Last update 21 Nov 2024

Trazodone Hydrochloride

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryTrazodone, a small molecule drug, targets the serotonin transporter and acts as a serotonin reuptake inhibitor. Although approved for treating several conditions, including major depressive disorder, diabetic neuropathies, sleep initiation and maintenance disorders, and premature ejaculation, the drug's mechanism of action remains elusive. Angelini Pharma was the first to approve the drug for use in December 1981. By increasing serotonin levels in the brain, Trazodone hydrochloride reduces symptoms of depression and improves mood. Additionally, the drug has sedative properties that make it effective in treating sleep disorders. However, Trazodone may produce unwanted side effects such as dizziness, drowsiness, and dry mouth and interact with other medications, resulting in unwanted consequences.

Drug Type

Small molecule drug

Synonyms

Oleptro, Trazodone, Trazodone HCl

+ [15]

Target

5-HT2 receptor x SERT

Mechanism

5-HT2 receptor antagonists(Serotonin 2 (5-HT2) receptor antagonists), Serotonin reuptake inhibitors

Therapeutic Areas

Other DiseasesNervous System DiseasesEndocrinology and Metabolic Disease+ [1]

Active Indication

Depressive Disorder, MajorDepressive DisorderDiabetic peripheral neuropathy+ [2]

Inactive Indication

Anxiety Disorders

Originator Organization

Angelini Pharma, Inc.

Active Organization

Angelini Pharma, Inc.

Shenyang Funing Pharmaceutical Co Ltd.

Lotus Pharmaceutical Co., Ltd.

+ [3]

Inactive Organization

Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA

Lee's Pharmaceutical Holdings Ltd.

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

+ [1]

Drug Highest PhaseApproved

First Approval Date

US (24 Dec 1981),

Depressive Disorder, Major

RegulationOrphan Drug (US)

Structure

Molecular FormulaC19H22ClN5O

InChIKeyPHLBKPHSAVXXEF-UHFFFAOYSA-N

CAS Registry19794-93-5

View All Structures (2)

100

Clinical Trials associated with Trazodone Hydrochloride

IRCT20240706062343N1 / SuspendedPhase 3IIT

Evaluating the effect of timing of administration of the drugs atomoxetine and trazodone in divided doses on the number of apneic episodes and sleep indexes in obstructive sleep apnea patients

Start Date22 Sep 2024

Sponsor / Collaborator

Tehran University of Medical Sciences

NCT06546358 / Not yet recruitingEarly Phase 1IIT

A Pilot, Double-blind, Randomized Trial of Quetiapine Versus Trazadone in Women With Postpartum Depression

Postpartum depression is a serious disorder that affects approximately 17% of women who have recently given birth. Untreated postpartum depression can negatively affect the mother, the infant, and the family. Lack of sleep is common after delivery and can trigger or worsen depression in some women. Trazodone is used for sleeplessness and depression, but it has not been studied for postpartum depression. There is preliminary evidence that quetiapine, another drug used for depression and sleeplessness, may be effective for postpartum depression. We are planning a study to compare the effectiveness and side effects of quetiapine and trazodone in women with postpartum depression. The results of this study will help us carry out larger studies comparing these drugs with a placebo (a sugar pill) in postpartum depression. We expect the results of our study will improve the mental health of mothers and the well-being of their babies and make it easier for healthcare staff to select the right drug for women with postpartum depression.

Start Date01 Sep 2024

Sponsor / Collaborator

Lawson Health Research Institute

CTR20243282 / RecruitingNot Applicable

盐酸曲唑酮缓释片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of trazodone hydrochloride extended-release tablets in healthy subjects under fasting and fed conditions

主要目的：比较空腹和餐后给药条件下，沈阳欣瑞制药有限公司生产的盐酸曲唑酮缓释片（150mg）与Aziende Chimiche Riunite Angelini Francesco-A.C.R.A.F.S.p.A持证的盐酸曲唑酮缓释片（150mg，商品名：TRITTICO）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。主要目的：评价空腹和餐后给药条件下，沈阳欣瑞制药有限公司生产的盐酸曲唑酮缓释片（150mg）与Aziende Chimiche Riunite Angelini Francesco-A.C.R.A.F.S.p.A持证的盐酸曲唑酮缓释片（150mg，商品名：TRITTICO）在健康成年人群中的安全性。

[Translation]

Main purpose: To compare the trazodone hydrochloride sustained-release tablets (150mg) produced by Shenyang Xinrui Pharmaceutical Co., Ltd. and the licensed trazodone hydrochloride sustained-release tablets (Aziende Chimiche Riunite Angelini Francesco-A.C.R.A.F.S.p.A.) under fasting and postprandial administration conditions. 150 mg, trade name: TRITTICO) in healthy adults, to evaluate its bioequivalence. Main purpose: To evaluate the efficacy of trazodone hydrochloride sustained-release tablets (150 mg) produced by Shenyang Xinrui Pharmaceutical Co., Ltd. and Aziende Chimiche Riunite Angelini Francesco-A.C.R.A.F.S.p.A's licensed trazodone hydrochloride sustained-release tablets ( 150 mg, trade name: TRITTICO) in healthy adults.

Start Date19 Aug 2024

Sponsor / Collaborator

Shenyang Xinrui Pharmaceutical Co., Ltd.

100 Clinical Results associated with Trazodone Hydrochloride

100 Translational Medicine associated with Trazodone Hydrochloride

100 Patents (Medical) associated with Trazodone Hydrochloride

2,128

Literatures (Medical) associated with Trazodone Hydrochloride

01 Dec 2024·European Journal of Neurology

Pharmacotherapy for behavioural manifestations in frontotemporal dementia: An expert consensus from the European Reference Network for Rare Neurological Diseases (ERN‐RND)

Article

Author: Rohrer, Jonathan ; Krüger, Johanna ; Van Langenhove, Tim ; Boban, Marina ; González, Manuel Menéndez ; Rusina, Robert ; Djamshidian, Atbin ; Cagnin, Annchiara ; Graessner, Holm ; Reinhard, Carola ; Krajcovicova, Lenka ; Vandenberghe, Rik ; Houot, Marion ; Rodriguez, Eloy Rodriguez ; Wittebrood, Casper ; Seelar, Harro ; Levin, Johannes ; De Winter, François‐Laurent ; Saracino, Dario ; Reetz, Kathrin ; Hjermind, Lena E. ; Capellari, Sabina

AbstractBackground and PurposeFrontotemporal dementia (FTD) is a neurodegenerative disorder characterized by pervasive personality and behavioural disturbances with severe impact on patients and caregivers. In current clinical practice, treatment is based on nonpharmacological and pharmacological approaches. Unfortunately, trial‐based evidence supporting symptomatic pharmacological treatment for the behavioural disturbances in FTD is scarce despite the significant burden this poses on the patients and caregivers.MethodThe study examined drug management decisions for several behavioural disturbances in patients with FTD by 21 experts across European expert centres affiliated with the European Reference Network for Rare Neurological Diseases (ERN‐RND).ResultsThe study revealed the highest consensus on drug treatments for physical and verbal aggression, impulsivity and obsessive delusions. Antipsychotics (primarily quetiapine) were recommended for behaviours posing safety risks to both patients and caregivers (aggression, self‐injury and self‐harm) and nightly unrest. Selective serotonin reuptake inhibitors were recommended for perseverative somatic complaints, rigidity of thought, hyperphagia, loss of empathy and for impulsivity. Trazodone was specifically recommended for motor unrest, mirtazapine for nightly unrest, and bupropion and methylphenidate for apathy. Additionally, bupropion was strongly advised against in 10 out of the 14 behavioural symptoms, emphasizing a clear recommendation against its use in the majority of cases.ConclusionsThe survey data can provide expert guidance that is helpful for healthcare professionals involved in the treatment of behavioural symptoms. Additionally, they offer insights that may inform prioritization and design of therapeutic studies, particularly for existing drugs targeting behavioural disturbances in FTD.

01 Dec 2024·Journal of Pharmacy Practice

Take It Easy! Serotonin Syndrome Precipitated by the Rapid Titration of Sertraline and Trazodone in the Setting of Risperidone Use

Article

Author: Martino, Julie ; Elfessi, Zane ; Antonishina, Katerina ; Szaflarska, Katarzyna ; Suh, Melody

Serotonin syndrome is a potentially life-threatening condition caused by a toxic excess of serotonin leading to overstimulation of the nervous system. Because it is a diagnosis of exclusion, it can be underrecognized, making the true incidence unknown. The classic triad of serotonin syndrome includes neuromuscular excitation, autonomic instability and altered mental status. If left unrecognized and untreated, patients are at a high risk of mortality. The most common class of medication that carries an increased risk of serotonin syndrome, when used in combination, is selective serotonin reuptake inhibitors (SSRIs); however, medications that increase serotonin production, increase serotonin release, inhibit serotonin metabolism and stimulate serotonin receptors can increase the possibility of serotonin syndrome. We report a case that details the presentation and treatment of a 25-year-old man who developed serotonin syndrome in the setting of rapid titration of risperidone, trazodone, and sertraline. The patient presented to the ED with acute agitation, diaphoresis, and altered mental status. He also had lower extremity myoclonus and was tremulous with an oral temperature of 100°F (37.8°C) and heart rate of 103 beats per minute. Serotonin syndrome was confirmed and the patient was treated successfully with benzodiazepines before being discharged from the hospital after 4 days.

30 Nov 2024·Clinical Psychopharmacology and Neuroscience

Relationship between Polygenic Risk Score and the Hypnotics in Bipolar I Disorder

Article

Author: Kelsoe, John R. ; Lee, Hyeon Woo ; Park, Young-Min ; Shekhtman, Tatyana ; Lee, Bun-Hee

ObjectiveBipolar disorder (BD) is marked by significant change in mood and energy levels with sleep disturbance a common feature, resulting in diminished quality of life and impaired daily functioning. This study assessed the association between BD-polygenic risk scores (PRS) and hypnotics in bipolar I disorder (BD-I) patients.MethodsLarge-sample data were collected from the genome-wide association study of a multicenter Bipolar Genomic Study, and 1,394 BD-I patients with available medication information were divided into two groups depending on whether they used hypnotics or not. The Diagnostic Interview for Genetic Studies (DIGS) score was used to assess the clinical manifestations and function of the participants and the association between the use of hypnotics and genetic risk was analyzed.ResultsOf the 1,394 total participants, 556 (40%) patients received hypnotics, mostly benzodiazepines, administered singly or in combination with other sleeping agents such as, Z-drugs, melatonin-related drugs, and trazodone. The DIGS score was significantly higher for negative categories in the group prescribed hypnotics as was the BD-PRS score, according to the four p value thresholds (p = 0.3, 0.2, 0.1, and 0.05). Logistic regression analysis confirmed a statistically significant association between the BD-PRS and hypnotic use.ConclusionOur results suggest an association between hypnotic use and genetic susceptibility to BD. Sleep disturbances in participants were based on the prescription status of hypnotics supporting the hypothesis that sleep disturbances may be associated with genetic aspects of BD-I. Further genetic studies on genetic overlaps between BD and specific phenotypes or medication responses are required.

News (Medical) associated with Trazodone Hydrochloride

23 May 2024

·www.globenewswire.com

Apnimed Announces a Robust Slate of Presentations at SLEEP 2024, Including an Analysis of the Prevalence of Obesity in Obstructive Sleep Apnea

New Data Underscore the Need for New OSA Treatments That Go Beyond Weight Loss to Address the Neuromuscular Root Cause of the DiseaseOral Presentations include Rationale and Design of SynAIRgy Phase 3 Study for AD109, a Potential Nighttime Oral Drug Treatment for OSA“Shining a Light on Living with Sleep Apnea” Symposium Features Premiere Sneak Preview of “Out of Breath” Film Featuring Struggles of Living with OSA, Followed by Panel Discussion CAMBRIDGE, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Apnimed, Inc., a clinical-stage pharmaceutical company focused on discovery, development and commercialization of novel oral therapies for the treatment of obstructive sleep apnea (OSA) and other sleep disorders, announced a series of five data presentations and a dinner symposium at the SLEEP 2024 annual meeting. Presentations include an epidemiologic study of the prevalence of obesity in OSA, which demonstrates that the majority of people with OSA are not obese. OSA is estimated to affect more than 50 million in the United States, though underdiagnosis continues to be a serious problem. “Apnimed is making significant contributions toward understanding the characteristics of people with OSA and the impact symptoms of OSA have on those who are not being treated. The data being presented at SLEEP 2024 reaffirm that this market has significant unmet needs,” said Larry Miller, MD, CEO of Apnimed. “AD109, our novel oral nighttime drug for OSA, currently in Phase 3 clinical development, has the potential to help patients across a broad spectrum of OSA severity and body mass index by addressing the neuromuscular root cause of OSA. Because there are no FDA approved products that specifically address the neuromuscular causes of OSA, the door is open for an oral therapy that can meet the needs of a broad range of OSA patients.” Additional presentations related to Apnimed’s pipeline of potential OSA treatments include both an oral and a poster discussion concerning the study design and rationale of SynAIRgy, the second Phase 3 registrational study for AD109, and data from the VicTor Study, a Phase 2 crossover study that evaluated an oral combination drug related to Apnimed’s pipeline development candidate AD817. SLEEP, the premier clinical and scientific sleep conference, is a joint meeting of the American Academy of Sleep Medicine (APSS) and the Sleep Research Society. SLEEP 2024, the 38th annual meeting of the APSS, will be held at the George R. Brown Convention Center in Houston from June 1-5. Apnimed SLEEP 2024 Presentation Details: POSTER:P-09, #147Prevalence of Obesity in Obstructive Sleep Apnea within a Large Community-based Cohort of Middled-aged/Older AdultsTime: Monday, June 3, 10:00-10:45 AM CTLocation:George R. Brown Convention Center, Hall A3Presenter:Neda Esmaeili, PhD, Brigham and Women's Hospital POSTER:P-08, #133Fatigue Negatively Impacts the Lives of Individuals Living with OSA: A Closer Look with Patient Reported Outcomes (PRO) MeasuresTime:Monday, June 3, 10:00-10:45 AM CTLocation:George R. Brown Convention Center, Hall A3Presenter:Helene Emsellem, MD, Director, The Center for Sleep & Wake Disorders & Sleep Health Institute SYMPOSIUM:Shining a Light on Living with Sleep ApneaSneak Preview:“Out of Breath,” an independent film about living with OSA followed by a panel discussion with the film’s director and starsTime:Tuesday, June 4, 6:15-8:30PM CTLocation:Marriott Marquis, Houston, Salon A-BRegister:https://bit.ly/3y2gbqe ORAL:O-26Aroxybutynin and Atomoxetine for the Treatment of OSA: Rationale and Design of theSynAIRgy Phase 3 RCTSession:Updates on Non-PAP Therapy for Sleep-Related Breathing DisordersTime: Wednesday, June 5, 2:15-2:30PM CTLocation:George R. Brown Convention Center, Room 362Presenter:Patrick Strollo, Jr., MD, Professor of Medicine and Clinical and Translational Science,Vice Chair of Medicine for Veterans Affairs, University of Pittsburgh School of Medicine POSTER:P-41, #274Aroxybutynin and Atomoxetine for the Treatment of OSA: Rationale and Design of the SynAIRgy Phase 3 RCTTime: Wednesday, June 5, 11:00-11:45 AM CTLocation: George R. Brown Convention Center, Hall A3Presenter:Patrick Strollo, Jr., MD, Professor of Medicine and Clinical and Translational Science, Vice Chair of Medicine for Veterans Affairs, University of Pittsburgh School of Medicine ORAL:O-26The Effect of Viloxazine and Trazodone in Obstructive Sleep Apnea Patients: A Randomized, Placebo-controlled, Crossover StudySession:Updates on Non-PAP Therapy for Sleep-Related Breathing DisordersTime: Wednesday, June 5, 2:30-2:45PM CTLocation:George R. Brown Convention Center, Room 362Presenter:Atqiya Aishah, PhD, Brigham and Women’s Hospital About the SynAIRgy StudyThe SynAIRgy Study (clinicaltrials.gov identifier NCT05813275) is a randomized, double blind, placebo-controlled, parallel-arm 6-month study of a fixed dose combination of aroxybutynin/atomoxetine (AD109) in adult participants with OSA who are intolerant of, or currently refuse, positive airway pressure (PAP) therapy. The SynAIRgy Study examines the use of AD109 in a range of OSA patients across all types of OSA from mild to severe and ranges of body mass index (BMI) from normal to obese. Participants (n=640) will be randomized 1:1 to either AD109 or placebo. The primary endpoint is designed to evaluate reduction of airway obstructions (AHI4) for AD109 vs. placebo. A key secondary endpoint is evaluating OSA symptoms based on the PROMIS-Fatigue scale for AD109 vs. placebo. Other standard objective and subjective metrics of OSA will also be evaluated. The trial also includes an additional cohort of up to 100 participants concomitantly on AD109 and a stable dose of a GLP-1 agonist for weight loss. The trial will include up to 65 enrolling centers across the US and Canada. SynAIRgy is continuing enrollment. Interested participants may check their eligibility at www.sleepapneatrial.com. Topline Phase 3 data for both AD109 registrational trials, LunAIRo and SynAIRgy, are expected in mid-2025. About AD109AD109 has the potential to be the first oral drug that could both treat the underlying nighttime airway obstruction and hypoxia that characterize OSA, as well as improve the daytime consequences of OSA, such as fatigue. It is a potential first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines Apnimed’s novel selective antimuscarinic (aroxybutynin) with a selective norepinephrine reuptake inhibitor (atomoxetine) in a fixed dose combination. AD109 targets key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. AD109 has the potential to become a safe, effective, and convenient treatment for OSA, addressing some of the key limitations of approved treatments that are often poorly tolerated (e.g., CPAP and oral devices) and/or invasive (e.g., surgery or implanted devices). AD109 has been granted Fast Track designation by the FDA and is currently in Phase 3 clinical trials. About the VicTor StudyThe VicTor Study (clinicaltrials.gov identifier NCT05793684) is a Phase 2 randomized double-blind placebo-controlled multiple-dose 3-period crossover study comparing a fixed dose combination of viloxazine/trazodone to viloxazine alone and to placebo in obstructive sleep apnea. About Obstructive Sleep Apnea Obstructive sleep apnea is one of the most common and serious sleep disorders. It is estimated to affect more than 50 million and as many as 80 million people in the United States, though underdiagnosis continues to be a serious problem and the number of affected Americans may be far greater. OSA impacts people across the spectrum of sex, age, ethnicity and BMI ranges from normal to obese. OSA is characterized by partial or complete upper airway collapse that occurs during sleep, which can cause dramatic reductions in overnight oxygen levels and often leads to poor sleep, and in the long term, has been shown to increase the risk of hypertension, diabetes, cardiovascular disease, and stroke. Additionally, OSA can impair work productivity, reduce daytime functional abilities, and lower quality of life. Sleep-related neuromuscular dysfunction is the key mechanism that causes a reduction in neuromuscular tone of the upper airway during sleep. The vast majority of diagnosed patients are prescribed positive air pressure therapy devices such as continuous positive airway pressure, or CPAP, but many patients are dissatisfied with these mechanical nighttime devices and fewer than half are compliant long term, leaving a significant population untreated or undertreated and at risk. Some OSA patients are overweight or obese, and sustained weight loss can reduce the severity of airway collapse and some symptoms. However, even substantial weight loss may not fully address the symptoms of OSA or reduce the need for treatments that help maintain an open airway during sleep, and if patients regain weight, OSA and its symptoms tend to return. About ApnimedApnimed is a clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Apnimed’s lead development program, AD109, targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., the company is developing a portfolio of novel pharmacologic therapies for sleep apnea and other sleep disorders. Apnimed has a pipeline of novel, oral pharmacologic programs including several that are part of our Joint Venture with Shionogi & Co., Ltd. called Shionogi-Apnimed Sleep Science, LLC. Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact:Amanda BreedingScient PRamanda@scientpr.com Mikala Whitaker Spectrum Sciencemwhitaker@spectrumscience.com Investor Contact:Brian Ritchie LifeSci Advisorsbritchie@lifesciadvisors.com

Phase 2Phase 3Fast Track

21 Feb 2024

·www.biospace.com

Enveric Biosciences Unveils Library of Preclinical Compounds Across Multiple Distinct Molecule Classes Targeting Mental Health Disorders

Novel compounds protected under Enveric’s intellectual property portfolio provide potential licensing opportunities and non-dilutive revenue streams. CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today announced the discovery of multiple, promising novel compounds sourced using the company’s Psybrary™ platform and proprietary computational chemistry and artificial intelligence (AI) drug-discovery system (PsyAI™). The novel compounds span seven distinct molecule classes totaling at least 57 unique product opportunities, all of which are protected by Enveric’s expansive intellectual property portfolio and represent potential out-licensing opportunities and non-dilutive revenue streams for the Company. Together, the novel and distinct molecule classes broaden and deepen Enveric’s library of assets targeting difficult-to-address mental health disorders, adding to its lead candidate EB-003, a first-in-class neuroplastogen designed to eliminate hallucinations, and EB-002, formerly EB-373, a next generation synthetic prodrug of the active metabolite, psilocin. “Our ability to identify EB-003 and EB-002 as our lead drug candidates was the result of an extensive process in which our research team analyzed more than one thousand compounds spanning numerous classes of molecules, utilizing our proprietary PsyAI and Psybrary platforms,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “As a result, Enveric now possesses what we believe to be one of the most diverse portfolios of potential drug molecules for the treatment of key, underserved mental health and neurological disorders. Our dedicated approach to protecting our discoveries should enable us to generate significant near- and long-term value for our shareholders via potential partnering and/or licensing agreements.” The novel compounds span seven diverse molecule classes and subclasses, including: Novel Serotonin-Norepinephrine-Dopamine Reuptake Inhibitors (SNDRI) Also known as triple reuptake inhibitors (TRIs), SNDRIs are an emerging class of medications designed to treat severe depression and anxiety disorders. Enveric SNDRI compounds show strong binding to serotonin transporter (SERT), norepinephrine transporter (NET) and dopamine transporter (DAT). Enveric SNDRI compounds also demonstrate distinct additional serotonin receptor binding profiles that bear similarities to those of the antidepressant Nefazodone and the anxiolytic Buspirone. Non-selective Serotonin Reuptake Inhibitor (NSRI) Enveric NSRI compounds show strong binding to SERT, as well as to the 5-HT1A receptor, known to be a therapeutically valuable target. Certain of Enveric’s NSRIs demonstrate additional binding to various serotonin and dopamine family receptors, with binding profiles similar to the antidepressant Vortioxetine and the atypical antipsychotic Aripiprazole. Novel MDMA Derivatives (EMD) Series Twenty novel MDMA derivatives are separated into three subgroups: Strong 5-HT2A receptor binding, Weak 5-HT2A binding, and No 5-HT2A receptor binding. Current literature indicates agonism of the 5-HT2A receptor is linked to hallucination in humans and also to the induction of neuroplasticity. Each subgroup of Enveric’s novel MDMA derivatives demonstrates unique and expanded receptor binding activity targeting adrenergic and/or dopaminergic receptors as well as epinephrine/norepinephrine family receptors. Some of the resulting receptor binding profiles are similar to the anxiolytic Buspirone, the antiepileptic Fenfluramine, the ADHD drug Guanfacine, and the atypical antipsychotic Aripiprazole. Bifunctional Psilocin Prodrugs (BPP) BPPs are readily absorbed, detectable in plasma, and converted to therapeutically relevant levels of plasma psilocin, with demonstrated lower Head Twitch Response (HTR) relative to psilocybin in mice; HTR is reported in the literature to be a predictive indicator for hallucination in humans. Each BPP parent prodrug demonstrates its own unique binding pro serotonin 5-HT1A receptor, 5-HT1B receptor and SERT, with similarities to anxiolytics Buspirone, antidepressant/anxiolytic Flesinoxan, and the antidepressant Paroxetine. Novel Psilocin Prodrug (NPP) Series NPPs are designed to be metabolized to release therapeutic levels of systemic psilocin at varying rates, providing treatment regimen optionality. Included in this series are four compounds that can be converted upon direct intravenous injection to psilocin: potentially bypassing the need for first-pass metabolism, making them amenable to non-oral forms of administration (e.g. intranasal, sublingual, buccal). Melatonin-Receptor Agonist (MRA) Series Melatonin, a natural indolamine, is essential for regulating circadian rhythm in mammals and is often used in to treat a variety of sleep disorders. Enveric MRA compounds demonstrate strong binding to the MT1 Melatonin receptor with some being highly selective for MT1 while others demonstrate expanded target binding profiles similar to the antidepressants Agomelatine, Vortioxetine, Imipramine, and Trazodone. Neuroplastogenic Antidepressant (NAD-01) Designed to induce neuroplasticity and promote long-term therapeutic benefit in patients suffering from severe depressive mood disorders. Demonstrates neuroplastogenic activity comparable to known 5-HT2A receptor agonist N,N-Dimethyltryptamine (DMT). Demonstrates weak 5-HT2A receptor binding affinity and activation. Produces lower Head Twitch Response relative to psilocin and DMT, while promoting recovery of sucrose preference (SP) in stressed mice - an accepted model for evaluation of antidepressant activity. For more information about Enveric’s novel preclinical compounds spanning multiple, distinct classes of molecules, please visit: . About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, Psybrary™, Enveric has created a robust intellectual property portfolio of New Chemical Entities for specific mental health indications. Enveric’s lead program, EB-003, is a first-in-class approach to the treatment of difficult-to-address mental health disorders designed to promote neuroplasticity without inducing hallucinations in the patient. Enveric is also developing EB-002, formerly EB-373, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment of psychiatric disorders. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposed,” “is expected,” “budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include historical statements and statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: carry out successful clinical programs in Australia; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

License out/in

31 Jan 2024

·www.sciencedaily.com

Precursor of cholesterol protects cells from ferroptosis

A precursor of cholesterol, previously categorized as harmful, can protect cancer cells from cell death. In a groundbreaking study, a team led by Würzburg Professor José Pedro Friedmann Angeli has shown that the cholesterol precursor 7-dehydrocholesterol (7-DHC) plays a crucial role as an antioxidant: it integrates into the cell membranes and protects the cells by preventing a certain type of cell death, known as ferroptosis. "Until now, the accumulation of 7-DHC was only associated to neurodevelopmental defects, now we show that it actually increases cellular fitness and could promote a more aggressive behaviour in cancers such as Burkitt's lymphoma and neuroblastoma," says Friedmann Angeli. The newly discovered protective function of 7-DHC opens up exciting prospects for further improving the treatment of cancer and other diseases associated with ferroptosis: "It gives us new opportunities to test potential inhibitors that target cholesterol biosynthesis and are already established in medical practice." The researchers report this in the journal Nature. In addition to the Würzburg team from the Rudolf Virchow Zentrum -- Center for Integrative and Translational Bioimaging, the following scientists contributed to the study: Dr Maria Fedorova (Dresden University of Technology), Marcus Conrad (Helmholtz Munich), Derek Pratt (University of Ottawa), and Andreas Trumpp and Hamed Alborzinia (German Cancer Research Center, DKFZ Heidelberg). Observing Changes in 7-DHC Levels High cholesterol levels are associated with health problems such as heart disease and diabetes. Most studies focus on how cholesterol contributes directly to these diseases. In this area, the discovery of the cholesterol precursor 7-DHC as an antioxidant opens up new possibilities: Studies on changes in 7-DHC levels could provide crucial new insights into the diseases. In addition, drugs that specifically block 7-DHC production should be researched in combination with other drugs -- this could have a positive effect in the treatment of some cancers. Possible Effects on Tumour Development "Our next research goal is to investigate the effects of 7-DHC accumulation during tumour development," says Würzburg ferroptosis expert José Pedro Friedmann Angeli. The team responsible for the publication in Nature also calls for further epidemiological studies. Background: There are drugs authorised by the US Food and Drug Administration (FDA) that can inhibit the DHCR7 enzyme. These include trazodone, which is prescribed around 20 million times a year in the USA, sometimes even for off-label use to treat insomnia. "Studies have shown that people taking this drug have elevated plasma levels of 7-DHC. Epidemiological studies are crucial to better understand possible effects here," says Friedmann Angeli. These studies would help to find out whether there is a connection between patient groups who regularly take ferroptose-modulating drugs such as trazodone and cancer incidence, the occurrence of metastases or other critical aspects of public health.

100 Deals associated with Trazodone Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00820	Trazodone Hydrochloride	N06AX05	DB00656

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Depressive Disorder, Major	FR	Angelini Pharma, Inc.	08 Dec 1996
Depressive Disorder	JP	Organon & Co.	28 Jun 1991
Depressive Disorder	JP	Pfizer Japan, Inc.	28 Jun 1991

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic peripheral neuropathy	Phase 2	CN	Shenyang Funing Pharmaceutical Co Ltd.	09 May 2017
Sleep Initiation and Maintenance Disorders	Phase 2	CN	Shenyang Funing Pharmaceutical Co Ltd.	19 Oct 2015
Diabetic Neuropathies	Discovery	PL	Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA	16 May 2017
Diabetic Neuropathies	Discovery	CZ	Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA	16 May 2017
Diabetic Neuropathies	Discovery	HU	Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA	16 May 2017
Anxiety Disorders	Discovery	CN	Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA	10 Nov 2011
Anxiety Disorders	Discovery	CN	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	10 Nov 2011
Depressive Disorder	Discovery	CN	Lee's Pharmaceutical Holdings Ltd.	01 Nov 2011
Depressive Disorder, Major	Discovery	US	Pragma Pharmaceuticals LLC	24 Dec 1981

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WSC2023	Not Applicable	REM Sleep Behavior Disorder	-	Trazodone 50mg	yajcfoiggk(zqqrouiebq) = oxeafjawcw rbpmcyizvm (zmautqmzhl )	-	23 Oct 2023
WSC2023	Not Applicable	Sleep Initiation and Maintenance Disorders	716	Lemborexant	vxcbvmfxuv(xolwoeegju) = ugqvytglyi uiargjmzls (kgervmekwi )	Positive	23 Oct 2023
				Trazodone	vxcbvmfxuv(xolwoeegju) = luvqvrmrbv uiargjmzls (kgervmekwi )
ATS2023	Not Applicable	-	-	Trazodone	vwrnzcdfia(vvpowpnpug) = Common presentations were QTc interval prolongation, bradycardia, and hyponatremia with seizures. Three case reports reported death as the final outcome. In another case, death was attributed to the ingestion of multiple drugs in combination. There were however no cases that reported hypotension. ttstsqlvph (gajhwbqljg )	-	21 May 2023
				Normal saline
NCT04162743 (Pubmed \| J Neurol)	Phase 4	Ischemic stroke	22	Trazodone 100 mg	vxvmakvsoc(svnihablqa) = vwmzunalpa mczzsoxbqs (swqdfrbnlg ) View more	-	24 Feb 2021
				Placebo	vxvmakvsoc(svnihablqa) = ushwhqudeq mczzsoxbqs (swqdfrbnlg ) View more
NCT03516630 (Pubmed \| J Clin Pharmacol)	Phase 1	-	20	Trazodone 20 mg	cgdudttlvr(hrfnwdskux) = jurdprvvbh oaiydvfnys (waudlvrzrz )	-	02 Jun 2020
				Trazodone 60 mg	cgdudttlvr(hrfnwdskux) = wdjvnqkapx oaiydvfnys (waudlvrzrz )
NCT02458469 (REST-SCI, CTgov)	Phase 2	Spinal Cord Injuries \| Sleep Apnea, Central	15	buspirone (Buspirone)	bsbxzjaney(rcgkbopiky) = xedyitawqc mlqvhqmcti (ycknpnasif, uzqodamjqe - boobjdznvb) View more	-	09 Apr 2020
				Trazodone (Trazodone)	bsbxzjaney(rcgkbopiky) = qfnkucpxjb mlqvhqmcti (ycknpnasif, zccpfawybg - ndklsgnchm) View more
WSC2019	Not Applicable	Depressive Disorder, Major Add-on	5	Trazodone	(qxerbnnzyq) = No significant adverse events were reported during the treatment fvaklkfsbh (smhmncycoe )	Positive	20 Sep 2019
NCT01348542 (CTgov)	Not Applicable	Sleep Initiation and Maintenance Disorders	24	Trazodone (Trazodone)	braxosszpa(njoctphbyk) = rduhrsdieb kiiflmdwkw (ugopxewkom, shcbkhtlsb - eoobtsplzg) View more	-	21 Jun 2019
				Cognitive Behavioral Therapy (Cognitive Behavioral Therapy)	braxosszpa(njoctphbyk) = zaavpqcfyv kiiflmdwkw (ugopxewkom, vrijednbms - mpoovdkfef) View more
NCT01662297 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Behavioural disorders \| Substance Abuse	1	Quetiapine (Quetiapine)	slratejrmt(furbsuanwn) = gxbpcuploc ngektonotp (dfteaiylmc, emaivgncio - bpuvrdrbey) View more	-	16 Oct 2018
				Trazodone (Trazodone)	btlxpobhlz(rveltivjqe) = tsnudzsrqq zrzdjjoxrb (nxmutgqjxn, tpljoznqfi - cicpjwpnkn) View more
NCT01943435 (CTgov)	Not Applicable	Osteoarthritis, Spine \| Spinal stenosis of lumbar region	259	Lumbar epidural injection+nortriptyline+acetaminophen+diclofenac+misoprostol+duloxetine+celecoxib+gabapentin+tramadol+sertraline+mirtazapine+ibuprofen+trazodone (Medical Care)	dttrcrjekn(nfnimytbrl) = lccobvscdb rpemchgery (gjlvzqekzg, fylhnnipek - zceboshacr) View more	-	17 May 2017
				Group Exercise: community setting (Group Exercise)	dttrcrjekn(nfnimytbrl) = yfvqseamhv rpemchgery (gjlvzqekzg, ppqtelovai - ymorftburd) View more

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