Clinical Trials
15
4 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2002
Active, not recruiting
4
26.7%
Completed
9
60.0%
Recruiting
2
13.3%
No approval data available
- The FDA has cleared Celon Pharma's CPL-936, a novel second-generation PDE10A inhibitor, to advance into Phase 3 trials for schizophrenia treatment following positive regulatory feedback. - The Phase 3 program will include two 28-day randomized, double-blind trials in patients with acute schizophrenia episodes and a 12-month safety extension study. - CPL-936 demonstrated robust efficacy in a 189-patient Phase 2 trial, with the 40 mg dose showing 6.3-point improvement in positive PANSS scores and 16.4-point reduction in total PANSS scores. - The company plans to expand the program into additional CNS indications, including Levodopa-Induced Dyskinesia in Parkinson's disease, with pivotal studies expected to begin in 2026.
- DelveInsight's comprehensive analysis reveals over 50 companies actively developing more than 55 JAK inhibitor therapies, demonstrating significant industry investment in this therapeutic class. - Recent FDA approvals include Leqselvi for alopecia areata in July 2024, Litfulo for severe alopecia areata in June 2023, and Ojjaara for myelofibrosis in September 2023. - Leading pipeline candidates include Povorcitinib by Incyte Corporation in Phase III trials, CPL409116 by Celon Pharma targeting dual JAK/ROCK inhibition, and ATI-2138 by Aclaris Therapeutics as an oral ITK/JAK3 inhibitor. - The pipeline spans multiple development stages from discovery to Phase III, with therapies targeting diverse conditions including autoimmune diseases, cancer, and dermatological disorders.
- DelveInsight's 2025 report reveals over 200 companies are actively developing more than 200 pipeline therapies for diabetes treatment, indicating a highly competitive and innovative landscape. - Several promising late-stage candidates are advancing through Phase III trials, including Cadisegliatin (vTv Therapeutics) for type 1 diabetes and Insulin efsitora alfa (Eli Lilly) as a once-weekly basal insulin. - Recent clinical trial announcements from major pharmaceutical companies demonstrate continued investment in diabetes research, with studies comparing novel formulations and combination therapies. - The pipeline encompasses diverse therapeutic approaches including liver-selective glucokinase activators, ultra-rapid-acting insulin analogs, and oral GLP-1 receptor agonists targeting different aspects of diabetes management.
• The global bipolar depression market is projected to experience significant growth through 2034, driven by increasing prevalence, with the United States accounting for approximately 85% of the market share across major regions. • Several pharmaceutical companies including NeuroRx, COMPASS Pathways, and Intra-Cellular Therapies are advancing novel treatments, with Johnson & Johnson's recent $14.6 billion acquisition of Intra-Cellular Therapies highlighting industry confidence in the sector. • Among current therapies, CAPLYTA (lumateperone) is expected to achieve the highest market share by 2034, while emerging treatments like NRX-100/101 and COMP 360 (psilocybin) show promise for addressing unmet needs in bipolar depression management.
- Phase 2 trial of CPL'36 demonstrates statistically significant improvement in Levodopa-Induced Dyskinesia symptoms, with primary endpoint reductions of 12.30 and 13.58 units for 20mg and 40mg doses respectively. - The novel PDE10A inhibitor showed rapid efficacy starting from Day 7, with a favorable safety profile and minimal severe adverse events compared to placebo. - Building on previous positive results in schizophrenia, CPL'36's unique pharmacodynamic profile with rapid enzyme dissociation suggests potential as a breakthrough treatment for LID in Parkinson's disease.
• The Janus Kinase (JAK) inhibitor pipeline is actively being developed by multiple companies, showing promise in treating various autoimmune and inflammatory diseases. • Key companies such as Incyte, AbbVie, and Bristol Myers Squibb are advancing JAK inhibitor therapies through clinical trials and regulatory submissions. • Emerging therapies like povorcitinib, upadacitinib, and deucravacitinib have demonstrated efficacy in treating conditions like hidradenitis suppurativa, axial spondyloarthritis, and plaque psoriasis. • The JAK inhibitor market is driven by the rising prevalence of chronic diseases and substantial investments in research and development, offering targeted treatment approaches.
