Roluperidone
- Generic Name
- Roluperidone
- Drug Type
- Small Molecule
- Chemical Formula
- C22H23FN2O2
- CAS Number
- 359625-79-9
- Unique Ingredient Identifier
- 4P31I0M3BF
- Background
Roluperidone has been used in trials studying the treatment of Schizophrenia.
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.
Sumitomo's Novel Schizophrenia Drug Ulotaront Fails to Meet Primary Endpoint in Phase 3 Trials
• Sumitomo Pharma America's ulotaront (SEP-363856), a novel TAAR1 and 5-HT1A agonist, failed to demonstrate statistical significance versus placebo in two Phase 3 trials for acute schizophrenia.
• Despite showing favorable safety profile with fewer metabolic side effects compared to current antipsychotics, the drug's efficacy was masked by an unexpectedly high placebo response in the DIAMOND 1 and 2 studies.
• The setback occurs amid ongoing development of other promising schizophrenia treatments, including Karuna's KarXT and Minerva's roluperidone, which are advancing toward potential market approval.
Roluperidone Shows Promise in Treating Negative Symptoms of Schizophrenia
• Roluperidone, currently in Phase 3 trials, offers hope for treating schizophrenia's negative symptoms by blocking serotonin rather than dopamine.
• Clinical data suggests Roluperidone improves global functioning in schizophrenia, primarily by reducing avolition, a key negative symptom.
• Anosognosia, a lack of awareness of one's illness, affects about half of schizophrenia patients and is a major predictor of medication refusal.
• Schizophrenia is increasingly recognized as a syndrome with multiple separable aspects, sharing similarities with other mental disorders.
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.
Drug Development Updates
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