Efficacy of Vornorexant for Insomnia in Hospitalized Patients and Its Association with Delirium:A Randomized Controlled Trial compared with Ramelteon (V-AID study)

Start Date09 Jul 2026

Sponsor / Collaborator-

NCT07598734

/ Not yet recruitingPhase 4IIT

Doxepin Versus Doxepin and Ramelteon Versus Placebo to Improve Sleep Quality After Primary Total Knee Arthroplasty: A Randomized Controlled Trial

Many patients experience poor sleep during recovery after total knee arthroplasty (TKA). Disturbed sleep can last weeks to months and may worsen pain, slow healing, and reduce overall quality of life. Few safe, effective, evidence-based options exist to improve sleep during this recovery period. This study aims to determine whether the medications doxepin, either alone or in combination with ramelteon, can improve sleep quality during early recovery after TKA. The investigators will also evaluate whether improved sleep leads to better pain control, knee function, and overall quality of life.

Start Date01 Jun 2026

Sponsor / Collaborator

University of Washington

CTR20254453

/ CompletedPhase 1

CB275舌下膜在健康参与者中的安全性和药代动力学特征及与对照制剂雷美替胺片相对生物利用度的I期临床研究

[Translation] A Phase I clinical study of the safety and pharmacokinetic characteristics of CB275 sublingual membrane in healthy participants and its relative bioavailability compared to the control formulation ramelteamide tablets.

主要目的是评价健康参与者单次舌下给药CB275舌下膜的药代动力学特征。同时评价健康参与者单次舌下给药CB275舌下膜的安全性、考察单次舌下给药CB275舌下膜及单次口服雷美替胺片的药代动力学特征，评价两制剂间相对生物利用度（F）和评价CB275舌下膜的适口性。

[Translation]

The primary objective was to evaluate the pharmacokinetic characteristics of a single sublingual administration of CB275 sublingual film in healthy participants. Simultaneously, the safety of a single sublingual administration of CB275 sublingual film in healthy participants was evaluated, the pharmacokinetic characteristics of a single sublingual administration of CB275 sublingual film and a single oral administration of ramelteamide tablets were investigated, the relative bioavailability (F) between the two formulations was assessed, and the palatability of the CB275 sublingual film was evaluated.

Start Date09 Dec 2025

Sponsor / Collaborator

Hangzhou Chengbang Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Ramelteon

100 Translational Medicine associated with Ramelteon

100 Patents (Medical) associated with Ramelteon

625

Literatures (Medical) associated with Ramelteon

01 Aug 2026·JOURNAL OF PHARMACOLOGICAL SCIENCES

Luzindole and ramelteon share a melatonin receptor-independent blocking effect on voltage-gated potassium KV4.2 channels

Article

Author: Umezawa, Naoki ; Yamamura, Aya ; Kuzuhara, Hibiki ; Mishima, Hiroki ; Suzuki, Yoshiaki ; Fujita, Sawa ; Kondo, Rubii ; Yamamura, Hisao ; Imaizumi, Yuji

Melatonin is a pineal hormone that regulates circadian rhythms primarily through melatonin receptors. We recently demonstrated that melatonin inhibits the voltage-gated potassium K_V4.2 channel (IC₅₀ = 479 μM) through a melatonin receptor-independent mechanism. However, it remains unclear whether this inhibitory effect is specific to melatonin or shared by structurally related compounds. In the present study, we examined the effects of melatonin-related compounds on K_V4.2 channels using human embryonic kidney 293 cells stably expressing K_V4.2 channels. Whole-cell patch-clamp recordings showed that luzindole, a melatonin receptor antagonist, inhibited K_V4.2 currents (IC₅₀ = 33 μM). Notably, ramelteon, a melatonin receptor agonist, also inhibited K_V4.2 currents (IC₅₀ = 177 μM). These results indicate that the inhibitory effects of luzindole and ramelteon are mediated by direct interactions with K_V4.2 channels rather than through melatonin receptors. In addition, luzindole inhibited K_V1.5 channels. In contrast, melatonin biosynthetic precursors failed to inhibit K_V4.2 currents, suggesting that the indole or indole-like structural motif alone is insufficient for K_V4.2 channel inhibition. Instead, specific structural features, including the methoxy group in melatonin and the furan ring in ramelteon, together with increased hydrophobicity, may be critical determinants of K_V4.2 channel blockade. Collectively, these findings reveal previously unrecognized pharmacological properties of melatonin-related compounds.

01 Jul 2026·BIOMEDICAL CHROMATOGRAPHY

UHPLC–MS/MS Determination of Ramelteon in Rat Plasma and Its Altered Pharmacokinetics Under Simulated High Altitude: Relevance to High‐Altitude Sleep Disorders

Article

Author: Li, Wenbin ; Ma, Wenjuan ; Zhang, Yingfei ; Fang, Jingyang ; Wang, Chang ; Yan, Wen ; Ma, Yuliang ; Ji, Qian ; Wang, Rong

ABSTRACT:

High‐altitude hypoxia alters drug‐metabolizing enzymes, potentially affecting the pharmacokinetics of sedative‐hypnotics. Ramelteon, a melatonin receptor agonist for insomnia, is primarily eliminated via CYP1A2‐mediated first‐pass metabolism. A sensitive, ICH M10‐compliant UHPLC–MS/MS method was developed for ramelteon quantification in rat plasma using only 50 μL of sample and a 3.0‐min gradient elution on a CORTECS T3 column. The method was linear over 0.5–250.0 μg/L (LLOQ 0.5 μg/L, R2 > 0.995). Intraday and interday accuracy and precision were within ± 15%, and matrix effects were consistent (IS‐normalized factor 89.5–95.7%, CV ≤ 7.8%). The method was applied to rats exposed to simulated high altitude (6500 m, 72 h). Compared with the local altitude group (1500 m), high‐altitude exposure significantly increased AUC0–∞ (from 247.9 to 555.8 μg · h/L) and Cmax (from 214.0 to 693.2 μg/L), while oral clearance ( CL / F ) was reduced by more than half (from 21.6 to 9.5 L/h/kg). The terminal half‐life remained unchanged. Together with a proportional decrease in volume of distribution, these findings suggest that reduced first‐pass metabolism and altered distribution collectively lead to an unchanged half‐life. The elevated exposure indicates that a dose reduction may be warranted when ramelteon is used for high‐altitude sleep disorders.

27 May 2026·CHEMBIOCHEM

Structural and Dynamics Insights into Melatonin Binding to MT1 Receptor

Article

Author: Angeloni, Debora ; Montebuglio, Martina ; Comai, Stefano ; Scebba, Francesca ; Malgieri, Gaetano ; Russo, Luigi ; Acconcia, Clementina ; Isernia, Carla ; della Valle, Maria ; Fattorusso, Roberto ; Paladino, Antonella

Melatonin (MLT) (N‐acetyl‐5‐methoxytryptamine), mainly acting through its two receptors MT1 and MT2, plays a crucial role in regulating circadian rhythms. In addition, MLT has antidepressant, anti‐inflammatory, anti‐tumor, antioxidant, locomotor activity‐regulating, vascular, and neuroprotective effects. Despite recent reports on X‐ray free‐electron laser and cryo‐EM structures of MT1 receptor in complex with agonists, such as agomelatine, 2‐phenylmelatonin and ramelteon, a detailed high‐resolution description of the MT1 binding by melatonin under near to native (physiological) conditions is still missing. To this aim, we used isolated cellular membranes overexpressing MT1 receptors to conduct a high‐resolution nuclear magnetic resonance interaction study. Combined with computational methodologies such as homology modeling, molecular docking and molecular dynamics simulations, this approach provides significant structural and dynamical insights into the interaction between MT1 receptor and melatonin. We found that MLT interacts, through hydrophobic interactions, with the orthosteric binding pocket enhancing receptor motions that in turn facilitate local rearrangements in the cytoplasmic portion of MT1.

News (Medical) associated with Ramelteon

14 Jul 2026

·www.biospace.com

Supernus Celebrates Five-Year Anniversary of Qelbree® FDA Approval, Continuing to Deliver on Real-World Experience in ADHD

Qelbree remains the first novel, non-stimulant ADHD medication approved in over a decade and is the only ADHD treatment with serotonin (5-HT 2C ) pharmacodynamics approved in its FDA product labeling. Qelbree has provided convenient 24-hour medication exposure for patients with ADHD ages 6 years and older, with approximately 3 million prescriptions filled since launch. As a non-controlled treatment option, Qelbree has no evidence of abuse potential and is supported by years of clinical and real-world data. ROCKVILLE, Md., July 14, 2026 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, celebrates the five-year anniversary of the U.S. Food and Drug Administration (FDA) approval of Qelbree (viloxazine extended-release capsules) for attention-deficit/hyperactivity disorder (ADHD). Since its initial approval for pediatric (6 to 17 years) ADHD in April 2021, and subsequent approval for adults in April 2022, Qelbree has served as a valuable option for the nearly 16 million adults and 7 million children and teens living with ADHD in the U.S., 1,2 showcasing Supernus’ 25+ year legacy in ADHD research. Five years after its market introduction, Qelbree offers a once-a-day, non-stimulant option that has been widely adopted in ADHD treatment plans, with approximately 3 million total prescriptions filled since launch and over 1 million prescriptions filled in 2025 alone. Qelbree has given healthcare providers an alternative, backed by clinical and real-world data, for those seeking non-stimulant approaches for help managing ADHD symptoms. First approved by the FDA for ADHD in pediatric patients 6 to 17 years old, Qelbree was the first novel, non-stimulant approach in ADHD in over a decade. With no evidence of abuse potential, 24-hour exposure, and versatile administration options – including the ability to be sprinkled and to be taken at any time of day – Qelbree offers added flexibility for patients. Recognizing the evolving understanding of ADHD, with 90% of children continuing to have symptoms into adulthood, 3 Supernus secured an expanded indication from the FDA in April 2022 for the treatment of ADHD in adults aged 18 years and older, marking the first non-stimulant treatment option for adults in two decades. The FDA approved labeling updates for Qelbree in January 2025 to include additional pharmacodynamic data. Today, Qelbree stands out as the first and only non-stimulant ADHD treatment with a multimodal pharmacodynamic profile, meaning it influences important chemical messengers in the brain in different ways. Qelbree takes a differentiated approach by helping to increase norepinephrine and also acting as a partial agonist at the serotonin (5-HT 2C ) receptor. This January 2025 labeling update also included lactation data for breastfeeding women, making Qelbree the first ADHD treatment to meet this post marketing requirement and receive labeling approval following the 2019 FDA guidance on Clinical Lactation Studies. “ADHD care is ever-changing, but one thing remains constant: the need for flexible treatment options that enable healthcare providers and patients to make truly tailored decisions. For the past five years, Qelbree has delivered on this need, standing as a trusted choice for many,” said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “ADHD can present differently throughout a person’s life – from childhood through adulthood. Our focus has been on delivering a versatile treatment option with demonstrated safety and efficacy that can be used in real-world clinical practice.” “This five-year milestone is a testament to the data, but also to the dedication of the whole Supernus team, whose continued hard work has helped make it possible,” he concluded. Supernus continues to expand its support for the ADHD community through initiatives designed to empower and provide resources for those living with and impacted by ADHD. Recent campaigns like You, Me & Qelbree and Ms. Represented aim to share real-life experiences of patients, educate on the different ways symptoms can present (especially in men versus women), and highlight the important role that support systems such as friends and loved ones play in management. For more information, visit . INDICATION Qelbree ® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older. IMPORTANT SAFETY INFORMATION Qelbree may increase suicidal thoughts and actions, in children and adults with ADHD, especially within the first few months of treatment or when the dose is changed. Tell your doctor if you or your child have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your or your child’s moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away. You or your child should not take Qelbree if you or your child: Take a medicine for depression called a monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI in the past 14 days. Also, you or your child should avoid alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline. Qelbree can increase blood pressure and heart rate. Your or your child’s doctor will monitor these vital signs. Qelbree may cause manic episodes in patients with bipolar disorder. Tell your doctor if you or your child show any signs of mania. Do not drive or operate heavy machinery until you know how Qelbree will affect you or your child. Qelbree may cause you or your child to feel sleepy or tired. The most common side effects of Qelbree in patients 6 to 17 years are sleepiness, not feeling hungry, feeling tired, nausea, vomiting, trouble sleeping, and irritability, and in adults, insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. These are not all the possible side effects of Qelbree. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning, and Medication Guide for Qelbree here . Qelbree (viloxazine extended-release capsules) is available in 100 mg, 150 mg and 200 mg capsules. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson’s disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, postpartum depression (PPD), epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel product candidates for CNS disorders. For more information, please visit . Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company's ability to sustain and increase its profitability; the Company's ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company's corporate strategy; the Company's future financial performance and projected expenditures; the Company's ability to increase the number of prescriptions written for each of its products, and the products of its subsidiaries; the Company's ability to increase its net revenue from its products, and the products of its subsidiaries; the Company's ability to commercialize its products, and the products of its subsidiaries; the Company's ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company's product research and development activities, including the timing and progress of the Company's clinical trials, and projected expenditures; the Company's ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company's product candidates; the Company's ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company's expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company's product candidates; the accuracy of the Company's estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company's ability to increase its manufacturing capabilities for its products and product candidates; the Company's projected markets and growth in markets; the Company's product formulations and patient needs and potential funding sources; the Company's staffing needs; changes to laws and regulations applicable to our industry, the impact of macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs; and other risk factors set forth from time to time in the Company's filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events. Centers for Disease Control and Prevention (CDC). ADHD in Adults: An Overview. October 8, 2024. CDC. Data and Statistics on ADHD. November 19, 2024. Sibley, M. et al. American Journal of Psychiatry. February 2022. CONTACTS: Jack A. Khattar, President and CEO Timothy C. Dec, Senior Vice President and CFO Supernus Pharmaceuticals, Inc. (301) 838-2591 Or INVESTOR CONTACT: Peter Vozzo ICR Healthcare (443) 213-0505 peter.vozzo@icrhealthcare.com Or MEDIA CONTACT: Rebecca Finck Burson (646) 358-7675 rebecca.finck@bursonglobal.com

01 Jan 2026

·www.businesswire.com

Insomnia Market Opportunity Assessment and Forecast Report 2022-2032: Z-Drugs Remain First-Line as Sparse Pipeline Adds $288 Million From Late-Stage Entrants - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Insomnia: Opportunity Assessment and Forecast Update" report has been added to ResearchAndMarkets.com's offering. This report covers the 7MM and provides an Excel-based forecast model for the Insomnia market through 2032. Z-drugs are the most common first-line treatment for insomnia across the US and 5EU. The insomnia pipeline in the 7MM is sparse but varied, containing products with varying mechanisms of action. There are five pipeline products in Phase II and III stages of clinical development for insomnia. The insomnia market across the 7MM was valued at $3.1 billion in the 2022 baseline year. Over the 10- year forecast period, the market is projected to grow at a compound annual growth rate (CAGR) of 2.1%, reaching $3.8 billion by 2032. The entry of the two pipeline products during the forecast period will have a significant impact on the market. They are anticipated to contribute $288 million in sales by 2032. Report Scope Reasons to Buy Key Topics Covered: 1. Preface 1.1. Contents 1.2. Abbreviations 1.3. Related Reports 2. Executive Summary 2.1. Summary of Updates 3. Disease Overview 3.1. Overview of Insomnia 3.2. Insomnia SWOT Analysis 3.3. Pathophysiology of Insomnia 3.4. Classification of Insomnia 4. Epidemiology 4.1. Total Prevalent Cases of Insomnia, Both Sexes, Ages 15 Years, 2022-32 4.2. Age-Specific Trends in the Total Prevalent Cases of Insomnia, Both Sexes, 2022 4.3. Sex-Specific Total Prevalent Cases of Insomnia, Both Sexes, Ages 15 Years, 2022 4.4. Sex-Specific Total Prevalent Cases of Acute Insomnia, Ages 15 Years, 2022 4.5. Sex-Specific Total Prevalent Cases of Chronic Insomnia, Ages 15 Years, 2022 4.6. Sources and Methodology for Acute and Chronic Insomnia Prevalence 4.7. Sources and Methodology - Total Prevalent Cases of Acute and Chronic Insomnia 5. Current Treatment Options 5.1. Treatment Paradigm 5.2. Current Treatment Options 5.3. Product Profile: Benzodiazepines (e.g., estazolam, temazepam, flurazepam) 5.4. Product Profile: Z-Drugs (zaleplon, zolpidem, zopiclone, eszopiclone) 5.5. Product Profile: Melatonin Receptor Agonists (ramelteon and melatonin ER) 5.6. Product Profile: Low-Dose Antidepressants (doxepin, trazodone, trimipramine) 5.7. Product Profile: Antihistamines (e.g., diphenhydramine, promethazine, hydroxyzine) 5.8. Product Profile: Gabapentinoids (e.g., gabapentin and pregabalin) 5.9. Product Profile: Merck & Co's Belsomra (suvorexant) 5.10. Product Profile: Eisai's Dayvigo (lemborexant) 5.11. Product Profile: Idorsia's Quviviq (daridorexant) 5.12. Product Profile: Taisho Pharmaceutical's Borzi (vornorexant) 5.13. Patient Flow: Insomnia in 2022 Across 7MM 6. Unmet Needs and Opportunities 6.1. Unmet Needs in Insomnia 6.2. New Therapeutic Options with Improved Efficacy 6.3. Improved Physician Awareness of Insomnia Treatments 6.4. Improved Patient Access to CBT-i 7. R&D Strategies 7.1. Trends in Clinical Trial Design in Insomnia 7.2. Trends in Deal-Making in Insomnia 8. Pipeline Assessment 8.1. Insomnia Pipeline Overview 8.2. Late-Stage Pipeline Agents for Insomnia 8.3. Product Profile: EUSOL Biotech's SM-1 8.4. Product Profile: Imbrium Therapeutics's Sunobinop 8.5. Product Profile: Vanda Pharmaceuticals's Hetlioz (tasimelteon) 8.6. Insomnia: Clinical Trials (Phase II/III) Overview 9. Market Outlook 9.1. Insomnia Market Forecast 9.2. Market Drivers and Barriers 10. Appendix 10.1. Primary Research: KOL Information 10.2. Primary Research: High-Prescriber Survey Information 10.3. Bibliography 10.4. About the Authors Companies Featured For more information about this report visit https://www.researchandmarkets.com/r/dns27p About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 2

03 Jun 2025

·www.enveric.com

Enveric Biosciences Announces Issuance of U.S. Patent Covering a Novel Family of Molecules Including Melatonin Receptor-Targeting Compounds

CAMBRIDGE, Mass. – 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 psychiatric and neurological disorders, today announced the issuance of a new U.S. patent (USPTO Number 12,187,679). The patent strengthens Enveric’s intellectual property portfolio and covers a structurally diverse class of novel molecules with potential therapeutic applications in the treatment of sleep and central nervous system (CNS) disorders. The newly granted patent, titled, “Hydroxylated Psilocybin Derivatives and Methods of Using,” expands Enveric’s proprietary drug discovery platform and includes a unique subset of compounds that demonstrate selective binding to the melatonin MT1 receptor-an established, therapeutic target known to regulate circadian rhythm and sleep-wake cycles. These molecules were identified through Enveric’s structure-activity screening efforts. Melatonin signaling is a clinically validated pathway in the treatment of sleep and mood disorders. Several approved therapies leverage this mechanism of action, including ramelteon (Rozerem®), a selective MT1/MT2 agonist approved by the FDA for insomnia, and agomelatine (Valdoxan®), an MT1/MT2 agonist and 5-HT C antagonist approved in Europe for major depressive disorder (MDD). These drugs provide market validation for targeting melatonergic pathways. Among the diverse molecules covered by the patent, select compounds exhibit potential to act as MT1-selective agonists, positioning them as promising candidates for the development of innovative sleep therapeutics. Some of these compounds also display more complex pharmacological profiles, engaging both melatonin and other CNS-relevant receptor systems. This receptor diversity may enable differentiated therapeutic approaches across a range of psychiatric and neurological indications. The Company believes this new patent enhances the strength of its drug discovery platform and supports continued expansion of its CNS-focused strategy targeting high-value therapeutic markets. Dr. Joseph Tucker, CEO of Enveric Biosciences, commented “This newly issued patent adds to the growing body of intellectual property that underpins our pipeline of next-generation neuroplastogenic therapeutics. The inclusion of selective melatonin receptor-binding compounds broadens our ability to target sleep disorders, a prevalent category representing a multi-billion-dollar annual market. This intellectual property milestone strengthens our strategic position to advance differentiated candidates in areas where current treatment options remain limited or suboptimal.” 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 psychiatric and neurological disorders. Leveraging its unique discovery and development Psybrary™ platform, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric’s lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing other novel, patented Psybrary™ platform drug candidates to third-party licensees advancing non-competitive market strategies for patient care. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit www.enveric.com. 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,” “proposes,” “budgets,” “explores,” “schedules,” “seeks,” “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 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: finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20250603483507/en/ Investor Relations Tiberend Strategic Advisors, Inc. David Irish (231) 632-0002 dirish@tiberend.com Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 cmcdonald@tiberend.com

Drug Approval

100 Deals associated with Ramelteon

External Link

KEGG	Wiki	ATC	Drug Bank
D02689	Ramelteon	N05CH02	DB00980

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	United States	Takeda Pharmaceuticals U.S.A., Inc.	22 Jul 2005

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Major	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Dec 2011
Depressive Disorder, Major	Phase 3	Argentina	Takeda Pharmaceutical Co., Ltd.	01 Dec 2011
Depressive Disorder, Major	Phase 3	Chile	Takeda Pharmaceutical Co., Ltd.	01 Dec 2011
Depressive Disorder, Major	Phase 3	Colombia	Takeda Pharmaceutical Co., Ltd.	01 Dec 2011
Depressive Disorder, Major	Phase 3	Mexico	Takeda Pharmaceutical Co., Ltd.	01 Dec 2011
Asthma	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Mar 2008
Bipolar I disorder	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Dec 2007
Sleep Apnea, Obstructive	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Jul 2006
Migraine With Aura	Phase 2	United States	Takeda Pharmaceutical Co., Ltd.	01 Apr 2008
Migraine Without Aura	Phase 2	United States	Takeda Pharmaceutical Co., Ltd.	01 Apr 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


JPRN-jRCTs031210673 (JORTC-PON02, ASCO2026)	Phase 3	Delirium	120	Ramelteon	adrdjuobxm(jbrrbppykx) = hvmkwbuuzc tyotkwhmik (lmsyzhimmw )	Positive	29 May 2026
				Placebo	adrdjuobxm(nkjthvrzbm) = bwxlavjvze lfvzsjbjky (oqpetojcju )
NCT03091738 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Fibrosis	10	Ramelteon Pill	fbjpfijvyl(iyftkucnxe) = snlnywnbmd mmkkntkkli (hgzdiqejpm, 2.97) View more	-	29 Mar 2021
NCT02324153 (RECOVER, CTgov)	Phase 2	Anesthesia \| Emergence Delirium \| Cognition Disorders	80	Microcrystalline Cellulose+Ramelteon+Riboflavin 100 mg (Treatment)	roltdrhwjx = unidhlomxg khssvwxpwj (rirhujzgoj, xxshrcpcpl - cdkpxbddlm) View more	-	30 Jun 2020
				Microcrystalline Cellulose+Riboflavin 100 mg (Placebo)	roltdrhwjx = qyyhggzgqf khssvwxpwj (rirhujzgoj, vuvjgbgbhi - pttlmqovxy) View more
NCT02324153 (RECOVER, Pubmed \| Am J Geriatr Psychiatry)	Phase 2	Emergence Delirium	80	Ramelteon (8 mg)	wpgmzcnbna(wfpcrbieak) = buhssflnqr bqudlewptg (jivpptakhv )	Negative	16 May 2020
				Placebo	wpgmzcnbna(wfpcrbieak) = ihkudkctlr bqudlewptg (jivpptakhv )
NCT02691013 (Pubmed \| Crit Care Med)	Not Applicable	-	-	Ramelteon 8mg	gfoshvsbsh(ljofssptvv) = lassbgwlct dzahihcfki (ilyroolhxo ) View more	Negative	01 Dec 2019
				Placebo	gfoshvsbsh(ljofssptvv) = qegordaayl dzahihcfki (ilyroolhxo ) View more
NCT02560324 (RAP, CTgov)	Phase 2	Tobacco Use Disorder	140	Ramelteon (Ramelteon)	upitfjasmm(fetxzhrwad) = lmrytzkcxz axogttkbaq (vtgiwjzdqj, 1.6) View more	-	04 Nov 2019
				Placebo (Placebo)	upitfjasmm(fetxzhrwad) = iguygyxdez axogttkbaq (vtgiwjzdqj, 1.6) View more
NCT02691013 (CTgov)	Not Applicable	Pulmonary Embolism \| Delirium \| Sleep Deprivation	120	Placebo (Placebo)	pvhluwsiou(onuwvnbdve) = pxbhjdmbbn dwcfrlvaoe (vxeijwlxbd, vmykrgblux - kocksxvimn) View more	-	20 Sep 2019
				Ramelteon (Ramelteon)	pvhluwsiou(onuwvnbdve) = uesysfpsek dwcfrlvaoe (vxeijwlxbd, vabklguwqt - xomwaromua) View more
NCT02669082 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Depressive Disorder, Major	26	Ramelteon	sfwnrzsesc(zjgvoepxzk) = puvodkgxjg qywppseayk (kwtjxhewtm, 32.498) View more	-	22 Jul 2019
NCT01048242 (CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders \| Sleep Apnea, Obstructive	27	rozerem (Ramelteon)	odejralool(imftvpmkuy) = faoygexxlf ridxhrbbri (iykeitspdr, 10.3) View more	-	03 May 2017
				Placebo (Sugar Pill)	odejralool(imftvpmkuy) = jigieebibs ridxhrbbri (iykeitspdr, 30.7) View more
NCT01467713 (CTgov)	Phase 3	Bipolar I disorder	642	Placebo (Placebo)	rzwcudzuan(mdvejspsrr) = krzizspwtf megutejwna (gltpkzmzer, 8.11) View more	-	16 May 2016
				Ramelteon SL (Ramelteon SL 0.1 mg)	rzwcudzuan(mdvejspsrr) = idiuexwxer megutejwna (gltpkzmzer, 8.83) View more

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