相关临床试验
13
4 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
2010
进行中（未招募）
4
30.8%
已完成
4
30.8%
招募中
3
23.1%
终止
1
7.7%
撤回
1
7.7%
暂无批准数据
- Kancera AB received positive FDA feedback on its clinical development program for KAND567 in ST-elevation myocardial infarction, with the agency agreeing the plan could support a marketing application. - The FDA confirmed that KAND567 qualifies for Fast Track Designation, recognizing the significant unmet medical need in heart attack patients undergoing primary intervention. - The company's development plan includes a phase IIb FRACTIVE study followed by a pivotal phase III trial to evaluate cardiovascular outcomes including mortality and heart failure. - FDA recommended evaluating an additional dose in the phase IIb study to better characterize the exposure-response relationship for optimal phase III dose selection.
- Kancera AB has partnered with US biotech Recardio Inc. to create a cardiovascular disease-focused specialty care company, with Recardio licensing candidate drugs KAND567 and KAND145. - The company expects FDA pre-IND feedback for its planned phase IIb FRACTIVE study of KAND567 in acute myocardial infarction by the end of Q2 2025. - Top-line results from the ongoing KANDOVA phase Ib/IIa study evaluating KAND567 plus carboplatin in ovarian cancer are expected in Q3 2025. - Kancera plans to rebrand as Novakand Pharma in September 2025, reflecting its strategic focus on cardiovascular therapeutics.
- Kancera AB shifts focus to cardiovascular diseases, emphasizing the development of KAND567 and KAND145 for ST-elevation myocardial infarction (STEMI) treatment. - Positive Phase IIa results from the FRACTAL study, showing reduced intramyocardial hemorrhage with KAND567, drive the strategic decision. - A Phase IIb study is planned to confirm cardio-protective effects, followed by a Phase III trial assessing major adverse cardiovascular events (MACE). - Kancera anticipates significant market potential and willingness to pay for an effective STEMI treatment, particularly in the US market.
