Brexanolone

With the anticipated introduction of new treatments such as COMP360 (COMPASS Pathways), Zuranolone (SAGE Therapeutics/Biogen), LY03005 (Luye Pharma), REL-1017 (Relmada Therapeutics), Seltorexant (Minerva Neurosciences/Janssen Pharmaceutical), ABV-1504 (BioLite/ABVC BioPharma), and other and increasing disease awareness, it's reasonable to expect a significant transformation in the major depressive disorder market in the coming years. LAS VEGAS, Nov. 25, 2024 /PRNewswire/ -- Major depressive disorder (MDD), commonly referred to as depression, is a serious medical condition that affects a person's mood, behavior, thinking, and physical well-being. It is different from the temporary feelings of sadness that everyone experiences and should not be confused with the deep grief following the loss of a loved one. MDD is typically a recurrent and episodic condition, meaning that someone who has experienced depression and recovered is likely to face additional episodes, often within 2 to 3 years. As per DelveInsight analysis, the total diagnosed prevalent cases of MDD in the 7MM were found to be approximately 44 million cases in 2023, which is expected to increase during the forecast period (2024–2034). Among the severity-specific diagnosed prevalent cases of MDD, the highest prevalence was observed in moderate cases accounting for approximately 17 million cases in the 7MM in 2023 followed by severe cases and mild cases. Major depressive disorder can be addressed through several treatment approaches, including pharmacological interventions, psychotherapy, interventional methods, and lifestyle changes. Initial treatment often involves either medication, psychotherapy, or a combination of both, with combined therapy proving more effective than using either alone. For severe cases of major depression, electroconvulsive therapy is the most effective option. The current range of recommended pharmacological treatments for major depressive disorder primarily includes antidepressants such as monoamines, tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), and selective reuptake inhibitors, including medications like VRAYLAR, BRINTELLIX (now TRINTELLIX), SPRAVATO, REXULTI, and FETZIMA. In the upcoming major depressive disorder treatment market landscape, there are a plethora of companies investigating agents for use in major depressive disorder which includes Sage Therapeutics, Relmada Therapeutics, Johnson & Johnson Services, Inc., Biogen, COMPASS Pathways, Luye Pharma, and others. Many more pharma companies are conducting clinical trials for therapies for major depressive disorder. To know more about upcoming major depressive disorder therapies showing positive results, visit @ Drugs for Major Depressive Disorder Treatment DelveInsight estimates that the market size for major depressive disorder is expected to grow from USD 7.1 billion in 2023 with a significant CAGR by 2034. The disease awareness and the emergence of new products in the pipeline will add to the market growth in the future. In addition, persistently rising cases of MDD in the forecast period will contribute to the rise in the MDD treatment market. The current pipeline for major depressive disorder includes a range of drugs with diverse mechanisms of action (MoA). COMP360 (COMPASS Pathways) , Zuranolone (SAGE Therapeutics/Biogen) , LY03005 (Luye Pharma) , REL-1017 (Relmada Therapeutics) , seltorexant (Minerva Neurosciences/Janssen Pharmaceutical) , ABV-1504 (BioLite/ABVC BioPharma), and some others are the most promising drugs of this indication. Ongoing research and current trials have the potential to change the MDD market. Keen to know how the MDD market will evolve by 2034? Find out @ Major Depressive Disorder Market Report The potential for effective major depressive disorder treatment in the future is expected to grow with the addition of numerous drugs to the pipeline of new therapeutics. Currently, a variety of candidate drugs for the treatment of major depressive disorder are being tested in various clinical trials, with some showing positive results. Any drug approved with increased safety and efficacy is expected to cause significant changes in the overall major depressive disorder market. Now, let's examine the pipeline therapies under investigation for major depressive disorder COMP360: COMPASS Pathways Phase III COMPASS Pathways is investigating the use of its experimental psilocybin therapy, COMP360, for treating serious mental health conditions like major depressive disorder. COMP360 is a synthesized version of psilocybin, the active compound found in certain "magic mushrooms," and is administered alongside psychological support. Psilocybin has shown promise in therapeutic applications, and COMP360 has been granted Breakthrough Therapy status by the US FDA as well as an Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Currently, COMPASS Pathways is running a Phase II trial for MDD, with a Phase III trial underway in partnership with Massachusetts General Hospital to further explore its potential in meeting mental health treatment needs. The company is anticipated to release top-line data from two key trials, COMP005 and COMP006, by the fourth quarter of 2024 and mid-2025, respectively, for the treatment of TRD. Zuranolone: SAGE Therapeutics/Biogen Phase III Zuranolone, being developed by SAGE Therapeutics and Biogen, is a next-generation oral, highly potent, and selective positive allosteric modulator, designed for specific targeting of synaptic and extrasynaptic GABAA receptors. The binding sites for neuroactive steroids (NASs) are different from those for GABA, benzodiazepines, and barbiturates. The GABA system, which is the primary inhibitory signaling pathway in the brain and central nervous system (CNS), plays a key role in regulating CNS function. SAGE-217 is currently in phase III clinical development for major depressive disorder and is being evaluated through the LANDSCAPE and NEST clinical trial programs, which include multiple studies involving thousands of participants, with varying dosing regimens, clinical endpoints, and treatment approaches. In February 2023, the US FDA accepted the New Drug Application (NDA) for zuranolone in the treatment of MDD. However, in August 2023, the FDA issued a Complete Response Letter (CRL) regarding the NDA for zuranolone for treating adults with MDD. Sage and Biogen are now assessing the feedback and determining their next steps. LY03005: Luye Pharma LY03005, developed by Luye Pharma, is one of the company's key products in the CNS therapeutic space. It is their exclusive extended-release tablet formulation of ansofaxine hydrochloride, a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI) designed for treating major depressive disorder. LY03005 aims to offer improved efficacy and fewer side effects compared to conventional antidepressants like SSRIs and SNRIs. Ansofaxine, a prodrug of desvenlafaxine, strongly inhibits dopamine reuptake in addition to serotonin and norepinephrine, demonstrating superior efficacy in clinical trials. In March 2020, the US FDA accepted the NDA submission for LY03005, which is currently in Phase III pivotal clinical trials for MDD treatment. Seltorexant: Minerva Neurosciences/Janssen Pharmaceutical Phase III Seltorexant, developed by Minerva Neurosciences and Janssen Pharmaceutical, is a selective orexin-2 receptor antagonist intended as an adjunctive treatment for major depressive disorder and for managing insomnia. It is the most advanced ORX2-specific molecule in clinical development, acting as an antagonist by binding to its receptor. Seltorexant is being studied for two main uses: insomnia without psychiatric disorders and MDD in patients who do not respond adequately to SSRIs or SNRIs. In May 2024, Johnson & Johnson reported positive topline results from the pivotal Phase III MDD3001 trial, which assessed its efficacy and safety as an add-on therapy to antidepressants in adults and elderly MDD patients. Discover which therapies are expected to grab major MDD market share @ New Treatments for Major Depressive Disorder REL-1017: Relmada Therapeutics Phase III REL-1017, being developed by Relmada Therapeutics, is a novel chemical entity (NCE) and an NMDA receptor (NMDAR) channel blocker that specifically targets overactive channels while preserving normal glutamatergic neurotransmission. The U.S. FDA has granted it Fast Track Designation as an immunotherapy for treating major depressive disorder. In a Phase II trial, REL-1017 exhibited rapid, strong, and lasting antidepressant effects, with statistically significant improvements over placebo in depression measures. The study also indicated a favorable safety, tolerability, and pharmacokinetic profile for the drug. Currently, it is in late-stage development for MDD, being tested in Phase III trials for both adjunctive and monotherapy. In June 2024, Relmada published clinical data from the Reliance I Study. The company is actively enrolling patients in ongoing trials for REL-1017, including Reliance II (Study 302), with top-line results expected in the latter half of 2024, and Relight (Study 304), which is anticipated to provide results about six months after the completion of Study 302. ABV-1504: ABVC BioPharma Phase II ABV-1504, developed by ABVC BioPharma, features PDC-1421 as its active ingredient and is classified as a botanical investigational new drug. Through its subsidiary BioLite, ABVC has completed a Phase II trial of ABV-1504, a botanical Norepinephrine Transporter (NET) inhibitor. This trial, conducted at Stanford University, showed that the PDC-1421 capsule was safe and well-tolerated among six enrolled adult patients. Both low and high doses of PDC-1421 successfully achieved the study's primary endpoints, showing a necessary 40% improvement in ADHD-RS-IV test scores. In April 2023, PDC-1421 was awarded a US patent (US 11,554,154 B2) for the treatment of Major Depressive Disorder (MDD). The drug has also completed a Phase II trial in MDD patients, and the company intends to hold an End of Phase II (EOP II) meeting with the FDA in the near future. Itruvone (PH10): VistaGen Therapeutics Phase II Itruvone (PH10), being developed by VistaGen Therapeutics, is an investigational first-in-class synthetic neurosteroid that is odorless and fast-acting, showing promise for various neuropsychiatric conditions related to depression and suicidal thoughts. VistaGen is focusing on PH10 as a potential quick-acting, non-sedating, and non-addictive treatment for MDD that patients can conveniently self-administer at home. When self-administered, a microgram-level dose of PH10 sprayed into the nose interacts with nasal chemosensory receptors, activating brain neural circuits to produce rapid antidepressant effects without the side effects, systemic exposure, or safety issues associated with FDA-approved treatments for MDD, such as oral antidepressants and esketamine. After successfully completing Phase IIa trials for MDD, VistaGen is now gearing up for the planned Phase IIb clinical development of PH10 for this condition. Moreover, in December 2022, PH10 received fast-track designation from the US FDA. LPCN 1154: Lipocine Phase II LPCN 1154, developed by Lipocine, is an oral formulation of brexanolone designed for rapid relief of postpartum depression. Its active ingredient is a naturally occurring positive allosteric modulator of the GABAa receptor. This medication is intended to provide an "at-home" treatment option, making it more accessible than the current standard care, which involves invasive procedures and hospitalization. In September 2022, the FDA approved Lipocine's proposal to demonstrate the efficacy of LPCN 1154 through a single pivotal pharmacokinetic bridge to the approved IV infusion of brexanolone via a 505(b)(2) NDA submission. In June 2024, Lipocine announced positive topline results from a pivotal pharmacokinetic study, confirming that LPCN 1154 is bioequivalent to IV brexanolone for PPD treatment. Lipocine aims to submit the NDA by the end of the fourth quarter of 2024. Discover more about drugs for major depressive disorder in development @ Major Depressive Disorder Clinical Trials DelveInsight's latest published market report titled as Major Depressive Disorder Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the major depressive disorder country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The major depressive disorder market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of MDD Gender-specific Diagnosed Prevalent Cases of MDD Severity-specific Diagnosed Prevalent Cases of MDD The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM major depressive disorder market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this major depressive disorder market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the major depressive disorder market. Also, stay abreast of the mitigating factors to improve your market position in the major depressive disorder therapeutic space. Related Reports Major Depressive Disorder Pipeline Major Depressive Disorder Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key major depressive disorder companies, including GH Research, Praxis Precision Medicines, AbbVie, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals, among others. Treatment-Resistant Depression Market Treatment-Resistant Depression Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key TRD companies, including Navitor Pharmaceuticals, Supernus Pharmaceuti, Novartis, Relmada Therapeutics, Beckley Psytech, COMPASS Pathways, Axsome Therapeutics, Celon Pharma, among others. Treatment-Resistant Depression Pipeline Treatment-Resistant Depression Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key treatment-resistant depression companies, including Axsome Therapeutics, COMPASS Pathways, Merck Sharp & Dohme Corp., Navitor Pharmaceuticals, Inc., Taisho Pharmaceutical Co., Ltd., GH Research Limited, Novartis Pharmaceuticals, Reckitt Benckiser LLC, Relmada Therapeutics, Inc., SAGE Therapeutics, Navitor Pharmaceuticals, Sumitomo Dainippon Pharma, Alkermes, AbbVie, Janssen Pharmaceuticals, Celon Pharma, ACADIA Pharmaceuticals, Pherin Pharmaceuticals, ATAI Life Sciences, among others. Postpartum Depression Market Postpartum Depression Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key postpartum depression companies, including Sage Therapeutics, Epharmix, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED