HTL-0016878
- Generic Name
- HTL-0016878
Neurocrine Biosciences Advances Novel Muscarinic M4 Agonist to Phase 3 Trials for Schizophrenia
• Neurocrine Biosciences has initiated a Phase 3 registrational program for NBI-1117568, an oral muscarinic M4 selective orthosteric agonist, following positive Phase 2 results in schizophrenia patients.
• The global double-blind, placebo-controlled trial will enroll approximately 280 adults with schizophrenia experiencing acute symptom exacerbation, with PANSS score reduction as the primary endpoint.
• NBI-1117568 represents a novel mechanism of action that achieved clinically meaningful results in Phase 2, showing an 18.2-point reduction from baseline in PANSS scores with minimal gastrointestinal and cardiovascular side effects.
Neurocrine Biosciences Appoints Dr. Sanjay Keswani as New Chief Medical Officer
• Neurocrine Biosciences has appointed Dr. Sanjay Keswani as Chief Medical Officer effective June 2, 2025, succeeding Dr. Eiry W. Roberts who served in the role for seven years.
• Dr. Keswani brings over 20 years of pharmaceutical industry experience as a physician-scientist with expertise across multiple therapeutic areas and will lead clinical development and medical affairs activities.
• Prior to joining Neurocrine, Dr. Keswani served as President and CEO of ImmunoBrain and held senior leadership positions at Hoffman La Roche and Bristol-Myers Squibb.
Neurocrine Launches Phase 1 Trial of Novel VMAT2 Inhibitor for Neurological Disorders
• Neurocrine Biosciences initiates Phase 1 clinical study of NBI-1140675, a second-generation VMAT2 inhibitor, evaluating safety and pharmacokinetics in healthy adults.
• The new compound builds on Neurocrine's success with valbenazine, which received FDA approval for tardive dyskinesia in 2017 and Huntington's disease chorea in 2023.
• NBI-1140675 joins NBI-1065890 in Neurocrine's pipeline of next-generation VMAT2 inhibitors, targeting various neurological and neuropsychiatric conditions.
Phase 4 KINECT-PRO Trial Shows Ingrezza Significantly Improves Quality of Life in Tardive Dyskinesia Patients
• Neurocrine Biosciences' phase 4 KINECT-PRO study demonstrates sustained improvements in physical, social, and emotional impacts of tardive dyskinesia with Ingrezza treatment across all severity levels.
• The 24-week trial showed significant patient-reported benefits starting as early as 4 weeks at the lowest dose (40mg), with 52 out of 59 enrolled patients completing the study.
• Results revealed consistent efficacy regardless of underlying psychiatric conditions, with improvements measured across multiple validated clinical scales including AIMS and TD Impact Scale.
Boehringer Ingelheim Expands Schizophrenia Pipeline with Sosei Heptares and Autifony Collaborations
• Boehringer Ingelheim licenses GPR52 agonists from Sosei Heptares for €755m, targeting a range of schizophrenia symptoms including positive, negative, and cognitive dysfunction.
• The collaboration with Autifony Therapeutics focuses on Kv3.1/3.2 positive modulators, with Boehringer funding R&D and holding an option to purchase AUT00206, currently in Phase 1b.
• These deals complement Boehringer's existing schizophrenia pipeline, including iclepertin (GlyT1 inhibitor) in Phase 3 and a digital therapeutic (DTx) in late-stage testing.
Schizophrenia Market Set for Strong Growth, Driven by Novel Therapies
• The schizophrenia market is expected to grow significantly, driven by the launch of novel therapies and increased diagnosis rates.
• Long-acting injectables (LAIs) are gaining traction despite higher costs, offering an alternative to oral antipsychotics.
• The US dominates the schizophrenia market due to a large patient population and high drug costs.
• Emerging treatments like Cobenfy, evenamide, Ingrezza, and iclepertin aim to address unmet needs in managing both positive and negative symptoms.
Nxera Pharma Initiates Phase 3 Trial of Daridorexant for Insomnia in South Korea
• Nxera Pharma has enrolled the first patient in a Phase 3 clinical trial in South Korea to evaluate daridorexant for treating insomnia.
• The trial aims to secure marketing authorization from South Korea's Ministry of Food and Drug Safety, with results expected in 1H 2026.
• Daridorexant, approved in Japan as QUVIVIQ™, is already available in the US, Europe and Japan, targeting overactive wake signaling in insomnia.
• Insomnia affects 15-25% of South Korean adults, highlighting the need for effective treatments like daridorexant to improve sleep quality.
AbbVie's Emraclidine Fails, Bolstering BMS's Lead in Schizophrenia Treatment
• AbbVie's emraclidine failed to demonstrate statistically significant improvement in schizophrenia symptoms in Phase II trials, a setback for the muscarinic pathway approach.
• Bristol Myers Squibb's Cobenfy (KarXT), a muscarinic agonist, now stands as the frontrunner in schizophrenia treatment after AbbVie's trial failures.
• Neurocrine Biosciences is advancing NBI-1117568, an oral muscarinic M4 selective agonist, with Phase III trials planned for early 2025, showing a potential path forward.
• Other companies like Neumora Therapeutics and Reviva Pharmaceuticals are also exploring novel mechanisms for schizophrenia treatment, indicating a dynamic therapeutic landscape.
AbbVie's Emraclidine Fails in Schizophrenia Trials, Analysts Still Bullish on Immunology Portfolio
• AbbVie's emraclidine failed to meet the primary endpoint in two Phase 2 trials for schizophrenia, showing no statistically significant improvement in PANSS scores compared to placebo.
• Analysts suggest Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride) is now positioned to face less competition in the schizophrenia market following AbbVie's setback.
• Despite the disappointing results, analysts maintain a positive outlook on AbbVie, emphasizing the strength and growth potential of its immunology franchise.
• The failure raises questions about AbbVie's neuroscience strategy, though the company's acquisition of Cerevel still holds promise with Tavapadon showing positive Phase 3 results in Parkinson's disease.
AbbVie's Emraclidine Fails in Phase 2 Schizophrenia Trials, Benefiting BMS
• AbbVie's emraclidine failed to show improvement over placebo in two Phase 2 trials (EMPOWER 1 and 2) for schizophrenia, impacting AbbVie's stock value.
• Emraclidine, a selective muscarinic M4 receptor-positive allosteric modulator (PAM), aimed to improve tolerability compared to current antipsychotics.
• The failure potentially benefits Bristol-Myers Squibb, whose schizophrenia drug Cobenfy (xanomeline tartrate/trospium chloride) recently gained FDA approval.
• AbbVie will analyze the data to determine the next steps for emraclidine, acquired as part of the Cerevel Therapeutics acquisition.
KarXT (Cobenfy) Approved for Schizophrenia: A Novel, Nondopaminergic Approach
• The FDA approved KarXT (Cobenfy) on September 26, 2024, marking the first new mechanism of action for schizophrenia treatment since 1954.
• KarXT combines xanomeline and trospium to modulate brain circuits via muscarinic cholinergic receptors, offering a nondopaminergic approach to managing schizophrenia symptoms.
• Clinical trials (EMERGENT-1, -2, -3, -4, -5) demonstrated significant improvements in PANSS scores and supported the long-term safety and efficacy of KarXT.
• Cobenfy's unique mechanism and adverse event profile necessitate prescriber education to optimize its use as a novel treatment option for schizophrenia.
Schizophrenia Clinical Trial Pipeline Boasts 60+ Drugs Under Development
• The schizophrenia treatment landscape is expanding with over 60 drugs in active development, driven by increased R&D and innovative therapies.
• Key players like Sumitomo Pharma, Boehringer Ingelheim, and Reviva Pharmaceuticals are advancing novel antipsychotics and personalized medicine approaches.
• Recent progress includes positive Phase III trial results for brilaroxazine and LY03020's IND approval in China, signaling potential new treatment options.
• COBENFY, a first-in-class muscarinic agonist, received FDA approval, marking a significant advancement in schizophrenia treatment after 35 years.
Neurocrine's Luvadaxistat Fails Phase II Trial for Cognitive Impairment in Schizophrenia
• Neurocrine Biosciences' ERUDITE Phase 2 trial of luvadaxistat did not meet its primary endpoint for improving cognitive impairment in schizophrenia patients.
• The trial's failure contrasts with positive results from the earlier INTERACT study, attributed to variability in cognitive measures and baseline imbalances.
• Neurocrine will halt luvadaxistat development and focus on Phase 3 trials of NBI-1117568 for schizophrenia and NBI-1065845 for major depressive disorder.
FDA Approves Cobenfy, a Novel Schizophrenia Treatment Targeting Cholinergic Receptors
• The FDA has approved Cobenfy (xanomeline and trospium chloride) as the first new class of drug for schizophrenia in over 30 years, offering a novel approach to treatment.
• Cobenfy targets muscarinic receptors, unlike traditional antipsychotics that focus on dopamine, potentially reducing side effects like weight gain and movement disorders.
• Clinical trials demonstrated Cobenfy significantly reduced schizophrenia symptoms compared to placebo, marking a transformative moment in managing this challenging condition.
• Expected to launch in late October, Cobenfy offers a new option for adults with schizophrenia, with ongoing studies exploring its potential in Alzheimer's psychosis and other conditions.
Nxera Pharma Secures $35M Milestone Payment After Positive Phase II Schizophrenia Trial
• Nxera Pharma received $35 million from Neurocrine Biosciences following positive Phase II trial results of NBI-1117568 in adults with schizophrenia.
• The Phase II trial met its primary endpoint, demonstrating a significant reduction in schizophrenia symptoms with a once-daily 20mg dose of NBI-1117568.
• NBI-568, an oral muscarinic M4 selective agonist, aims to alleviate both positive and negative symptoms of schizophrenia by influencing dopamine signaling.
• Neurocrine plans to advance NBI-568 into Phase III clinical trials in early 2025, potentially generating up to $202 million in sales by 2030 if approved.
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