AstraZeneca's Proposal to Increase Sample Size in Zibotentan-Dapagliflozin Global Trial Gets SEC Nod
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended approval of a protocol amendment increasing the sample size in an ongoing global trial of the investigational combination therapy of Zibotentan and Dapagliflozin.
AstraZeneca Pharma India Limited presented its proposal for approval of a protocol amendment, version 2.0 dated 14.02.2025, to the SEC. The amendment pertains to protocol number D4325C00010, which had earlier been reviewed and recommended by the SEC (Renal) in its meeting dated 20.05.2025.
In its latest submission, the firm sought approval for increasing the sample size of the trial from 1,500 to 1,800 participants. Justification for the amendment was presented to the committee as part of the revised protocol documents.
The study involves the evaluation of Zibotentan 0.25 mg + Dapagliflozin 10 mg and Zibotentan 0.75 mg + Dapagliflozin 10 mg.
AstraZeneca Pharma India Limited, headquartered in Bengaluru, is a subsidiary of AstraZeneca UK. The company focuses on major therapeutic areas including oncology, cardiovascular, renal, and metabolic diseases, and has an established presence in India through research partnerships and marketed products such as Dapagliflozin under the brand name Forxiga.
Zibotentan is an endothelin receptor antagonist being developed by AstraZeneca, while Dapagliflozin is a well-established SGLT2 inhibitor used in the management of type-2 diabetes, chronic kidney disease, and heart failure. The combination aims to provide enhanced renoprotection and address unmet needs in patients at risk of progression of renal disease.
After detailed deliberation, the SEC recommended approval of the protocol amendment for the increased sample size as presented by the firm.
This will allow AstraZeneca to recruit additional participants, thereby strengthening the trial’s ability to generate robust safety and efficacy data to support further regulatory submissions.
