Sun Pharma Gets CDSCO Panel Nod for Phase IV Sovateltide Trial
New Delhi: Sun Pharma Laboratories Limited has received a recommendation from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase IV clinical trial of Sovateltide for Injection 30 µg.
This came after firm presented Phase-IV Clinical Trial protocol of the drug Sovateltide for Injection 30 μg, (Protocol No. SP/Neurology/Sovateltide/PIV-01-2025, Version No. 1.0; Dated 03 Nov 2025) before the committee.
Sovateltide is an endothelin-B receptor agonist used in India for cerebral ischaemic stroke. It has been studied as a treatment alongside standard care for patients with acute cerebral ischaemic stroke.
At the recent SEC meeting for Neurology and Psychiatry, the expert panel examined the Phase-IV Clinical Trial protocol of the drug Sovateltide for Injection 30 μg, presented by Sun Pharma Laboratories.
The committee, however, asked the company to remove the control arm and include all patients in the drug arm.
After deliberation, the committee observed that the proposed study did not include sufficient government centres. It said the clinical trial sites should be geographically distributed across the country, including more government centers.
Finally, the committee recommended a grant of permission to conduct Phase IV clinical trial as the protocol presented by the firm. In line with the above, the expert panel asked the firm to submit Phase IV clinical trial report to CDSCO for further review by the committee.
