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 Nov 2024

Sponsor / Collaborator

Pharmazz, Inc.

NCT05955326 / RecruitingPhase 4

A Prospective, Multicentric, Randomized, Double-blind, Parallel, Phase IV Study to Assess the Safety and Efficacy of 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 (PMZ-1620, IRL-1620) as a potential treatment for cerebral ischemic stroke.

Start Date08 Jan 2024

Sponsor / Collaborator

Pharmazz, Inc.

CTRI/2023/12/060404 / RecruitingPhase 4

A prospective, multicentric, randomized, double-blind, parallel, phase IV study to assess the safety and efficacy of TycamzziTM (sovateltide) in patients with acute cerebral ischemic stroke - Nil

Start Date15 Dec 2023

Sponsor / Collaborator

Pharmazz India Pvt Ltd.

100 Clinical Results associated with Sovateltide

100 Translational Medicine associated with Sovateltide

100 Patents (Medical) associated with Sovateltide

328

Literatures (Medical) associated with Sovateltide

01 Sep 2023·Drugs

Sovateltide: First Approval.

Review

Author: Keam, Susan J

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.

01 Jan 2023·Current vascular pharmacology

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

Article

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

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 (ET_A) antagonist to the brain suggested that endogenous ETs bind to ET receptor type B (ET_B) to elicit effects.

OBJECTIVE:

The aim of the present work was to evaluate the role of central ET_B 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 (ET_B 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 ET_B 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 ET_B 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.

01 Dec 2022·Neuropeptides

Role of endothelin in the pathophysiology of migraine: A new view on an old player

Article

Author: Lopes, Raphael Vieira ; Yuasa, Gianna Hissae ; Costa, Nathalya Luana Van Kan ; Chichorro, Juliana Geremias ; Rae, Giles Alexander ; Baggio, Darciane Favero

There is cumulating evidence that endothelin-1 (ET-1) may play a role in migraine, however controversial findings still impede a conclusion to be drawn. Herein we tested the hypothesis that endothelin ETB receptors are major contributors to migraine-like responses. ET-1, IRL-1620 (selective ETB receptor agonist) or CGRP were injected into the trigeminal ganglion (TG) of female Wistar rats, and the development of periorbital mechanical allodynia was assessed hourly with von Frey hairs. Twenty-four hours later, rats were exposed to an aversive light for 1 h, after which the reactivation of periorbital mechanical allodynia (indicating photic sensitivity) was assessed up to 4 h. Moreover, the effect of systemic Bosentan (ETA/ETB receptors antagonist) or the selective antagonists of ETA (BQ-123) and ETB (BQ-788) receptors injected into the TG were evaluated against CGRP-induced responses. ET-1 and IRL-1620 injection into the TG induced periorbital mechanical allodynia and photic sensitivity. Bosentan attenuated periorbital mechanical allodynia but failed to affect photic sensitivity induced by CGRP. Selective blockade of ETB receptors in the TG fully prevented the development of periorbital mechanical allodynia and photic sensitivity induced by CGRP, but ETA receptor blockade caused only a slight reduction of periorbital mechanical allodynia without affecting photic sensitivity. ETB receptor-operated mechanisms in the TG may contribute to migraine-like responses in female rats.

News (Medical) associated with Sovateltide

22 Mar 2024

·www.globenewswire.com

Pharmazz Inc. and Dr. Reddy's Laboratories have entered into a licensing agreement to market Centhaquine (Lyfaquin) as a resuscitative agent for hypovolemic shock in India

Centhaquine is a first-of-its-kind resuscitative agent to treat hypovolemic shock by increasing stroke volume and cardiac output due to an increase in (preload) venous blood return to the heart and a decrease in (afterload) due to arterial dilatationIndia is the first global territory where Centhaquine is being launched immediately 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). As per the agreement, Dr. Reddy's has received exclusive rights to market and distribute Centhaquine in India. Pharmazz will be entitled to upfront payments and royalties. Dr. Reddy’s will market the product under the brand name Lyfaquin®, which it shall own. In addition to India, Dr. Reddy’s also receives marketing rights for Lyfaquin® from Pharmazz for Nepal. The inventor, Dr. Prof. Anil Gulati, M.D., Ph.D., who is the CEO and Chairman of the Board of Pharmazz, said: "India's emergence as a hub for developing and introducing innovative medicines is a remarkable achievement. It reflects the country's growing capabilities in research and development within the pharmaceutical sector. It is a large step for Pharmazz to partner with Dr. Reddy's, a leading global pharmaceutical company from India. For patients with hypovolemic shock, I believe Dr. Reddy's is the best partner for Pharmazz to market Centhaquine, an innovative, first-in-class novel resuscitative agent, in India." M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s, said: “The partnership with Pharmazz and launch of this first-in-class drug marks the latest in our effort to enter into strategic collaborations to bring novel molecules to India to meet genuine unmet patient needs. The clinical studies for Lyfaquin® have demonstrated significantly better and promising outcomes, making it as a potential add-on drug in the management of hypovolemic shock and enhancing the current standard of care for its treatment in India.” Centhaquine is a frontline therapy used along with the standard of care and is well-positioned to a critical unmet need as a pharmacologically active resuscitative agent. A decrease in the volume of blood circulation from blood or fluid loss due to trauma, gastrointestinal bleeding, major surgery, postpartum hemorrhage, diarrhea, or vomiting can cause hypovolemic shock. About 1.9 million people worldwide die because of hemorrhagic shock every year, most dying within the first 6 hours. Centhaquine activates venous alpha2B adrenergic receptors to increase cardiac preload and activates central alpha2A adrenergic receptors to decrease cardiac afterload. Thereby, Centhaquine converts the venous unstressed blood volume to stressed blood volume and improves cardiac output and blood circulation, making it an ideal candidate for the resuscitation of patients with hypovolemic shock. Centhaquine was approved in India by Drugs Controller General of India following a successful Ph III clinical trial there, the results of which are published in a manuscript titled "A Multicentric, Randomized, Controlled Ph III Study of Centhaquine (Lyfaquin, as a Resuscitative Agent in Hypovolemic Shock Patients." The manuscript is published in DRUGS and is available at: https://link-springer-com.libproxy1.nus.edu.sg/article/10.1007/s40265-021-01547-5. Pharmazz received permission from the U.S. Food and Drug Administration (FDA) to conduct a Phase III clinical trial of Centhaquine in hypovolemic shock patients. It assesses the safety and efficacy of Centhaquine in patients with hypovolemic shock. The Phase III randomized double-blind, placebo-controlled study will be conducted in 430 patients, where patients will receive either an intravenous infusion of 0.01 mg/Kg of Centhaquine or a placebo. All patients will receive the standard of care. A 28-day all-cause mortality is the primary endpoint. The Phase III clinical trial is registered at clinicaltrials.gov (NCT05251181), providing details of the trial design and all the endpoints. U.S. FDA clearance of our Phase III IND is an important milestone for Pharmazz and the potential future treatment of hypovolemic shock patients. About Pharmazz, Inc. Pharmazz is a privately held company 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, the 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. Contacts: Pharmazz, Inc. Investors David CostelloMediaShruti Gulati Tel:+1 630 780 6087 Tel:+1 630 780 6087Email:david.costello@pharmazz.com Email:shruti.gulati@pharmazz.com About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com. CONTACTS: Investor RelationsRicha PeriwalRichaperiwal@drreddys.com Media RelationsUsha IyerUshaiyer@drreddys.com

Phase 3License out/inDrug Approval

02 Oct 2023

·www.globenewswire.com

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

Sovateltide stimulates neural progenitor cells in the brain and promotes neurovascular remodeling by forming new neurons (neurogenesis) and blood vessels (angiogenesis). Sovateltide also protects neural mitochondria and enhances their biogenesis.Sovateltide is being marketed in India by Sun Pharmaceuticals under its brand name Tyvalzi™ and can be administered up to 24 hours after the onset of symptoms. 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." The FDA completed its review and agreed that the study's design and planned analysis could adequately address objectives supporting regulatory submission and a future marketing application with the US FDA. The final determination for the approval of the marketing application is made after a complete review. The FDA previously approved the phase 3 IND application. This SPA agreement by the FDA provides a clear-cut regulatory path for sovateltide, our first-in-class drug for acute cerebral ischemic stroke. In addition, our SPA agreement with the FDA solidifies our trial's alignment with regulatory objectives and underscores the FDA's confidence in Sovateltide's potential. It's a seal of approval that offers our team and investors unique assurance. Sovateltide will fulfill an unmet medical need since no new drug other than rtPA has been approved for treating stroke for over two decades. The narrow time window of rtPA of 4.5 hours limits its use in most patients with cerebral ischemic stroke. Sovateltide is a true standout; it can be administered up to 24 hours following the onset of stroke symptoms, presenting a remarkable market advantage. This is a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical study to assess the safety and efficacy of sovateltide along with the standard of care in patients with acute cerebral ischemic stroke. The target population is adult patients aged 18 – 80 years of age with cerebral ischemic stroke presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and <20 as well as 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. The primary endpoint is the proportion of acute cerebral ischemic stroke patients having a good functional outcome with a modified Rankin Scale (mRS) score of 0-2 on day 90 post-randomization. For an individual patient, the duration of the study will be 3 months (90 days), with 4 study visits. Five hundred and fourteen patients (257 in each treatment arm) will be randomized into 2 groups and stratified based on early vs. late enrollment (<12 hours vs. ≥12 hours) and by the use vs. non-use of rtPA. 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 3 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. Contacts: Pharmazz, Inc. InvestorsMediaDavid CostelloShruti GulatiTel+1 630 780 6087Tel+1 630 780 6087E maildavid.costello@pharmazz.comE mailshruti.gulati@pharmazz.com

Phase 3Drug Approval

18 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 symptoms India is the first global territory where Tyvalzi™ (Sovateltide) is being introduced 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. 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). The content above comes from the network. if any infringement, please contact us to modify.

Phase 3Drug ApprovalLicense out/inCell Therapy

100 Deals associated with Sovateltide

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB06138

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Acute Ischemic Stroke	IN	Pharmazz, Inc.	31 May 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	IN	Pharmazz, Inc.	23 Aug 2022
Cerebral Infarction	Phase 3	IN	Pharmazz, Inc.	10 Nov 2019
Solid tumor	Phase 3	US	Pharmazz, Inc.	25 Dec 2016
Asphyxia Neonatorum	Phase 2	IN	Pharmazz, Inc.	06 Sep 2023
Hypoxia-Ischemia, Brain	Phase 2	IN	Pharmazz, Inc.	06 Sep 2023
Neonatal encephalopathy	Phase 2	IN	Pharmazz, Inc.	06 Sep 2023
Asphyxia	Phase 2	US	Pharmazz, Inc.	23 Aug 2022
Asphyxia	Phase 2	IN	Pharmazz, Inc.	23 Aug 2022
acute spinal cord injury	Phase 2	IN	Pharmazz, Inc.	10 Jan 2019
Non-Small Cell Lung Cancer	Phase 2	US	Spectrum Pharmaceuticals, Inc.	01 May 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04047563 (GlobeNewswire) Manual	Phase 3	Acute Ischemic Stroke	158	Sovateltide	sqqyasuyjz(qhecafzdhn) = qpnarkfuvh mqavyrqrod (mxutfzezuw ) View more	Positive	31 Oct 2022
				Placebo	sqqyasuyjz(qhecafzdhn) = hpikadtxfv mqavyrqrod (mxutfzezuw ) View more
NCT04047563 (GlobeNewswire) Manual	Phase 3	Acute Ischemic Stroke	158	Sovateltide	qoyubovxns(nvwamxvkaf) = significant reduction flzdcrdgkz (ftpgbujldx )	Positive	25 May 2022
NCT04047563 (Biospace) Manual	Phase 3	Acute Ischemic Stroke	158	standard of care+Sovateltide	vctabjuppe(noxehjhuje) = improvement of ≥6 points on NIHSS jqsghsqlsw (xtjwhufmqw ) View more	Positive	25 May 2022
				standard of care+Placebo
NCT04052737 (PRNewswire) Manual	Phase 2	Alzheimer Disease	62	sovateltide	zprhjqigph(wjwvwpqhto) = tuqaqnaugr euyalmdneo (xnjrznurna, 0.955) View more	Positive	10 Jun 2021
				Placebo	zprhjqigph(wjwvwpqhto) = zstmpmixhe euyalmdneo (xnjrznurna, 0.920) View more
NCT04046484 (Pubmed) Manual	Phase 2	Ischemic stroke	36	Sovateltide	xjwksietqp(dmimlsswxn) = qynzxgzfie ythsnrjwik (qokytbpjqa ) View more	Positive	01 Jan 2021
				Placebo	xjwksietqp(dmimlsswxn) = evjlrpdjtj ythsnrjwik (qokytbpjqa ) View more
AAIC2018	Not Applicable	Alzheimer Disease	-	IRL-1620	tvzrbqhydi(vastlmtdgh) = doahdrnasq kxmxmftlof (gxmtwcajci ) View more	-	01 Jul 2018
				Vehicle	tvzrbqhydi(vastlmtdgh) = sqbaggzjin kxmxmftlof (gxmtwcajci ) View more
NCT05691244 (Pubmed \| Ann N Y Acad Sci)	Phase 3	Brain Ischemia	-	IRL-1620	hratoyugyf(vyuzeqvmre) = ggmdnqkpmx tkhbsjlwjk (sgszqjfzxb )	-	29 Jun 2012
				Vehicle	hratoyugyf(vyuzeqvmre) = dvqovogjyb tkhbsjlwjk (sgszqjfzxb )

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