相关临床试验
9
1 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
N/A
进行中（未招募）
1
11.1%
已完成
4
44.4%
招募中
1
11.1%
终止
2
22.2%
撤回
1
11.1%
暂无批准数据
- FDA reviewed the KOURAGE trial protocol amendment and interim safety data for Auxora in acute kidney injury patients and raised no comments or questions. - An earlier enrollment pause was triggered by a mortality imbalance that the IDMC and external experts attributed to baseline disease severity, not drug-related toxicity. - The protocol amendment refines patient inclusion criteria and stratification methodology based on a comprehensive safety assessment of 107 dosed patients. - CalciMedica also expects FDA feedback on a potential pivotal program for Auxora in acute pancreatitis in the third quarter of 2026.
- CalciMedica terminated its Phase II KOURAGE trial evaluating Auxora in acute kidney injury patients after the independent data monitoring committee identified safety concerns requiring study design reevaluation. - The company's stock dropped over 75% following the announcement, with shares falling from $5.12 to $1.25 at market close, reflecting investor concerns about the program's future. - Despite the trial halt, CalciMedica reported no treatment-related deaths and no serious adverse events requiring expedited FDA reporting, with plans to review unblinded data to guide future development. - The company remains committed to advancing Auxora in acute pancreatitis, with plans to finalize a pivotal trial design in the first half of 2026 pending FDA feedback.
- CalciMedica has announced a collaboration with Telperian to integrate artificial intelligence tools for analyzing Phase 2 clinical trial datasets of Auxora, its CRAC channel inhibitor. - The AI-powered analysis will focus on refining target patient populations and efficacy endpoints to optimize the design of upcoming pivotal trials for acute pancreatitis. - Auxora has demonstrated positive results in multiple Phase 2 trials including CARPO for acute pancreatitis and CARDEA for severe COVID-19 pneumonia, with over 350 critically ill patients dosed. - The collaboration aims to provide deeper insights into treatment effects across patient subgroups and support regulatory discussions with the FDA for pivotal development.
- CalciMedica has secured a $32.5M credit facility from Avenue Venture Opportunities Fund, with an initial $10M tranche extending cash runway into mid-2026. - The company is advancing development of Auxora, their lead CRAC channel inhibitor, with Phase 2 trial data in acute kidney injury expected in 2025. - The financing provides strategic flexibility for CalciMedica's clinical programs, including preparations for Phase 3 trials in acute pancreatitis.
- Post-hoc analysis of CARDEA Phase 2 trial reveals Auxora reduced mortality by 62.7% in COVID-19 patients with acute kidney injury compared to placebo, with benefits persisting through 60 days. - CalciMedica's CRAC channel inhibitor demonstrates promising tissue-protective and immunomodulatory effects in preclinical studies, suggesting potential therapeutic mechanism for AKI treatment. - Results support ongoing Phase 2 KOURAGE trial investigating Auxora in patients with Stage 2 or 3 AKI and acute hypoxemic respiratory failure, with data expected in 2025.
- Zegocractin, a CRAC channel inhibitor, significantly reduced the time to solid food tolerance in acute pancreatitis patients with systemic inflammatory response syndrome (SIRS). - Higher doses of zegocractin (1.0 and 2.0 mg/kg) showed no new cases of severe respiratory failure compared to placebo in the CARPO phase 2b trial. - The study suggests that zegocractin has the potential to decrease the risk of respiratory failure and necrotizing pancreatitis in acute pancreatitis patients. - The phase 2b trial results support further late-stage assessment for zegocractin as a potential treatment for acute pancreatitis and acute kidney injury.
