A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Masupirdine (SUVN-502) for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type

This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

Start Date01 Nov 2022

Sponsor / Collaborator

Suven Life Sciences Ltd.

NCT02580305

/ CompletedPhase 2

A Phase 2a Multicenter, Randomized, Double-Blind, Parallel Group, 26-Week, Placebo-Controlled Study of SUVN-502 in Subjects With Moderate Alzheimer's Disease Currently Treated With Donepezil Hydrochloride and Memantine Hydrochloride

This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized, parallel group, placebo-controlled study to compare the efficacy and safety of treatment with SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving stable doses of donepezil HCl and memantine HCl.

Start Date01 Sep 2015

Sponsor / Collaborator

Suven Life Sciences Ltd.

NCT03564964

/ No longer availableNot Applicable

An Intermediate-Size, Expanded Access to SUVN-502 for the Treatment of Subjects With Alzheimer's Disease Who Have Completed the CTP2S1502HT6 Study

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to SUVN-502 for the treatment of Alzheimer's Disease. Investigator as well as the subject/caregiver must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the patient's medical history and program eligibility criteria.
Subjects will not be evaluated for efficacy and safety during the expanded access.

Start Date-

Sponsor / Collaborator

Suven Life Sciences Ltd.

100 Clinical Results associated with Masupirdine(Suven Life Sciences Ltd.)

100 Translational Medicine associated with Masupirdine(Suven Life Sciences Ltd.)

100 Patents (Medical) associated with Masupirdine(Suven Life Sciences Ltd.)

402

Literatures (Medical) associated with Masupirdine(Suven Life Sciences Ltd.)

01 Mar 2025·NEOPLASIA

Phase I clinical trial of a novel procaspase-3 activator SM-1 with temozolomide in recurrent high-grade gliomas

Article

Author: Li, Shenglan ; Li, Shangwei ; Xiao, Yantao ; Zhang, Botao ; Huang, Mengqian ; Li, Wenbin ; Kang, Zhuang

OBJECTIVE:

Despite a standard of care, the mortality of recurrent high-grade gliomas (HGGs) remains high. SM-1 is a novel molecular activator that has shown to target procaspase-3, which is overexpressed in HGGs. A phase I clinical trial was conducted to evaluate the safety, pharmacokinetics, and primary clinical efficacy of SM-1 plus TMZ. Participants received escalating doses of daily oral SM-1 (450, 600, and 800 mg) plus standard TMZ therapy.

METHODS:

In the preclinical study, the synergistic effects of SM-1 and temozolomide (TMZ) in rodent models were evaluated. In the clinical study, adult patients received SM-1 therapy in various doses in combination with a standard TMZ dosing. The tolerability and pharmacokinetics data of the combination therapy were tested. The primary efficacy was measured by tumor response in accordance with the RANO criteria.

RESULTS:

A total of 13 patients with recurrent HGG were enrolled, with 11 patients completed ≥ two cycles of therapy and received tumor assessment. Among them, one patient had complete response, whereas two patients had partial response for the best change from baseline. No dose-limited toxicities were observed, and no maximum tolerated dose was reached.

CONCLUSION:

SM-1 has the potential to enhance antitumor activity while alleviating the side effects of TMZ. SM-1 exhibited mild toxicity in patients with recurrent HGG. The combination of SM-1 and TMZ warrants further investigation, with promising clinical outcomes. The monotherapy phase and expansion phase of SM-1 are still ongoing. (ClinicalTrials.gov number, CTR20221641).

01 Jan 2025·NEUROSCIENCE

Comparison of the efficacy of updated drugs for the treatment on the improvement of cognitive function in patients with Alzheimer ’s disease: A systematic review and network meta- analysis

Review

Author: Guo, Kun ; Li, Rong ; Liu, Zhiqin ; Xi, Jing ; Sun, Fanya ; Di, Zhengli ; Zhao, Hongwei ; Gu, Naibing ; Cao, Weili ; Jia, Xiaotao ; Chang, Hongye ; Zhu, Bo ; Ding, Le ; Shen, Jia

BACKGROUND:

The recent emergence of updated drugs for the treatment of Alzheimer's disease (AD) has produced encouraging cognitive and clinical results in clinical trials, but there is still controversy over how to choose effective treatment options among these numerous drugs. The purpose of this network meta-analysis (NMA) is to compare and rank these drugs based on their efficacy.

METHODS:

We systematically searched in PubMed, Web of Science databases and Cochrane LIbrary, gov for randomized controlled trials for data from 2020 to 2024, and then performed a random-effect network meta-analysis.

RESULTS:

Our NMA results showed that in several main indicators ADAS-cog, CDR-SB and ADCS-ADL. GV-971 (MD -2.36, 95 % CI -5.08, 0.35), Lecanemab (MD -2.00, 95 % CI -5.25, 1.26), Donanemab (MD -1.45, 95 % CI -4.70, 1.81), Masupirdine (MD -0.83, 95 % CI -3.49, 1.84) were more effective than placebo in improving ADAS-cog. In terms of CDR-SB, Lecanemab (MD -3.11,95 % CI -5.23, -0.99) was more effective. Compared with placebo, Donanemab was more effective in ADCS-ADL (MD 3.26,95 % CI 1.48,5.05). SUCRA values showed that GV-971 (76.1 % and 68.7 %) could achieve better therapeutic effects in ADAS-cog) and NPI, and Lecanema (98.1 %) was more effective in improving CDR-SB scores than other drugs. Donanemab (99.8 %) may be the most promising way to slow down the decline in ADCS-ADL scores. The effect of Masupirdine (80.7 %) on MMSE was significantly better than that of several other drugs.

CONCLUSION:

Donanemab and Lecanemab showed good efficacy in ADCS-ADL and CDR-SB, respectively. GV-971 is the best choice to improve ADAS cogs and NPI.

02 Oct 2024·INTERNATIONAL JOURNAL OF RADIATION BIOLOGY

Study on the sensitizing effect of SM-1 combined with irradiation on head and neck squamous cell carcinoma

Article

Author: Xiao, Yan-Tao ; Wang, Dan-Dan ; Hou, Wen-Bin ; Liu, Gai-Ting ; Li, Yi-Liang ; Hu, Tong ; Gou, Wen-Feng ; Zuo, Dai-Ying

PURPOSE:

Head and neck squamous cell carcinoma (HNSCC) is globally prevalent with high recurrence, low survival rate, and poor quality of life for patients. Derived from PAC-1, SM-1 can activate procaspase-3 and induce apoptosis in cancer cells to exert anti-tumor effects. However, the inhibitory effect of SM-1 on HNSCC after combination with radiation are unclear. This study aims to investigate the radiosensitizing effect of SM-1 on HNSCC in vitro and in vivo.

METHODS:

MTT method was used to detect the effect of SM-1 on the viability of HNSCC cell lines (HONE1, HSC-2, and CAL27). The effects of SM-1 combined with radiation on the survival index of HONE1, HSC-2, and CAL27 cell lines were determined by colony formation assay. Flow cytometry was used to investigate the effects of SM-1 and radiation combination on cell apoptosis and cell cycle, and western blot experiments were performed to detect the expression of apoptosis and cell cycle-related proteins. Finally, a xenograft tumor model of CAL27 was established to evaluate the anti-tumor effect of SM-1 combined with radiation in vivo.

RESULTS:

In vitro, SM-1 effectively inhibited the activity of HNSCC cell lines HONE1, HSC-2, and CAL27 cells, and synergistically showed anti-proliferation activity during combined irradiation. Meanwhile, anti-tumor effect of SM-1 on HNSCC was higher than that of Debio1143, and the radiosensitivity of cells was greatly increased. Flow cytometry and western blot analysis showed that SM-1 induced G2/M phase arrest of head and neck squamous cell carcinoma cells via inhibiting the expression of CyclinB1 and CDC2. Moreover, SM-1 activated caspase-3 activity and up-regulated the cleaved form of PARP1 to induce cell apoptosis. In vivo, SM-1 combined irradiation showed a good anti-tumor effect.

CONCLUSION:

SM-1 enhances HNSCC cell radiation sensitivity in vitro and in vivo, supporting its potential as a radiosensitizer for clinical trials in combination with radiotherapy.

News (Medical) associated with Masupirdine(Suven Life Sciences Ltd.)

16 May 2023

·www.prnewswire.com

Psychosis in Parkinson's and Alzheimer's Disease Market to Observe Stunning Growth at a CAGR of 15.6% in the US During the Study Period (2019-2032), Examines DelveInsight

The psychosis in Parkinson's and Alzheimer's disease market size shall grow during the forecast period (2023–2032). This increase will be due to rising disease awareness and improving diagnosis, besides the launch of emerging therapies by key companies, including Sunovion Pharmaceuticals, Karuna Therapeutics, Vanda Pharmaceuticals, and others. LAS VEGAS, May 16, 2023 /PRNewswire/ -- DelveInsight's Psychosis in Parkinson's and Alzheimer's Disease Market Insights report includes a comprehensive understanding of current treatment practices, psychosis in Parkinson's and Alzheimer's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Psychosis in Parkinson's and Alzheimer's Disease Market Report As per DelveInsight analysis, the psychosis in Parkinson's and Alzheimer's disease market size in the 7MM was approximately USD 1.2 billion in 2022. According to the assessment done by DelveInsight, the estimated total diagnosed prevalent psychosis in Parkinson's and Alzheimer's disease cases in the 7MM were approximately 6.7 million in 2022. Leading psychosis in Parkinson's and Alzheimer's disease companies such as Sunovion Pharmaceuticals, Karuna Therapeutics, Vanda Pharmaceuticals, Suven Life Sciences, Enterin, Intra-Cellular Therapies, Merck Sharp & Dohme, and others are developing novel psychosis in Parkinson's and Alzheimer's disease drugs that can be available in the psychosis in Parkinson's and Alzheimer's disease market in the coming years. The promising psychosis in Parkinson's and Alzheimer's disease therapies in the pipeline include Ulotaront (SEP-363856), KarXT (xanomeline-trospium), FANAPT (iloperidone), Masupiridine (SUVN-502), ENT-01, ITI-1284, MK-8189 , and others. Discover which therapies are expected to grab the major psychosis in Parkinson's and Alzheimer's disease market share @ Psychosis in Parkinson's and Alzheimer's Disease Market Report Psychosis in Parkinson's and Alzheimer's Disease Overview Psychosis is a group of symptoms that affect the mind and indicate a loss of contact with reality. Individuals' ideas and perceptions are altered during a psychotic episode, making it difficult to distinguish between what is genuine and what is not. In Parkinson's disease and Alzheimer's disease, both exogenous and endogenous factors contribute to the development of psychosis. Old age, sleep difficulties, long-term neurodegenerative conditions, depression, cognitive impairment, and vision abnormalities are all risk factors for the disease. Parkinson's disease psychosis (PDP) is a prevalent occurrence in Parkinson's disease patients that is associated with significant morbidity and mortality. It is caused by anomalies in dopamine, serotonin, and glutamate neurotransmission induced by Lewy body deposition in the brain. Alzheimer's disease psychosis (ADP), which is common in Alzheimer's disease patients, is caused by increased excitatory neuron sensitivity and post-transcriptional mechanisms that alter synaptic protein in the brain. Due to the complexity of the aetiologies and physiological hypotheses, many diagnostic techniques, including neuroimaging, neurophysiological, genotypic, and serologic examinations, are used to diagnose psychosis in Parkinson's and Alzheimer's disease patients. Psychosis in Parkinson's and Alzheimer's Disease Epidemiology Segmentation DelveInsight estimates that there were approximately 6.7 million diagnosed prevalent cases of psychosis in Parkinson's and Alzheimer's disease in the 7MM in 2022. Among the 7MM, the US contributed to the largest diagnosed prevalent psychosis population in Parkinson's and Alzheimer's disease, acquiring ~34% in 2022. In contrast, the UK accounted for the least, with approximately 4% of the total population share in 2022. The psychosis in Parkinson's and Alzheimer's disease market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total diagnosed prevalent cases of Parkinson's and Alzheimer's disease Age-specific cases of Parkinson's and Alzheimer's disease Gender-specific cases of Parkinson's and Alzheimer's disease Total diagnosed prevalent cases of Psychosis in Parkinson's and Alzheimer's disease Psychosis in Parkinson's and Alzheimer's Disease Treatment Market The current treatment of psychosis in Parkinson's and Alzheimer's disease includes both nonpharmacological and pharmacological treatments. The major goal of psychosis in Parkinson's and Alzheimer's disease treatment is to lessen the frequency and severity of psychotic symptoms while causing little worsening of motor symptoms. The use of conventional and atypical antipsychotics (e.g., aripiprazole, clozapine, quetiapine, and others) is the first-line treatment. However, atypical antipsychotics are frequently chosen in the initial therapy, which minimizes the likelihood of further worsening in patients. Aside from antipsychotics, 5-HT3 receptor antagonists, acetylcholinesterase inhibitors (donepezil, rivastigmine), and various antidepressants are utilized. While cognitive behavioral therapy (CBT), reasoning, and rehabilitation are used to reduce behavioral and psychological symptoms of dementia (BPSD), anxiety, psychosis, agitation, aggression, sleep difficulties, and other symptoms linked with psychosis in Parkinson's and Alzheimer's disease. The US FDA has approved ACADIA's NUPLAZID (pimavanserin), a receptor antagonist (5-HT2A, 5-HT2C), for the treatment of hallucination and delusion associated with psychosis in Parkinson's disease patients. It is the only approved therapy available in the US. Recent trials also suggest that the medicine is helpful in Alzheimer's disease patients with more severe psychosis. At the same time, more long-term studies are needed to define better the efficacy and long-term safety profile of pimavanserin for treating psychosis in Alzheimer's disease. Though the expensive cost of pimavanserin certainly restricts its use, the findings in Parkinson's disease psychosis patients and evidence from Alzheimer's disease trials are convincing. There are currently no approved medicines for Alzheimer's disease psychosis patients; the major treatment is antipsychotics. Off-label therapies that are routinely utilized include quetiapine, clozapine, risperidone, aripiprazole, citalopram, and escitalopram. Aripiprazole has been shown in clinical tests to be effective and safe. In contrast, citalopram has been shown to be useful in lowering agitation and the severity of hallucinations and delusions in Alzheimer's disease psychosis patients. To know more about psychosis in Parkinson's and Alzheimer's disease treatment guidelines, visit @ Psychosis in Parkinson's and Alzheimer's Disease Management Psychosis in Parkinson's and Alzheimer's Disease Pipeline Therapies and Key Companies Ulotaront (SEP-363856): Sunovion Pharmaceuticals KarXT (xanomeline-trospium): Karuna Therapeutics FANAPT (iloperidone): Vanda Pharmaceuticals Masupiridine (SUVN-502): Suven Life Sciences ENT-01: Enterin ITI-1284: Intra-Cellular Therapies MK-8189: Merck Sharp & Dohme Learn more about the FDA-approved drugs for psychosis in Parkinson's and Alzheimer's disease @ Drugs for Psychosis in Parkinson's and Alzheimer's Disease Treatment Psychosis in Parkinson's and Alzheimer's Disease Market Dynamics The psychosis in Parkinson's and Alzheimer's disease market dynamics are anticipated to change in the coming years due to increasing awareness and improved diagnosis. Increased awareness and a better understanding of disease pathogenesis have improved diagnosis and treatment. Moreover, the recent FDA approval of NUPLAZID, the first approved therapy for treating hallucinations and delusions associated with Parkinson's disease psychosis, suggests a positive shift in the psychosis in Parkinson's and Alzheimer's disease market. Furthermore, pharma companies have an opportunity to develop therapies with enhanced safety and tolerability profiles, effectively lowering symptoms and preventing the recurrence of psychosis in Parkinson's and Alzheimer's disease. In addition, the advancement of biomarkers for cognitive impairment enables exact diagnosis and individualized therapy. However, several factors are impeding the growth of psychosis in the Parkinson's and Alzheimer's disease market. Psychosis in Parkinson's disease and Alzheimer's disease is related to low quality of life, higher healthcare resource utilization, and a significant economic burden. NUPLAZID and the other atypical antipsychotics recommended for treatment include black box warnings and adverse effects. Moreover, a lack of a medication development pipeline, the ongoing use of antipsychotics despite the hazards, and a lack of specialized nonpharmacological interventions may cause a dip in the growth of psychosis in the Parkinson's and Alzheimer's disease market. Furthermore, there is a high attrition rate when drug development proceeds from first-in-human trials to pivotal registration studies due to a lack of efficacy. Hence all these factors may hamper the psychosis in Parkinson's and Alzheimer's disease market growth in the coming years. Scope of the Psychosis in Parkinson's and Alzheimer's Disease Market Report Therapeutic Assessment: Psychosis in Parkinson's and Alzheimer's Disease current marketed and emerging therapies Psychosis in Parkinson's and Alzheimer's Disease Market Dynamics: Attribute Analysis of Emerging Psychosis in Parkinson's and Alzheimer's Disease Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Psychosis in Parkinson's and Alzheimer's Disease Market Access and Reimbursement Discover more about psychosis in Parkinson's and Alzheimer's disease drugs in development @ Psychosis in Parkinson's and Alzheimer's Disease Clinical Trials Table of Contents Related Reports Parkinson's Disease Psychosis Pipeline Parkinson's Disease Psychosis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Parkinson's disease psychosis companies, including Vanda Pharmaceuticals, Sumitomo Pharma, among others. Psychosis Market Psychosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psychosis companies, including Teva Pharmaceutical Industries Ltd., Amgen Inc., Pfizer Inc., Novartis International AG., Merck & Co. Inc., Sanofi S.A., among others. Parkinson's Disease Psychosis Market Parkinson's Disease Psychosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease psychosis companies, including Vanda Pharmaceuticals, Sumitomo Pharma, among others. Alzheimer's Disease Market Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alzheimer's disease companies, including AZTherapies, Cerecin, Neurotrope, Lyndra, AC Immune, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Drug Approval

13 Oct 2008

·www.biospace.com

Suven Life Sciences Ltd Release: SUVN-502 data being presented at 16th BioPartnering in London

HYDERABAD, INDIA (October 13, 2008) – Suven Life Science is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products, which are first in class or best in class therapies through the use of GPCR targets for CNS disorders with unmet medical need and high market potential, today announced that it is scheduled to present at the 16th Annual Bio Partnering Europe on 14th Oct 2008. Mr. Venkat Jasti CEO of Suven Life Sciences is scheduled to discuss the company’s business strategy, corporate overview and to present the data on their lead Phase 1 clinical candidate SUVN-502 for cognition in Alzheimer’s and Schizophrenia at 1.30 pm at the QE11 Conference Centre, London, UK where the world’s most innovative companies present themselves to a targeted audience of decision makers. Suven Life Sciences has six internally discovered therapeutic drug candidates currently in clinical and pre-clinical stage of development targeting conditions such as ADHD, dementia, and depression, Huntington's disease. Parkinson's disease and obesity are in addition to developmental candidates in Alzheimer's disease and Schizophrenia. Risk Statement: Except for historical information, all of the statements, expectations and assumptions, including expectations and assumptions, contained in this news release may be forward-looking statements that involve a number of risks and uncertainties. Although Suven attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. Other important factors which could cause results to differ materially including outsourcing trends, economic conditions, dependence on collaborative partnership programs, retention of key personnel, technological advances and continued success in growth of sales that may make our products/services offerings less competitive.

First in ClassBest in Class

100 Deals associated with Masupirdine(Suven Life Sciences Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB06140

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Agitation	Phase 3	United States	Suven Life Sciences Ltd.	01 Nov 2022
Agitation	Phase 3	Croatia	Suven Life Sciences Ltd.	01 Nov 2022
Agitation	Phase 3	Poland	Suven Life Sciences Ltd.	01 Nov 2022
Agitation	Phase 3	Serbia	Suven Life Sciences Ltd.	01 Nov 2022
Dementia due to Alzheimer's disease (disorder)	Phase 3	United States	Suven Life Sciences Ltd.	01 Nov 2022
Dementia due to Alzheimer's disease (disorder)	Phase 3	Croatia	Suven Life Sciences Ltd.	01 Nov 2022
Dementia due to Alzheimer's disease (disorder)	Phase 3	Poland	Suven Life Sciences Ltd.	01 Nov 2022
Dementia due to Alzheimer's disease (disorder)	Phase 3	Serbia	Suven Life Sciences Ltd.	01 Nov 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02580305 (CTgov)	Phase 2	Alzheimer Disease	564	Placebo+Memantine+Donepezil	fctqqjobij(ephqoauwrv) = cyuamhtfzz tmqxrzfajz (nhbzuhgfco, 0.5) View more	-	09 Jun 2023
NCT02580305 (Pubmed \| Int J Geriatr Psychiatry)	Phase 2	Alzheimer Disease	158	Masupirdine 100 mg	blmnzhfreh(jqjgvpgtkr): P-Value = 0.007	-	01 Oct 2022
				Placebo
AAIC2014	Not Applicable	-	12	SUVN-502 (Fasted)	elbytjnqyk(kclvsehvsy) = nuaeadtlmd yrhfcdokeh (rzzlxnfryx ) View more	-	01 Jul 2014
				SUVN-502 (Fed)	elbytjnqyk(kclvsehvsy) = aosbgubqud yrhfcdokeh (rzzlxnfryx ) View more
AAIC2008	Not Applicable	Alzheimer Disease	-	SUVN-502	bnxvygzrzg(vbkkqntcum) = dvnyxhyama axbxyadvyz (qlwnynpwfi ) View more	-	01 Jul 2008

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