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更新于：2026-06-23
Alixorexton
更新于：2026-06-23
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评突破性疗法 (美国)、孤儿药 (美国)、孤儿药 (欧盟) |
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关联
6
项与 Alixorexton 相关的临床试验NCT07540897
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 304)
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
开始日期2026-06-01 |
申办/合作机构 |
NCT07455383
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 302)
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
开始日期2026-04-06 |
申办/合作机构 |
NCT06843590
A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)
The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets
开始日期2025-05-22 |
申办/合作机构 |
100 项与 Alixorexton 相关的临床结果
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100 项与 Alixorexton 相关的转化医学
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100 项与 Alixorexton 相关的专利（医药）
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2
项与 Alixorexton 相关的文献（医药）2025-11-01·CURRENT OPINION IN PULMONARY MEDICINE
Understanding idiopathic hypersomnia: diagnosis, pathophysiology, and management
Review
作者: Renee Monderer ; Madeeha Shahzadi ; Michael J. Thorpy
Purpose of review:
Idiopathic hypersomnia is a chronic and often disabling sleep disorder characterized by excessive daytime sleepiness despite adequate or prolonged nighttime sleep. With recent advances in diagnosis and treatment, this review is timely in addressing evolving approaches to understanding and managing idiopathic hypersomnia, a condition that remains underrecognized and frequently misdiagnosed.
Recent findings:
Idiopathic hypersomnia is clinically distinct from narcolepsy, lacking REM-related features such as cataplexy and hypnagogic hallucinations. Until recently, treatment options for idiopathic hypersomnia were limited and often off-label. The 2021 FDA approval of low-sodium oxybate (LXB) marked the first medication specifically indicated for idiopathic hypersomnia. Additional agents such as modafinil, pitolisant, and traditional stimulants are used off-label with varying efficacy. Ongoing research is exploring promising treatments, including orexin-2 receptor agonists (e.g. ALKS 2680, ORX-750), serdexmethylphenidate, and flumazenil, which offer new hope for personalized management.
Summary:
Growing insights into the pathophysiology and clinical features of idiopathic hypersomnia have led to improved diagnostic clarity and therapeutic innovation. These developments carry significant implications for clinical practice, offering hope for better symptom control and quality of life in affected individuals. Ongoing research is crucial for refining treatment strategies and deepening our understanding of this complex condition.
Frontiers in Neuroscience
Hypocretin: a promising target for the regulation of homeostasis
Review
作者: Mao, Jian ; Wang, Yutong ; Jiang, Hong ; Cui, Kun ; Fu, Su
Hypocretin, also known as orexin, is a hypothalamic neuropeptide that regulates essential physiological processes including arousal, energy metabolism, feeding behavior, and emotional states. Through widespread projections and two G-protein-coupled receptors—HCRT-1R and HCRT-2R—the hypocretin system exerts diverse modulatory effects across the central nervous system. The role of hypocretin in maintaining wakefulness is well established, particularly in narcolepsy type 1 (NT1), where loss of hypocretin neurons leads to excessive daytime sleepiness and cataplexy. However, the mechanisms by which hypocretin stabilizes transitions between sleep stages remain incompletely understood. Additionally, while hypocretin integrates metabolic signals such as glucose, leptin, and ghrelin to promote feeding and energy expenditure, NT1 patients paradoxically experience weight gain despite reduced caloric intake—highlighting unresolved questions about hypocretin’s role in energy homeostasis. In the affective domain, preclinical studies suggest hypocretin enhances stress resilience and modulates anxiety- and depression-related behaviors. Yet, human data remain inconsistent, in part due to methodological variability and the limited availability of cerebrospinal fluid sampling to accurately assess central hypocretin function. Therapeutically, the hypocretin system is a promising target across several domains. Dual hypocretin receptor antagonists (DORAs), such as suvorexant and daridorexant, are clinically approved for insomnia. Selective HCRT-2R agonists—including TAK-861 and ALKS-2680—are in clinical trials for NT1 and show encouraging results. Additionally, HCRT-2R antagonists like seltorexant are being explored for major depressive disorder. This review will highlight the anatomical distribution, receptor mechanisms, and physiological functions of the hypocretin system. It will also focus to discuss its role in narcolepsy, metabolic regulation, and mood disorders, while addressing key challenges and open questions that must be resolved to fully harness hypocretin’s therapeutic potential.
96
项与 Alixorexton 相关的新闻（医药）2026-06-17
— First Large Phase 2 Study of an Orexin 2 Receptor Agonist to Demonstrate Clinically Meaningful and Statistically Significant Improvements in Wakefulness and Excessive Daytime Sleepiness Compared to Placebo in Narcolepsy Type 2 —
— Improvements in Wakefulness and Patient-Reported Cognition and Fatigue Were Sustained Through 13 Weeks —
— Alixorexton Was Generally Well Tolerated at All Doses Tested —
DUBLIN --(BUSINESS WIRE)--Jun. 17, 2026-- Alkermes plc (Nasdaq: ALKS) today announced detailed positive results from the Vibrance-2 phase 2 dose-ranging study evaluating alixorexton in patients with narcolepsy type 2 (NT2). Once-daily alixorexton met the study’s dual primary endpoints, demonstrating statistically significant and clinically meaningful improvements from baseline compared to placebo on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) at week eight in adults with NT2 (n=93). Patient-reported improvements in wakefulness were sustained through the five-week open-label extension period. Alixorexton also demonstrated clinically meaningful improvements across exploratory patient-reported outcomes (PROs) evaluating fatigue and cognition. Alixorexton was generally well tolerated at all doses tested (10 mg, 14 mg and 18 mg). Alixorexton is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for narcolepsy type 1 (NT1), NT2 and idiopathic hypersomnia (IH). Topline results from the Vibrance-2 study were previously announced in November 2025 .
“The Vibrance-2 results presented at SLEEP provide compelling evidence that alixorexton meaningfully improved measures of wakefulness, fatigue and cognition in patients with narcolepsy type 2. As excitement builds around innovative, potential new treatments, these findings are particularly notable as the first orexin 2 receptor agonist to demonstrate such clinically meaningful benefits in patients with narcolepsy type 2, a population without known orexin deficiency,” said Richard K. Bogan , M.D., FCCP, FAASM, Principal of Bogan Sleep Consultants, LLC and Associate Clinical Professor at the University of South Carolina School of Medicine . “Alongside positive Vibrance-1 data in narcolepsy type 1, these results underscore alixorexton’s potential to become an important new treatment option for patients with narcolepsy.”
Results from Vibrance-2 were presented in an oral presentation at the 40th annual meeting of the Associated Professional Sleep Societies (APSS), taking place June 14-17, 2026 in Baltimore, MD . Key highlights related to the randomized double-blind treatment (RDBT) period and open-label extension include:
Dual Primary Endpoints
MWT1: Alixorexton demonstrated clinically meaningful improvements from baseline compared to placebo in mean sleep latency on the MWT at week eight at all doses tested. Based on the pre-specified analysis, the 14 mg (p=0.049) and 18 mg (p=0.047) doses achieved statistical significance.2 Participants had a mean sleep latency of approximately 6 minutes at baseline. At week eight, observed mean sleep latencies were approximately 16 minutes, 14 minutes, and 14 minutes for the 10, 14, and 18 mg doses, respectively. ESS3: Alixorexton demonstrated clinically meaningful improvements from baseline compared to placebo in excessive daytime sleepiness on the ESS across all doses tested at week eight, with statistical significance at the 18 mg dose (p=0.046) based on the pre-specified analysis. At baseline, participants had a mean ESS score of approximately 17, reflecting severe excessive daytime sleepiness. At week eight, the majority of participants receiving alixorexton across all dose groups reported normal or mild excessive daytime sleepiness.3 At week 13, mean ESS scores across all dose groups were within the normal range.
Exploratory Endpoints
In Vibrance-2, clinically meaningful improvements were observed across a number of exploratory PROs evaluating fatigue and cognition. All reported p-values were nominal for PROs, which include:
PROMIS (Patient-Reported Outcomes Measurement Information System)-Fatigue4: Across all doses tested, alixorexton demonstrated clinically meaningful improvements from baseline in fatigue as compared to placebo at week eight (p=0.044 and p=0.001 at the 14 mg and 18 mg doses, respectively). Improvements in PROMIS-Fatigue scores were observed as early as week two and continued to improve through week 13, with mean values within the normal range at week 13. British Columbia Cognitive Complaints Inventory (BC-CCI)5: Across all doses tested, alixorexton demonstrated clinically meaningful improvements from baseline in the severity of cognitive impairment compared to placebo at week eight (p=0.042 at the 18 mg dose). Improvements in BC-CCI scores were observed as early as week two with continued improvement through week 13.
Safety
Alixorexton was generally well tolerated across all doses tested throughout the eight-week RDBT period and the five-week open label extension. No serious treatment-emergent adverse events (TEAEs) were reported. There were no safety signals observed in hepatic or renal parameters, vital signs or ECGs, and no treatment-related clinically meaningful changes were observed on ophthalmic exams. Most TEAEs were mild to moderate in severity. The most common TEAEs6 in patients treated with alixorexton were pollakiuria, insomnia, micturition urgency, dizziness and headache. More than 95% of participants (n=90) completed treatment in the eight-week RDBT period, and nearly 90% of all participants (n=82) completed the 13-week open-label extension study.
“People living with narcolepsy type 2 frequently experience a lengthy and challenging diagnostic journey, and many continue to live with significant symptom burden following diagnosis. The Vibrance-2 dataset reinforces our belief that alixorexton has the potential to deliver clinically meaningful benefits across key symptoms. Alkermes is committed to researching potential new medicines with the goal of advancing care for people living with central disorders of hypersomnolence,” said Craig Hopkinson , M.D. (MBChB), Chief Medical Officer and Executive Vice President, Research & Development at Alkermes.
Based on the positive results demonstrated by alixorexton in the phase 2 Vibrance Studies, Alkermes has initiated a global phase 3 program evaluating once-daily and split dose regimens of alixorexton in patients with NT1 and NT2. More information can be found at www.brilliancestudies.com (for U.S . audiences only) and www.clinicaltrials.gov (Brilliance NT1 – Study 302: NCT07455383; Brilliance NT2 – Study 303: NCT07502443; Brilliance NT1 – Study 304: NCT07540897).
About the Vibrance-2 Phase 2 Study (NCT06555783) Vibrance-2 was a phase 2, randomized, double-blind, dose-range-finding, placebo-controlled study evaluating the safety and efficacy of alixorexton (formerly referred to as ALKS 2680) in adults with narcolepsy type 2 (NT2). Participants (n=93) were randomized to receive one of three doses of alixorexton (10 mg, 14 mg, or 18 mg) or placebo to be taken once-daily for eight weeks. The dual primary endpoints assessed whether participants taking alixorexton experienced an improvement in wakefulness compared to participants taking placebo, as measured by the change from baseline in mean sleep latency on the maintenance of wakefulness test (MWT) at week eight, and a greater decrease in sleepiness as measured by the change from baseline in Epworth Sleepiness Scale (ESS) score at week eight. The secondary endpoint evaluated the safety and tolerability of alixorexton in patients with NT2, including incidence of adverse events, vital signs and clinical laboratory assessments. The study also included a number of exploratory patient-reported outcome measures, which evaluated the effect of alixorexton on participants’ disease severity, fatigue and cognition. All participants in the double-blind portion of the study were eligible to continue to an optional five-week open-label safety extension portion of the study, followed by a long-term safety study.
About Alixorexton Alixorexton (formerly referred to as ALKS 2680) is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain.7 Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease.8 Alixorexton is currently being evaluated in the phase 3 Brilliance Studies in patients with NT1 and NT2, and in the phase 2 Vibrance-3 study in patients with IH. The U.S. Food and Drug Administration (FDA) has granted alixorexton Breakthrough Therapy designation for the treatment of NT1 and Orphan Drug Designation (ODD) for the treatment of IH. The European Commission has granted ODD to alixorexton for the treatment of narcolepsy.
About Alkermes plc Alkermes plc (Nasdaq: ALKS), a mid-cap growth and value equity, is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy. Alkermes’ pipeline includes late-stage clinical candidates in development for narcolepsy and idiopathic hypersomnia, and orexin 2 receptor agonists in early clinical development for other neurological disorders, including attention-deficit hyperactivity disorder (ADHD) and fatigue associated with multiple sclerosis and Parkinson’s disease. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of alixorexton. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: clinical study results for alixorexton may not be predictive of results of future stages of ongoing clinical studies, future clinical studies or real-world results; clinical studies for alixorexton may not be initiated or completed on expected timelines or at all; alixorexton may be shown to be ineffective or unsafe; the FDA may not agree with the company’s regulatory strategies or components of its development program for alixorexton, including clinical trial designs, conduct and methodologies; potential changes in the cost, scope and duration of the alixorexton development program; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2025 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.
1 The last MWT assessment was conducted at week 8; it was not assessed during the open-label extension. 2 Reported p-values for dual primary endpoints are adjusted for multiplicity. Study used a graphical analysis procedure to control for multiplicity, which precluded the assessment of statistical significance of the MWT endpoint at the 10 mg dose. 3 ESS: Self-administered, 8-item questionnaire (score range: 0-24) that measures severity of excessive daytime sleepiness over the past 7 days (score ≤10 = normative; score 11-12 = mild). 4 PROMIS-Fatigue: 6-item self-administered questionnaire assessing the severity of a patient’s fatigue over the past 7 days. Items are scored and transformed to T-scores (<55 = normative). 5 BC-CCI: 6-item self-administered questionnaire (score: 0-18) assessing perceived problems with concentration, memory, expressing thoughts, word finding, slow thinking, and difficulty solving problems over the past 7 days (≤4 = normative). 6 TEAEs in ≥10% of all alixorexton-treated patients during RDBT period. 7 Buysse, D. Diagnosis and assessment of sleep and circadian rhythm disorders. Journal of Psychiatric Practice. 2005; 11(2):102-115. 8 Ten-Blanco M, Flores A, Cristino L, Pereda-Perez I. Targeting the orexin/hypocretin system for the treatment of neuropsychiatric and neurodegenerative diseases: From animal to clinical studies. Frontiers in Neuroendocrinology. 2023;69(101066). https://www.sciencedirect.com/science/article/pii/S0091302223000146.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260617871260/en/
For Investors: Sandy Coombs, +1 781 609 6377 For Media: Gretchen Murphy, +1 781 609 6419
Source: Alkermes plc
2026-06-15
DUBLIN--(BUSINESS WIRE)--
Alkermes plc
(Nasdaq: ALKS) today announced that alixorexton, a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), was recently granted orphan drug designations (ODD) from leading regulatory bodies in the U.S. and Europe. The U.S. Food and Drug Administration (FDA) has granted ODD to alixorexton for the treatment of IH, and the European Commission has granted ODD to alixorexton for the treatment of narcolepsy.
“Narcolepsy and idiopathic hypersomnia are rare, chronic neurological conditions for which significant unmet need remains. These orphan drug designations represent important milestones for the alixorexton program and underscore its potential, if approved, to advance care for the narcolepsy and idiopathic hypersomnia patient communities,” said Craig Hopkinson, M.D., (MBChB), Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. “Alixorexton’s phase 2 clinical trial results in narcolepsy type 1 and type 2 underscore its potential to become a differentiated treatment option. We look forward to continuing our momentum in the alixorexton development program as we enroll the phase 3 Brilliance Studies and work to complete the Vibrance-3 phase 2 study in IH this year.”
Orphan drug designation supports the development of medicines intended to treat rare diseases. In the U.S., orphan drug designation qualifies the drug developer for a variety of development incentives, including tax credits for qualified clinical testing, exemptions from certain FDA application fees, and seven years of market exclusivity, if approved. In the European Union, orphan designation provides incentives that may include protocol assistance, reduced regulatory fees, and up to 10 years of market exclusivity, if approved.
Alixorexton previously received Breakthrough Therapy designation for the treatment of NT1 from the FDA. Alixorexton is currently being evaluated in the phase 3 Brilliance Studies in adults with NT1 and NT2, and in the phase 2 Vibrance-3 study in adults with IH (Brilliance NT1 – Study 302: NCT07455383; Brilliance NT2 – Study 303: NCT07502443; Brilliance NT1 – Study 304: NCT07540897; Vibrance-3: NCT06843590).
About Narcolepsy
Narcolepsy is a rare, chronic, neurological disorder that affects the brain’s ability to regulate the sleep/wake cycle. Excessive daytime sleepiness is the hallmark symptom of narcolepsy; additional symptoms can include sleep paralysis, sleep-related hallucinations and disturbed nighttime sleep.
1
There are two types of narcolepsy: narcolepsy type 1 is characterized by the loss of orexin-producing neurons, and is also associated with cataplexy, a sudden loss of muscle control while a person is awake, often triggered by strong emotions.
2
The underlying neuropathology of narcolepsy type 2 remains to be fully elucidated; however the orexin pathway may play an important role.
3
About Idiopathic Hypersomnia
Idiopathic hypersomnia (IH) is a rare, chronic, neurological sleep disorder characterized by excessive daytime sleepiness despite normal sleep durations.
4,5
Additional common symptoms can include severe sleep inertia (individuals may feel groggy or disoriented for prolonged periods after waking up), unrefreshing naps, fatigue and cognitive dysfunction.
6,7
The underlying neuropathology of idiopathic hypersomnia is unknown.
4
IH affects an estimated 40,000 people in the U.S.
8
About Alixorexton
Alixorexton (formerly referred to as ALKS 2680) is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain.
9
Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease.
10
Alixorexton is currently being evaluated in the phase 3 Brilliance Studies in patients with NT1 and NT2, and in the phase 2 Vibrance-3 study in patients with IH. The U.S. Food and Drug Administration (FDA) has granted alixorexton Breakthrough Therapy designation for the treatment of NT1 and Orphan Drug Designation (ODD) for the treatment of IH. The European Commission has granted ODD to alixorexton for the treatment of narcolepsy.
About Alkermes plc
Alkermes plc (Nasdaq: ALKS), a mid-cap growth and value equity, is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy. Alkermes’ pipeline includes late-stage clinical candidates in development for narcolepsy and idiopathic hypersomnia, and orexin 2 receptor agonists in early clinical development for other neurological disorders, including attention-deficit hyperactivity disorder (ADHD) and fatigue associated with multiple sclerosis and Parkinson’s disease. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes’ website at
.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of alixorexton, its potential regulatory approval, and timelines for its continued clinical development. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: initial clinical results for alixorexton may not be predictive of results of future stages of ongoing clinical studies, future clinical studies or real-world results; ongoing or future clinical studies for alixorexton may not be initiated or completed on expected timelines or at all; alixorexton may be shown to be ineffective or unsafe; the FDA may not agree with the company’s regulatory strategies or components of its development program for alixorexton, including clinical trial designs, conduct and methodologies; potential changes in the cost, scope and duration of the alixorexton development program; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2025 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at
. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.
1
Ruoff C, Rye D. The ICSD-3 and DSM-5 guidelines for diagnosing narcolepsy: clinical relevance and practicality.
Curr Med Res Opin
. 2016;32(10):1611-1622. doi:10.1080/03007995.2016.1208643
2
Dauvilliers Y, Siegel JM, Lopez R, Torontali ZA, Peever JH. Cataplexy--clinical aspects, pathophysiology and management strategy.
Nat Rev Neurol
. 2014;10(7):386-395. doi:10.1038/nrneurol.2014.97
3
Bassetti CLA, Adamantidis A, Burdakov D, et al. Narcolepsy - clinical spectrum, aetiopathophysiology, diagnosis and treatment.
Nat Rev Neurol
. 2019;15(9):519-539. doi:10.1038/s41582-019-0226-9
4
Trotti LM, Arnulf I. Idiopathic Hypersomnia and Other Hypersomnia Syndromes. Neurotherapeutics. 2021;18(1):20-31. doi:10.1007/s13311-020-00919-1
5
American Academy of Sleep Medicine. The International Classification of Sleep Disorders. Third Edition (ICSD-3). 2014.
6
Trotti LM. Waking up is the hardest thing I do all day: Sleep inertia and sleep drunkenness. Sleep Med Rev 2016.
7
Vernet C, Leu-Semenescu S, Buzare MA, Arnulf I. Subjective symptoms in idiopathic hypersomnia: beyond excessive sleepiness. J Sleep Res. 2010;19:525–534.
8
Acquavella et al. Prevalence of narcolepsy and other sleep disorders and frequency of diagnostic tests from 2013-2016 in insured patients actively seeking care. J Clin Sleep Med. 16:1255 (2020).
9
Buysse, D. Diagnosis and assessment of sleep and circadian rhythm disorders.
Journal of Psychiatric Practice
. 2005; 11(2):102-115
10
Ten-Blanco M, Flores A, Cristino L, Pereda-Perez I. Targeting the orexin/hypocretin system for the treatment of neuropsychiatric and neurodegenerative diseases: From animal to clinical studies. Frontiers in Neuroendocrinology. 2023;69(101066).
Contacts
For Investors: Sandy Coombs, +1 781 609 6377
For Media: Gretchen Murphy, +1 781 609 6419
2026-06-04
— 26 Abstracts Accepted Demonstrate Alkermes’ Commitment to Advancing Understanding and Treatment of Narcolepsy and Idiopathic Hypersomnia —
—
Detailed Positive Results from Vibrance-2 Phase 2 Study of Alixorexton, an Orexin 2 Receptor Agonist, in Patients With Narcolepsy Type 2 to be Shared in Oral Presentation —
DUBLIN--(BUSINESS WIRE)--
Alkermes plc
(Nasdaq: ALKS) today announced plans to present new data from its industry-leading portfolio of sleep medicine research at SLEEP 2026, the 40
th
annual meeting of the Associated Professional Sleep Societies (APSS), taking place June 14-17, 2026 in Baltimore, MD. The company will present 26 abstracts, including posters featuring LUMRYZ
®
(sodium oxybate) extended-release oral suspension, now part of Alkermes’ sleep portfolio following the acquisition of Avadel Pharmaceuticals plc in February 2026, and alixorexton, Alkermes’ novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH).
The company will present detailed results from the alixorexton Vibrance-2 study, the first large phase 2 clinical trial to demonstrate positive results with an OX2R agonist in patients with NT2 (n=93). The data will be shared in an oral presentation by Richard Bogan, M.D., FCCP, FAASM, Principal of Bogan Sleep Consultants, LLC and Associate Clinical Professor at the University of South Carolina School of Medicine. Primary and secondary efficacy and safety data, and exploratory patient-reported outcomes related to fatigue and cognition from the eight-week randomized, double-blind treatment period and optional five-week open-label extension, will be presented.
Abstracts accepted for late-breaking poster presentations include:
Baseline characteristics from the phase 3 REVITALYZ
SM
study evaluating the investigational use of LUMRYZ in adults with IH, for which positive topline results were recently announced; and
Two posters detailing the study designs and methods for the Brilliance Studies, a phase 3 clinical trial program evaluating the safety and efficacy of alixorexton compared to placebo in patients with NT1 and NT2.
“SLEEP 2026 is a defining moment for Alkermes as we strengthen our leadership in sleep medicine. Alkermes data being presented at SLEEP highlight the scope and scale of our scientific research in the field of sleep medicine and underscore our commitment to advancing care for people living with narcolepsy and idiopathic hypersomnia,” said Craig Hopkinson, M.D. (MBChB), Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. “We look forward to sharing detailed data from our alixorexton Vibrance-2 phase 2 study with clinicians, including findings related to fatigue and cognitive impairment in this population, and sharing compelling new data further characterizing the pro LUMRYZ. As we apply our neuroscience expertise to deepen our collective understanding of narcolepsy and idiopathic hypersomnia, our goal is to advance differentiated treatment approaches for patients impacted by these complex diseases.”
Additional highlights to be presented at SLEEP 2026 include:
Alixorexton clinical development
Exploratory findings from the Vibrance-1 phase 2 study evaluating the impact of alixorexton compared to placebo on quality-of-life measures in patients with NT1.
LUMRYZ real-world evidence
Posters showing real-world experience and patient survey findings from REFRESH, a prospective multicenter, real-world study in patients with narcolepsy, including those who switched to LUMRYZ from a twice-nightly oxybate and those new to oxybate treatment or returning to oxybate treatment after discontinuing a twice-nightly oxybate.
Research advancing understanding of hypersomnolence disorders
Findings from the ASPIRE survey study evaluating the impact of cognitive impairment and fatigue on work productivity and health-related quality of life in people with NT1, NT2 and IH.
Data from a claims database describing estimated prevalence of central disorders of hypersomnolence (CDoH), treatment patterns, and differences in treatment patterns across social determinants of health, including age, race, ethnicity and income level.
Findings from a survey of people with idiopathic hypersomnia featuring data regarding patient experiences and preferences for oxybate treatment.
The SLEEP 2026 abstracts are available on the SLEEP Meeting website:
A full list of Alkermes’ presentations at SLEEP 2026 follows:
Title
Session Date and Time
Oral Presentation
Vibrance-2: A Randomized Phase 2 Study Evaluating Efficacy and Safety of the Orexin 2 Receptor Agonist Alixorexton in Patients with Narcolepsy Type 2
Session O-23
Wednesday, June 17 from 4:15-4:30 p.m.
Poster Presentations
Improvements in Quality of Life in Patients with Narcolepsy Type 1 Treated with the Orexin 2 Receptor Agonist Alixorexton
Poster #373
Monday, June 15 from 10:00-10:45 a.m.
Safety and Efficacy of the Orexin 2 Receptor Agonist Alixorexton in Patients With Narcolepsy Type 1: The Phase 2 Vibrance-1 Study
Poster #385
Monday, June 15 from 10:00-10:45 a.m.
Drug Class Utilization and Age-Related Trends in Narcolepsy and Idiopathic Hypersomnia: A Claims Database Analysis
Poster #376
Monday, June 15 from 11:00-11:45 a.m.
Polysomnographic Findings in Pediatric Patients With Narcolepsy Type 1 and Narcolepsy Type 2: A Retrospective Review
Poster #307
Tuesday, June 16 from 10:00-10:45 a.m.
Real-World Experience and Impact of Fatigue in Narcolepsy and Idiopathic Hypersomnia: Survey Results from the ASPIRE Study
Poster #313
Tuesday, June 16 from 10:00-10:45 a.m.
Impact of Economic Status Across Race and Ethnicity on Narcolepsy Treatment Access: A Claims Database Analysis
Poster #317
Tuesday, June 16 from 10:00-10:45 a.m.
Treatment Access for Narcolepsy Across Patient Demographic Characteristics: A Claims Database Analysis
Poster #319
Tuesday, June 16 from 10:00-10:45 a.m.
Alixorexton Improved Patient-Reported Disease Severity, Cognitive Functioning, and Fatigue in Patients With Narcolepsy Type 1 in the Vibrance-1 Study
Poster #323
Tuesday, June 16 from 10:00-10:45 a.m.
Improvement in Sleepiness With Once-Nightly Sodium Oxybate in People With Narcolepsy Type 1 and Narcolepsy Type 2: A Specialty Pharmacy Data Analysis
Poster #327
Tuesday, June 16 from 10:00-10:45 a.m.
Oxybate Treatment Patterns in Patients With Narcolepsy: Cohort Data From Mayo Clinic and Duke Health
Poster #329
Tuesday, June 16 from 10:00-10:45 a.m.
Sleepiness Improvement With Once-Nightly Sodium Oxybate in Patients With and Without Prior Twice-Nightly Oxybate Use: Specialty Pharmacy Data Analysis
Poster #333
Tuesday, June 16 from 10:00-10:45 a.m.
Oxybate Treatment Experience and Preferences of People With Idiopathic Hypersomnia
Poster #341
Tuesday, June 16 from 10:00-10:45 a.m.
Brilliance NT1: Study Design and Methods for 2 Phase 3, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating Alixorexton in Patients With Narcolepsy Type 1
Poster #531
Tuesday, June 16 from 10:00-10:45 a.m.
Demographics and Disease Characteristics Among Pediatric Patients With Narcolepsy
Poster #306
Tuesday, June 16 from 11:00-11:45 a.m.
Demographics and Comorbidities of Patients With Narcolepsy: A Propensity Score–Matched Cohort Study
Poster #308
Tuesday, June 16 from 11:00-11:45 a.m.
Real-World Experience and Impact of Cognitive Impairment in Narcolepsy and Idiopathic Hypersomnia: Survey Results from the ASPIRE Study
Poster #312
Tuesday, June 16 from 11:00-11:45 a.m.
Relative Prevalence of Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia: A Claims Database Analysis
Poster #314
Tuesday, June 16 from 11:00-11:45 a.m.
Impact of Sex and Race on Treatment of Narcolepsy: A Claims Database Analysis
Poster #318
Tuesday, June 16 from 11:00-11:45 a.m.
Once-Nightly Sodium Oxybate Improves Symptoms in People With Narcolepsy: Final Results From the Real-World REFRESH Study
Poster #328
Tuesday, June 16 from 11:00-11:45 a.m.
Nighttime Symptom Experience and Treatment Challenges: Perspectives From People With Narcolepsy
Poster #340
Tuesday, June 16 from 11:00-11:45 a.m.
Real-World Experience of Once-Nightly Sodium Oxybate Treatment in People With Narcolepsy: Final Results From REFRESH
Poster #342
Tuesday, June 16 from 11:00-11:45 a.m.
REVITALYZ: A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Withdrawal Trial of Extended-Release Sodium Oxybate for Idiopathic Hypersomnia
Poster #530
Tuesday, June 16 from 11:00-11:45 a.m.
Brilliance NT2: Study Design and Methods for a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Alixorexton in Patients With Narcolepsy Type 2
Poster #532
Tuesday, June 16 from 11:00-11:45 a.m.
Demographic and Clinical Characteristics of People Receiving Once-Nightly Sodium Oxybate Treatment: A Specialty Pharmacy Data Analysis
Poster #345
Wednesday, June 17 from 10:00-10:45 a.m.
Risk Evaluation and Mitigation Strategies: From Burden to Benefit
Poster #190
Wednesday, June 17 from 11:00-11:45 a.m.
About LUMRYZ
®
(sodium oxybate) for extended-release oral suspension
LUMRYZ (sodium oxybate) for extended-release oral suspension is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
IMPORTANT SAFETY INFORMATION
WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE
Central Nervous System Depression
LUMRYZ
®
(sodium oxybate) is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with LUMRYZ at recommended doses. Many patients who received LUMRYZ during clinical trials in narcolepsy were receiving CNS stimulants.
Abuse and Misuse
LUMRYZ (sodium oxybate) is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and death.
Because of the risks of CNS depression and abuse and misuse, LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the LUMRYZ REMS.
CONTRAINDICATIONS
LUMRYZ is contraindicated for use in:
combination with sedative hypnotics or alcohol
patients with succinic semialdehyde dehydrogenase deficiency
WARNINGS AND PRECAUTIONS
Central Nervous System Depression
The concurrent use of LUMRYZ with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating antiepileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. If use of these CNS depressants in combination with LUMRYZ is required, dose reduction or discontinuation of one or more CNS depressants (including LUMRYZ) should be considered. In addition, if short-term use of an opioid (eg, post- or perioperative) is required, interruption of treatment with LUMRYZ should be considered.
After first initiating treatment and until certain that LUMRYZ does not affect them adversely (eg, impair judgment, thinking, or motor skills), caution patients against engaging in hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes. Also caution patients against engaging in these hazardous activities for at least six (6) hours after taking LUMRYZ. Patients should be queried about CNS depression-related events upon initiation of LUMRYZ therapy and periodically thereafter.
Abuse and Misuse
LUMRYZ is a Schedule III controlled substance. The active ingredient of LUMRYZ, sodium oxybate, is the sodium salt of gamma-hydroxybutyrate (GHB), a Schedule I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The rapid onset of sedation, coupled with the amnestic features of GHB, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (eg, assault victim). Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.
LUMRYZ REMS
LUMRYZ is available only through a restricted distribution program called the LUMRYZ REMS because of the risks of central nervous system depression and abuse and misuse.
Notable requirements of the LUMRYZ REMS include the following:
Healthcare providers who prescribe LUMRYZ are specially certified.
LUMRYZ will be dispensed only by pharmacies that are specially certified.
LUMRYZ will be dispensed and shipped only to patients who are enrolled in the LUMRYZ REMS with documentation of safe use conditions.
Further information is available at
or by calling 1-877-453-1029.
Respiratory Depression and Sleep-Disordered Breathing
LUMRYZ may impair respiratory drive, especially in patients with compromised respiratory function. In overdoses of oxybate with illicit use of GHB, life-threatening respiratory depression has been reported. Increased apnea and reduced oxygenation may occur with LUMRYZ administration. A significant increase in the number of central apneas and clinically significant oxygen desaturation may occur in patients with obstructive sleep apnea treated with LUMRYZ. Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients, in men, in postmenopausal women not on hormone replacement therapy, and among patients with narcolepsy.
Depression and Suicidality
Depression, and suicidal ideation and behavior, can occur in patients treated with LUMRYZ. In an adult clinical trial in patients with narcolepsy (n=212), there were no suicide attempts, but one patient with a history of depression and anxiety developed suicidal ideation in the LUMRYZ-treated group. In a clinical trial in pediatric narcolepsy patients administered immediate-release sodium oxybate, one patient experienced suicidal ideation and two patients reported depression. The emergence of depression in patients treated with LUMRYZ requires careful and immediate evaluation. Patients with a previous history of a depressive illness and/or a suicide attempt should be monitored carefully for the emergence of depressive symptoms while taking LUMRYZ.
Other Behavioral or Psychiatric Adverse Reactions
Other behavioral and psychiatric adverse reactions can occur in patients taking LUMRYZ. During adult clinical trials in patients with narcolepsy administered LUMRYZ, 2% of 107 patients treated with LUMRYZ experienced a confusional state. No patients treated with LUMRYZ discontinued treatment because of confusion. Anxiety occurred in 7.5% of 107 patients treated with LUMRYZ in the adult trial in patients with narcolepsy. Other psychiatric reactions reported in adult clinical trials in patients with narcolepsy administered LUMRYZ included irritability, emotional disorder, panic attack, agitation, delirium, and obsessive thoughts. Other neuropsychiatric reactions reported in adult clinical trials in patients with narcolepsy administered immediate-release sodium oxybate and in the postmarketing setting for immediate-release sodium oxybate include hallucinations, paranoia, psychosis, aggression, and agitation. In a clinical trial in pediatric patients administered immediate-release sodium oxybate, neuropsychiatric reactions including acute psychosis, confusion, and anxiety were reported. The emergence or increase in the occurrence of behavioral or psychiatric events in patients taking LUMRYZ should be carefully monitored.
Parasomnias
Parasomnias can occur in patients taking LUMRYZ. Sleepwalking, defined as confused behavior occurring at night and at times associated with wandering, was reported in 3% of 107 adult patients with narcolepsy treated with LUMRYZ. No patients treated with LUMRYZ discontinued due to sleepwalking. Episodes of sleepwalking should be fully evaluated and appropriate interventions considered.
Use in Patients Sensitive to High Sodium Intake
LUMRYZ has a high sodium content. In patients sensitive to sodium intake (eg, those with heart failure, hypertension, or renal impairment), consider the amount of daily sodium intake in each dose of LUMRYZ.
MOST COMMON ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5% and greater than placebo) reported for any dose of LUMRYZ in a trial of adults with narcolepsy were nausea, dizziness, enuresis, headache, and vomiting. Similarly, in a trial of pediatric narcolepsy patients receiving immediate-release sodium oxybate, the most commonly observed adverse reactions (incidence ≥5%) were nausea, enuresis, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking.
ADDITIONAL ADVERSE REACTIONS
Additional adverse reactions that occurred in ≥2% of adult patients with narcolepsy treated with LUMRYZ and were more frequent in the LUMRYZ treatment group than with placebo were vomiting, nausea, decreased weight, decreased appetite, dizziness, somnolence, headache, enuresis, anxiety, and somnambulism.
DRUG INTERACTIONS
LUMRYZ is contraindicated for use in combination with alcohol or sedative hypnotics. Use of other CNS depressants may potentiate the CNS-depressant effects of LUMRYZ.
PREGNANCY AND LACTATION
There are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women. LUMRYZ should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. GHB is excreted in human milk after oral administration of sodium oxybate. There is insufficient information on the risk to a breastfed infant, and there is insufficient information on milk production in nursing mothers. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LUMRYZ and any potential adverse effects on the breastfed infant from LUMRYZ or from the underlying maternal condition.
PEDIATRIC USE
LUMRYZ has not been studied in a pediatric clinical trial for narcolepsy. The safety and effectiveness of LUMRYZ in the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy is supported by evidence from a double-blind, placebo-controlled, randomized-withdrawal study of immediate-release sodium oxybate. Safety and effectiveness of LUMRYZ in pediatric patients below the age of 7 years have not been established.
GERIATRIC USE
Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
HEPATIC IMPAIRMENT
LUMRYZ should not be initiated in patients with hepatic impairment because appropriate dosage adjustments for initiation cannot be made with the available dosage strengths. Patients with hepatic impairment who have been titrated to a maintenance dosage of another oxybate product can be switched to LUMRYZ if the appropriate dosage strength is available.
DEPENDENCE AND TOLERANCE
There have been case reports of withdrawal, ranging from mild to severe, following discontinuation of illicit use of GHB at frequent repeated doses (18 g to 250 g per day) in excess of the recommended dosage range. Signs and symptoms of GHB withdrawal following abrupt discontinuation included insomnia, restlessness, anxiety, psychosis, lethargy, nausea, tremor, sweating, muscle cramps, tachycardia, headache, dizziness, rebound fatigue and sleepiness, confusion, and, particularly in the case of severe withdrawal, visual hallucinations, agitation, and delirium. These symptoms generally abated in three (3) to fourteen (14) days. In cases of severe withdrawal, hospitalization may be required. The discontinuation effects of LUMRYZ have not been systematically evaluated in controlled clinical trials.
Tolerance to LUMRYZ has not been systematically studied in controlled clinical trials. There have been some case reports of symptoms of tolerance developing after illicit use at dosages far in excess of the recommended LUMRYZ dosage regimen.
Please see full
Prescribing Information
, including BOXED Warning.
About Alixorexton
Alixorexton (formerly referred to as ALKS 2680) is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain.
1
Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease.
2
Once-daily oral administration of alixorexton was previously evaluated in a phase 1 study in healthy volunteers and patients with NT1, NT2 and IH, and in Vibrance-1 and Vibrance-2, phase 2 studies in patients with NT1 and NT2, respectively. Alixorexton is currently being evaluated in the phase 3 Brilliance Studies in patients with NT1 and NT2, and in the phase 2 Vibrance-3 study in patients with IH. Alixorexton has received Breakthrough Therapy designation for the treatment of NT1 from the U.S. Food and Drug Administration (FDA).
About Alkermes plc
Alkermes plc (Nasdaq: ALKS), a mid-cap growth and value equity, is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy. Alkermes’ pipeline includes late-stage clinical candidates in development for narcolepsy and idiopathic hypersomnia, and orexin 2 receptor agonists in early clinical development for other neurological disorders, including attention-deficit hyperactivity disorder (ADHD) and fatigue associated with multiple sclerosis and Parkinson’s disease. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes’ website at
.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of alixorexton and LUMRYZ. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk.
Contacts
Alkermes Contacts:
For Investors: Sandy Coombs, +1 781 609 6377
For Media: Gretchen Murphy, +1 781 609 6419
Read full story here
临床2期临床结果临床3期上市批准
100 项与 Alixorexton 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 特发性睡眠过度 | 临床3期 | 美国 | 2025-01-27 | |
| 特发性睡眠过度 | 临床3期 | 澳大利亚 | 2025-01-27 | |
| 特发性睡眠过度 | 临床3期 | 比利时 | 2025-01-27 | |
| 特发性睡眠过度 | 临床3期 | 捷克 | 2025-01-27 | |
| 特发性睡眠过度 | 临床3期 | 法国 | 2025-01-27 | |
| 特发性睡眠过度 | 临床3期 | 意大利 | 2025-01-27 | |
| 特发性睡眠过度 | 临床3期 | 荷兰 | 2025-01-27 | |
| 特发性睡眠过度 | 临床3期 | 西班牙 | 2025-01-27 | |
| 发作性睡病 | 临床3期 | 澳大利亚 | 2025-01-27 | |
| 发作性睡病 | 临床3期 | 法国 | 2025-01-27 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床2期 | 92 | Alixorexton 4 mg | 餘繭衊衊衊鏇願憲壓鏇(製襯願鏇衊齋齋膚鏇鑰) = 鑰夢網選範窪襯網顧築 淵網範選鬱廠鹹鑰鏇夢 (鬱鹹壓艱構廠蓋簾獵製 ) 更多 | 积极 | 2025-09-08 | ||
Alixorexton 6 mg | 餘繭衊衊衊鏇願憲壓鏇(製襯願鏇衊齋齋膚鏇鑰) = 積憲鹽鑰範醖醖醖獵獵 淵網範選鬱廠鹹鑰鏇夢 (鬱鹹壓艱構廠蓋簾獵製 ) 更多 | ||||||
临床2期 | 92 | ALKS-2680 4 mg | 積蓋鏇選製廠遞窪憲窪(簾餘齋鹽憲廠鏇糧憲選) = 製壓糧窪淵憲蓋艱醖衊 夢鬱鹹範壓選餘範遞夢 (膚鏇積積鹹窪憲廠觸艱 ) | 积极 | 2025-07-21 | ||
ALKS-2680 6 mg | 積蓋鏇選製廠遞窪憲窪(簾餘齋鹽憲廠鏇糧憲選) = 積構獵壓選鹹壓壓鑰鹽 夢鬱鹹範壓選餘範遞夢 (膚鏇積積鹹窪憲廠觸艱 ) | ||||||
临床1期 | 8 | 簾構觸鬱壓鏇獵窪醖選(衊製製選範蓋齋餘網醖) = Treatment with once-daily, oral ALKS 2680 was generally well tolerated. 壓顧鹽夢鹽鬱選醖顧選 (憲遞憲鏇範窪繭衊築蓋 ) 更多 | 积极 | 2024-09-23 | |||
Placebo | |||||||
临床1期 | 10 | 網艱淵襯獵衊鹽鑰衊構(齋膚鹹襯膚鬱網餘鹹艱) = 積蓋網鬱獵夢鹹淵觸鏇 構遞糧範築繭膚網鹽鹹 (夢繭衊衊繭構醖憲鏇鹽 ) 更多 | 积极 | 2024-06-03 | |||
網艱淵襯獵衊鹽鑰衊構(齋膚鹹襯膚鬱網餘鹹艱) = 願積觸鹽積顧夢夢淵範 構遞糧範築繭膚網鹽鹹 (夢繭衊衊繭構醖憲鏇鹽 ) 更多 | |||||||
临床1期 | - | (narcolepsy type 2 + 5 mg) | 遞築範糧構構憲鏇襯廠(製鹽餘鑰顧糧積糧餘遞) = 艱構遞鬱遞積鹽餘築衊 廠網繭襯選鏇繭築壓鹽 (願壓鏇鏇顧鹹獵鏇餘範 ) | 积极 | 2024-04-09 | ||
(narcolepsy type 2 + 12 mg) | 遞築範糧構構憲鏇襯廠(製鹽餘鑰顧糧積糧餘遞) = 廠憲襯製憲鏇糧觸繭網 廠網繭襯選鏇繭築壓鹽 (願壓鏇鏇顧鹹獵鏇餘範 ) | ||||||
临床1期 | - | 繭艱壓夢醖獵蓋艱範網(築淵鬱鑰糧願遞膚鏇顧) = ALKS 2680 was orally absorbed and showed biphasic distribution/elimination, with a terminal half-life suitable for maintaining daytime wakefulness with once-daily administration. 鏇艱顧襯構憲襯齋築鹽 (糧範窪範淵鑰獵觸構網 ) 更多 | 积极 | 2023-10-10 | |||
placebo |
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