Sun Pharma Gets SEC Recommendation to Conduct Phase IV Trial of Sovateltide

CDSCO Expert Panel Reviews Sovateltide Clinical Trial Protocol

Sun Pharma Laboratories Limited has received a recommendation from the Subject Expert Committee (SEC) under India's Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase IV clinical trial of Sovateltide for Injection 30 μg.

The recommendation came after Sun Pharma presented its proposed Phase IV clinical trial protocol for the drug before the SEC's Neurology and Psychiatry expert panel.

The protocol submitted by the company was identified as Protocol No. SP/Neurology/Sovateltide/PIV-01-2025, Version No. 1.0, dated November 3, 2025.

The committee reviewed the proposed study and suggested several changes to the trial design, including changes to the control arm and the selection and distribution of clinical trial sites.

What Is Sovateltide?

Sovateltide is an endothelin-B receptor agonist that is used in India for cerebral ischaemic stroke.

Cerebral ischaemic stroke happens when blood flow to part of the brain is blocked. When this happens, brain cells may not receive enough oxygen and nutrients.

Sovateltide has been studied as a treatment used alongside standard care for patients with acute cerebral ischaemic stroke.

The Phase IV trial will provide additional clinical information about the medicine after its use in the approved setting.

Sun Pharma Presented the Phase IV Trial Protocol

During the recent SEC meeting for Neurology and Psychiatry, Sun Pharma Laboratories presented its proposed Phase IV clinical trial protocol for Sovateltide for Injection 30 μg.

Phase IV studies are generally conducted after a medicine has already received approval. These studies can provide additional information about how a medicine performs when used in broader patient populations and in routine clinical settings.

For Sun Pharma, the proposed study is part of the company's continued clinical evaluation of Sovateltide in cerebral ischaemic stroke.

SEC Asked Sun Pharma to Remove the Control Arm

During its review, the SEC asked Sun Pharma to make a change to the proposed study design.

The committee instructed the company to remove the control arm and include all patients in the drug treatment arm.

In a clinical trial, a control arm normally provides a comparison group against which the treatment group can be evaluated. In the protocol reviewed by the SEC, the committee wanted the proposed Phase IV study to include all enrolled patients in the Sovateltide treatment arm.

The company will need to follow the committee's recommendation as it moves forward with the study.

Committee Raises Concerns About Clinical Trial Centres

The SEC also reviewed the locations proposed for conducting the Phase IV clinical trial.

According to the committee, the proposed study did not include enough government centres.

The expert panel asked Sun Pharma to include more government clinical trial centres in the study.

The committee also said that the trial sites should be geographically distributed across the country.

This means the study should not be concentrated in only a limited number of locations. Including sites from different parts of India can help the company collect clinical data from a broader range of patients and healthcare settings.

SEC Recommends Permission for the Phase IV Trial

After reviewing the protocol and discussing the proposed changes, the SEC recommended granting permission to conduct the Phase IV clinical trial.

The recommendation was made based on the protocol presented by Sun Pharma, along with the observations and requirements discussed during the meeting.

The recommendation allows the company to move ahead with the next steps required for conducting the post-approval clinical study, subject to the applicable regulatory process.

Sun Pharma Asked to Submit the Phase IV Trial Report

The SEC also asked Sun Pharma to submit the Phase IV clinical trial report to CDSCO after the study is completed.

The report will be reviewed by the expert committee as part of the regulatory follow-up.

The submission will give the committee additional clinical information from the Phase IV study and allow it to assess the findings after the trial has been conducted.

Why the Trial Matters for Sovateltide

The Phase IV study is expected to generate additional information on Sovateltide in patients with cerebral ischaemic stroke.

Because the study will be conducted after the medicine's approval and use in India, the resulting data can add to the existing clinical evidence for the treatment.

The SEC's request for geographically distributed sites and more government centres also means the study is expected to involve a wider range of healthcare settings across India.

What Happens Next?

Sun Pharma will need to incorporate the SEC's recommendations into the clinical trial process, including the changes related to the control arm and clinical trial centres.

The company will then proceed with the required regulatory and study-related steps for the Phase IV trial.

Once the study is completed, Sun Pharma will be required to submit the Phase IV clinical trial report to CDSCO for further review by the expert committee.

The SEC's recommendation gives Sun Pharma a regulatory pathway to proceed with the proposed Phase IV evaluation of Sovateltide for Injection 30 μg in cerebral ischaemic stroke.

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