Zuranolone
- Generic Name
- Zuranolone
- Brand Names
- -
- Drug Type
- Small Molecule
- Chemical Formula
- C25H35N3O2
- CAS Number
- 1632051-40-1
- Unique Ingredient Identifier
- 7ZW49N180B
- Background
Zuranolone is a neuroactive steroid that acts as a positive allosteric modulator of the GABA receptors. Unlike other more common GABA positive allosteric modulators on the market like benzodiazepines, zuranolone can modulate both synaptic and extrasynaptic GABA conductance due to binding to a non-benzodiazepine site on the receptor. Zuranolone was designed with a pharmacological profile of a neuroactive steroid in mind while also possessing a pharmacokinetics profile of an oral, once-daily dosing formulation.
Zuranolone was approved by the FDA on August 4th, 2023, and it is currently the only approved treatment for women with postpartum depression. This approval was based on favorable results from 2 phase 3 clinical trials.
- Indication
Zuranolone is indicated for the treatment of postpartum depression (PPD) in adults.
- Associated Conditions
- Postpartum Depression
- Associated Therapies
- -
Major Depressive Disorder Market to Register Immense Growth by 2034 Owing to a Robust Pipeline
New treatments like COMP360, Zuranolone, LY03005, REL-1017, Seltorexant, and ABV-1504 are expected to significantly transform the major depressive disorder (MDD) market. MDD affects 44 million diagnosed cases in the 7MM, with moderate cases being the most prevalent. Treatment approaches include pharmacological interventions, psychotherapy, and lifestyle changes. The market size for MDD is projected to grow from USD 7.1 billion in 2023, driven by disease awareness and new product launches.
Difficult to Treat Depression: Focus on Approach, Algorithms, and Access
The Southwest Forum on Difficult to Treat Depression, chaired by Jordan F. Karp, MD, convened experts to discuss novel mechanisms, evidence-informed algorithms, and access to comprehensive depression care. Topics included advanced treatments like brain stimulation and neurosteroids, challenges in late-life depression, digital mental health treatments, and the role of biomarkers in precision psychiatry. The forum emphasized the need for equitable access and personalized medicine to improve outcomes in treatment-resistant depression.
Cybin's Breakthrough: Psychedelic Depression Drug CYB003 Sustains 12-Month Symptom
Cybin's CYB003, a deuterated psilocin drug for MDD, showed 12-month efficacy with 100% response rate and 71% sustained remission. The FDA's Breakthrough Therapy Designation supports its potential over existing therapies, with no new adverse events reported. Cybin plans to launch Phase 3 PARADIGM program for global efficacy and safety assessment.
AbbVie Shares Plummet 12% as Cerevel Schizophrenia Asset Fails Phase II Trials
AbbVie's emraclidine, from the $9 billion Cerevel acquisition, failed in two Phase II trials for schizophrenia, causing a 12% share drop. Despite high placebo response, the drug showed no significant symptom improvement. Analysts are now questioning AbbVie's neuroscience strategy and growth outlook.
Navigating Perinatal Loss
Ms Anderson, a 36-year-old with a history of major depressive disorder and recurrent pregnancy losses, experienced a stillbirth at 34 weeks, leading to increased anxiety and sadness. Perinatal loss is common, affecting 15% of pregnancies, with disparities among racial and ethnic groups. Psychiatric sequelae include grief, postpartum depression, anxiety, and PTSD. Treatment strategies involve nonpharmacologic approaches like support groups and psychotherapy, with pharmacologic options considered for severe cases.
Sage lays off 55% of R&D workforce and refocuses pipeline
Sage Therapeutics to lay off 165 employees, 55% of R&D team, to restructure and focus on Zurzuvae, an FDA-approved oral treatment for postpartum depression. The restructuring aims to strengthen financial and operational positions, incurring $26–28m in Q4 2024. Sage also discontinued dalzanemdor development in Alzheimer’s after Phase II trial failure.
Related Clinical Trials:
Rural Iowa mothers face severe postpartum depression
Iowa doctors assess new postpartum depression medication, zuranolone, approved by FDA. Rural areas face higher risk and stigma. Zuranolone shows rapid effectiveness within days, improving over previous treatments.
Shionogi Submits New Drug Application in Japan for Zuranolone as a Treatment for Major Depressive Disorder
Shionogi submitted a New Drug Application in Japan for zuranolone, a treatment for major depressive disorder, based on Phase 3 data. Zuranolone showed rapid efficacy in MDD symptoms, potentially addressing the need for fast-acting therapies in Japan's 5 million depression patients.
Bragar Eagel & Squire, P.C. Reminds Investors That Class
Bragar Eagel & Squire, P.C. reminds investors of class actions against Sage Therapeutics, Outset Medical, Allarity Therapeutics, and Super Micro Computer. Lead plaintiff deadlines are set for October 28, 2024, for Sage and Outset, November 12, 2024, for Allarity, and October 29, 2024, for Super Micro. The complaints allege misleading statements and omissions regarding product effectiveness and regulatory compliance.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2024. All Rights Reserved by MedPath