相关临床试验
47
20 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2018
进行中（未招募）
20
42.5%
已完成
22
46.8%
招募中
4
8.5%
终止
1
2.1%
暂无批准数据
- A new catalyst monitor report identifies 13 significant regulatory and clinical trial events expected in Q1 2026, based on key opinion leader interviews and predictive intelligence. - Major regulatory approval decisions are anticipated for GSK's depemokimab in asthma and sinusitis, Regenxbio's gene therapy for Hunter syndrome, and Omeros' narsoplimab for thrombotic microangiopathy. - Ongoing late-stage clinical trials from Xenon Pharmaceuticals, Cerevel, and Neumora are expected to deliver critical data across neurological and psychiatric conditions. - The pipeline momentum spans diverse therapeutic areas including respiratory diseases, rare genetic disorders, neurological conditions, and major depressive disorder.
- Formation Bio appointed four senior executives including Louis Brenner, MD as Chief Medical Officer and Daniel Neil, PhD as Chief Technology Officer to strengthen its AI-native pharmaceutical model. - Former Pfizer CFO Frank D'Amelio and ex-Incyte CSO Dashyant Dhanak, PhD joined as Strategic Advisors to guide the company's drug licensing and acquisition decisions. - The leadership expansion supports Formation Bio's plan to grow its pipeline from current assets to 10-15 drug candidates over the next 3-5 years. - The company recently secured a €545M out-licensing deal and added a new autoimmune disease asset to its development portfolio.
- RION has launched INTENT Biologics as an independent biotechnology company focused exclusively on developing first-in-class exosome therapies for inflammation and immunology indications. - The new company receives exclusive worldwide rights to RION's Purified Exosome Product (PEP) biologic platform and will advance it into Phase 3 clinical development for tissue regeneration and dermatologic conditions. - Former Pfizer executive Suneet Varma has been appointed CEO, bringing over 30 years of biopharma leadership to capitalize on what the company describes as a $30 billion market opportunity. - PEP Biologic represents a novel therapeutic approach using platelet-derived exosomes to modulate T-cells and macrophages, addressing underlying biology where current treatments fail.
- AbbVie has agreed to pay $65 million upfront for an option deal with Gilgamesh Pharmaceuticals, with potential payments reaching $1.95 billion for neuroplastogen compounds targeting mood and anxiety disorders. - The partnership focuses on developing next-generation psychiatric medicines that harness psychedelic mechanisms while reducing psychoactive effects like hallucinations that require controlled clinical settings. - Gilgamesh's pipeline includes GM-1020, an oral NMDA receptor blocker in Phase 2a for major depressive disorder, and GM-2505, a serotonin 5-HT2A agonist also in Phase 2 development. - The deal represents AbbVie's continued expansion into neuroscience following recent acquisitions including the $9 billion Cerevel Therapeutics purchase and reflects growing pharmaceutical industry interest in psychedelic-based therapies.
- The TEMPO-1 and TEMPO-2 trials demonstrated that tavapadon, a selective D1/D5 dopamine receptor agonist, significantly improved motor function in newly diagnosed Parkinson's disease patients compared to placebo. - Tavapadon's once-daily dosing regimen and targeting of D1/D5 receptors may offer advantages over traditional D2/D3 agonists, with lower incidence of impulse control disorders, somnolence, and other dopaminergic side effects. - The TEMPO-3 trial showed tavapadon's efficacy as an adjunctive therapy, increasing "on" time by 1.1 hours in patients with advanced Parkinson's disease who experience motor fluctuations while on levodopa.
- 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.
- AbbVie reports significant market penetration for Skyrizi and Rinvoq in IBD indications, capturing approximately 50% market share in Crohn's disease and ulcerative colitis treatment spaces. - Despite Humira's 32% sales decline following biosimilar entry in 2023, only 20% of patients have transitioned to biosimilars, with many physicians preferring AbbVie's newer immunology drugs. - The company is exploring combination therapy potential, particularly investigating TL1A therapies with Skyrizi, while also advancing its neurology pipeline with tavapadon showing promising Phase III results in Parkinson's disease.
- AbbVie's emraclidine failed to meet primary endpoints in Phase II trials for schizophrenia, leading to a $3.5 billion impairment charge and a reevaluation of its development path. - The company is now focusing on emraclidine as an adjunctive treatment for schizophrenia and as a monotherapy for psychosis related to Alzheimer's and Parkinson's diseases. - AbbVie plans to conduct a multiple ascending dose study of emraclidine, with data expected in early 2026, to explore higher doses and potentially revive monotherapy prospects. - Despite the setback, AbbVie's revenue growth remains strong, driven by Skyrizi and Rinvoq, with the neuroscience portfolio showing a 16.6% increase.
• Novo Nordisk's Ozempic faces scrutiny as Danish regulators request an EMA review due to reports of a rare eye disease in patients using the GLP-1 medication. • Novo Holdings received regulatory clearances to finalize its $16.5 billion acquisition of CDMO Catalent, marking a significant investment in biopharmaceutical manufacturing. • The biopharmaceutical industry saw a year of strategic manufacturing investments, shifting M&A activity, challenging IPO landscape, and clinical trial outcomes.
- Roche's anti-TIGIT drug, tiragolumab, failed to demonstrate a life-extending benefit in a Phase 3 trial for non-small cell lung cancer, raising concerns about the TIGIT inhibitor class. - AbbVie's emraclidine, a muscarinic agonist for schizophrenia acquired from Cerevel Therapeutics, failed in two mid-phase clinical trials, performing no better than placebo. - Cassava Sciences' simufilam, targeting filamin-A for Alzheimer's, failed in a Phase 3 trial, with patients showing no improvement on functional or cognitive measures.
