相关临床试验
41
4 进行中
药物批准
15
批准总数
监管机构
3
监管机构数
成立时间
1949
进行中（未招募）
4
9.8%
已完成
27
65.8%
No Longer Available
1
2.4%
招募中
4
9.8%
终止
5
12.2%
- Cognizant will support the implementation of Benchling's AI platform at Kyowa Kirin's Tokyo Research Park and Fuji Research Park in Japan. - The platform aims to automate experimental design and data collection, accelerating the research cycle from target identification to new drug candidate selection. - Kyowa Kirin expects the initiative to standardize workflows and structure data, establishing a next-generation drug discovery foundation. - The collaboration supports Kyowa Kirin's focus on bone and mineral disorders, hemato oncology, intractable hematologic diseases, and rare diseases.
- Clinically meaningful improvements in skin itch, flaking, and redness were observed as early as week 4 and sustained through 48 weeks in the PROSPER real-world study. - By week 48, 30% of patients reported at least a 2-point improvement in sleep and 37% reported better body temperature regulation. - Patients showed significant, clinically meaningful improvements in disease-specific health-related quality-of-life scores beginning at week 12 with further gains through week 48. - The study, conducted across 19 sites in six countries, enrolled 73 patients with relapsed or refractory MF or SS and was designed with patient and caregiver input.
- The FDA selected Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin for its new PreCheck pilot program aimed at accelerating domestic manufacturing facility reviews. - The program allows regulators to review new manufacturing facilities during construction, potentially saving companies up to 14 months in approval timelines. - Lilly's Lebanon, Indiana API facility for GLP-1 medicines and Regeneron's $2 billion Saratoga Springs, New York biologics site are among the selected projects. - The initiative is part of a broader Trump administration push to strengthen domestic drug manufacturing and improve U.S. supply chain resilience.
- The FDA selected seven pharmaceutical and biotechnology companies from over 80 applicants for its new PreCheck Pilot Program launched on February 1, 2026. - The initiative offers early regulatory engagement and a more predictable approval pathway for companies building new U.S.-based manufacturing facilities. - Selected participants include Amneal, Cellares, Eli Lilly, FUJIFILM Biotechnologies, Kriya Therapeutics, Kyowa Kirin, and Regeneron, spanning small molecules, biologics, and gene therapies. - The two-phase model provides early technical guidance and enhanced pre-submission meetings to expedite facility evaluation and inspections.
- The FDA has approved new dosing options for CRYSVITA (burosumab-twza) in adults with X-linked hypophosphatemia, allowing healthcare providers to increase dose frequency for patients with suboptimal serum phosphorus levels. - Patients whose serum phosphorus remains below normal range after initial treatment can now receive 0.5 mg/kg every two weeks, with potential escalation to 1 mg/kg every two weeks if needed. - The expanded dosing regimen provides a more personalized treatment approach for the rare genetic disease that affects bone and muscle health through phosphorus deficiency. - CRYSVITA remains the only FDA-approved treatment for XLH, working by blocking FGF23 to restore phosphorus reabsorption and increase active vitamin D levels.
- Orchard Therapeutics has been awarded Innovation Passport designation for OTL-201, an investigational gene therapy for mucopolysaccharidosis type IIIA (MPS-IIIA), under the UK's refreshed Innovative Licensing and Access Pathway. - OTL-201 is one of only three investigational therapies initially granted this designation, which aims to accelerate development timelines and patient access to transformative medicines addressing significant medical needs. - MPS-IIIA is a rare, fatal neurometabolic disorder affecting approximately one in 100,000 live births, with children rarely surviving past adolescence and no currently approved disease-modifying therapies available. - The ex vivo autologous HSC gene therapy uses a modified virus to insert a functional copy of the SGSH gene into patients' harvested stem cells, currently being evaluated in an ongoing UK clinical trial.
- A phase 2 clinical trial of burosumab in 12 patients with fibrous dysplasia successfully restored phosphate levels to the mid-to-upper normal range in all participants by week 48. - Two severely affected children experienced transformational mobility improvements, with one progressing from full-time wheelchair use to independent walking and another achieving walker-assisted ambulation after never walking independently. - The monoclonal antibody treatment targeting FGF23 was well-tolerated and showed substantial reductions in alkaline phosphatase levels, a marker of disease activity, by 49% at week 48. - Results support targeting higher phosphate levels than previously used in other FGF23 excess disorders, potentially offering a new therapeutic approach for this rare skeletal condition.
- Kyowa Kirin has terminated its rocatinlimab development collaboration with Amgen and will regain full control of the global program, including regulatory filings and commercialization. - The anti-OX40 monoclonal antibody demonstrated positive results in Phase 3 trials involving nearly 1,500 adults with moderate-to-severe atopic dermatitis, meeting all co-primary and key secondary endpoints. - Regulatory submission is planned for the first half of 2026, with the U.S. filing expected first, followed by Japan and other global markets. - The comprehensive Phase 3 ROCKET program has enrolled more than 3,300 patients across eight pivotal studies, showing a generally favorable benefit-risk profile.
- Ardelyx has dosed the first patient in ACCEL, a Phase 3 clinical trial evaluating IBSRELA (tenapanor) for chronic idiopathic constipation in adults. - The multicenter, randomized, double-blind, placebo-controlled study aims to enroll approximately 700 patients over 26 weeks with topline data expected in the second half of 2027. - Chronic idiopathic constipation affects more than 34 million Americans and is associated with significantly impaired quality of life and high healthcare costs. - The trial represents Ardelyx's effort to expand IBSRELA's patient population beyond its current indication for irritable bowel syndrome with constipation.
- Ardelyx achieved approximately $378 million in total product revenue for 2025, with IBSRELA generating $274 million representing 73% growth compared to 2024. - The company projects IBSRELA revenue to reach $410-430 million in 2026 and expects to achieve $1 billion in revenue by 2029. - A Phase 3 clinical trial evaluating IBSRELA for chronic idiopathic constipation has commenced and is expected to complete in the second half of 2027. - Ardelyx received patent protection extending intellectual property coverage for both IBSRELA and XPHOZAH until December 2041.
