Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
NCT ID: NCT05691244
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
514 participants
INTERVENTIONAL
2025-07-24
2026-11-30
Brief Summary
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Detailed Description
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The global burden of ischemic stroke is nearly 4-fold greater than hemorrhagic stroke with close to 87% of the total incidence of stroke attributed to acute cerebral ischemic stroke (ACIS). ACIS is a critical care emergency caused by a significant reduction in blood flow to the brain by a blood clot or embolism. This nearly halts cerebral blood flow to the affected region leading to neuronal death. Neuronal cell death is followed by plasma membrane disruption, swelling of organelles, leaking of cell contents into extracellular space, and loss of neuronal function. Other events that take place include inflammation, excitotoxicity, free radical mediated toxicity, cytokine mediated cytotoxicity, impaired blood-brain-barrier, and oxidative stress.
Therapeutic management of ACIS is a multidisciplinary approach with a primary goal of revascularization and limiting neuronal injury. A stroke team consists of emergency medicine physicians, neurologists/neurosurgeons, radiologists, nurses and advanced care providers, clinical pharmacists, therapists, technicians, and laboratory personnel. Currently, the only FDA-approved pharmacological agent for ischemic stroke is tissue plasminogen activator (t-PA). It is a thrombolytic agent which restores blood flow by breaking down a clot. However, timing is crucial in administration of t-PA as the therapeutic time window is very narrow and the patient must receive it within 4.5 hours of onset of stroke symptoms. Therapeutic administration after this timeframe can result in hemorrhagic transformation, leading to additional brain damage. Nevertheless, even upon timely administration of t-PA in ACIS, only about 30% of patients obtain stroke resolution having minimal or no disability at the 90-day mark.
Sovateltide (PMZ-1620, IRL-1620) is a highly selective ETB receptor agonist and a synthetic analog of ET-1. Studies conducted to determine the effects brought about by sovateltide upon its interaction with neural ETB receptors and have found that it enhances angiogenesis and neurogenesis as well as promotes neural repair and regeneration. In a rat model of ischemic stroke, sovateltide was found to be neuroprotective as well as enhance angiogenic and neurogenic remodeling. Sovateltide significantly improved survival, reduced neurological and motor function deficit, while effectively decreasing infarct volume, edema, and oxidative stress.
Sovateltide was also found to be safe and well tolerated in healthy human volunteers in a phase I clinical trial (CTRI/2016/11/007509). A phase II study was also conducted in patients with acute ischemic stroke where sovateltide demonstrated significant improvement when compared to standard of care (CTRI/2017/11/010654, NCT04046484). A recent phase III study conducted in patients of acute ischemic stroke demonstrated improved favorable functional and neurological outcome at 3 months compared to standard of care (CTRI/2019/09/021373, NCT04047563).
Clinical phase II and III results indicate that sovateltide is a first-in-class neuronal progenitor cell therapeutic that promotes quick recovery and significantly improves neurological outcomes in cerebral ischemic stroke patients. With this convincing evidence, the plan is to conduct a multicentric, randomized, double-blind, parallel, placebo-controlled phase III clinical study in the United States, Canada, United Kingdom and Europe (the demographics and standard of treatment being similar in these countries) to further assess the safety and efficacy of sovateltide in patients with acute cerebral ischemic stroke.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Normal Saline + Standard of care
Normal saline will be used as a comparator. It will be available in a 5.0 mL vial. Three doses will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.
Drug: Normal Saline
Normal saline to be used as vehicle in the phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke.
Sovateltide + Standard of care
The test product is sovateltide. It is available as a lyophilized injection containing 30 µg of sovateltide in a 5.0 mL vial. Three doses of 0.3 μg/kg will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.
Sovateltide
Phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke.
Interventions
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Drug: Normal Saline
Normal saline to be used as vehicle in the phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke.
Sovateltide
Phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Adult males or females aged 18 - 80 years of age.
2. Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures.
3. A stroke is ischemic in origin that is diagnosed clinically and/or radiologically confirmed by Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment. No hemorrhage as proved by cerebral CT/MRI scan.
4. Cerebral ischemic stroke patients presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and \<20, NIHSS Level of Consciousness (1A) score \<2 at the time of screening. This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke having a pre-stroke historical measure of mRS score of 0-2.
5. The patient is \<24 hours from the time of stroke onset when the first dose of sovateltide is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when the patient was last seen or was self- reported to be normal.
6. Reasonable expectation of availability to receive the full sovateltide/placebo course of therapy and to be available for subsequent follow-up visits.
Exclusion Criteria
2. Patients classified as comatose are defined as a patient who requires repeated stimulation to attend or is obtunded and requires strong or painful stimulation to make movements (NIHSS Level of Consciousness (1A) score ≥2).
3. Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan.
4. Known pregnancy and lactating women.
5. Known medical history of neurological (other than current acute ischemic stroke) or psychiatric condition that, in the investigator's opinion, would confound the neurological and functional evaluations, lead to further deterioration of neurological status, or interfere with participation in this study.
6. Concurrent participation in any other therapeutic clinical trial.
7. Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol impair the assessment of outcome, or in which sovateltide therapy would be contraindicated or might cause harm to the patient.
18 Years
80 Years
ALL
No
Sponsors
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Pharmazz, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Anil Gulati, MD, PhD
Role: STUDY_CHAIR
Pharmazz, Inc.
Locations
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The University of Arizona - College of Medicine
Tuscon, Arizona, United States
Mercy Medical Group
Carmichael, California, United States
St. John's Regional Medical Center
Oxnard, California, United States
SSM Health Neurosciences
Bridgeton, Missouri, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
CHI Memorial Neuroscience Institute
Chattanooga, Tennessee, United States
Houston Medical Neurological Institute
Houston, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
Klinikum Altenburger Land GmbH
Altenburg, Altenburg, Germany
Universitaetsklinikum Goettingen
Göttingen, Lower Saxony, Germany
Klinikum der Stadt Ludwigshafen gGmbh
Rhein, Ludwigshafen Am, Germany
Muhlenkreiskliniken (MKK) - Johannes Wesling Klinikum Minden - Neurologische Klinik
Minden, North Rhine-Westphalia, Germany
Klinik fuer Neurologie, Stroke Unit und Fruehrehabilitation Dorstener Strae 151
Recklinghausen, Recklinghausen, Germany
Charite-Universitaetsmedizin Berlin
Berlin, State of Berlin, Germany
Universitätsklinikum Essen AöR
Essen, , Germany
Universitätsklinikum Schleswig-Holstein AöR
Lübeck, , Germany
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Complejo Hospitalario Universitario de Albacete
Albacete, Castille-La Mancha, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Madrid, Spain
Hospital Clínico Universitario Virgen de Arrixaca
El Palmar, Murcia, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain
Hospital Universitari Joan XXIII
Tarragona, Tarragona, Spain
Instituto de Investigación Biomédica de A Coruña
A Coruña, , Spain
Hospital Universitario Infanta Cristina (HUB)
Badajoz, , Spain
Hospital Universitario de Cruces
Barakaldo, , Spain
Institut Catala d'Oncologia (ICO) - Hospital Universitari Doctor Josep Trueta
Girona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Clinico Universitario de Santiago
Santiago, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Fairfield General Hospital
Bury, Bury, United Kingdom
National Hospital for Neurology & Neurosurgery
London, London, United Kingdom
King's College Hospital NHS Foundation Trust
London, London, United Kingdom
University Hospital Southampton
Southampton, Southampton, United Kingdom
New Cross Hospital - Royal Wolverhampton NHS Trust
Wolverhampton, Wolverhampton, United Kingdom
Hospitals NHS Foundation Trust - Royal Victoria Infirmary RVI
Newcastle, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Firas Kaddouh, MD
Role: primary
Lucian Maidan, MD
Role: primary
Mani Nezhad
Role: primary
Amer Alshekhlee, MD
Role: primary
Yousef Hannawi
Role: primary
Dr Jussie Correia Lima
Role: primary
Thomas Devlin
Role: primary
David Chui, MD
Role: primary
Mahan Shahrivari, MD
Role: primary
Joerg Berrouschot
Role: primary
Ilko Maier
Role: primary
Dr Simon Nagel
Role: primary
Dr Peter Schellinger
Role: primary
Dr Stephan Klebe
Role: primary
Christian Nolte
Role: primary
Prof. Dr. med. Martin Köhrmann
Role: primary
Prof. Dr. George Royl
Role: primary
María Hernández Pérez
Role: primary
Carlos Alberto Molina Cateriano
Role: primary
Dr Tomas Segura Martin
Role: primary
Exuperio Díez Tejedor
Role: primary
Dr Joaquin Carneado Ruiz
Role: primary
Dr Ana Morales Ortiz
Role: primary
Soledad Pérez Sánchez
Role: primary
Dr Xavier Ustrell Roig
Role: primary
Dr Maria del Mar Castellanos Rodrigo
Role: primary
Dr Jose Maria Ramirez Moreno
Role: primary
Dr Mari Mar Freijo Guerrero
Role: primary
Dr Yolanda Silva Blas
Role: primary
Dr Jaime Masjuan Vallejo
Role: primary
Dr Jose Antonio Egido Herrero
Role: primary
Dr Manuel Rodriguez Yanez
Role: primary
Dr Francisco Moniche Alvarez
Role: primary
Dr. Alejandro Ponz
Role: primary
Dr Irene Escudero Martinez
Role: primary
Dr Herbert Tejada Meza
Role: primary
Dr Narayanamoorthi Saravanan
Role: primary
Dr Richard Perry
Role: primary
Dr Yee Mah
Role: primary
Dr Richard Marigold
Role: primary
Dr Nasar Ahmad
Role: primary
Dr. Anand Dixit
Role: primary
References
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Gulati A, Adwani SG, Vijaya P, Agrawal NR, Ramakrishnan TCR, Rai HP, Jain D, Sundarachary NV, Pandian JD, Sardana V, Sharma M, Sidhu GK, Anand SS, Vibha D, Aralikatte S, Khurana D, Joshi D, Karadan U, Siddiqui MSI. Efficacy and Safety of Sovateltide in Patients with Acute Cerebral Ischaemic Stroke: A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase III Clinical Trial. Drugs. 2024 Dec;84(12):1637-1650. doi: 10.1007/s40265-024-02121-5. Epub 2024 Nov 15.
Ranjan AK, Gulati A. Sovateltide Mediated Endothelin B Receptors Agonism and Curbing Neurological Disorders. Int J Mol Sci. 2022 Mar 15;23(6):3146. doi: 10.3390/ijms23063146.
Gulati A, Agrawal N, Vibha D, Misra UK, Paul B, Jain D, Pandian J, Borgohain R. Safety and Efficacy of Sovateltide (IRL-1620) in a Multicenter Randomized Controlled Clinical Trial in Patients with Acute Cerebral Ischemic Stroke. CNS Drugs. 2021 Jan;35(1):85-104. doi: 10.1007/s40263-020-00783-9. Epub 2021 Jan 11.
Ramos MD, Briyal S, Prazad P, Gulati A. Neuroprotective Effect of Sovateltide (IRL 1620, PMZ 1620) in a Neonatal Rat Model of Hypoxic-Ischemic Encephalopathy. Neuroscience. 2022 Jan 1;480:194-202. doi: 10.1016/j.neuroscience.2021.11.027. Epub 2021 Nov 23.
Ranjan AK, Briyal S, Gulati A. Sovateltide (IRL-1620) activates neuronal differentiation and prevents mitochondrial dysfunction in adult mammalian brains following stroke. Sci Rep. 2020 Jul 29;10(1):12737. doi: 10.1038/s41598-020-69673-w.
Ranjan AK, Briyal S, Khandekar D, Gulati A. Sovateltide (IRL-1620) affects neuronal progenitors and prevents cerebral tissue damage after ischemic stroke. Can J Physiol Pharmacol. 2020 Sep;98(9):659-666. doi: 10.1139/cjpp-2020-0164. Epub 2020 Jun 23.
Gulati A, Hornick MG, Briyal S, Lavhale MS. A novel neuroregenerative approach using ET(B) receptor agonist, IRL-1620, to treat CNS disorders. Physiol Res. 2018 Jun 27;67(Suppl 1):S95-S113. doi: 10.33549/physiolres.933859.
Briyal S, Nguyen C, Leonard M, Gulati A. Stimulation of endothelin B receptors by IRL-1620 decreases the progression of Alzheimer's disease. Neuroscience. 2015 Aug 20;301:1-11. doi: 10.1016/j.neuroscience.2015.05.044. Epub 2015 May 27.
Leonard MG, Prazad P, Puppala B, Gulati A. Selective Endothelin-B Receptor Stimulation Increases Vascular Endothelial Growth Factor in the Rat Brain during Postnatal Development. Drug Res (Stuttg). 2015 Nov;65(11):607-13. doi: 10.1055/s-0034-1398688. Epub 2015 Mar 25.
Briyal S, Shepard C, Gulati A. Endothelin receptor type B agonist, IRL-1620, prevents beta amyloid (Abeta) induced oxidative stress and cognitive impairment in normal and diabetic rats. Pharmacol Biochem Behav. 2014 May;120:65-72. doi: 10.1016/j.pbb.2014.02.008. Epub 2014 Feb 20.
Leonard MG, Gulati A. Endothelin B receptor agonist, IRL-1620, enhances angiogenesis and neurogenesis following cerebral ischemia in rats. Brain Res. 2013 Aug 28;1528:28-41. doi: 10.1016/j.brainres.2013.07.002. Epub 2013 Jul 11.
Leonard MG, Briyal S, Gulati A. Endothelin B receptor agonist, IRL-1620, provides long-term neuroprotection in cerebral ischemia in rats. Brain Res. 2012 Jun 29;1464:14-23. doi: 10.1016/j.brainres.2012.05.005. Epub 2012 May 9.
Leonard MG, Briyal S, Gulati A. Endothelin B receptor agonist, IRL-1620, reduces neurological damage following permanent middle cerebral artery occlusion in rats. Brain Res. 2011 Oct 28;1420:48-58. doi: 10.1016/j.brainres.2011.08.075. Epub 2011 Sep 7.
Keam SJ. Sovateltide: First Approval. Drugs. 2023 Sep;83(13):1239-1244. doi: 10.1007/s40265-023-01922-4.
Briyal S, Ranjan AK, Gulati A. Oxidative stress: A target to treat Alzheimer's disease and stroke. Neurochem Int. 2023 May;165:105509. doi: 10.1016/j.neuint.2023.105509. Epub 2023 Mar 11.
Other Identifiers
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Sovateltide/ACIS/IND2022
Identifier Type: -
Identifier Source: org_study_id