Novo Nordisk Gets CDSCO Panel Nod To study CDR132L
New Delhi: Novo Nordisk has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical trial of CDR132L 45.2 (45,2) mg/vial, a synthetic oligonucleotide that's being developed to treat heart failure.
This came after Novo Nordisk presented phase 2 clinical study protocol no. NN6706-8282 version 1.0 dated 21 November 2024.
CDR132L is an oligonucleotide-based inhibitor directed against miRNA132 (miR-132), designed to halt and reverse the development of detrimental cardiac remodeling. CDR132L selectively blocks aberrant miR-132 levels, leading to the reversal of cellular pathology and restoration of normal function in cardiomyocytes, contributing to improved cardiac systolic and diastolic function in patients with heart failure.
In a phase 1b trial published in the European Heart Journal, CDR132L was reported to be safe and well tolerated and the results suggested cardiac functional improvements in people with heart failure compared to placebo.
CDR132L is a highly stable water-soluble oligonucleotide formulated for parenteral or subcutaneous application.
Patients with acute myocardial infarction (MI) and subsequent LV dysfunction and remodeling have limited therapeutic options and may profit from early CDR132L treatment.
At the recent SEC meeting for Cardiovascular held on 28th January 2025, the expert panel reviewed phase 2 clinical study protocol no. NN6706-8282 version 1.0 dated 21 November 2024.
After detailed deliberation, the committee recommended granting permission to conduct the trial as presented by the firm.
Also Read: CDSCO Panel Approves Novo Nordisk Proposal Amendment Proposal for Etavopivat study
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