Iclepertin
- Generic Name
- Iclepertin
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.
Major Pipeline Expansion in Schizophrenia Treatment: 55+ Companies Developing 60+ Novel Therapies
• DelveInsight's latest pipeline report reveals over 55 pharmaceutical companies actively developing 60+ innovative drug candidates for schizophrenia treatment, indicating significant industry investment in addressing this serious mental illness.
• Several promising candidates are advancing in clinical trials, including Lyndra's weekly oral risperidone (LYN-005), AbbVie's selective M4 receptor PAM emraclidine, and Kynexis's cognitive function-targeting KYN-5356.
• Multiple clinical trials are scheduled for early 2025, including LB-102 for acute schizophrenia, Click Therapeutics' digital therapeutics, and Cerevel's emraclidine safety study, demonstrating diverse therapeutic approaches.
Boehringer Ingelheim's Iclepertin Fails to Meet Endpoints in Phase III Schizophrenia Trials
• Boehringer Ingelheim's iclepertin, a GlyT1 inhibitor, failed to demonstrate statistically significant benefits in improving cognitive function in schizophrenia patients.
• The Phase III CONNEX program, involving over 1,800 patients across 41 countries, did not meet primary or key secondary endpoints at six months.
• As a result of the disappointing outcomes, Boehringer Ingelheim has discontinued the CONNEX-X long-term extension trial.
• The company remains committed to developing solutions for serious mental illnesses, with over 20 investigative therapies in its pipeline.
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.
Johnson & Johnson to Acquire Intra-Cellular Therapies for $14.6 Billion, Bolstering Neuroscience Portfolio
• Johnson & Johnson (J&J) will acquire Intra-Cellular Therapies for $14.6 billion, gaining access to Caplyta and a pipeline of CNS disorder treatments.
• Caplyta, approved for schizophrenia and bipolar depression, has a supplemental NDA under FDA review for major depressive disorder (MDD) as adjunctive therapy.
• The acquisition includes ITI-1284, a Phase II asset targeting generalized anxiety disorder (GAD) and Alzheimer's-related psychosis, expanding J&J's pipeline.
• The deal is expected to close in late 2025, pending regulatory approval, and aims to strengthen J&J's position in neuropsychiatric and neurodegenerative disorders.
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.
Japan Recommends Approval for Brukinsa and Balversa; Grants Sakigake Designation to Brogidirsen and Iclepertin
• Japan's health authorities are set to approve Brukinsa (zanubrutinib) for hematological malignancies and Balversa (erdafitinib) for urothelial carcinoma, expanding treatment options for these cancers.
• Brogidirsen, a gene therapy for Duchenne Muscular Dystrophy (DMD), and Iclepertin are slated to receive Sakigake designation, expediting their development and potential approval.
• The Pharmaceuticals and Medical Devices Agency (PMDA) has established a full-time office in the US, enhancing regulatory collaboration and oversight.
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.
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.
Boehringer Ingelheim Plans 25 New Treatments by 2030, Bolstered by Oncology and Metabolic Disease Programs
• Boehringer Ingelheim aims to launch 25 new treatments by 2030, focusing on oncology, mental health, cardiovascular, renal, and metabolic diseases.
• Key candidates include Brigimadlin, an MDM2-p53 agonist for dedifferentiated liposarcoma, and zongertinib, a HER2 tyrosine kinase inhibitor, showing promising early data.
• Survodutide, a glucagon/GLP-1 candidate, demonstrated significant improvement in liver disease due to metabolic dysfunction-associated steatohepatitis in Phase II trials.
• Despite slow sales of its Humira biosimilar, Cyltezo, Boehringer reported a 9.7% net sales increase in 2023, driven by Jardiance and Ofev.
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