A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants with Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)

This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.

Start Date01 Feb 2025

Sponsor / Collaborator

University of California, Los Angeles

[+1]

NCT06655883 / Not yet recruitingPhase 3

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Suvorexant for the Treatment of Insomnia in Participants With Opioid Use Disorder

People with opioid use disorder (OUD) can have trouble falling or staying asleep. Researchers want to know if suvorexant will help people with OUD fall asleep and stay asleep. The goal of this study is to learn about the safety of suvorexant and how well people tolerate it. Researchers also want to learn if suvorexant helps people sleep longer compared to people who take placebo. A placebo looks like the study medicine but has no actual study medicine in it.

Start Date02 Dec 2024

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT06484075 / RecruitingPhase 1/2IIT

Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms

Background:
Alcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed. Dopamine, a chemical that carries signals between brain cells, is thought to play a role in alcohol addiction. Researchers want to learn how Suvorexant, a drug used to treat sleep disorders, affects dopamine receptors in the brain.
Objective:
To see how Suvorexant affects dopamine receptors in people with AUD and in healthy people.
Eligibility:
People aged 18 to 75 years seeking treatment for AUD. Healthy volunteers are also needed.
Design:
Participants with AUD will stay in the clinic for at least 3 to 4 weeks for alcohol detoxification. They will receive normal treatment for AUD.
Suvorexant is a medicine used to treat sleep problem that is taken taken by mouth, once a day. Some participants will take the study drug. Others will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.
Participants will wear a device that looks like a wristwatch to track their movements during their clinic stay.
Participants will have blood tests and 3 brain imaging scans before starting on the study drug: 2 positron emission tomography (PET) and 1 magnetic resonance imaging (MRI) scan. They will be injected with a radioactive tracer during each PET scan.
Participants will have tests to assess their thinking, memory, and attention. They will have sleep studies.
Imaging scans and other tests will be repeated at the end of the study.
Healthy volunteers will have 1 MRI and 2 PET scans. They will have tests to assess of their thinking, memory, and attention. They will wear a wristwatch like movement monitor for 1 week.

Start Date21 Nov 2024

Sponsor / Collaborator

National Institute on Alcohol Abuse & Alcoholism

100 Clinical Results associated with Suvorexant

100 Translational Medicine associated with Suvorexant

100 Patents (Medical) associated with Suvorexant

409

Literatures (Medical) associated with Suvorexant

01 Dec 2024·Journal of Pharmaceutical and Biomedical Analysis

Validated UPLC-MS/MS method for quantification of melatonin receptor agonists and dual orexin receptor antagonists in human plasma and breast milk: Application to quantify suvorexant and lemborexant in clinical samples

Article

Author: Furugen, Ayako ; Ishikawa, Shuhei ; Kobayashi, Masaki ; Aoyagi, Ryoichi ; Narumi, Katsuya ; Sugawara, Mitsuru ; Nishimura, Ayako ; Takekuma, Yoh ; Ishikawa, Hina ; Okamoto, Keisuke ; Umazume, Takeshi

Pharmaceutical care is important for mental health during the perinatal period, which is often characterized by insomnia. In recent years, prescriptions of melatonin receptor agonists (MRAs) and dual orexin receptor antagonists (DORAs) for insomnia have increased; however, their use during the perinatal period has scarcely been reported. In the present study, we developed a UPLC-MS/MS method for the quantification of ramelteon, its metabolite M-II, suvorexant, and lemborexant in human plasma and breast milk to accumulate information on the safety and transfer of MRAs and DORAs into breast milk. Samples of MRAs (ramelteon and M-II) in plasma and breast milk were prepared using liquid-liquid extraction (LLE) with ethyl acetate. For DORAs (suvorexant and lemborexant), LLE with ethyl acetate was applied to plasma samples. For breast milk samples, significant ion suppression was observed for LLE with ethyl acetate. Solid-phase extraction (SPE) cartridges capable of removing phospholipids improved the matrix effects. Finally, protein precipitation with methanol and an SPE cartridge, InertSep® Phospholipid Remover, were selected for breast milk sample preparation. An ACQUITY UPLC BEH C18 column was used for analyte separation. MRAs and DORAs were eluted using isocratic and gradient elution, respectively, and analyzed using electrospray ionization in the positive mode with multiple reaction monitoring. The range of calibration curve for MRAs and DORAs was 0.1-25 and 0.5-50 ng/ml, respectively. Both the plasma and breast milk samples exhibited good linearity over this range. The method was validated by evaluating its accuracy and precision, matrix effect, recovery, carry-over, stability, and dilution integrity. The validated method was successfully applied to clinical samples donated by breastfeeding women and the milk/plasma (M/P) ratio and relative infant dose (RID) of lemborexant (one case) and suvorexant (two cases) were estimated. The M/P ratio of lemborexant was <1, and the RID was 1.05 %. The M/P ratio of suvorexant was <0.1, and RID was 0.11-0.20 %. This method will be useful for future studies evaluating the safety of these drugs during breastfeeding.

01 Dec 2024·European Journal of Pharmacology

Stimulation of kappa opioid receptors in the nucleus accumbens promotes feeding behavior in mice: Acute restoration of feeding during anorexia induced by 5-fluorouracil

Article

Author: Waddington, John L ; Ikeda, Hiroko ; Waddington, John L. ; Nagase, Hiroshi ; Yonemochi, Naomi

Though μ and δ opioid receptors are reported to regulate energy homeostasis, any role for κ opioid receptors in these processes remains unclear. The present study investigated the role of κ opioid receptors in regulation of feeding behavior and plasma glucose levels using nalfurafine, a κ opioid receptor agonist used clinically. Systemic injection of nalfurafine increased food intake under non-fasted conditions, but not after food deprivation, and this effect was inhibited by the κ opioid receptor antagonist norbinaltorphimine. In contrast, nalfurafine did not affect plasma glucose levels. I.c.v. injection of nalfurafine increased food intake, whereas systemic injection of nalfurafine methiodide, which does not penetrate the blood brain barrier, was without effect. In addition, nalfurafine tended to increase preproorexin mRNA in the hypothalamus. However, neither the orexin OX1 receptor antagonist YNT-1310 nor the non-selective orexin receptor antagonist suvorexant inhibited the increase in food intake induced by nalfurafine. While nalfurafine injected into the lateral hypothalamus did not affect food intake, nalfurafine injected into the nucleus accumbens increased food intake, which was inhibited by norbinaltorphimine. Finally, we examined the effect of nalfurafine on anorexia induced by the anti-cancer agent 5-fluorouracil. Reduced food intake at 2 days following 5-fluorouracil administration was alleviated across the first 3 h following daily injection of nalfurafine, though daily food intake was not influenced. These results indicate that nalfurafine promotes feeding behavior through stimulation of κ opioid receptors in the nucleus accumbens and may be a candidate for reducing anorexia due to anti-cancer agents.

01 Dec 2024·Sleep Medicine

Improvement in self-reported, but not actigraphic, sleep measures with suvorexant in people with well-controlled Restless Legs Syndrome and persistent insomnia

Article

Author: Winkelman, John W. ; Zackon, Jordana ; Winkelman, John W ; Kilty, Adysn

BACKGROUNDSleep disturbance remains common in people with Restless Legs Syndrome (RLS), even after RLS symptoms are sufficiently controlled with medication. We conducted a placebo-controlled crossover trial to examine the efficacy of suvorexant in improving sleep quality and quantity in people with well-controlled RLS and persistent insomnia.METHODSIn this double-blind, randomized, placebo-controlled crossover trial, 34 participants (70.6 % female, mean age = 62.7) with well-controlled RLS were randomized to placebo or suvorexant (10-20 mg) for 6 weeks, followed by a 2-week washout and then the opposite treatment. Study inclusion required an IRLS score <15, insomnia diagnosis per DSM-5, and a diary-reported combined Sleep Onset Latency (SOL) and Wake After Sleep Onset (WASO) > 45 min and a Total Sleep Time (TST) < 7 h on 7/14 baseline nights. The primary outcome was actigraphically-derived TST, and secondary outcomes were Insomnia Severity Index (ISI) score and actigraphically-derived WASO. Data for all sleep metrics were collected at baseline and for the last two weeks of each treatment period.RESULTSThere were no significant improvements in actigraphically-derived TST (p = 0.58) or WASO (p = 0.99) while taking suvorexant compared to placebo. However, there were significant reductions in insomnia symptoms, measured by the ISI, as well as increases in diary-reported TST (p = 0.01) while taking suvorexant compared to placebo. The most commonly reported side effect of suvorexant was fatigue (29.4 %).CONCLUSIONSWe observed no significant differences between treatments in actigraphically-derived sleep measures, but support for suvorexant's benefit for overall insomnia and self-reported quantity of sleep in people with well-controlled RLS who continue to suffer from insomnia.CLINICAL TRIALS REGISTRATION NUMBERNCT04706091.

News (Medical) associated with Suvorexant

30 Sep 2024

·www.globenewswire.com

Superluminal Medicines Announces Formation of Scientific Advisory Board

Multidisciplinary board members bring expertise in drug discovery, clinical development, computational life science, GPCRs and drug formulationBOSTON, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Superluminal Medicines, Inc., “The Membrane Company” using generative biology, chemistry and machine learning approaches to revolutionize the speed and accuracy of how medicines are created, today announced the formation of its Scientific Advisory Board (SAB). Comprised of renowned experts whose skillsets span drug discovery, computational life science, translational research, GCPRs, clinical trials and commercialization, the newly formed SAB has a deep understanding of Superluminal Medicines and its strategic priorities and will play a crucial role in advising the Company as it progresses its lead program into clinical development and increases the number of small molecule drug discovery programs focused on high-value G protein-coupled receptor (GPCR) targets. “The members of our new Scientific Advisory Board are world-renowned experts in their fields who have pushed the boundaries of science, established new areas of research and have brought new therapeutics to market,” said Cony D'Cruz, CEO of Superluminal Medicines. “I can think of no better set of advisors to help Superluminal Medicines take our lead program into clinical development, advance six small molecule programs and build our discovery platform to quickly and efficiently generate therapeutics for any membrane drug target.” Inaugural members of Superluminal Medicine’s Scientific Advisory Board include: Morris J. Birnbaum MD, PhD, SAB Chairman, is a physician-scientist who has led research teams in academic and pharmaceutical settings, investigating fundamental problems in metabolic regulation and their relevance to chronic disease. Dr. Birnbaum was Senior Vice President and Chief Scientific Officer, at Pfizer Inc., initially of the Cardiometabolic and later the Internal Medicine Research Unit, where he was responsible for the discovery and early clinical development of drugs designed to treat metabolic diseases. Under his leadership, Pfizer brought seven novel potential medicines into clinical development. Dr. Birnbaum has held faculty positions at Harvard Medical School, the Perelman School of Medicine at the University of Pennsylvania, and the Howard Hughes Medical Institute. Dr. Birnbaum received his AB, PhD and MD from Brown University and completed an Internal Medicine residency at Barnes Hospital at Washington University in St. Louis, followed by postdoctoral training at the University of California, San Francisco, and Sloan-Kettering Institute in New York. John Griffin, PhD, is an entrepreneur and advisor to science-driven organizations. With more than 30 years of R&D leadership experience, he is the Co-Founder and former Chief Scientific Officer of Theravance, Inc. Dr. Griffin was Chief Scientific Officer of Numerate, a startup that sought to overcome major challenges in drug discovery by applying novel machine-learning algorithms to drug design at cloud scale which was acquired by Valo Health. After the acquisition, he was Vice President at Valo Health—a technology company focused on utilizing large-scale data and AI-driven computation to discover and develop therapeutics. Dr. Griffin was also an Assistant Professor of Chemistry at Stanford University, has authored 40 publications and is co-inventor of 29 patents. He received his BS in Chemistry from Hope College, a PhD in Chemistry from the California Institute of Technology and was a National Science Foundation Postdoctoral Fellow at Harvard Medical School. Carrie Haskell-Luevano, PhD, conducts research focused on GPCRs, the neuroendocrine regulation of pain (opioid receptors), food intake and energy homeostasis (melanocortin receptors). She is the Philip S. Portoghese Endowed Chair in Chemical Neuroscience at the University of Minnesota’s Department of Medicinal Chemistry. The Haskell-Luevano laboratory uses a variety of multidisciplinary techniques and research approaches including peptide, small molecule and combinatorial chemistry synthesis; cell-based assays; chemical biology; neuromolecular pharmacology; developing knock-out mice and neuroscience. The Haskell Luevano laboratory has published over 130 peer-reviewed manuscripts, reviews, book chapters and conference proceedings. Dr. Haskell-Luevano completed her postdoctoral studies and started an independent research program at the University of Florida Department of Medicinal Chemistry, where she was promoted through the ranks of Assistant, Associate, and Full Professor. Dr. Haskell-Luevano received her BS degree in Chemistry from the California State University of Fresno and her PhD in Chemistry at the University of Arizona. Terrence Kenakin, PhD, is a leader in the use of pharmacologic tools and concepts to characterize the activity of molecules in biological systems using quantified molecular properties so that their activity can be predicted in therapeutic and other systems. Currently, Dr. Kenakin is Professor of Pharmacology at the University of North Carolina School of Medicine in Chapel Hill, where he optimizes the design of drug activity assay systems, discovery and testing of allosteric molecules for therapeutic application and quantitative modeling of drug effects. He joined Burroughs-Wellcome as an associate scientist following a postdoctoral fellowship at University College London, UK . Dr. Kenakin worked in drug discovery for 25 years at Glaxo, Inc., Glaxo Wellcome and GlaxoSmithKline’s Research and Development laboratories. He has authored numerous articles and 10 books on Pharmacology. Dr. Kenakin received his BSc in Organic Chemistry and PhD in Pharmacology from the University of Alberta in Canada. Georgia McGaughey, PhD, is a veteran scientific leader with more than 30 years of corporate experience in drug discovery and digital transformation earned at Pfizer, Merck and Vertex Pharmaceuticals. In 2024, she retired from Vertex Pharmaceuticals where she was Vice President of the global Data and Computational Sciences (DCS) group and a member of the Research Leadership Team, which is responsible for the scientific strategy and direction for the entire Vertex drug discovery portfolio. Under her leadership, the DCS group was responsible for leveraging data and advanced analytics with impact from research to FDA approval and played a central role in the approval of CASGEVY®, a gene-editing CRISPR therapy. Dr. McGaughey spent 13 years at Merck in a variety of roles in infectious diseases, CNS and other therapeutic areas, contributing directly to Belsomra®, Filorexant, MK-8189 and MK-8193, a PET-tracer used to measure target engagement for PDE10. Upon her departure from Vertex, Dr. McGaughey founded Trilligant to continue lending her expertise in digital transformation for a wide variety of businesses from sports analytics to drug discovery. Dr. McGaughey completed her PhD studies at the University of Georgia and has published over 100 peer-reviewed scientific publications and contributed to numerous patents. Sandeep Menon, MD, PhD, MPH, MS, is the Chief Development Officer at Alnylam Pharmaceuticals, where he leads a multifunctional global team and oversees end-to-end development. Before, Dr. Menon was Senior Vice President and head of Early Clinical Development at Pfizer. He oversaw Pfizer’s early clinical pipeline of assets from IND through Phase 2b across all therapeutic areas, playing a critical leadership role in increasing Pfizer’s R&D productivity resulting in a Phase II success rate of over 50%. In 2021, his team co-led the early clinical development of Paxlovid, which went from first-in-human to emergency use authorization in nine months. He also served as Chief Scientific Officer for AI and Digital Sciences, overseeing the cutting-edge Pfizer Innovation and Research Lab (PfIRE Lab), responsible for using state-of-the-art technology to develop meaningful novel quantitative digital endpoints through dynamic and remote monitoring of human behaviors. Prior to Pfizer, Dr. Menon was at Biogen where he worked on Tecfidera and Tysabri; prior to that he was a Research fellow at Harvard Clinical Research Institute. Dr. Menon received his medical degree from Karnataka University, India, his Master’s in Public Health and PhD in Biostatistics at Boston University and his MS in Translational Pharmacology from Ohio State University. He has published over 70 peer-reviewed scientific publications and book chapters and co-authored / co-edited 9 books. About Superluminal Medicines Inc. Superluminal Medicines is a generative biology and chemistry company developing a differentiated pipeline and revolutionizing the speed and accuracy of how medicine is created. The company’s platform creates candidate-ready compounds with unprecedented speed using a comprehensive combination of deep biology and chemistry expertise, machine learning, and proprietary big data infrastructure. The predict-design-test architecture accurately models protein shapes and designs highly selective compounds to target the precise structural change for therapeutic effect. Its discovery engine is powered by an industry-leading, pharmacokinetic and toxicology in silico prediction capability. The company’s proprietary pipeline validates its platform with initial programs focused on high-value GPCR targets. Based in Boston, the company is backed by a strong network of investors including RA Capital Management, Insight Partners, NVentures, Catalio Capital Management, Eli Lilly and Company, Gaingels, and Cooley LLP. For more, visit www.superluminalrx.com. Media ContactJanine McCargo6 Degreesjmccargo@6degreespr.com

AcquisitionExecutive ChangePhase 2

22 Aug 2024

·www.prnewswire.com

NATIONALLY RECOGNIZED BEHAVIORAL SCIENTIST DR. KELLY DUNN NAMED DIRECTOR OF THE KAHLERT INSTITUTE FOR ADDICTION MEDICINE AT THE UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE

BALTIMORE, Aug. 22, 2024 /PRNewswire/ -- University of Maryland School of Medicine (UMSOM) Dean Mark T. Gladwin, MD, announced today the appointment of Kelly Dunn, PhD, MBA, one of the nation's leading researchers on opioid use disorder, as the inaugural Director of the School's Kahlert Institute for Addiction Medicine. She will also serve as a Professor in the Department of Psychiatry with a secondary appointment in the Department of Neurobiology at UMSOM. Dr. Dunn is currently a Professor of Psychiatry and Behavioral Sciences at Johns Hopkins School of Medicine with a joint appointment in Health Policy and Management at the Johns Hopkins University School of Public Health. Dr. Dunn has been the Principal Investigator on projects totaling more than $21 million in awards from the National Institutes of Health. She has authored more than 130 peer-reviewed publications in the area of substance use and opioid use disorder. The Kahlert Institute for Addiction Medicine, launched in 2023 with a major gift from the Kahlert Foundation, is uniquely positioned to bring together leading addiction experts from across basic science and clinical care to transform the prevention, treatment, education, and research of addiction. "With addiction, substance use disorder, and overdose deaths reaching epidemic proportions here in Maryland and in the U.S., we are extremely pleased to attract a top academician and leader in this field to move the Institute forward with a long-term impact," said Dean Gladwin. Growing up in rural Central New York in the late 1990's, Dr. Dunn watched several close friends become dependent on opioids, after first being exposed through prescription medications, and eventually go on to develop opioid use disorder (OUD). "This prompted my life-long passion for understanding motivations for opioid use, identifying methods to prevent the onset of OUD, and helping to improve treatments for OUD," said Dr. Dunn. "I'm honored and thrilled to take the helm of the Kahlert Institute and to work together with all of the stellar faculty who are world-class leaders in addiction research to advance the science of addiction medicine." Since 2012, Dr. Dunn has been a faculty member in the Johns Hopkins University Behavioral Pharmacology Research Unit (BPRU) located within the Department of Psychiatry and Behavioral Sciences. Her current work focuses on the conduct of Phase II/III randomized controlled assessments of medications, mainly those targeted for opioid use disorder. She has also managed trials focused on treatments for cigarette smoking and alcohol use disorder and has conducted several basic science human laboratory examinations of drug effects, which is complemented by a body of work focused on epidemiological and machine-learning analyses of publicly available datasets. She has held multiple leadership roles in the substance use field, including serving as President for the American Psychological Association's Society for Psychopharmacology and Substance Use and the College on the Problems of Drug Dependence (CPDD) as well as Co-Editor of the Journal of Addiction Medicine and Editor-in-Chief of the journal Experimental and Clinical Psychopharmacology. "Dr. Dunn's current work in the field is impressive, " said Greg Kahlert, President of The Kahlert Foundation. "I am confident with her experience, passion and collaborative spirit, she will help find treatments and cures for those suffering from addiction. I could not be more excited that she is the first director of the Kahlert Institute for Addiction Medicine." Dr. Dunn is currently the principal investigator on a multisite examination of a treatment for co-morbid pain in people with opioid use disorder. She is also an investigator on a Phase II trial examining the use of the drug suvorexant to treat sleep disorders, withdrawal, and craving in people initiating treatment with buprenorphine for opioid use disorder. Other studies include a combination laboratory/clinical trial examining phenotypes of opioid withdrawal and a pilot trial examination of suvorexant for cocaine use in people being treated for OUD. Dr. Dunn recently completed a series of human laboratory trials examining genetic contributions to opioid sensitivity and opioid-cannabinoid interactions for pain treatment in healthy and clinical populations. In addition to her numerous peer-reviewed original and review publications, Dr. Dunn edited the Oxford Handbook on Opioids and Opioid Use Disorder. She received her PhD Degree from the University of Vermont in 2009 and earned an MBA Degree from Johns Hopkins University Carey School of Business in 2019. This news release was issued on behalf of Newswise™. For more information, visit SOURCE University of Maryland School of Medicine

Phase 2Executive Change

16 Nov 2023

·medcitynews.com

We’re at a Turning Point for Alzheimer’s Disease Research

Right now, roughly six million Americans are forgetting their lives as a result of Alzheimer’s— a devastating disease that progressively interferes with, and eventually destroys, cognitive function and memory— and unless we do something drastic about it, this number will more than double by 2050. That’s a tall order considering that both 2022 and 2023 were hailed as the “era of Alzheimer’s Disease treatments” and it’s likely that medical advancements for Alzheimer’s will continue strong well into 2024. As we learn more about the disease and dementia in general, the closer we come to putting an end to Alzheimer’s once and for all. What we know about Alzheimer’s dictates how we develop treatments The exact cause of Alzheimer’s is unknown. However, scientists believe that its onset and progression are connected to changes in the brain. These changes include the buildup of reactive and toxic proteins— including beta-amyloid 42— around brain cells and neurons. In turn, this causes inflammation and damage that disrupts cellular and neural activity and ultimately results in decreased memory, cognitive function, and eventually the ability to carry out the simplest of tasks, like dialing a phone number. Medical science has made significant strides in the development of advanced treatments over the past decade. However, the majority of FDA-approved treatments for Alzheimer’s focus on the management of symptoms or delayed progression of the disease. There are two categories of drugs approved by the FDA for the treatment of Alzheimer’s: drugs that treat the cognitive and non-cognitive symptoms of the disease, and drugs that change disease progression. Treatments available to patients now are offering hope and some relief There are currently five FDA-approved drugs available for the treatment of the cognitive symptoms of Alzheimer’s Disease, like memory and thinking— donepezil, galantamine, rivastigmine, memantine, and memantine + donepezil— and two FDA-approved drugs for the treatment of non-cognitive symptoms— suvorexant for insomnia, and brexpiprazole for agitation. Treatments specifically targeted at slowing the decline of cognitive function in patients with early Alzheimer’s have provided some hope in recent years. There are just two treatments currently approved for the change of progression in Alzheimer’s Disease, though there are also promising drug candidates in development right now. Just two years ago, in 2021, the FDA approved aducanumab, a breakthrough treatment for Alzheimer’s Disease that data shows can slow the progression of the disease in patients with early or mild Alzheimer’s, ultimately increasing and extending quality of life. Lecanemab (Elsai and Biogen) received accelerated approval in January 2023 for its potential to slow cognitive decline in patients with early to moderate Alzheimer’s. Lecanemab also has shown no signs of being able to reverse the symptoms or provide long-term, sustained improvement, even after 18 months of treatment. Drug candidate donanemab (Eli Lilly and Company) is showing significant progress in stemming the progression of Alzheimer’s Disease from one stage to the next in clinical trials. Though all of these treatments come with side effects, this rapid progress in the treatment of Alzheimer’s Disease is helping patients right now while researchers continue to improve on these and other treatments. The future of Alzheimer’s Disease diagnosis and treatment There is currently no FDA-approved Alzheimer’s Disease treatment on the market that can reverse the symptoms and damage done by the disease. But that doesn’t mean it won’t ever happen. In fact, right now, researchers are working on new treatment candidates for Alzheimer’s Disease that are showing promising results. Last year, a new treatment candidate made headlines when results from phase 2a clinical trials showed not only that the drug could improve cognition and function during the one-month double-blind study, but that it was happening in patients with moderate to severe Alzheimer’s. Importantly, those improvements happened with little to no side effects. The Open Label Extension (OLE) study that followed showed disease reversal in 47 percent and disease stabilization in 28 percent of participants, including those with severe Alzheimer’s Disease, after only three months of treatment. An upcoming phase 2b clinical trial will collect and analyze clinical data in moderate to severe Alzheimer’s patients over the course of a full year to further prove the efficacy, safety, and sustainability of the treatment. The outcome of the phase 2b clinical trials, paired with prior results, could help to put this new treatment on an accelerated pathway to distribution, a move that if it occurs, would mark the availability of the first drug with the potential to reverse the effects of Alzheimer’s Disease. As exciting as this future is, there’s more work yet to be done. Patients typically have Alzheimer’s Disease long before they experience outward symptoms. Known as pre-clinical Alzheimer’s Disease, the effects of dementia can begin to occur 10 to 15 years before patients experience the types of symptoms that result in doctor’s visits and diagnosis. Diagnosis itself can also require many medical appointments over successive months, and treatment may not always begin right away. We need better diagnostics paired with earlier diagnosis and improved patient access and education. Empowering patients and their families to understand symptoms, family history, and what to do about it are critical in combatting the devastating effects of Alzheimer’s Disease. The best diagnostics in the world, paired with the best treatments, or even an eventual cure, won’t help if people don’t know when to talk to their medical provider. A future without Alzheimer’s Disease could be just over the horizon. But we have to all work together to make it happen.

Phase 2Drug ApprovalClinical Result

100 Deals associated with Suvorexant

External Link

KEGG	Wiki	ATC	Drug Bank
D10082	Suvorexant	N05CM19	DB09034

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	US	Merck Sharp & Dohme Corp.	13 Aug 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Opioid abuse	Phase 3	-	Merck Sharp & Dohme LLC	02 Dec 2024
Sleep Initiation and Maintenance Disorders	Phase 3	-	Merck Sharp & Dohme LLC	02 Dec 2024
Delirium	Phase 3	JP	Merck Sharp & Dohme Corp.	22 Oct 2020
Alzheimer Disease	Discovery	-	Merck Sharp & Dohme Corp.	23 May 2016
Pulmonary Disease, Chronic Obstructive	Discovery	-	Merck Sharp & Dohme LLC	25 Mar 2011
Sleep Apnea, Obstructive	Discovery	-	Merck Sharp & Dohme Corp.	19 Mar 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02729714 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Parkinson Disease	21	Suvorexant (Suvorexant Period)	dgkrvhfeka(qjoqrrsvfk) = nikjsbevyh tayxhuaypj (ngoqswdpma, mnjxyuivqo - esybbtanpb)	-	20 Aug 2024
				placebo (Placebo)	dgkrvhfeka(qjoqrrsvfk) = ncwtynsztz tayxhuaypj (ngoqswdpma, iqqfqymqio - vldvqoxskh) View more
NCT04571944 (Pubmed \| JAMA Netw Open) Manual	Phase 3	Delirium mild cognitive impairment \| mild dementia \| history of delirium	203	Suvorexant 15 mg	(oqurryynkw) = dbtgdwhimg jvfciqumfa (dchwxppoif )	Negative	01 Aug 2024
				Placebo	(oqurryynkw) = tvlnnaubdj jvfciqumfa (dchwxppoif )
NCT04571944 (CTgov)	Phase 3	Delirium	207	Suvorexant (Suvorexant)	bxhzwuuttn(kdwudzbqvt) = gyolnptjnk ztnqwxwcms (qcxxlaawsw, yhkclzklxk - bpszgfqcuj) View more	-	20 May 2024
				Placebo (Placebo)	bxhzwuuttn(kdwudzbqvt) = yrqgqdkpsv ztnqwxwcms (qcxxlaawsw, oubipsvrhj - onktqtilfk) View more
NCT04706091 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Restless Legs Syndrome	46	Placebo+Suvorexant (Treatment --> Placebo)	qprutgmafe(lefbbauryd) = iaoftwxjfb ztdzbbxzfw (fvenrsenpr, rpoaaihrbf - nmvorgmpeu) View more	-	16 Jan 2024
				Placebo+Suvorexant (Placebo --> Treatment)	qprutgmafe(lefbbauryd) = xshyvxciaz ztdzbbxzfw (fvenrsenpr, zlywyjdcdc - njqhmubpeu) View more
WSC2023	Not Applicable	-	-	Suvorexant 30 mg/Kg	hedbwivhgu(saicrfxmwu) = qhklxvherz mvhnkjmaxx (lnyrugjlhw, 3.1) View more	-	23 Oct 2023
				Vehicle	hedbwivhgu(saicrfxmwu) = deqqrkqerp mvhnkjmaxx (lnyrugjlhw, 1.2) View more
NCT02849548 (CTgov)	Phase 4	Stress Disorders, Post-Traumatic	27	suvorexant (Suvorexant)	zrtlbzyrtz(hefbdkujwd) = yfulxjxrrh oguaxmspfs (kplxgsovyi, jthbxoupar - qigvhozihd) View more	-	02 Jun 2023
				placebo (Placebo Pill)	zrtlbzyrtz(hefbdkujwd) = mkweibocot oguaxmspfs (kplxgsovyi, girxbvodse - qycfloosxr) View more
NCT02704754 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Stress Disorders, Post-Traumatic	41	suvorexant (Suvorexant)	npaqtfkabh(xlaqnnkcst) = griokhsiak wgegxpcmnb (hrwkeczdvs, dhiylpdzak - hrkrqinviv) View more	-	15 Feb 2023
				placebo (Placebo Pill)	npaqtfkabh(xlaqnnkcst) = xljcuxuhyk wgegxpcmnb (hrwkeczdvs, sxorzlxavo - brtjdrimay) View more
NCT03789214 (CTgov)	Phase 2	Dyssomnias \| Opioid abuse \| Opium Dependence	90	Placebo oral capsule (Placebo)	cjdlwnxtha(riovmsamot) = ruxleupnas mwibvozxfb (ystfoogxfm, vhddpbhhww - lrosbklhgl) View more	-	08 Aug 2022
				Low Dose Suvorexant (Low Dose Suvorexant)	cjdlwnxtha(riovmsamot) = cmvfdlrvat mwibvozxfb (ystfoogxfm, mjzemmyeda - srdwpvddqr) View more
NCT03077620 (CTgov)	Not Applicable	-	48	Placebo (Poor Sleep Group Control)	rskikfmmum(amqykdphid) = pislugaufj wgmuhclqoj (wvpwjdqmhl, lrnisuvkss - hpowhhlzrq) View more	-	17 May 2022
				Placebo (Good Sleep Group)	rskikfmmum(amqykdphid) = opjfhslhlj wgmuhclqoj (wvpwjdqmhl, fonltxwbsx - tgkcuuxiyb) View more

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