Pharmazz, Inc. Receives U.S. FDA Orphan Drug Designation for Sovateltide for the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy (NHIE)
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Pharmazz has secured FDA Orphan Drug Designation for sovateltide, an investigational treatment for neonatal hypoxic-ischemic encephalopathy (NHIE).
Pharmazz, Inc., a biopharmaceutical company developing novel therapeutics for critical care and neurovascular conditions, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to its investigational agent, sovateltide, for the treatment of neonatal hypoxic-ischemic encephalopathy (NHIE).
Neonatal hypoxic-ischemic encephalopathy is a serious, life-threatening brain injury caused by oxygen deprivation and restricted cerebral blood flow around the time of birth. NHIE remains a major cause of acute neonatal mortality and chronic neurodevelopmental disabilities, including cerebral palsy, epilepsy, and cognitive impairment, with limited therapeutic interventions currently available.
"Receiving Orphan Drug Designation from FDA for sovateltide in neonatal hypoxic-ischemic encephalopathy marks an important milestone in our mission to address severe neurovascular conditions with high unmet medical needs," said Dr. Anil Gulati, M.D., Ph.D., Chairman and Chief Executive Officer of Pharmazz, Inc. "NHIE presents a devastating burden for newborns and their families. Through its selective endothelin B receptor agonist pathway promoting neural regeneration, neurovascular repair, and neuroprotection, we believe sovateltide has strong potential to improve clinical outcomes for these vulnerable patients. We look forward to advancing our clinical development program in close communication with FDA."
Five presentations will be made on-site at the upcoming 18th World Stroke Congress, taking place 21-23 October 2026, at the Convention & Exhibition Center, Seoul, South Korea.
About Orphan Drug Designation
The FDA's Orphan Drug Designation program provides orphan status to investigational drugs and biological products intended to safely and effectively treat, diagnose, or prevent rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation qualifies the sponsor for specific development incentives under the Orphan Drug Act, which may include tax credits for qualified clinical testing, exemptions from prescription drug user fees (PDUFA), and potential eligibility for seven years of market exclusivity in the U.S. upon regulatory approval for the designated indication.
About Sovateltide
Sovateltide (IRL-1620) is a first-in-class endothelin-B receptor agonist that promotes neurogenesis, angiogenesis, and neuronal survival following acute hypoxic and ischemic insults. The drug is currently being evaluated in clinical programs for acute ischemic conditions. The Phase 3 RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244) trial is being conducted at 57 sites in the US, Germany, Spain, and the UK, and is designed to enroll 514 stroke patients.
About Pharmazz, Inc.
Pharmazz, Inc. is a visionary biopharmaceutical company dedicated to developing and commercializing innovative therapeutics for critical care medicine. Founded in 2010 and led by Professor Dr. Anil Gulati, a distinguished pharmacologist, inventor, and academic, Pharmazz is making groundbreaking advances in neurovascular pharmacology to address major unmet medical needs worldwide.
