India Pharma Outlook Team | Monday, 15 September 2025
AstraZeneca has received a green signal from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) for a protocol being amended to widen the ongoing global clinical trial of the astonishing combination of Zibotentan and Dapagliflozin.
AstraZeneca Pharma India Limited gave its proposal for amendment version 2.0 dated 14th February 2025 related to protocol number D4325C00010. This clinical trial protocol came up for review at the SEC (Renal) meeting in May 2025. In this submission, AstraZeneca requested permission to raise the sample size from 1,500 to 1,800 with rationale and documentation. The SEC, after the elaborate examination, endorsed the mentioned amendment.
The present study constructs two dosage combinations—Zibotentan 0.25 mg + Dapagliflozin 10 mg and Zibotentan 0.75 mg + Dapagliflozin 10 mg. Zibotentan as one of the contenders in the endothelin receptor antagonist class is being tailored to bring about renal protection, and at the same time, Dapagliflozin, which is an SGLT2 inhibitor with proven efficacy and is sold all over the world under the name Forxiga, is the drug of choice for type-2 diabetes, chronic kidney disease, and heart failure.
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Interestingly, AstraZeneca Pharma India, located in Bengaluru and owned by AstraZeneca UK, has been a major player in the development of oncology, cardiovascular, renal, and metabolic disease portfolios. The increase in the sample size is expected to advance the trial’s statistical power thus opening up a wider horizon for a more detailed safety and efficacy evaluation.
The recommendation by the SEC will allow AstraZeneca to speed up the patient recruitment process thereby collecting data that is more extensive and would be a strong basis for regulatory filings and future therapeutic approvals.
