Press Releases
Developing products that are first-in-class with unique mechanism of action and are different from those of existing therapies
Pharmazz Inc. and Dr. Reddy's Laboratories enter into an agreement to market Centhaquine (Lyfaquin®) in India
WILLOWBROOK, Ill., March 22, 2024 (GLOBE NEWSWIRE) -- Pharmazz, Inc. ("Pharmazz"), a biopharmaceutical company developing and commercializing drug products to treat critically ill patients, announced that it has entered into a license agreement with Dr. Reddy's Laboratories Limited ("Dr. Reddy's"), a global pharmaceutical company, to commercialize a first-in-class innovative drug Centhaquine in India. Developed by Pharmazz for potential global use, Centhaquine is a resuscitative agent presently indicated for treating hypovolemic shock by Drugs Controller General of India (DCGI).
A Special Protocol Assessment Agreement Reached with the U.S. Food and Drug Administration for Phase 3 clinical trial of Sovateltide for the treatment of acute cerebral ischemic stroke patients
WILLOWBROOK, Ill., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Pharmazz, Inc. ("Pharmazz" or the "Company"), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, announced that it has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the study design and statistical analysis plan of its Phase 3 clinical trial of Sovateltide (Tycamzzi™) for the treatment of acute cerebral ischemic stroke patients. The protocol is titled "The Safety And Efficacy Of Sovateltide In Patients With Acute Cerebral Ischemic Stroke."
Pharmazz Inc. and Sun Pharma enter into licensing agreement for introducing Tyvalzi™ (Sovateltide) in India
WILLOWBROOK, Ill., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz” or the “Company”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, announced that it has entered into a license agreement with Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) to commercialise a first-in-class innovative drug, Tyvalzi™ (Sovateltide) in India. Developed by Pharmazz for potential global use, Sovateltide is indicated for treating cerebral ischemic stroke.
Pharmazz, Inc. Announces Marketing Approval of Sovateltide in India for Acute Cerebral Ischemic Stroke Patients
WILLOWBROOK, Ill., May 31, 2023 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz” or the “Company”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, announced that The Directorate General of Health Services, India on May 31st, 2023, granted the manufacture and marketing of Sovateltide Injection for cerebral ischemic stroke patients. The company is preparing to launch Sovateltide, an endothelin-B receptor agonist, for the treatment of patients with acute cerebral ischemic stroke. The company plans to make Sovateltide available to patients in India in the third quarter of 2023.
Pharmazz Inc. Announces Key Publications Regarding the Role of Adrenergic Receptors in Venous Blood Return to Treat Shock
WILLOWBROOK, Ill., March 20, 2023 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, announced two key publications. These publications further our understanding of adrenergic receptors in treating shock. A free version of the article published in the Journal of Clinical Medicine is available at: https://www.mdpi.com/2077-0383/12/3/1108. Controls of central and peripheral blood pressure are critical in treating patients with hemorrhagic/hypovolemic shock. It has been demonstrated that alpha2-adrenergic receptors could be a suitable target for managing hypovolemic shock. Centhaquine is the Company’s alpha2 adrenergic receptor agonist that showed an absolute 8.8 percent reduction in 28-day all-cause mortality in Phase III clinical trial for hypovolemic shock conducted in India.
Pharmazz, Inc. Announces US FDA Clearance for a Phase III Clinical Trial of Sovateltide (PMZ-1620) in Acute Cerebral Ischemic Stroke Patients
WILLOWBROOK, III., Feb. 13, 2023 /PRNewswire/ -- Pharmazz, Inc. ("Pharmazz" or the "Company"), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, announced that the US Food and Drug Administration (FDA) has issued a proceed forward letter regarding the Company's Investigational New Drug ("IND") application that includes the protocol entitled, "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." The FDA completed a safety review of the protocol and concluded that the Company could proceed with the proposed clinical investigation. Since this upcoming trial may be used as a potential pivotal efficacy study to support a future NDA, Pharmazz plans to incorporate the FDA's suggestions to the study design and update the protocol for a Special Protocol Assessment as recommended by the FDA.
Clinical Phase III Trial Results Demonstrating Sovateltide's Efficacy to Treat Acute Cerebral Ischemic Stroke Presented at The International Stroke Conference 2023
WILLOWBROOK, Ill., Feb. 10, 2023 /PRNewswire/ -- Pharmazz, Inc. ("Pharmazz"), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, presented positive results of its Phase III clinical trial evaluating sovateltide as a treatment for acute ischemic stroke. Sovateltide demonstrated statistically significant and clinically meaningful improvements in multiple neurological outcomes in patients with acute cerebral ischemic stroke and was well tolerated. The trial results were presented in an oral session at the American Stroke Association, International Stroke Conference 2023, on February 9, 2023, in Dallas. The presentation is titled "A Multicentric, Randomized, Controlled Phase III Study With Sovateltide (Tycamzzi™) Improving Outcomes In Patients With Acute Cerebral Ischemic Stroke."
Pharmazz Inc. Presents Positive Results of Phase III Clinical Trial Demonstrating Sovateltide’s Efficacy as a Treatment for Acute Cerebral Ischemic Stroke
WILLOWBROOK, Ill., Oct. 31, 2022 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, today presented positive results of its Phase III clinical trial evaluating sovateltide as a treatment for acute ischemic stroke. Sovateltide demonstrated statistically significant and clinically meaningful improvements in multiple neurological outcomes in patients with acute cerebral ischemic stroke and was well tolerated. The trial results were presented in an oral session at the 14th World Stroke Congress in Singapore.
Pharmazz Inc. Presents Data From its Positive Phase III Study of Centhaquine (PMZ-2010) as a Resuscitative Agent in Hypovolemic Shock Patients at Upcoming Military Health System Research Symposium
WILLOWBROOK, Ill., Sept. 13, 2022 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, will present a poster on its positive Phase III study of centhaquine (PMZ-2010) as a resuscitative agent in hypovolemic shock patients at the Military Health System Research Symposium (MHSRS) September 12-15, 2022. Centhaquine is the Company’s resuscitative agent free of arterial constriction and is commercially available to health care professionals in India with the brand name, Lyfaquin . The poster will be presented by Anil Gulati, M.D., founder, Chief Executive Officer, and Chairman of the Board of Pharmazz, during the poster session at 10:00 am EDT on September 13 2022.
Pharmazz Inc. announces Indian Central Drugs Standard Control Organization (CDSCO) Clearance of IND to conduct a Phase II clinical trial of sovateltide (PMZ-1620) in hypoxic-ischemic encephalopathy in neonates
WILLOWBROOK, Ill., Aug. 29, 2022 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, today announced the clearance of an Investigational New Drug (IND) application by the India Central Drugs Standard Control Organization (CDSCO) to conduct a Phase II clinical trial of sovateltide in hypoxic-ischemic encephalopathy (HIE) in neonates. Sovateltide is the Company’s endothelin-B receptor agonist that increases blood flow, shows anti-apoptotic activity, protects neural mitochondria, and produces neurovascular remodeling. Sovateltide is currently undergoing marketing authorization review by CDSCO to treat acute cerebral ischemic stroke.
Pharmazz Inc. Announces Positive Results of Phase III Clinical Trial Evaluating Sovateltide as a Treatment for Acute Cerebral Ischemic Stroke
WILLOWBROOK, Ill, May 25, 2022 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, announced today positive topline results of its Phase III clinical trial evaluating sovateltide as a treatment for acute ischemic stroke. The data at 90 days showed mRS had a significantly greater number of patients with an improvement of ≥2 points on mRS (p=0.0045), mRS with a significant median score reduction (p=0.0078) and a significantly greater number of patients with an improvement of ≥6 points on NIHSS (p=0.0330). In addition, sovateltide was well tolerated, with no drug-related adverse event reported. The results have prompted Pharmazz to apply for marketing authorization from the Indian Central Drugs Standard Control Organization (CDSCO).
U.S. Food and Drug Administration (FDA) cleared Investigational New Drug (IND) application for a Phase II clinical trial of centhaquine COVID-19 patients with acute respiratory distress syndrome (ARDS).
WILLOWBROOK, Ill., March 10, 2022 (GLOBE NEWSWIRE) -- Pharmazz (“Pharmazz”), Inc., a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, today announced U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for a Phase II clinical trial of centhaquine as an adjuvant to the standard of care in critically ill COVID-19 patients with acute respiratory distress syndrome (“ARDS”). Centhaquine is the Company’s resuscitative agent free of arterial constriction that is commercially available in India and about to start in a Phase III trial in the U.S. for the treatment of hypovolemic shock.
Pharmazz Inc. Announces Completion of Enrollment of Phase III Clinical Trial Evaluating Sovateltide as a Treatment for Acute Cerebral Ischemic Stroke
WILLOWBROOK, Ill., Feb. 17, 2022 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, announced today that its Phase III clinical trial evaluating sovateltide as a treatment for acute ischemic stroke is now fully enrolled. Sovateltide is a highly selective endothelin B receptor agonist that increases blood flow, shows anti-apoptotic activity, protects neural mitochondria, and produces neurovascular remodeling.
Pharmazz Inc. submits Investigational New Drug Application to India Central Drugs Standard Control Organization for a Phase II clinical trial of sovateltide (PMZ-1620) in hypoxic-ischemic encephalopathy in neonates
WILLOWBROOK, Ill., Feb. 03, 2022 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, today announced that it has submitted an Investigational New Drug Application (IND) to the India Central Drugs Standard Control Organization (CDSCO) for a Phase II clinical trial of sovateltide in hypoxic-ischemic encephalopathy (HIE) in neonates. Sovateltide is the Company’s endothelin-B receptor agonist that is also in a Phase III trial for the treatment of cerebral ischemic stroke.
US FDA approved IND submitted by Pharmazz, Inc. to initiate a phase III clinical trial of centhaquine in patients with hypovolemic shock
WILLOWBROOK, Ill., Sept. 29, 2021 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, is pleased to announce that its Phase III clinical study of the drug candidate, centhaquine, has been approved by the US FDA for the treatment of hypovolemic shock. The Phase III clinical study will be a multi-centric, double-blind, placebo-controlled to be conducted on 430 patients randomly assigned equally to both arms with 28-day mortality as the primary endpoint. Pharmazz is expected to begin enrollment towards the end of 2021 or the beginning of 2022.
Sovateltide (PMZ-1620), a first-in-class investigational product, shows promise to slow down the progression of Alzheimer's disease in patients
WILLOWBROOK, Ill., June 10, 2021 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care. The Company is developing sovateltide for Alzheimer's disease.Drugs approved for Alzheimer's disease treatment include the cholinesterase inhibitors donepezil, rivastigmine, and galantamine, and the N-methyl-D-aspartate antagonist memantine. Recently, aducanumab a monoclonal antibody that targets β-amyloid was approved by the US FDA. Although aducanumab improves Clinical Dementia Rating, there is an unmet need for therapies that halt or slow the progression of Alzheimer's disease.
Centhaquine Improved Shock Index, ARDS, MODS, Reduced Blood Lactate Levels, And 8.8% Absolute Reduction In 28-Day All-Cause Mortality
WILLOWBROOK, Ill., June 10, 2021 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care. The Company is developing sovateltide for Alzheimer's disease.Drugs approved for Alzheimer's disease treatment include the cholinesterase inhibitors donepezil, rivastigmine, and galantamine, and the N-methyl-D-aspartate antagonist memantine. Recently, aducanumab a monoclonal antibody that targets β-amyloid was approved by the US FDA. Although aducanumab improves Clinical Dementia Rating, there is an unmet need for therapies that halt or slow the progression of Alzheimer's disease.
Resuscitative Effect of Centhaquine (Lyfaquin®) in Hypovolemic Shock Patients: A Randomized, Multicentric, Controlled Trial
WILLOWBROOK, Ill., May 10, 2021 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care. The Company is marketing Centhaquine Citrate, with the brand name Lyfaquin® to health care professionals in India.Pharmazz is pleased to announce the peer-reviewed publication of the manuscript titled "Resuscitative Effect of Centhaquine (Lyfaquin®) in Hypovolemic Shock Patients: A Randomized, Multicentric, Controlled Trial."
Lyfaquin®, a resuscitative agent marketed in India, restores renal blood flow and protects tissue damage after hemorrhagic shock-induced acute kidney injury (AKI)
May 3, 2021, - WILLOWBROOK, Ill., May 3, 2021 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care. The Company is marketing Centhaquine Citrate, with the brand name Lyfaquin® to health care professionals in India. Pharmazz is pleased to announce the peer-reviewed publication of the manuscript titled "Centhaquine Restores Renal Blood Flow and Protects Tissue Damage After Hemorrhagic Shock and Renal Ischemia." The manuscript is published in Frontier in Pharmacology and is available https://doi.org/10.3389/fphar.2021.616253. Lyfaquin® increased renal blood flow, augmented hypoxia response, decreased tissue damage, and apoptosis following hemorrhagic shock-induced acute kidney injury (AKI) in the rat.
Lyfaquin®, a first-in-class resuscitative agent for patients with excessive blood loss, to be launched in India
July 20, 2020, - WILLOWBROOK, Ill., July 20, 2020 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, announced that it has successfully received marketing authorization and is preparing to launch Lyfaquin® (centhaquine), a novel resuscitative agent indicated for the treatment of patients with hypovolemic shock as a frontline adjuvant to standard of care. The company plans to make Lyfaquin® available to patients by the middle of September 2020.
Marketing authorization received for Lyfaquin™ (centhaquine) to treat patients with hypovolemic shock from Indian regulatory agency
May 14, 2020, - WILLOWBROOK, Ill., May 14, 2020 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced that it has received marketing authorization of centhaquine, a first-in-class drug, to manage patients with hypovolemic shock from the Indian regulatory agency. Centhaquine is likely to be a transformational therapy for hypovolemic shock because it ameliorates key drivers of mortality.
Sovateltide significantly (p=0.0157) improved clinical outcome (modified Rankin Scale) in patients with acute cerebral ischemic stroke when compared to standard of care
Apr 27, 2020, - WILLOWBROOK, Ill., April 27, 2020 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced that sovateltide, an endothelin-B receptor agonist, significantly (p=0.0157; two-tailed unpaired t-test; t=2.476; df=70) improved modified Rankin Scale (mRS) of acute cerebral ischemic stroke patients when compared to patients receiving the best standard of care. These results are based on an interim 30-day analysis of multicentric, randomized, blinded, controlled efficacy clinical trials (NCT04046484; NCT04047563) in acute ischemic stroke patients.
Centhaquine can provide hemodynamic stability, improve tissue oxygenation, reduce pulmonary edema, acute respiratory distress syndrome (ARDS), multiple organ dysfunction score (MODS) and mortality in coronavirus disease 2019 (COVID-19) patients
Apr 09, 2020, - WILLOWBROOK, Ill., April 9, 2020 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced that centhaquine, a drug in final stage of development, can provide hemodynamic stability, improve tissue oxygenation, reduce pulmonary edema, reduce acute respiratory distress syndrome (ARDS), reduce multiple organ dysfunction score (MODS) and decrease mortality in patients with coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
Dosing of first patient in phase 3 pivotal study of sovateltide (PMZ-1620), a first-in-class investigational product, for acute cerebral ischemic stroke
Nov. 23, 2019, - WILLOWBROOK, Ill., Nov. 23, 2019 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced the initiation of dosing in its pivotal, phase 3 clinical trial evaluating sovateltide for the treatment of acute cerebral ischemic stroke
Pharmazz submits application for marketing authorization of centhaquine (PMZ-2010), a first-in-class investigational product, for patients with hypovolemic shock
Oct. 28, 2019, - WILLOWBROOK, Ill., Oct. 28, 2019 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced that it successfully submitted Application for Marketing Authorization of centhaquine to the Central Drugs Standard Control Organization (CDSCO)...
Sovateltide (PMZ-1620), an Endothelin-B receptor Agonist, has the potential to be a first-in-class neuronal progenitor cell therapeutics
Sept. 30, 2019, - WILLOWBROOK, Ill., Sept. 30, 2019 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced that it made 5 presentations at the Sixteenth International Conference on Endothelin held in Kobe...
PMZ-1620, an Endothelin-B Agonist, enters Phase III Trial in Patients with Cerebral Ischemic Stroke
July 18, 2019, - WILLOWBROOK, Ill., July 18, 2019 /PRNewswire/ -- Pharmazz, Inc., today announced that it has received permission to initiate a prospective, multicentric, randomized, double-blind, parallel, phase III clinical study to assess efficacy of PMZ-1620 along with standard treatment in patients of acute ischemic stroke in India...
Results on Efficacy of PMZ-1620, an Endothelin-B Agonist, from Ongoing Phase II Trial in Patients with Cerebral Ischemic Stroke Presented at International Stroke Conference 2019
Feb. 07, 2019, - NAPERVILLE, Ill., Feb. 7, 2019 /PRNewswire/ -- Pharmazz, Inc., today announced that data from the Phase 2 clinical study in patients with acute cerebral ischemic stroke, were presented in the late breaking Multicenter, Ongoing Clinical Trials Posters II (Board CTP27) session at the International Stroke Conference 2019 in Honolulu, Hawaii February 6-8, 2019...
Phase 2 Results on Efficacy of PMZ-2010 (Centhaquin) in Patients with Hypovolemic Shock Presented at AHA Scientific Sessions 2018
Nov. 12, 2018, - NAPERVILLE, Ill., Nov. 12, 2018 /PRNewswire/ -- Pharmazz, Inc., today announced that data from the Phase 2 clinical study in patients with hypovolemic shock, were presented in the Drug Discovery-Heart Failure Oral Abstracts Session II at the American Heart Association Scientific Sessions in Chicago November 12, 2018.