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).

Acute kidney injury is a sudden decrease in kidney function that can occur after major surgeries, especially heart surgeries. This condition can be serious and may lead to complications or even long-term kidney problems. TIN816 is being developed specifically to address this risk in patients undergoing cardiac surgery.

At the recent SEC meeting held on 17th December 2024 for Renal, the expert panel reviewed the protocol amendment version 01 dated 17 Apr 2024 and protocol amendment version 02 dated 29 Apr 2024 protocol no. CTIN816B12202.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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