Safety and efficacy study of sovateltide in patients with acute cerebral ischaemic stroke
Research type
Research Study
Full title
A multicentric, randomized, double-blind, parallel, placebo-controlled phase III study to assess the safety and efficacy of sovateltide in patients with acute cerebral ischemic stroke.
IRAS ID
1011112
Contact name
Prof. Anil Gulati
Contact email
Sponsor organisation
Pharmazz EU Limited (A Wholly Owned Subsidiary of Pharmazz, Inc.)
Clinicaltrials.gov Identifier
Research summary
A study of an investigational drug called sovateltide as a possible treatment for acute cerebral ischaemic stroke (ACIS). An investigational drug is one that has not been approved by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States (US), the European Medicines Agency (EMA) in the European Union (EU), or Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.
Sovateltide targets specific receptors called ETB receptors present in the brain and blood vessels. These receptors act like tiny locks on the surface of cells in the brain. When sovateltide binds to these receptors, it activates them and triggers several important processes in the brain. It helps the growth of new blood vessels and new brain cells, which are important for repairing and regenerating damaged brain tissues after a stroke. The activation of these receptors by sovateltide also protects them from further damage and may restore their function. In studies with rats, sovateltide not only helped in brain cell regrowth but also reduced brain swelling and stress. This led to better survival rates, improvements in movement (indicating reduced disability) and brain function. Also, in prior studies in human participants with stroke, sovateltide has been found to be a safe and effective therapeutic option.
The main purpose of this study is to see how safe and effective sovateltide is compared with a placebo to improve the symptoms of acute cerebral ischaemic stroke. A placebo is an intravenous (IV) injection that looks exactly like sovateltide but does not have any sovateltide; it only contains ingredients that do not have any medicinal effects on the body. Researchers use a placebo to see if the drug works better or is safer than taking nothing. From here on, sovateltide and placebo will be referred to as the “study drug.”REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0055
Date of REC Opinion
22 May 2025
REC opinion
Further Information Unfavourable Opinion