Last update 15 Sep 2023

Sovateltide

Last update 15 Sep 2023

Overview

R&D Status

Clinical Trial Result

Core Patent

Clinical Trial Analysis

Approval

Regulation

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Sovatelitide, PMZ-1620, SPI-1620

+ [2]

Target

ETB(Endothelin receptor type B)

Mechanism

ETB agonists(Endothelin receptor type B agonists), Angiogenesis inducers, Neurogenesis stimulants

Therapeutic Areas

Nervous System Diseases, Endocrinology and Metabolic Disease, Cardiovascular Diseases+ [3]

Active Indication

Acute Ischemic Stroke, Alzheimer Disease, Cerebral Infarction+ [8]

Inactive Indication

Biliary Tract Neoplasms, Carcinoma, Non-Small Cell Lung Cancer

Originator Organization

University of Illinois

Active Organization

Pharmazz, Inc.

Inactive Organization

Endogenx, Inc.

Spectrum Pharmaceuticals, Inc.Ciba-Geigy AG

Highest Phase (Global)Approved

First Approval Date(Global)

IN (May 2023),

Acute Ischemic Stroke

Regulation-

Structure

Molecular FormulaC86H117N17O27

InChIKeyDXPHNGAMYPPTBJ-TZMIJSMNSA-N

CAS Registry142569-99-1

Gene Sequence

Sequence Code 77516

Source: WHOINN

Clinical Trials associated with Sovateltide

NCT05955326 / RecruitingPhase 4 Clinical

A Prospective, Multicentric, Randomized, Double-blind, Parallel, Phase IV Study to Assess the Safety and Efficacy of TYCAMZZI™ (Sovateltide) in Patients With Acute Cerebral Ischemic Stroke

This is a prospective, multicenter, randomized, double-blind, parallel, phase IV study designed to evaluate the safety and efficacy of sovateltide (TYCAMZZI™, PMZ-1620, IRL-1620) as a potential treatment for cerebral ischemic stroke.

Start Date01 Sep 2023

Sponsor / Collaborator

Pharmazz, Inc.

NCT05691244 / Not yet recruitingPhase 3 Clinical

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.

Extensive research is being conducted in search of neuroprotective agents for possible use in the acute phase of stroke and agents that can be used for neurorepair in later stages of stroke. Several trials have been conducted and are in progress using different pharmacological agents, but none of the studies involve the stimulation of ETB receptors to treat cerebral ischemic stroke. Sovateltide (IRL-1620, PMZ-1620) has been effective in animal models of cerebral ischemic stroke. Its safety and tolerability have been demonstrated in a human phase I study with 7 subjects. Clinical phase II and III results indicate that sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral ischemic stroke. Safety and significant efficacy in improving the National Institutes of Health Stroke Scale (NIHSS), Modified Rankin scale (mRS), and Barthel index (BI) obtained in phase II and III studies in patients with cerebral ischemic stroke in India are convincing and encouraged us to investigate its safety and efficacy in cerebral ischemic stroke patients in the United States. Therefore, the plan is to conduct a phase III clinical study to evaluate the safety and efficacy of sovateltide therapy along with standard of care in patients of acute ischemic stroke.

Start Date01 Aug 2023

Sponsor / Collaborator

Pharmazz, Inc.

NCT05514340 / RecruitingPhase 2 Clinical

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase-II Trial to Assess Safety, and Efficacy of Sovateltide in the Treatment of Hypoxic-ischemic Encephalopathy in Neonates

Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a "Treatment for hypoxic-ischemic encephalopathy in neonates," which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.

Start Date01 Jul 2023

Sponsor / Collaborator

Pharmazz, Inc.

100 Patents (Medical) associated with Sovateltide

344

Literatures (Medical) associated with Sovateltide

24 Jul 2023·Drugs

Sovateltide: First Approval.

Review

Author: Susan J Keam

Sovateltide (Tycamzzi™), a highly selective endothelin-B receptor agonist and synthetic analog of endothelin-1, is being developed by Pharmazz, Inc. as a neural progenitor cell therapeutic agent for the treatment of acute cerebral ischemic stroke (ACIS), hypoxic-ischemic encephalopathy (HIE), spinal cord injuries and Alzheimer's disease. In May 2023, sovateltide was approved in India for the treatment of cerebral ischemic stroke within 24 h of stroke onset. This article summarizes the milestones in the development of sovateltide leading to this first approval for use in patients with ACIS.

22 Jun 2023·Current vascular pharmacology

Role of Brain Endothelin Receptor Type B (ETB) in the Regulation of Tyrosine Hydroxylase in the Olfactory Bulb of DOCA-Salt Hypertensive Rats.

Article

Author: Luis Cassinotti ; María Guil ; Liliana Bianciotti ; Marcelo Vatta

BACKGROUND:

We previously reported that endothelins (ETs) regulate tyrosine hydroxylase (TH) activity and expression in the olfactory bulb (OB) of normotensive and hypertensive animals. Applying an ET receptor type A (ETA) antagonist to the brain suggested that endogenous ETs bind to ET receptor type B (ETB) to elicit effects.

OBJECTIVE:

The aim of the present work was to evaluate the role of central ETB stimulation on the regulation of blood pressure (BP) and the catecholaminergic system in the OB of deoxycorticosterone acetate (DOCA)-salt hypertensive rats.

METHODS:

DOCA-salt hypertensive rats were infused for 7 days with cerebrospinal fluid or IRL-1620 (ETB receptor agonist) through a cannula placed in the lateral brain ventricle. Systolic BP (SBP) and heart rate were recorded by plethysmography. The expression of TH and its phosphorylated forms in the OB were determined by immunoblotting, TH activity by a radioenzymatic assay, and TH mRNA by quantitative real-time polymerase chain reaction.

RESULTS:

Chronic administration of IRL-1620 decreased SBP in hypertensive rats but not in normotensive animals. Furthermore, the blockade of ETB receptors also decreased TH-mRNA in DOCA-salt rats, but it did not modify TH activity or protein expression.

CONCLUSION:

These findings suggest that brain ETs through the activation of ETB receptors contribute to SBP regulation in DOCA-salt hypertension. However, the catecholaminergic system in the OB does not appear to be conclusively involved although mRNA TH was reduced. Present and previous findings suggest that in this salt-sensitive animal model of hypertension, the OB contributes to chronic BP elevation.

07 Mar 2023·Nature communications

Structural basis of peptide recognition and activation of endothelin receptors.

Article

Author: Yujie Ji ; Jia Duan ; Qingning Yuan ; Xinheng He ; Gong Yang ; Shengnan Zhu ; Kai Wu ; Wen Hu ; Tianyu Gao ; Xi Cheng ; Hualiang Jiang ; H Eric Xu ; Yi Jiang

Endothelin system comprises three endogenous 21-amino-acid peptide ligands endothelin-1, -2, and -3 (ET-1/2/3), and two G protein-coupled receptor (GPCR) subtypes-endothelin receptor A (ET_AR) and B (ET_BR). Since ET-1, the first endothelin, was identified in 1988 as one of the most potent endothelial cell-derived vasoconstrictor peptides with long-lasting actions, the endothelin system has attracted extensive attention due to its critical role in vasoregulation and close relevance in cardiovascular-related diseases. Here we present three cryo-electron microscopy structures of ET_AR and ET_BR bound to ET-1 and ET_BR bound to the selective peptide IRL1620. These structures reveal a highly conserved recognition mode of ET-1 and characterize the ligand selectivity by ETRs. They also present several conformation features of the active ETRs, thus revealing a specific activation mechanism. Together, these findings deepen our understanding of endothelin system regulation and offer an opportunity to design selective drugs targeting specific ETR subtypes.

News (Medical) associated with Sovateltide

14 Sep 2023

·www.globenewswire.com

Pharmazz Inc. and Sun Pharma enter into licensing agreement for introducing Tyvalzi™ (Sovateltide) in India

Sovateltide is a first of its kind drug to treat acute cerebral ischemic stroke that can be administered up to 24 hours after the onset of symptomsIndia is the first global territory where Tyvalzi™ (Sovateltide) is being introduced 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. As per agreement terms, Sun Pharma is granted rights for marketing Sovateltide in India under the brand name Tyvalzi™ (Sovateltide). Pharmazz will be entitled to upfront and milestone payments, including royalties. Kirti Ganorkar, CEO – India Business, Sun Pharma said, “The Phase 3 clinical trial for Tyvalzi™ conducted in India demonstrated statistically and clinically meaningful improvement in neurological outcomes in ischemic stroke. Tyvalzi™ is a first-in-class innovative drug which can help improve the quality of life of stroke patients. The drug can be administered within 24 hours for the treatment of ischemic stroke. The current treatment options provide a narrow time window of 4-5 hours limiting its use in most patients.” Dr. B. S. Paul, a leading neuro-physician at Dayanand Medical College & Hospital, Ludhiana, who was a part of the clinical trials of Tyvalzi™ (Sovateltide), said, “No new drug other than rTPA has been approved for the treatment of stroke for more than two decades. The narrow time window of rTPA of 4.5 hours limits its use in a vast majority of patients with cerebral ischemic stroke. There is an urgent need for new therapies to treat stroke, the 2nd leading cause of mortality & morbidity worldwide. Sovateltide (Tyvalzi™), a selective endothelin B receptor agonist, a new first-in-class drug recently approved for treating cerebral ischemic stroke, can be administered up to 24 hours post cerebral ischemic stroke. Sovateltide (Tyvalzi™) produced statistically significant and clinically meaningful improvements in neurological outcomes at 90 days post-treatment in clinical trials as measured by the NIHSS, mRS, and B.I. scales. Sovateltide (Tyvalzi™) is a neuronal progenitor cell therapy that promotes neurogenesis, angiogenesis, and synaptogenesis, thereby inducing neurovascular remodeling. I believe that Sovateltide (Tyvalzi™) is an exciting new, approved, effective, and well-tolerated therapy for treating cerebral ischemic stroke patients.” Dr. Prof. Anil Gulati, M.D., Ph.D., inventor, CEO, and Chairman of the Board of Directors of Pharmazz, said: “It is a significant step for Pharmazz to partner with Sun Pharma, the largest pharmaceutical company in India. For patients with cerebral ischemic stroke, I believe Sun Pharma is the best partner for Pharmazz to market Tyvalzi™ (Sovateltide), an innovative, first-in-class novel treatment for cerebral ischemic stroke, in India.” The global burden of disease project1 estimated the number of incident cases of stroke in India to be 1,175,778. In India, studies estimate that the incidence of stroke population varies from 116 to 163 per 100,000 population2. Stroke is the fourth leading cause of death and the fifth leading cause of disability3 in India. By 2050, more than 80% of the predicted global burden of new strokes of 15 million will occur in low and middle-income countries. Sun Pharmaceutical is the owner of the brand name Tyvalzi™. About Tyvalzi™ (Sovateltide) Tyvalzi™ is a first-in-class drug to treat acute cerebral ischemic stroke, a condition in which the loss of blood supply to the brain prevents brain tissue from receiving oxygen and nutrients, resulting in potential brain damage, neurological deficits, or death. Tyvalzi™ is unique in that its site of action is the neural progenitor cells. Tyvalzi™ promotes neurovascular remodeling by forming new neurons (neurogenesis) and blood vessels (angiogenesis). Tyvalzi™ also protects neural mitochondria and enhances their biogenesis. About Pharmazz, Inc. Pharmazz is a privately held company engaged in developing novel products in critical care medicine. Pharmazz, Inc. obtained marketing authorization for two of its first-in-class drug molecules, Centhaquine and Sovateltide, for hypovolemic shock and ischemic stroke, respectively, in India. In addition, U.S. Food and Drug Administration (FDA) has approved two phase III INDs for Centhaquine as an agent for hypovolemic shock and Sovateltide for cerebral ischemic stroke. Additional information may be found on the Company’s website, www.pharmazz.com. About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050): Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India, and is a leading generic company in the US as well as Global Emerging Markets. Sun’s high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, onco-dermatology and accounts for over 16% of company sales. The company’s vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit www.sunpharma.com and follow us on Twitter @SunPharma_Live. References: GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2019; 48: 439–458.https://main.mohfw.gov.in/organisation/Departments-of-Health-and-Family-Welfare/national-programme-prevention-and-control-cancer-diabetes-cardiovascular-disease-and-Stroke-NPCDCS (accessed on 28th August 2023).Directorate General of Health Services: Ministry of Health and Family Welfare. National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke. Government of India 2019, July 13, https://main.mohfw.gov.in/Major-Programmes/non-communicable-diseases-injury-trauma/Non-Communicable-Disease-II/National-Programme-for-Prevention-and-Control-of-Cancer-Diabetes-Cardiovascular-diseases-and-Stroke-NPCDCS (2019, accessed 21 September 2020). Disclaimer: Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Pharmazz, Inc. Investors David CostelloMediaShruti GulatiTel+1 630 780 6087 Tel+1 630 780 6087E maildavid.costello@pharmazz.com E mailshruti.gulati@pharmazz.com Contacts: Sun Pharma Investors Dr. Abhishek SharmaMediaGaurav ChughTel+91 22 4324 4324, Xtn 2929 Tel+91 22 4324 4324, Xtn 5373Tel (D)+91 22 4324 2929 Tel (D)+91 22 4324 5373Mobile+91 98196 86016 Mobile+91 98104 71414E mailabhi.sharma@sunpharma.com E mailgaurav.chugh@sunpharma.com

Phase 3Drug ApprovalLicense out/inCell Therapy

31 May 2023

·www.globenewswire.com

Pharmazz, Inc. Announces Marketing Approval of Sovateltide in India for Acute Cerebral Ischemic Stroke Patients

The proportion of acute cerebral ischemic stroke patients with the mRS of 0-2 on day 90 post-randomization was statistically significant (p=0.002) Sovateltide is a first-in-class drug that increases blood flow, inhibits apoptosis, and induces neurovascular remodeling 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. “Marketing authorization is a significant milestone for Pharmazz and acute ischemic stroke patients in India,” said Anil Gulati, M.D., Ph.D. Inventor, Chief Executive Officer, and Chairman of the Board of Pharmazz. “Previously, we reported the results of our successful Phase III trial in acute cerebral ischemic stroke patients that we conducted in India. That trial demonstrated a significantly (p=0.0045) greater number of patients showing an improvement of 2 or more points on the modified Rankin Score (mRS). Additionally, the proportion of acute cerebral ischemic stroke patients with the mRS of 0-2 on day 90 post-randomization was statistically significant (p=0.002). Moreover, the drug was well tolerated, with no drug-related adverse events reported.” In addition, 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.” Pharmazz is working with the FDA on suggestions for the study design and updating the protocol for a Special Protocol Assessment. More details on the clinical trial design, including the complete list of secondary endpoints, can be found on clinicaltrials.gov (NCT05691244). About Pharmazz, Inc. Pharmazz, Inc. is a privately held company developing novel products in critical care medicine. Additional information may be found on the Company’s website, www.pharmazz.com. Media Contact:Shruti GulatiPharmazz Inc.Email: shruti.gulati@pharmazz.comPhone: (630) 780-6087

Phase 3Clinical ResultDrug Approval

13 Feb 2023

·www.prnewswire.com

Pharmazz, Inc. Announces US FDA Clearance for a Phase III Clinical Trial of Sovateltide (PMZ-1620) in Acute Cerebral Ischemic Stroke Patients

The primary endpoint is the proportion of patients with a good outcome as a modified Rankin Score (mRS) of 0-2 on day 90 post-randomizationSovateltide is an endothelin-B receptor agonist that has been shown to increase blood flow, inhibit apoptosis, and induce neurovascular remodeling 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. Continue Reading "FDA clearance of our Phase III trial is a significant milestone for Pharmazz and the potential future treatment of acute ischemic stroke patients," said Anil Gulati, M.D., Ph.D. Inventor, Chief Executive Officer, and Chairman of the Board of Pharmazz. In October last year, we reported the results of our successful Phase III trial in acute cerebral ischemic stroke patients that we conducted in India. That trial demonstrated a significantly (p=0.0045) greater number of patients showing an improvement of 2 or more points on the modified Rankin Score (mRS). Additionally, the proportion of acute cerebral ischemic stroke patients with the mRS of 0-2 on day 90 post-randomization was statistically significant (p=0.002), which is the primary endpoint for the US trial. Moreover, the drug was well tolerated, with no drug-related adverse events reported. The full data set from the successful Indian Phase III trial was presented last week at the American Stroke Association International Stroke Conference on February 9 2023, in Dallas, TX. That trial reassures us that the US trial could generate a similar outcome. US FDA Clears Phase III Clinical Trial of Sovateltide in Acute Cerebral Ischemic Stroke Patients Tweet this The upcoming US Phase III trial is designed as a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of sovateltide in 444 patients with acute cerebral ischemic stroke. Patients will be randomized 1:1 to receive either 3 doses of sovateltide, at a dose of 0.3 μg/kg as an intravenous bolus over 1 minute every 3 hours ± 1 hour on days 1, 3, and 6 plus standard of care, or placebo injections at the same time points plus standard of care. The primary endpoint is the proportion of acute cerebral ischemic stroke patients having a good functional outcome with the mRS of 0-2 on day 90 post-randomization. Key secondary endpoints include the proportion of acute cerebral ischemic stroke patients having an excellent functional outcome with the mRS of 0-1 on day 90 post-randomization and the proportion of cerebral ischemic stroke patients with NIHSS score ≥ 6, mRS > 2, and BI score ≤ 60 on day 6, day 30, and day 90 post-randomization and the number of deaths within day 90 post-randomization, and any adverse events or serious adverse events associated with sovateltide. More details on the clinical trial design, including the complete list of secondary endpoints, can be found on clinicaltrials.gov (NCT05691244). About Pharmazz, Inc. Pharmazz, Inc. is a privately held company developing novel products in critical care medicine. Additional information may be found on the Company's website, . Media Contact: Shruti Gulati Pharmazz Inc. Email: [email protected] Phone: (630) 780-6087 SOURCE Pharmazz, Inc.

Phase 3Clinical ResultIND

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB06138

R&D Status

Indication	Highest Phase	Country/Location	Organization
Acute Ischemic Stroke	Approved	IN More	Pharmazz, Inc. More
Alzheimer Disease	Phase 3 Clinical	IN More	Pharmazz, Inc. More
Hypoxia-Ischemia, Brain	Phase 2 Clinical	IN More	Pharmazz, Inc. More
Asphyxia	Phase 2 Clinical	US More	Pharmazz, Inc. More
Biliary Tract Neoplasms	Discontinued	US More	Spectrum Pharmaceuticals, Inc. More

Clinical Trial Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05691244 (pubmed) AI	Phase 3	Brain Ischemia	-	IRL-1620	czxzdwkfcb = ikkmiolvyt gvujtfaaci (ehuwhtcocs )	-	29 Jun 2012
				Vehicle	czxzdwkfcb = fxsrionthl gvujtfaaci (ehuwhtcocs )
NCT05691244 (pubmed) AI	Phase 3	Infarction, Middle Cerebral Artery	-	IRL-1620	ofmrlookmz = nkuzkldcha fhrfxzbqib (nercghgslg )	-	28 Oct 2011
				BQ788	ofmrlookmz = ikmjksfiwq fhrfxzbqib (nercghgslg )

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Sovateltide

Overview

Basic Info

Structure

Gene Sequence

Related

External Link

R&D Status

Clinical Trial Result

Core Patent

Clinical Trial Analysis

Approval

Regulation