Seltorexant

Insomnia market report forecasts growth from 2020 to 2034, driven by increasing prevalence, awareness, and emerging therapies like Seltorexant and TS-142. Challenges include high treatment costs and patient non-compliance, with unmet needs for long-term solutions with minimal side effects.

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.

Dr. Husseini Manji, former J&J neuroscience head, developed Spravato, a first-in-class depression medication approved by the FDA in 2019. Despite initial skepticism, Spravato is now poised for blockbuster status. Psychiatric drug development, once abandoned by Big Pharma, is experiencing a renaissance with over 160 mental health medications in clinical trials. Manji advocates for precise diagnoses and targeted treatments. Recent setbacks include Alto Neuroscience's ALTO-100 failing to beat a placebo in a mid-stage trial for major depressive disorder. Emerging precision approaches include targeting orexin receptors, AMPA modulation, kappa opioid receptors, and inflammation reduction.

Despite approvals for Leqembi and Kisunla, attrition in Alzheimer’s and Parkinson’s pipelines persists, with Roche, Johnson & Johnson, Sage Therapeutics, and Otsuka discontinuing programs. Analysts attribute these decisions to clinical trial data and evolving commercial opportunities, noting the Alzheimer’s market is projected to be worth $15.5 billion by 2031, while Parkinson’s drugs are expected to reach $6.63 billion by 2029.

Seltorexant, a potent, selective orexin-2 receptor antagonist, improved symptoms of major depressive disorder (MDD) and insomnia in a phase III trial. The study drug, when combined with current antidepressant treatment, showed a significant reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo. Seltorexant is unique as it targets only OX2 receptors, potentially filling an unmet need for new therapies for MDD and insomnia.

Johnson & Johnson (J&J) has discontinued several clinical programmes, including a Phase II study of seltorexant for Alzheimer’s disease. The neuroscience pipeline was most affected, losing two Phase II programmes and a Phase I candidate. Seltorexant, a promising neuroscience candidate, had positive results in a Phase III trial for major depressive disorder but its potential in Alzheimer’s was cut. J&J’s asset prioritisation changes were reflected in a pipeline list on their website. The company reported strong Q3 financial results for 2024, with oncology drug sales up nearly 19%.