An Open Label Balanced Randomized Two Treatments Two Periods Two Sequence Crossover Single Dose Bioequivalence Study of Test Product T Sovateltide for Injection 30 microgram 0.3 microgram per kg manufactured by Gufic Bioscience Ltd Comparing with Reference Product R Tyvalzi Sovateltide for Injection 30 microgram Manufactured by Pharmazz India Pvt Ltd in Healthy Adult Human Participants under Fasting Conditions - NIL

Start Date10 Apr 2026

Sponsor / Collaborator

Gufic Biosciences Ltd.

CTRI/2025/07/090752

/ Not yet recruitingNot ApplicableIIT

A prospective, open-label study to assess the efficacy of sovateltide in filariasis patients with lower limb lymphedema - Nil

Start Date28 Jul 2025

Sponsor / Collaborator-

NCT05691244

/ RecruitingPhase 3

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.

100 Clinical Results associated with Sovateltide

100 Translational Medicine associated with Sovateltide

100 Patents (Medical) associated with Sovateltide

321

Literatures (Medical) associated with Sovateltide

01 May 2026·INFLAMMOPHARMACOLOGY

Sovateltide at the heart–brain axis crosstalk in Alzheimer’s disease: a promising multi-target and cutting-edge therapeutic approach

Review

Author: Kushawaha, Shiv Kumar ; Ashawat, Mahendra Singh ; Kumar, Himanshu ; Baldi, Ashish ; Anaklgi, Amar Deep ; Vashisht, Kanika

Alzheimer’s disease (AD), a devastating neurodegenerative disorder characterized by synaptic loss, cognitive decline, oxidative stress, neurotransmitter imbalance, amyloid-β accumulation, tau tangles, chronic neuroinflammation, and dysregulated signaling, is further exacerbated by endothelin (ET) system dysregulation, where elevated ECE-2 and ET-1 correlate with Aβ-driven pathology in vitro and in vivo. Against this backdrop, Sovateltide (IRL-1620), a highly selective endothelin-B receptor agonist, has emerged as a next-generation, multi-target therapeutic with remarkable neuroprotective promise. Preclinical studies reveal that Sovateltide promotes neurogenesis, synaptogenesis, and angiogenesis, preserves mitochondrial function, and enhances neuronal survival. At the molecular level, it fine-tunes pivotal AD-related pathways, including MAPK, NF-κB, PI3K/Akt/mTOR, Notch, Wnt/β-catenin, and NLRP3 inflammasome, thereby suppressing the release of pro-inflammatory cytokines, inhibiting BACE1 activity, and mitigating the amyloid-β burden. Functionally, Sovateltide enhances learning, memory, and synaptic plasticity in Aβ-induced rodent models, while reducing oxidative stress and increasing neurotrophic factors, including BDNF and NGF. Early clinical evidence highlights its favorable safety and tolerability, as well as its potential cognitive benefits, reinforcing its translational relevance. Beyond neuroprotection, this review underscores how Sovateltide aligns with the emerging heart–brain axis paradigm by targeting vascular dysfunction and modulating convergent signaling pathways, including MAPK, NF-κB, PI3K/Akt/mTOR, Notch, Wnt/β-catenin, and the NLRP3 inflammasome that orchestrate both cardiovascular and neurological decline. This dual action positions it not only as a potential disease-modifying therapy for AD but also as a therapeutic bridge to neurocardiac and psychocardiac disorders. Looking forward, multicenter clinical trials, biomarker-driven patient stratification, and combinatorial strategies will be crucial in validating its efficacy and integrating Sovateltide within the precision medicine framework for dementia care.

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).

News (Medical) associated with Sovateltide

14 May 2026

·www.biospace.com

Pharmazz, Inc. Appoints Ajay Bansal as Chief Financial Officer

Seasoned Biotech CFO with IPO and M&A track record joins as Company advances pivotal Phase 3 trial of sovateltide, RESPECT-ETB, for acute cerebral ischemic stroke (NCT05691244) WILLOWBROOK, Ill., May 14, 2026 (GLOBE NEWSWIRE) -- Pharmazz, Inc. today announced the appointment of Ajay Bansal as Chief Financial Officer, effective immediately. Mr. Bansal is a highly accomplished finance executive with more than two decades of experience leading financial strategy at development-stage and commercial biopharmaceutical companies. He has raised over $1 billion in capital across a broad range of instruments, including IPOs, secondary offerings, convertible notes, venture debt, and PIPEs. His appointment comes at a pivotal moment for Pharmazz, as the Company executes its multi-country Phase 3 RESPECT-ETB clinical trial ( NCT05691244 ) of sovateltide (Tycamzzi®/Tyvalzi™) for the treatment of acute cerebral ischemic stroke. “We are at an extraordinarily exciting juncture in Pharmazz’s history,” said Emeritus Prof. Anil Gulati, CEO and Founder of Pharmazz. “We believe sovateltide has the potential to redefine the treatment of ischemic stroke, which is a condition that has not seen a new FDA-approved non-thrombolytic therapy in more than 30 years. Bringing Ajay on board as CFO is a statement of intent. His deep expertise leading biotech companies through IPOs and transformative M&A transactions, combined with his ability to build the financial architecture that supports complex clinical and commercial operations, makes him exactly the right leader at this critical juncture.” “I am excited to be joining Pharmazz at this juncture as the company progresses sovateltide in its pivotal Phase 3 trial in ischemic stroke,” said Ajay. Mr. Bansal’s experience spans pharma, biotech, genomics, and medical devices. He most recently served as CFO of Cerapedics, an ortho-biologics company, and has previously held CFO roles at Truvian Sciences, Urovant Sciences, ViewRay Incorporated, Onconova Therapeutics, Complete Genomics, Lexicon Therapeutics, Tercica, and Nektar Therapeutics. He led the successful IPOs of Complete Genomics in 2010 and Onconova Therapeutics in 2013, and spearheaded the sale of Tercica (2008), Complete Genomics (2013), and Urovant Sciences (2021). Earlier in his career, Mr. Bansal held roles at Capital One, Mehta Partners, AD Little, Novartis, McKinsey & Company, and ZS Associates. 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 is actively enrolling and treating patients 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 forming 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. 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, . 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: Investors Kabir Marwah Media Shruti Gulati Tel +1 630 780 6087 Tel +1 630 780 6087 E mail kabir.marwah@pharmazz.com E mail shruti.gulati@pharmazz.com 1 Centers for Disease Control. 2 Drugs. 2024 Nov 15;84(12):1637–1650. doi: 10.1007/s40265-024-02121-5

Phase 3Executive ChangeDrug ApprovalIPO

06 Feb 2026

·www.globenewswire.com

Pharmazz Presents Positive Phase IV Interim Analysis of Sovateltide for Acute Ischemic Stroke at the International Stroke Conference 2026

Feb. 04, 2026 -- Pharmazz, Inc. today announced the presentation of positive interim results from its ongoing Phase IV clinical study of sovateltide (Tycamzzi®) in patients with acute cerebral ischemic stroke at the International Stroke Conference (ISC) 2026 in New Orleans. The Phase IV study (NCT05955326) is a multicenter, randomized, controlled trial being conducted in India to further evaluate the real-world safety and effectiveness of sovateltide, a first-in-class, highly selective endothelin-B (ET-B) receptor agonist, when administered within 24 hours of stroke onset. The interim analysis included 80 patients (39 sovateltide; 41 control) who completed 90-day follow-up assessments. Results demonstrated a clinically and statistically significant improvement in functional outcomes among patients treated with sovateltide: • 92.3% of sovateltide-treated patients achieved a modified Rankin Scale (mRS) score of 0–2 at Day 90, compared with 58.5% in the control group (Odds Ratio 8.50; 95% CI 2.44–29.01; p=0.0005) • An absolute 33% increase in favorable functional outcomes (mRS 0–2) was observed with sovateltide treatment • 84.6% of sovateltide-treated patients achieved an improvement of ≥2 points on the mRS, compared with 51.2% in controls (p=0.0014) • Baseline characteristics, including age, NIHSS score, and time from stroke onset to treatment, were comparable between groups • No drug-related adverse events were observed, and safety outcomes were consistent with prior studies Patients aged 18–78 years with radiologically confirmed ischemic stroke and NIHSS ≥6 were randomized to receive either sovateltide (0.3 µg/kg) or saline placebo. The study drug was administered as three intravenous bolus doses over one minute at 3±1 hour intervals on Days 1, 3, and 6. Outcomes were assessed at Day 90 using the modified Rankin Scale. Sovateltide is approved for marketing in India and was launched in September 2023. To date, over 100,000 patients have been treated. The drug has demonstrated neuroprotective, pro-angiogenic, and neurogenic effects across preclinical and clinical studies, with a favorable safety profile. A global Phase III randomized, double-blind, placebo-controlled trial (RESPECT-ETB; NCT05691244) is currently underway across the United States, Europe, the United Kingdom, and Australia, evaluating sovateltide in more than 500 patients with acute ischemic stroke. Pharmazz, Inc. is a biopharmaceutical company focused on developing novel therapies for critical care and neurological disorders. Its lead programs target conditions with high unmet medical need, including acute ischemic stroke and hypovolemic shock. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug Approval

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

100 Deals associated with Sovateltide

External Link

KEGG	Wiki	ATC	Drug Bank
D11964	-	-	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
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
Advanced Bile Duct Carcinoma	Phase 2	United States	Spectrum Pharmaceuticals, Inc.	01 Apr 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	fiuhfnmxhb(cioyixygxi) = nahaxvrzcq qnzeabrnzr (kxpmfkcwnd ) View more	Positive	15 Nov 2024
				Control (Placebo)	nmwtticpmv(ogbggythfm) = svmyxfhkqo wcwdzhfuhj (qidjqizqpg ) View more
NCT04047563 (GlobeNewswire) Manual	Phase 3	Acute Ischemic Stroke	158	Sovateltide	zwthehzehh(ipbloyaweu) = husogtwexo ejaqsxolry (txedzwpyzv ) View more	Positive	31 Oct 2022
				Placebo	zwthehzehh(ipbloyaweu) = afaefhxexl ejaqsxolry (txedzwpyzv ) View more
NCT04047563 (Biospace) Manual	Phase 3	Acute Ischemic Stroke	158	standard of care+Sovateltide	nndoretzkx(omuqqkbtfm) = improvement of ≥6 points on NIHSS fvzqwqqdhm (pnxcebwnkn ) View more	Positive	25 May 2022
				standard of care+Placebo
NCT04052737 (PRNewswire) Manual	Phase 2	Alzheimer Disease	62	sovateltide	ikxfmtjidt(srmktnqftw) = rtjuayqjfl bkiwvadkdr (rvvghgmdku, 0.955) View more	Positive	10 Jun 2021
				Placebo	ikxfmtjidt(srmktnqftw) = favyaedxvn bkiwvadkdr (rvvghgmdku, 0.920) View more
NCT04046484 (Pubmed \| CNS Drugs) Manual	Phase 2	Ischemic stroke	36	Sovateltide	osbwsprjsr(mpmcdbifaq) = bvnaoxddmm auvbhrheur (orlvpnjbxk ) View more	Positive	01 Jan 2021
				Placebo	osbwsprjsr(mpmcdbifaq) = shagrbxwfy auvbhrheur (orlvpnjbxk ) View more
NCT05691244 (Pubmed \| Brain Res)	Phase 3	Brain Ischemia	-	IRL-1620	kaixvrsjhi(nxoxelzkxa) = pzliocyujp dwpxanwkvo (krzebjdnpr )	-	29 Jun 2012
				Vehicle	kaixvrsjhi(nxoxelzkxa) = ibttbolbcs dwpxanwkvo (krzebjdnpr )
NCT05691244 (Pubmed \| Brain Res)	Phase 3	Infarction, Middle Cerebral Artery	-	IRL-1620	inicahzyuv(zdlvokmbwn) = ovjhhiiocj kryeubctzi (aoynycrkke )	-	28 Oct 2011
				BQ788	inicahzyuv(zdlvokmbwn) = hkgcwdient kryeubctzi (aoynycrkke )

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