CDSCO Panel approves Novartis Protocol Amendment Proposal For TIN816 study in Sepsis-associated Acute Kidney Injury
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the protocol amendment proposal presented by Novartis for the renal drug TIN816 study.
This came after the firm presented protocol amendment version 01 dated 17 Apr 2024 and protocol amendment version 02 dated 29 Apr 2024, protocol no. CTIN816B12202. This is a multicenter, randomized, double-blind, placebo-controlled, four-arm, parallel-group, dose-finding phase 2b study to investigate the safety and efficacy of TIN816 via a single intravenous infusion in the treatment of participants with sepsis-associated acute kidney injury (SA-AKI)".
TIN816 is a new drug that is currently being studied for its potential to help patients who are at risk of developing acute kidney injury (AKI) after undergoing cardiac surgery
TIN-816 is under development for the treatment of sepsis-associated acute kidney injury (SA-AKI) and acute kidney injury following cardiac surgery. It is administered through the intravenous route in the form of powder. The drug candidate acts by targeting adenosine triphosphatase (ATP).
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