and other targets."

Journal • Review • CNS Disorders • Depression • Epilepsy • Inflammation • Major Depressive Disorder • Mental Retardation • Postpartum Depression • Psychiatry

Zuranolone (Zurzuvae) for Treatment of Severe Postpartum Depression in Adults. (PubMed, Am Fam Physician) - No abstract available

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

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 investigated as possible treatments for bipolar depression: NMDA antagonists and indirect AMPA agonists (ketamine, esketamine, riluzole, felbamate), GABA-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

#Zuranolone: How TikTokers Perceive the First Available Oral Medication for Postpartum Depression. (PubMed, Arch Womens Ment Health) - No abstract available

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

Zuranolone for Postpartum Depression After Highly Lethal Suicide Attempt: Two Case Illustrations and a Narrative Literature Review. (PubMed, J Acad Consult Liaison Psychiatry) - "Postpartum suicidality is complex and often emerges rapidly. Our case series demonstrated that zuranolone may effectively treat PPD with rapid-onset highly lethal suicide attempts. We advocate for more research on fast-acting novel treatments, such as zuranolone and brexanolone, for PPD and postpartum suicidality."

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

FDA-Approved Zuranolone: First Oral Treatment for Postpartum Depression, Ushering in a New Era of Hope; A Narrative Review. (PubMed, Health Sci Rep) - "However, concerns regarding its safety for breastfeeding women and potential side effects necessitate further research and cautious use. Despite these challenges, zuranolone offers hope for improved outcomes and enhanced quality of life for individuals affected by PPD."

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

Activation of zona incerta gamma-aminobutyric acid-ergic neurons alleviates depression-like and anxiety-like behaviors induced by chronic restraint stress. (PubMed, World J Psychiatry) - "Activity of GABAergic neurons in the ZI was closely associated with depression-like phenotypes in mice, suggesting that these neurons could be a potential therapeutic target for treating depression."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

Biogen’s soft guidance reflects pressure on MS drugs (Firstwordpharma Press Release) - "One of these growth drivers already on market is the Alzheimer's disease therapy Leqembi, which generated around $87 million in the fourth quarter of 2024, including $50 million in the US....Another recent launch is the Friedreich’s ataxia treatment Skyclarys, which booked $102 million in sales in the fourth quarter, coming in below expectations of around $112 million. Biogen noted that US sales of the product at $71 million were low due to stockpiling and Medicare discount dynamics. Meanwhile, the postpartum depression drug Zurzuvae brought in $22.9 million, short of predictions of $26 million....The company's overall sales in the three-month period rose 3% to $2.5 billion — topping estimates of $4.1 billion — although revenue from MS drugs fell 8% to $1.1 billion."

Sales • Alzheimer's Disease • Friedreich ataxia • Multiple Sclerosis • Postpartum Depression

Sage Therapeutics Announces Fourth Quarter and Full Year 2024 Financial Results and Highlights Pipeline and Business Updates (Businesswire) - "SAGE-324: The Company is evaluating potential indications, including seizures in developmental and epileptic encephalopathies (DEEs), and expects to provide an update on next steps, if any, in mid-2025....Collaboration revenue from sales of ZURZUVAE was $11.4 million in the fourth quarter of 2024 compared to $0.8 million for the same period in 2023. For the year ended December 31, 2024, the first full year of sales, collaboration revenue from sales of ZURZUVAE was $36.1 million. Reported collaboration revenue is 50% of the net revenues Biogen records for ZURZUVAE in the U.S. Net revenue from sales of ZULRESSO was $0.4 million in the fourth quarter of 2024 compared to $2.0 million in the same period of 2023."

Clinical • Commercial • CNS Disorders • Epilepsy • Postpartum Depression

Clinical Utility of Zuranolone for Postpartum Depression: A Narrative Review. (PubMed, Neuropsychiatr Dis Treat) - "Zuranolone relevant infant dose lactation data suggest that its use is compatible with breastfeeding, though future research is needed to measure potential adverse effects on the breastfed infant. Key aspects of clinical decision-making in patients with PPD are discussed."

Journal • Review • Anesthesia • CNS Disorders • Depression • Insomnia • Mood Disorders • Pain • Postpartum Depression • Psychiatry • Sleep Disorder • Suicidal Ideation

Effect of two novel GABAA receptor positive allosteric modulators on neuropathic and inflammatory pain in mice. (PubMed, Neuropharmacology) - "This study tested the antinociceptive properties of two novel NAS PAMs, ganaxolone and zuranolone, in segmental spinal nerve ligation (SNL)-induced neuropathic pain and complete Freund's adjuvant (CFA)-induced inflammation pain models. Furthermore, the PAMs alleviated SNL-induced mechanical allodynia synergistically with diazepam or GABAA receptor activator muscimol at inactive doses, consistent with the non-competitive activity and distinct binding sites from benzodiazepines. In summary, our findings suggest that NASs may not only acutely modulate GABA receptor activity but also induce sustained metabotropic effects on GABAA receptors and thus exert long-lasting antinociceptive effects."

Journal • Preclinical • Inflammation • Neuralgia • Pain

AHA: Allopregnanolone in Post-Stroke Depression (clinicaltrials.gov) - P2 | N=6 | Not yet recruiting | Sponsor: Nada El Husseini, MD, MHS | Trial completion date: Oct 2027 ➔ Jun 2026 | Initiation date: Jun 2025 ➔ Apr 2025 | Trial primary completion date: Oct 2026 ➔ Jun 2026

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

Neurosteroids as treatment of postpartum depression: a critical literature review (PubMed, Tijdschr Psychiatr) - "Placebo-controlled studies support the effectiveness of treatment with brexanolone and zuranolone in postpartum depression, showing a rapid and statistically significant improvement in mood symptoms. However, the place of neurosteroids in practice is still unclear and needs to be clarified by future research and clinical experience."

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

ASSESSING PERSONAL EXPERIENCES WITH POSTPARTUM DEPRESSION POSTED ON REDDIT TO INVESTIGATE TREATMENT RECOMMENDATIONS AND BARRIERS. (WRMC 2025) - "Methods Used Reddit posts in English published between March 2019 to August 2024 were searched using the keywords "Zulresso," "Zurzuvae," "brexanolone," "zuranolone," "PPD," and "postpartum depression" with ≥5 votes for the post and ≥5 comments. Additionally, the lack of institutional and healthcare provider support illustrated the importance of improving healthcare policies. Ultimately, the experiences shared through Reddit underscored the need for individualized treatment approaches, enhanced education, and refined healthcare policies to better support and improve PPD patient outcomes."

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

Mechanisms of action of antidepressive pharmacotherapy: brain and mind-body and environment (PubMed, Nervenarzt) - "Instead of attributing factors such as environment, body and social interaction to placebo effects, they should be tested as essential components of the antidepressive effect and considered in the clinical practice."

Journal • Review • CNS Disorders • Depression • Psychiatry

Neurosteroid replacement therapy using tiagabine and zuranolone restores cerebellar neurodevelopment and reduces hyperactive behaviour following preterm birth. (PubMed, J Dev Orig Health Dis) - "Overall, this study demonstrates the neuroprotective attributes of neurosteroid replacement therapy using tiagabine and zuranolone, thereby demonstrating their potential to mitigate long-term neurodevelopmental impairments. Furthermore, the sexually dimorphic effects observed suggest future investigations may show increased benefit by using sex-specific treatment regimes."

Journal • Solid Tumor • OLIG2

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

New P2 trial • Cardiovascular • CNS Disorders • Depression • Mood Disorders • Psychiatry

Zuranolone for postpartum depression: a systematic review and meta-analysis of two randomized studies. (PubMed, Rev Bras Ginecol Obstet) - "These findings suggest that zuranolone might present a safe and effective medication for out-of-hospital treatment of PPD. Sedation effects need to be further assessed."

Clinical • Journal • Retrospective data • Review • Anesthesia • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Postpartum Depression • Psychiatry

Extending the concept of "obstetric violence" to post-partum experiences: cautions regarding the "first ever" pill for post-partum depression. (PubMed, Sex Reprod Health Matters) - "However, the biomedical framing shifts attention from the socio-political causes of emotional distress-with significant consequences for individual women and public health. Taking the recent approval of the 'first-ever' pill for post-partum depression, zuranolone (brand name Zurzuvae) as a case example, we argue here that the reduction of reproductive subjects' experiences to biochemical disorders, and the lowering of regulatory standards for the pharmaceutical industry, threaten to perpetuate a subtle but damaging form of obstetric violence, which warrants concern."

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

Current Developments in the Treatment of Postpartum Depression: Zuranolone. (PubMed, Eurasian J Med) - "Selective serotonin reuptake inhibitors, serotonin-noradrenaline reuptake inhibitors, tricyclic antidepressants, estradiol, progesterone, psychotherapies, electroconvulsive therapy, and brexanolone can be used to treat PPD. In addition, the newest drug approved by the FDA (Food and Drug Administration) for this condition is oral zuranolone. This review aims to analyze recent developments on zuranolone, the latest drug approved by the FDA for PPD, based on current studies."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Postpartum Depression • Psychiatry • Psychomotor Agitation • Sleep Disorder

Zuranolone The First and Only Oral Agent for Postpartum Depression Raising Awareness for a Breakthrough Treatment Option (ASHP 2024) - No abstract available

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

Longterm Efficacy Profile of Zuranolone in Postpartum Depression Compared to Selective Serotonin Reuptake Inhibitors A Literature Review (ASHP 2024) - No abstract available

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