CDSCO Panel approves Novartis Protocol Amendment Proposal For TIN816 study in Sepsis-associated Acute Kidney Injury

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-01-05 12:00 GMT | Update On 2025-01-05 12:00 GMT

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.

Also Read:AstraZeneca Gets CDSCO Panel Nod To study Anti-Cancer Drug Rilvegostomig

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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CDSCO Panel approves Novartis Protocol Amendment Proposal For TIN816 study in Sepsis-associated Acute Kidney Injury

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