Pharmazz, Inc. Receives U.S. FDA IND Clearance to Initiate Phase 3 Clinical Trial of Sovateltide in Traumatic Brain Injury

Milestone Validates Proprietary Neural Repair Discovery Engine and Marks Major Expansion of First-in-Class Endothelin-B Receptor Agonist into a Critical Neurotrauma Indication with Significant Unmet Need

Sovateltide is currently enrolling patients in RESPECT-ETB, a global Phase 3 clinical trial for treatment of acute ischemic stroke, and was recently granted Orphan Drug Designation for treatment of hypoxic‑ischemic encephalopathy (HIE)

WILLOWBROOK, Ill., Sept. 30, 2026 (GLOBE NEWSWIRE) — Pharmazz, Inc. (“Pharmazz” or the “Company”), a late-stage biopharmaceutical company focused on developing and commercializing first-in-class therapeutics for critical care and neurological conditions, today announced that U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to proceed with a pivotal Phase 3 clinical trial evaluating sovateltide (IRL-1620) for the treatment of patients with acute traumatic brain injury (TBI).

“FDA clearance for our Phase 3 IND in traumatic brain injury represents a monumental regulatory and clinical milestone for Pharmazz,” said Anil Gulati, M.D., Ph.D., Founder, Chief Executive Officer, and Chairman of the Board of Pharmazz, Inc. “Despite decades of intensive clinical research, there are currently no approved neuroprotective or neuroregenerative pharmacotherapies for patients suffering from acute traumatic brain injury. This TBI clearance underscores the broad applicability of sovateltide across acute and chronic neurovascular indications.”

“Sovateltide has demonstrated a remarkable ability to promote endogenous repair mechanisms and restore neurological function across severe acute brain injuries. It has been approved in India for treatment of ischemic stroke, is enrolling patients in a global Phase 3 study (RESPECT-ETB) in ischemic stroke and was recently granted Orphan Drug Designation for treatment of HIE,” continued Dr. Gulati.

About the Phase 3 TBI Clinical Trial Design

The multicentre, randomized, double-blind, placebo-controlled Phase 3 TBI trial is designed to assess the safety, tolerability, and clinical efficacy of intravenous sovateltide administered alongside standard of care in adult patients presenting with acute moderate-to-severe traumatic brain injury:

• Study Population: Adult (18 to 90 years of age) patients presenting within the acute therapeutic window following trauma, stratified by baseline injury severity (Glasgow Coma Scale [GCS] score) and neuroimaging findings.
• Treatment Regimen: Patients (n=214) will be randomized to receive either sovateltide (administered as an intravenous bolus over 1-2 minutes at spaced dosing intervals across the first week post-injury) plus standard critical care (n=107), or matching placebo plus standard critical care (n=107).
• Primary Endpoint: Proportion of patients achieving a favorable functional recovery as measured by the Glasgow Outcome Scale-Extended (GOS-E) at Day 90 post-injury.
• Key Secondary Endpoints:
  • All-cause mortality rate through Day 90 and Day 180.
  • Reduction in neurocognitive and motor disability evaluated by the Disability Rating Scale (DRS) and NIH Stroke Scale (NIHSS).
  • Length of stay in the Intensive Care Unit (ICU) and total hospital stay.
  • Circulating biomarkers of neuronal and glial damage (including GFAP and UCH-L1).
  • Comprehensive safety, tolerability, and intracranial pressure monitoring.

The Unmet Medical Need in Traumatic Brain Injury

Traumatic brain injury (TBI) is one of the leading causes of death and long-term disability worldwide, contributing to millions of emergency visits, hospitalizations, and deaths annually. In the United States alone, the Centers for Disease Control and Prevention (CDC) estimates that over 2.5 million TBI-related medical encounters occur each year.

While the primary insult occurs immediately upon biomechanical impact, much of the long-term morbidity and mortality stems from progressive secondary injury cascades—including cellular energy failure, ischemia, cerebral edema, oxidative stress, and delayed apoptosis occurring over subsequent hours and days. Current medical management remains strictly supportive (surgical decompression, intracranial pressure management, and hemodynamic optimization). There is currently no approved drug therapy designed to stop cellular damage and promote tissue regeneration in acute TBI.

Ongoing Global Phase 3 Trial: The RESPECT-ETB Study in Acute Cerebral Ischemic Stroke

The expansion of sovateltide into TBI builds on substantial clinical momentum established by Pharmazz’s ongoing pivotal program in stroke:

• Pivotal Phase 3 Evaluation: Sovateltide is currently being evaluated in RESPECT-ETB, a randomized, double-blind, multicenter, placebo-controlled Phase 3 trial enrolling acute cerebral ischemic stroke patients across sites in the United States and Europe.
• Clinical Focus & Window: The RESPECT-ETB trial assesses the safety and functional efficacy of sovateltide administered within an extended therapeutic window post-stroke onset alongside standard medical management (including thrombolytic therapy where applicable).
• Building on Demonstrated Efficacy: The study follows regulatory approval in India, where pivotal Phase 3 data demonstrated statistically significant and sustained improvements in neurological and functional recovery on the modified Rankin Scale (mRS) and NIH Stroke Scale (NIHSS) at 90 days. Sovateltide is marketed in India as Tyvalzi™ by Sun Pharmaceuticals.

Harnessing a Proprietary Platform to Broaden CNS Indications

Pharmazz’s drug discovery and development platform leverages deep expertise in cellular GPCR signaling—specifically targeting endothelin receptor subtypes—to discover agents orchestrating endogenous neurorepair.

Rather than relying solely on acute symptom mitigation, the Company’s platform targets conserved secondary injury pathways common to multiple severe neurological conditions:

• Broad Indication Pipeline: By mobilizing neural progenitor cell migration and stabilizing microvascular integrity, the platform enables sovateltide to address a wide spectrum of CNS conditions beyond stroke and TBI, including hypoxic-ischemic encephalopathy (HIE), and progressive neurodegenerative diseases such as Alzheimer’s disease.
• Dual Action Mechanisms: The platform designs therapeutics that combine immediate cytoprotective actions (mitochondrial preservation, anti-apoptotic signaling, anti-inflammation) neuroregenerative recovery (neurogenesis, synaptogenesis, and neo-angiogenesis).

About Sovateltide (IRL-1620)

Sovateltide is an investigational synthetic peptide that functions as a highly selective endothelin-B () receptor agonist. Following acute cerebral trauma or ischemia, sovateltide crosses the compromised blood-brain barrier and activates receptors expressed on endothelial cells, astrocytes, and neural progenitor cells (NPCs):

• Neurovascular Remodeling: Stimulates the differentiation and migration of endogenous neural progenitor cells, fostering neurogenesis (formation of new functional neurons) and angiogenesis (formation of new microvasculature).
• Mitochondrial Protection & Biogenesis: Preserves mitochondrial membrane potential, mitigates secondary energy failure, and reduces toxic oxidative cascades.
• Anti-Apoptotic & Anti-Inflammatory Effects: Inactivates downstream apoptotic pathways in penumbral tissue and downregulates secondary neuroinflammatory cascades.
• Microvascular Perfusion: Enhances cerebral blood microcirculation without causing adverse systemic hypotension.

About Pharmazz, Inc.
Pharmazz, Inc. is a late-stage biopharmaceutical company focused on the development and commercialization of innovative, first-in-class therapies for critical care medicine and neurological disorders. Founded in 2010 by Professor (Dr.) Anil Gulati, Pharmazz is advancing a deep pipeline anchored by two proprietary platform molecules: sovateltide (IRL-1620), targeting acute ischemic stroke, traumatic brain injury, hypoxic-ischemic encephalopathy, and Alzheimer’s disease; and centhaquine (PMZ-2010), a first-in-class resuscitative agent being developed for hypovolemic and septic shock.
For more information, please visit www.pharmazz.com.

Safe Harbor / Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding the initiation, timing, design, and progress of clinical trials for sovateltide, the potential therapeutic benefits and clinical outcomes, regulatory submissions and approvals, and commercial potential, are forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that may cause Pharmazz’s actual results, performance, or achievements to be materially different from any future results expressed or implied by the forward-looking statements. Pharmazz undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Contacts: Pharmazz, Inc.