From India to the World: The Rise of Sovateltide in Stroke Recovery

Stroke cases are rising, with limited therapies available. Sovateltide (Tyvalzi) shows promise, improving outcomes in India and advancing in global Phase 3 trials. Backed by Sun Pharma, Pharmazz aims to expand stroke care and develop new life-saving drugs.

 Shahid Akhter, Consulting Editor, FEHealthcare, spoke to Prof. Anil Gulati, Founder Director & Chairman, Pharmazz, and also Emeritus Professor at Midwestern University and the University of Illinois, Chicago, to know more about Sovateltide’s clinical success in India and its promising Phase 3 U.S. and global trial progress.

What are the key challenges and emerging opportunities in stroke care today? 

Acute cerebral ischemic stroke causes damage to brain tissues, which may lead to disabilities or death. The incidence of brain stroke is increasing, particularly in the younger population. In 2021 alone, 93.8 million people were living with stroke, and 11.9 million new cases occurred worldwide. 

Clot-breaking medications such as tissue plasminogen activator (tPA) and surgical procedures such as stentrievers can restore blood flow to the brain, minimizing the impact of a stroke but with limited success. There has not been a new FDA-approved non-thrombolytic therapy for stroke in over 30 years. Therefore, continuous efforts are underway to develop better therapies. However, due to the complex pathophysiology of stroke, the development of a new promising drug is challenging, as evident by the failure of several agents in late-stage clinical trials. 

We have shown promising results in our previous Phase 3 study, which showed that sovateltide (brand name Tyvalzi) could be a meaningful advance over the standard of care to promote a fast recovery and improve neurological outcomes in cerebral ischemic stroke patients. 

Sovateltide was introduced in India in 2023. What has the clinical response been so far? Can you also update us on the progress and expectations around the pending Phase 3 trial in the U.S.?

In a Phase 3 study of 158 patients in India, Sovateltide showed statistically significant and clinically meaningful results demonstrating improvements in key neurological outcomes.

Sovateltide was approved in India in May 2023 for cerebral ischemic stroke, and an exclusive sales, marketing, and distribution agreement for India was executed with Sun Pharmaceuticals, who launched sovateltide in India under its brand name Tyvalzi on September 14, 2023. Over 60,000 patients have been treated to date since the commercial launch in India.

The US Food and Drug Administration (FDA) has given the go-ahead to initiate the Phase 3 study. In addition, a Special Protocol Assessment agreement was reached with the FDA for the Phase 3 trial of sovateltide to treat cerebral ischemic stroke. The Phase 3 clinical trial is designed for a total of 514 stroke patients at 65 sites in the US, Germany, Spain, Australia, and the UK. The primary endpoint is the proportion of patients demonstrating functional independence post-stroke, defined as a modified Rankin Scale (mRS) score of 0–2 at 90 days after stroke onset. Pharmazz has now enrolled and treated its first patient in the Phase 3 RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244). 

 Could you elaborate on Sun Pharma’s investment in Pharmazz? How does this strategic partnership impact the roadmap for Sovateltide and other pipeline candidates?

In June 2025 Sun Pharma did a $25 million equity investment in Pharmazz, Inc., and this strategic investment brings Sun Pharma’s total commitment in Pharmazz to $40 million, including an earlier $15 million equity investment. We now have sufficient capital to complete this study to further cement the potential for sotatercept in the USA and the rest of the world. This investment gives us the operational runway to execute a complex, multi-country clinical trial and scale the company responsibly as we prepare for a potential public offering. 

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