喜报!麦科奥特MT1013 Ⅲ期临床研究,顺利完成全部试验参与者入组!
MICOT
点击蓝字 关注我们

Slide to view different languages
<< 滑动查看不同语言 >>
麦科奥特MT1013 Ⅲ期临床研究
顺利完成全部试验参与者入组
2026年4月10日,麦科奥特申办的「一项评估MT1013治疗慢性肾脏病维持性血液透析伴继发性甲状旁腺功能亢进受试者有效性及安全性的多中心、随机、双盲双模拟、与西那卡塞阳性对照的Ⅲ期临床研究」,正式达成重要里程碑——顺利完成全部试验参与者入组,为这款创新药物的上市之路筑牢关键根基!

本研究自2025年9月迎来重要突破:当月顺利完成首家研究中心启动,同步实现首例试验参与者入组,正式拉开Ⅲ期临床研究的序幕。此后,在全国100余家研究中心的鼎力支持、临床研究者的严谨履职,以及麦科奥特项目团队的通力协作下,我们高效推进各项研究工作,全力保障入组流程的规范与顺畅。
MICOT
截至2026年4月10日,本研究顺利完成第435例试验参与者入组,标志着整个入组阶段圆满收官!从首例入组到末例入组,仅用时6个月,较原计划提前20余天,用专业与效率,彰显了麦科奥特在创新药研发领域的硬实力,也凝聚着所有参与者的心血与付出。
此次入组里程碑的顺利达成,不仅是MT1013临床研究进程中的重要节点,更为该产品后续上市申报进一步打下坚实基础。接下来,研究重心将正式转移至下一阶段——试验参与者随访与数据清理工作。

麦科奥特将始终秉持“以患者为中心”的理念,严格遵循临床试验规范,严谨梳理每一份临床数据,全力推进后续各项工作,力争以高质量的临床数据助力NDA(新药上市申请),早日将MT1013带给广大慢性肾脏病维持性血液透析伴继发性甲状旁腺功能亢进(SHPT)患者,为他们带来更优的治疗选择,守护生命健康!
感恩同行,共赴新程!感谢全国100余家研究中心、所有临床研究者及试验参与者的支持与付出,麦科奥特将持续深耕创新,不负期待,在医药创新的道路上稳步前行,书写更多健康篇章!
MICOT


欢迎关注
麦科奥特|MICOT
Good News! Micot’s MT1013 Phase Ⅲ Clinical Study Completes Enrollment of All Participants!
On April 10, 2026, the Phase Ⅲ clinical study sponsored by Micot – "A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled (vs. Cinacalcet) Study to Evaluate the Efficacy and Safety of MT1013 in Patients with Chronic Kidney Disease on Maintenance Hemodialysis and Secondary Hyperparathyroidism" – officially reached a significant milestone: the successful enrollment of all trial participants, laying a critical foundation for the path to market for this innovative drug.

This study achieved a major breakthrough in September 2025, when the first site was initiated and the first participant was enrolled, marking the official start of the Phase Ⅲ clinical trial. Since then, with the strong support of over 100 clinical trial centers nationwide, the rigorous efforts of the clinical investigators, and the close collaboration of the Micot project team, we have efficiently advanced all research activities and ensured the standardization and smoothness of the enrollment process.
MICOT
As of April 10, 2026, the study has completed the enrollment of the 435th trial participant, marking the successful conclusion of the entire enrollment phase. From the enrollment of the first participant to the last, it took only six months – more than 20 days ahead of schedule. This achievement demonstrates Micot’s strength in innovative drug R&D through professionalism and efficiency, and embodies the dedication and hard work of all participants.
The successful completion of this enrollment milestone is not only a key step in the MT1013 clinical research process but also further solidifies the foundation for the product’s future NDA submission. Moving forward, the focus of the study will officially shift to the next phase: participant follow-up and data cleaning.

Micot remains committed to a patient-centered approach, strictly adhering to clinical trial standards, rigorously analyzing every piece of clinical data, and advancing all subsequent work to support the NDA with high-quality clinical data. We aim to bring MT1013 to patients with chronic kidney disease on maintenance hemodialysis and secondary hyperparathyroidism (SHPT) as soon as possible, offering them better treatment options and safeguarding life and health.
We extend our sincere thanks to the over 100 clinical research centers, all clinical investigators, and trial participants for their support and dedication. Micot will continue to innovate deeply, live up to expectations, and steadily advance on the path of pharmaceutical innovation, writing more healthy chapters to come!
MICOT


欢迎关注
麦科奥特|MICOT
详情
奋斗为本、求是创新、协作共赢