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 Date24 Jul 2025

Sponsor / Collaborator

Pharmazz, Inc.

CTRI/2024/07/070459

/ Not yet recruitingPhase 4

Safety and efficacy of sovateltide in acute cerebral ischemic stroke patients at a tertiary care centre-a double blinded block randomised placebo controlled study - NIL

Start Date22 Jul 2024

Sponsor / Collaborator

Pondicherry Institute of Medical Sciences

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.

100 Clinical Results associated with Sovateltide

100 Translational Medicine associated with Sovateltide

100 Patents (Medical) associated with Sovateltide

389

Literatures (Medical) associated with Sovateltide

01 Mar 2025·EXPERIMENTAL NEUROLOGY

Microglial cell proliferation is regulated, in part, by reactive astrocyte ETBR signaling after ischemic stroke

Article

Author: Torsney, Emily E ; LeComte, Matthew D ; Del Rio-Guerra, Roxana ; Poynter, Matthew E ; Spees, Jeffrey L ; McInnis, John J ; Reed, Leah F

Reciprocal communication between reactive astrocytes and microglial cells provides local, coordinated control over critical processes such as neuroinflammation, neuroprotection, and scar formation after CNS injury, but is poorly understood. The vasoactive peptide hormone endothelin (ET) is released and/or secreted by endothelial cells, microglial cells and astrocytes early after ischemic stroke and other forms of brain injury. To better understand glial cell communication after stroke, we sought to identify paracrine effectors produced and secreted downstream of astroglial endothelin receptor B (ETB_R) signaling. Using a genetic loss-of-function screen, we identified angiopoietin-2 (Ang-2) as a factor produced by reactive astrocytes in response to ET. In experiments with primary adult astrocytes stimulated by IRL1620, a specific ETB_R agonist, we found that ERK1/2 and NFkB mediated the effects of ET on Ang-2 production. To determine astroglial Ang-2 levels in vivo, reactive astrocytes expressing the high affinity glutamate transporter (GLAST, EAAT1) were isolated by magnetic-activated cell sorting 3 days after stroke. Astrocytes obtained from the ipsilateral hemisphere expressed significantly more Ang-2 compared with astrocytes isolated from the contralateral hemisphere, or from cortices of sham-operated (control) mice. Notably, analysis of microglia sorted from CX3CR1-eGFP mice demonstrated increased cell surface expression of Tie-2, the Ang-2 receptor, on cells obtained from ipsilateral versus contralateral tissue. Addition of recombinant Ang-2 to astrocyte-conditioned medium significantly increased the number of SIM-A9 murine microglial cells cultured under hypoxic conditions (1 % oxygen for 48 h). In transgenic GFAP-CreER™-EDNRB-^fl/fl mice with stroke, conditional knockout of astroglial ETB_R significantly decreased the number of proliferating cells in the peri-infarct area with a microglial phenotype (Ki67⁺/CD11b⁺). Our results indicate that Ang-2, and possibly other paracrine effectors functioning downstream of astroglial ETB_R signaling, are important mediators of microglial cell dynamics after stroke.

01 Dec 2024·DRUGS

Efficacy and Safety of Sovateltide in Patients with Acute Cerebral Ischaemic Stroke: A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase III Clinical Trial

Article

Author: Siddiqui, Mohd Shafat Imam ; Adwani, Sikandar Gokuldas ; Khurana, Dheeraj ; Sidhu, Gursaran Kaur ; Joshi, Deepika ; Karadan, Ummer ; Ramakrishnan, T C R ; Aralikatte, Saroja ; Rai, Hari Prakash ; Sundarachary, Nagarjunakonda Venkata ; Sharma, Mridul ; Vijaya, Pamidimukkala ; Jain, Dinesh ; Anand, Sidharth Shankar ; Vibha, Deepti ; Agrawal, Nilesh Radheshyam ; Gulati, Anil ; Pandian, Jeyaraj Durai ; Sardana, Vijay

BACKGROUND AND OBJECTIVES:

Sovateltide (Tycamzzi™), an endothelin-B (ET-B) receptor agonist, increases cerebral blood flow, has anti-apoptotic activity, and promotes neural repair following cerebral ischaemic stroke. The objectives of this study were to evaluate the efficacy and safety of sovateltide in adult participants with acute cerebral ischaemic stroke.

METHODS:

This was a randomised, double-blind, placebo-controlled, multicentre, Phase III clinical trial of sovateltide in participants with cerebral ischaemic stroke receiving standard of care (SOC) in India. Patients aged 18-78 years presenting up to 24 h after the onset of symptoms with radiologic confirmation of ischaemic stroke and a National Institutes of Health Stroke Scale score (NIHSS) of ≥ 6 were enrolled. Patients with recurrent stroke, receiving endovascular therapy, or with intracranial haemorrhage were excluded. The study drug (saline or sovateltide [0.3 µg/kg] was administered intravenously in three doses at 3 ± 1 h intervals on Days 1, 3, and 6, and follow-up was 90 days). The Multivariate Imputation by Chained Equations (MICE) was used to impute the missing assessments on the endpoints. An unpaired t-test, two-way analysis of variance with Tukey's multiple comparison test, and the Chi-square test were used for the statistical analysis. The objective was to determine at Day 90 (1) the number of patients with a modified Rankin Scale score (mRS) 0-2, and (2) the number of patients with an NIHSS 0-5 at 90 days.

RESULTS:

Patients were randomised with 80 patients in the sovateltide and 78 in the control group. Patients received the investigational drug at about 18 h of stroke onset in both control and sovateltide groups. The median NIHSS at randomisation was 10.00 (95% CI 9.99-11.65) in the control group and 9.00 (95% CI 9.11-10.46) in the sovateltide group. Seventy patients completed the 90-day follow-up in the control group and 67 in the sovateltide group. The proportion of intention-to-treat (ITT) patients with mRS 0-2 score at Day 90 post-randomisation was 22.67% higher (odds ratio [OR] 2.75, 95% CI 1.37-5.57); similarly, the proportion of patients with NIHSS score of 0-5 at Day 90 was 17.05% more (OR 2.67, 95% CI 1.27-5.90) in the sovateltide group than in the control group. An improvement of ≥ 2 points on the mRS was observed in 51.28% and 72.50% of patients in the control and sovateltide groups, respectively (OR 2.50, 95% CI 1.29-4.81). Seven of 78 patients (8.97%) in the control group and 7 of 80 (8.75%) in the sovateltide group developed intracranial haemorrhage (ICH). The adverse events were not related to sovateltide.

CONCLUSIONS:

The sovateltide group had a greater number of cerebral ischaemic stroke patients with lower mRS and NIHSS scores at 90 days post-treatment than the control group. This trial supported the regulatory approval of sovateltide in India, but a multinational RESPECT-ET_B trial will be conducted for US approval.

TRIAL REGISTRATION:

Clinical Trials Registry, India (CTRI/2019/09/021373) and the United States National Library of Medicine, ClinicalTrials.gov (NCT04047563).

01 Oct 2024·Neurocritical care

Sovateltide (ILR-1620) Improves Motor Function and Reduces Hyperalgesia in a Rat Model of Spinal Cord Injury

Article

Author: Karampela, Eleftheria ; Xanthos, Theodoros ; Mavridi, Artemis ; Gkiokas, George ; Iacovidou, Nicoletta ; Mavridis, Theodoros ; Galanos, Antonis

BACKGROUND:

Spinal cord injury (SCI) presents a major global health challenge, with rising incidence rates and substantial disability. Although progress has been made in understanding SCI's pathophysiology and early management, there is still a lack of effective treatments to mitigate long-term consequences. This study investigates the potential of sovateltide, a selective endothelin B receptor agonist, in improving clinical outcomes in an acute SCI rat model.

METHODS:

Thirty male Sprague-Dawley rats underwent sham surgery (group A) or SCI and treated with vehicle (group B) or sovateltide (group C). Clinical tests, including Basso, Beattie, and Bresnahan scoring, inclined plane, and allodynia testing with von Frey hair, were performed at various time points. Statistical analyses assessed treatment effects.

RESULTS:

Sovateltide administration significantly improved motor function, reducing neurological deficits and enhancing locomotor recovery compared with vehicle-treated rats, starting from day 7 post injury. Additionally, the allodynic threshold improved, suggesting antinociceptive properties. Notably, the sovateltide group demonstrated sustained recovery, and even reached preinjury performance levels, whereas the vehicle group plateaued.

CONCLUSIONS:

This study suggests that sovateltide may offer neuroprotective effects, enhancing neurogenesis and angiogenesis. Furthermore, it may possess anti-inflammatory and antinociceptive properties. Future clinical trials are needed to validate these findings, but sovateltide shows promise as a potential therapeutic strategy to improve functional outcomes in SCI. Sovateltide, an endothelin B receptor agonist, exhibits neuroprotective properties, enhancing motor recovery and ameliorating hyperalgesia in a rat SCI model. These findings could pave the way for innovative pharmacological interventions for SCI in clinical settings.

News (Medical) associated with Sovateltide

29 Jul 2025

·pipelinereview.com

Pharmazz Inc. Announces Enrollment of First Patient in Phase 3 Clinical Trial of Sovateltide for Treating Patients with Cerebral Ischemic Stroke

The Phase 3 clinical trial of sovateltide, RESPECT-ETB, is expected to enroll over 500 patients with a primary endpoint of proportion of patients demonstrating functional independence at 90 days and is being conducted under a Special Protocol Assessment (SPA) with the FDA. Sovateltide, a potential first-in-class, highly selective endothelin-B (ETB) receptor agonist, has previously demonstrated significant improvement in stroke patients compared to standard of care in a Phase 3 trial that served as the basis for regulatory approval in India. Recent $25 million equity investment from Sun Pharmaceutical Industries Limited, provides sufficient capital to complete the Phase 3 trial. WILLOWBROOK, IL, USA I July 29, 2025 I Pharmazz, Inc. (“Pharmazz” or the “Company”), a late-stage biopharmaceutical company developing innovative therapies for unmet medical needs in critical care and neurology, today announced that the first patient has been enrolled and treated in the pivotal Phase 3 RESPECT-ETB clinical trial assessing the safety and efficacy of sovateltide for the treatment of acute cerebral ischemic stroke ( NCT05691244 ). Sovateltide represents a potential breakthrough as a first-in-class endothelin-B receptor agonist, uniquely promoting neurovascular remodeling—generating new neurons (neurogenesis), blood vessels (angiogenesis), and enhancing mitochondrial function. “There has not been a new FDA approved non-thrombolytic therapy for stroke in over 30 years. We have already shown promising results in our previous Phase 3 study, which showed that sovateltide could be a meaningful advance over standard of care to promote a fast recovery and improve neurological outcomes in cerebral ischemic stroke patients,” said Emeritus Prof. Anil Gulati, CEO and Founder of Pharmazz. “We have now treated the first patient in our US-based Phase 3 clinical trial and have sufficient capital to complete this study to further cement the potential for sovateltide to transform the treatment of cerebral ischemic stroke.” “There is a massive and ongoing medical burden associated with ischemic stroke, which continues to be a leading cause of long-term disability, affecting hundreds of thousands of patients each year,” said Dr. Thomas Devlin, MD, PhD, FSVIN, physician executive of Neurosciences and medical director at CHI Memorial Stroke and Neuroscience Center, and principal investigator of the Phase 3 trial. “Current treatment options remain limited, underscoring the critical need for novel therapies. Given the promising results already demonstrated with sovateltide, this rigorous Phase 3 study represents an important step toward addressing this urgent unmet medical need.” Phase 3 Trial of Sovateltide for Stroke Covered by Special Protocol Assessment Sovateltide is a first-in-class endothelin-B receptor (ETBR) agonist to treat acute cerebral ischemic stroke that can be administered up to 24 hours after the onset of symptoms. Pharmazz has received agreement from the US 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 for the treatment of acute cerebral ischemic stroke patients. Pharmazz has now enrolled and treated the first patient in its Phase 3 trial, RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244 ). The Phase 3 clinical trial is designed to enroll a total of 514 stroke patients at 65 sites in the US, Germany, Spain, and the UK. The primary endpoint is the proportion of patients demonstrating functional independence post-stroke, defined as a modified Rankin Scale (mRS) score of 0–2 at 90 days after stroke onset. About Sovateltide and Stroke Stroke is a leading cause of long-term disability in the United States, affecting more than 795,000 people each year, and reduces mobility in more than half of stroke survivors over the age of 65 1 . Sovateltide 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. Sovateltide is unique because its action site is the neural progenitor cells. Sovateltide promotes neurovascular remodeling by inducing the formation of new neurons (neurogenesis) and blood vessels (angiogenesis). Sovateltide also protects neural mitochondria and enhances their biogenesis. The Phase 3 trial that served as the basis for approval in India was published in 2024 and showed that the sovateltide group (n=80) had a significantly greater number of cerebral ischemic stroke patients with lower mRS and NIHSS scores at 90 days post-treatment than the control group (n=78). 2 About Pharmazz, Inc. Pharmazz is a privately held company developing novel products in critical care medicine. Pharmazz, Inc. has obtained marketing authorization for two of its first-in-class drug molecules, centhaquine and sovateltide, for the treatment of hypovolemic shock and ischemic stroke, respectively, in India. In addition, the US 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 . SOURCE: Pharmazz

Phase 3Drug Approval

11 Jun 2025

·www.globenewswire.com

Pharmazz Inc. Secures $25 Million Strategic Equity Investment from Sun Pharmaceutical Industries Ltd.

Funding supports pivotal Phase 3 trial for sovateltide, a potential first-in-class therapy that could transform the treatment of acute cerebral ischemic strokeWILLOWBROOK, Ill., June 11, 2025 (GLOBE NEWSWIRE) -- Pharmazz, Inc. ("Pharmazz" or the "Company"), a late-stage biopharmaceutical company developing innovative therapies for unmet medical needs in critical care and neurology, has announced a $25 million equity investment from Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies), one of the world’s leading pharmaceutical companies. This strategic investment brings Sun Pharma’s total commitment in Pharmazz to $40 million (including a previous $15 million equity investment). “We believe sovateltide has the potential to redefine the treatment of ischemic stroke, which has not seen a new FDA approved non-thrombolytic therapy in over 30 years. This investment means we are now fully funded to complete our pivotal Phase 3 study and execute on our mission to make this first in class therapy available to stroke patients,” said Emeritus Prof. Anil Gulati, CEO and Founder of Pharmazz. “We deeply value Sun Pharma’s continued partnership, which strengthens our ability to bring our therapies to patients worldwide.” The new funding will provide Pharmazz with the capital required to complete the pivotal U.S. Phase 3 clinical trial of sovateltide (known as Tycamzzi® and Tyvalzi™ in international markets), its lead drug candidate for treating acute cerebral ischemic stroke. Dr. Neil Marwah, President of Pharmazz, added, “This investment gives us the operational runway to execute a complex, multi-country clinical trial and scale the company responsibly as we prepare for a potential public offering. We are thrilled to strengthen our partnership with Sun Pharma, whose continued support reflects deep confidence in our platform and our ability to execute.” Phase 3 Trial of Sovateltide for Stroke Covered by Special Protocol Assessment Sovateltide is a first-in-class endothelin-B receptor agonist to treat acute cerebral ischemic stroke that can be administered up to 24 hours after the onset of symptoms. Pharmazz has received agreement from the US 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 for the treatment of acute cerebral ischemic stroke patients. Pharmazz is initiating the Phase 3 RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244) trial at 65 sites in the US, Germany, Spain, and the UK, designed to enroll 514 stroke patients. The primary endpoint is the proportion of patients demonstrating functional independence post-stroke, defined as a modified Rankin Scale (mRS) score of 0–2 at 90 days after stroke onset. Commercially Approved in India: Early Validation from 60,000+ patients Sovateltide was approved in 2023 in India and marketed by Sun Pharma under the brand name Tyvalzi™, offering compelling proof of concept for global commercialization. In a randomized, placebo-controlled, multicenter clinical trial conducted in 158 cerebral ischemic stroke patients conducted in India, the product was shown to be well tolerated and effective in improving neurological outcomes when administered within 24 hours of stroke symptoms. Patients on Sovateltide were 22.7% more likely to achieve functional independence at 90 days (as measured by mRS score 0–2; p=0.0045)Sovateltide delivered a 17.1% higher rate of favorable National Institutes of Health Stroke Scale (NIHSS) scores (p=0.0024)The ordinal shift in mRS and NIHSS score between control and sovateltide groups was favorable towards sovateltide across the entire range.Results represent the first statistically significant clinical data in stroke in 30 years, since the introduction of alteplase (tPA)Over 60,000 patients treated to date since commercial launch in India Targeting a Multibillion-Dollar Market with a Broader Therapeutic Window Stroke remains one of the leading causes of disability and death globally, with over 7 million ischemic strokes annually. Today, fewer than 15% of patients receive approved interventions, largely due to their narrow treatment window and strict eligibility criteria. Sovateltide’s 24-hour dosing window and broader eligibility could expand access—particularly for underserved populations—and position it as a major advance in acute stroke care. If successful in Phase 3 and subsequently approved, sovateltide has strong commercial potential and is expected to be a foundational product in the Pharmazz emerging neurology franchise. About Sovateltide Sovateltide 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. Sovateltide is unique because its action site is the neural progenitor cells. Sovateltide promotes neurovascular remodeling by forming new neurons (neurogenesis) and blood vessels (angiogenesis). Sovateltide also protects neural mitochondria and enhances their biogenesis. 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 US 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 leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. and global emerging markets. Sun Pharma’s high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and oncodermatology and accounts for over 18% 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 multicultural workforce drawn from over 50 nations. For further information, please visit www.sunpharma.com. 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 Kabir MarwahMediaShruti Gulati Tel+1 630 780 6087 Tel+1 630 780 6087E mailkabir.marwah@pharmazz.com E mailshruti.gulati@pharmazz.com

Phase 3Drug Approval

26 May 2025

·www.echemi.com

Sun Pharma Amplifies Investment in Pharmazz to $25 Million, Elevating Stake to 22.7%

In a decisive move to bolster its presence in the biopharmaceutical sector, Sun Pharmaceutical Industries Ltd has announced an increased investment in U.S.-based Pharmazz Inc., raising its total commitment to $25 million and expanding its ownership stake to 22.7%. This strategic investment, structured in multiple tranches, is set to be completed by November 30, 2025. The initial tranche includes $10 million, along with the remaining $7.5 million from a prior SAFE (Simple Agreement for Future Equity) arrangement, to be invested by May 31, 2025. A subsequent $15 million tranche is scheduled for investment by November 30, 2025, or another mutually agreed date. Pharmazz is at the forefront of developing innovative treatments for critical care, with two leading drug candidates: Sovateltide, aimed at treating acute cerebral ischemic stroke, and Centhaquine, designed for hypovolemic shock. Both drugs have received approval in India and are marketed under the brand names Tyvalzi and Lyfaquin, respectively. These therapies are currently undergoing development for the U.S. and other international markets. With this enhanced investment, Sun Pharma secures an option to negotiate licensing rights for Sovateltide in certain developed markets, expanding upon its existing exclusive rights in select emerging markets. This move underscores Sun Pharma’s commitment to advancing its portfolio in critical care therapeutics and strengthening its global footprint in the pharmaceutical industry.

License out/inDrug Approval

100 Deals associated with Sovateltide

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB06138

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Ischemic Stroke	India	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	India	Pharmazz, Inc.	23 Aug 2022
Brain Infarction	Phase 3	India	Pharmazz, Inc.	10 Nov 2019
Solid tumor	Phase 3	United States	Pharmazz, Inc.	25 Dec 2016
Asphyxia Neonatorum	Phase 2	India	Pharmazz, Inc.	06 Sep 2023
Hypoxia-Ischemia, Brain	Phase 2	India	Pharmazz, Inc.	06 Sep 2023
Neonatal encephalopathy	Phase 2	India	Pharmazz, Inc.	06 Sep 2023
Asphyxia	Phase 2	United States	Pharmazz, Inc.	23 Aug 2022
Asphyxia	Phase 2	India	Pharmazz, Inc.	23 Aug 2022
acute spinal cord injury	Phase 2	India	Pharmazz, Inc.	10 Jan 2019
Non-Small Cell Lung Cancer	Phase 2	United States	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 (CTRI/2019/09/021373, Pubmed \| Drugs) Manual	Phase 3	Acute Ischemic Stroke	158	Sovateltide	licpkbywlo(xhiivajjur) = dwejfjbqdx sjkifofixg (szuljxdklq ) View more	Positive	15 Nov 2024
				Control (Placebo)	estlxjryca(tucghkhaiv) = kthjvvdsmm tsebmjyjon (fjlrqqutmc ) View more
NCT04047563 (GlobeNewswire) Manual	Phase 3	Acute Ischemic Stroke	158	Sovateltide	jmbbadxpbi(wpiihkmypj) = wruapdjegl begwezleov (jrjfsjhtyy ) View more	Positive	31 Oct 2022
				Placebo	jmbbadxpbi(wpiihkmypj) = ucxwuymcud begwezleov (jrjfsjhtyy ) View more
NCT04047563 (Biospace) Manual	Phase 3	Acute Ischemic Stroke	158	standard of care+Sovateltide	pddbdhloag(cozcpkgcaz) = improvement of ≥6 points on NIHSS bwhjrkuzql (lgvheypivb ) View more	Positive	25 May 2022
				standard of care+Placebo
NCT04052737 (PRNewswire) Manual	Phase 2	Alzheimer Disease	62	sovateltide	rcghdtktre(yypeqvwvdz) = ynzergrmxz svistitxfd (skiystpvqd, 0.955) View more	Positive	10 Jun 2021
				Placebo	rcghdtktre(yypeqvwvdz) = gcpwwwwtyk svistitxfd (skiystpvqd, 0.920) View more
NCT04046484 (Pubmed \| CNS Drugs) Manual	Phase 2	Ischemic stroke	36	Sovateltide	kkkipcuoiy(xhbxnnelhm) = movtfvuani hintmzbudx (loegdoxhmc ) View more	Positive	01 Jan 2021
				Placebo	kkkipcuoiy(xhbxnnelhm) = wmzilickfq hintmzbudx (loegdoxhmc ) View more
NCT05691244 (Pubmed \| Brain Res)	Phase 3	Brain Ischemia	-	IRL-1620	vgbfpqlmgc(aopzkwxybp) = tbwfskklip ewmdptctom (uuvobyhuam )	-	29 Jun 2012
				Vehicle	vgbfpqlmgc(aopzkwxybp) = ykkfjacggd ewmdptctom (uuvobyhuam )
NCT05691244 (Pubmed \| Brain Res)	Phase 3	Infarction, Middle Cerebral Artery	-	IRL-1620	jbeozceymu(dxjebxuawi) = lttsygvwtw mfksxzcrsk (mmisgdpygl )	-	28 Oct 2011
				BQ788	jbeozceymu(dxjebxuawi) = sucqgexhoq mfksxzcrsk (mmisgdpygl )

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