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

Alkermes, Inc.

NCT07455383

/ Recruiting临床3期

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)

开始日期2026-04-06

申办/合作机构

Alkermes, Inc.

NCT06843590

/ Recruiting临床2期

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

Alkermes, Inc.

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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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.

项与 Alixorexton 相关的新闻（医药）

2026-06-26

·BioPharmaDive

Alkermes’ incoming CEO has a plan to outplay Lilly and Takeda

Shares of Alkermes, the Dublin-based developer of brain drugs, have surged nearly 50% in the last month, in good part because of positive clinical data for the companys most talked about research program.The data, released in mid-June, showed Alkermes experimental pill alixorexton was significantly better than a placebo at keeping patients with the more common, Type 2 form of narcolepsy awake and alert. Patients also tolerated the drug well, as there were no serious treatment-emergent adverse events. Alkermes has since initiated a global, Phase 3 program that will evaluate its pill in patients with Type 2 as well as Type 1 narcolepsy, which is hallmarked by a specific kind of loss in muscle control.On Wall Street, analysts see a multibillion-dollar opportunity in a new class of drugs that includes alixorexton as well as medicines from Takeda Pharmaceutical, Eli Lilly and Eisai.These therapies stimulate certain proteins, orexins, that are found through the circuits of the brain and regulate key functions like stress, energy, mood, learning and attention. As such, developers expect that orexin-targeting agents will be valuable treatments not only for narcolepsy, but for conditions like ADHD as well as other sleep disorders like idiopathic hypersomnia.Blair Jackson, Alkermes chief operating officer and soon-to-be CEO, spoke to BioPharma Dive about his companys strategy to compete against much larger rivals and how he, in his new role, will navigate whats poised to be the most important 12-month period in Alkermes history.The following conversation has been edited and condensed for clarity.BIOPHARMA DIVE: The narcolepsy Type 2 data Alkermes just disclosed, how closely did they match with the companys expectations? Were there any findings that surprised you?JACKSON: When you move from an NT1 group, which has no orexin, and you go into an orexin-adequate person, you expect to see an even more tolerable profile. We actually saw that, and I think that was a surprise for a number of people, a number of investors, and the community as a whole. What a lot of people missed is: that bodes really well for these orexin agonists moving outside of idiopathic hypersomnia and narcolepsy and into other, bigger indications like ADHD and fatigue. So that was very validating for us and consistent with our investment hypothesis.Where we saw a couple surprises had to do with the heterogeneity of the population. The NT1 group, that population performed similarly along the way. They were very responsive to orexin agonism. What we found with NT2 is the disease is a little more heterogeneous; different patients needed different doses. They also had different responses to treatment overall, depending on what lane they were put in. Some would respond, some wouldn't. But when we moved them into the open-label, where they could select their appropriate dose, we saw a movement to the normal range.So there are always learnings through these studies, and this was one of them. The other was just being really fastidious in standardizing measurements. We saw some variability in how some of the treatment centers and physicians would enact some of the tests, and we spent a long time thinking about that as we started our Phase 3 planning. You have 100 sites around the world they need to be doing it the same way so you can maintain statistical power.I remember there was a lot of discussion among analysts about your drug potentially causing visual impairments in some patients. Is that still a big concern?JACKSON:That was pretty much a Wall Street phenomenon. We started to see early in the program a few patients would get a visual disturbance. It was typically something like they're in a dark room and we turn the lights on, and they go, The lights look brighter. That's a visual disturbance. And it goes away really, really quickly.We had a handful of those, and Wall Street started to lose it. They were all over the place about it, and that was being sort of prodded on by some of our competition. What was interesting is when you talk to the treating physicians, to the sleep community, no one really cared. It wasn't going to impact their treatment. But, out of an abundance of caution, we put visual testing into our Phase 2 program just to make sure if someone had a visual disturbance, we could follow up.In the intervening time, I think people have started to recognize that [if the adverse event] is not impacting the patient's outcome, if it's not impacting their lives, then its nothing to worry about. Really, the prominent things you see related to this class are [more frequent urination], a bit of transient insomnia and some dizziness.How important is narcolepsy Type 2 to the commercial success of alixorexton?JACKSON:Very important. Not from a market [perspective], because the markets individually are very, very large. But when you look at this patient group as a whole, whether you're talking about NT1, NT2 or IH, the diagnosis between them can sometimes be blurred.Blair Jackson, Alkermes chief operating officer and incoming CEO.Permission granted by AlkermesYou can imagine a situation where, when Takeda enters the marketplace with their drug, it can only be used in NT1. When that happens, payers are going to say to the doctors, “You must prove this patient has NT1. And you can do that in only a few ways. One is a lumbar puncture, which nobody does. The other is to look at a genetic marker in the gene HLA1. A lot of people don't get that done either. So you put this hurdle up in front of the physician to prove this patient has NT1.Our goal is to come in and get approval across all three indications, so doctors don't have to justify their diagnosis. They could just say, I think the patient is NT1, start them on a dose. And if they need to move them around, they can easily do that. It gives a lot of flexibility and a lot of treatment options for those patients without having to deal with the payer every time you turn around.The way things are going, youll likely be competing against two much larger, more resourced competitors in Takeda and Eli Lilly. How, specifically, will you win there?JACKSON:When you look at this space, you're talking about a rare disease with a limited number of doctors, which minimizes the advantage that [those bigger players] have. This isn't like going after obesity, where we're going to see commercials everywhere and have to go to thousands of doctors and spend a ton of money. In fact, you're limited in how much you can really spend and do there.Takeda, I've heard them throw around something like maybe 120, 160 reps; that's about the size of our Vivitrol sales force. That's a small sales force in the scheme of things, so the way you compete in a smaller set like this is with the best asset. Creating the best clinical profile, the best outcomes, the best label, that helps.It becomes more difficult moving into these bigger markets, where Lilly can then start to push alot of their weight into the DTC and all that stuff. There, we take a different strategy.Stifel analysts recently spoke to a couple key opinion leaders, one of whom believed there isnt much differentiating the profiles of the leading orexin programs, which puts added weight on first-mover advantage. How much do you agree or disagree with that idea?JACKSON:Its true in one context, and maybe not in another.In some of the endpoints, you might see that we have similar results or are all highly efficacious. As you look at the way the market stacks up, we see that Takeda's drug is really good, but it's limited in its ability to be dosed higher. So there's going to be one dose for each of these patients, and it's going to be limited. If it works for you, great. If you need more, or if you want to go later in the day and get later coverage, you're kind of out of luck.I think it's going to launch really well, but I think it's going to leave a lot of room for improvement. And that's where we'll be able to come in with multiple doses across every different indication NT1, NT2 and IH and the ability to flex your dosing into the evening with our split-dose option. Differentiation is coming from the embodiment of the drug, the flexibility of the drug, the ability to give the doctors and patients what they need.As it then comes to Lilly, we don't know what Lilly has. We haven't seen their data. At best, we think they could be similar to us. But our goal is to try to minimize their ability to differentiate as much as possible, so that our second-mover advantage is really providing a barrier for them to get market share later.When Takeda presented data last year, at least some analysts described Alkermes as firmly planted in the No. 2 position. Do you think that perception is fair or creates any kind of impediment for you?JACKSON:We are going to be second to market, not second in preference.So I actually don't think that at all. Our data is being appreciated more and more. Physicians are really getting behind us.Doctors and analysts see huge opportunities for orexin drugs outside of sleep. How much is Alkermes willing to invest to probe those opportunities?We're leaders in the space of taking this mechanism and trying to understand where it works outside of narcolepsy. We've identified upwards of 19 different areas just within neuroscience; that's not looking at inflammation and metabolism.We started moving drugs forward a number of years ago. Our two programs now are in the clinic 7290 and 4510 we're gonna have data on ADHD by the end of the year for 7290. So were at the front edge of that.Having Lilly and others in the space is actually a benefit to us, because it means they're also going to be looking at a number of areas. We can then focus on the ones we know and can do really well in, and if they hit a really interesting spot, we could go there as well while not having to spend as much money as you would if you're the only one trying to see where this works.Youre transitioning into the CEO role later this summer. What are one or two concrete, top-of-mind things you will be focused on achieving in the first few months after you take the reins?JACKSON: In the next 12 months, we have a number of different clinical programs coming out with data. So the amount of execution needed over the next year is going to be higher than we've seen here in a really long time. I want to focus on that. I want to make sure we are delivering.The other thing I really want to do is focus a lot on our commercial organization preparation for the launch of alixorexton, but also the build out of the oxybate class. This acquisition of Avadel and bringing in the Lumryz business [means] we've got a commercial business thats going to deliver north of $1.7 billion this year. It's anchored by our legacy business, but the addition of Lumryz is very important within the sleep space.Now that we can have both the night treatment with the oxybate and the morning treatment with the orexin agonists, we're getting a lot of interest from patients and physicians. So bolstering up that clinical data set so we can show the benefits of each of these drugs and how they can best be used, these are the things that I'm going to be spending a lot of time on over the next little while. '

临床2期临床3期并购

2026-06-17

·investor.alkermes.com

Alkermes Presents Detailed Positive Results From Vibrance-2 Phase 2 Study of Alixorexton in Adults With Narcolepsy Type 2 at SLEEP 2026

— 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

·BioSpace

Alkermes Announces Orphan Drug Designations for Alixorexton in the U.S. and Europe

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

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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	Alkermes, Inc.	2025-01-27
特发性睡眠过度	临床3期	澳大利亚	Alkermes, Inc.	2025-01-27
特发性睡眠过度	临床3期	比利时	Alkermes, Inc.	2025-01-27
特发性睡眠过度	临床3期	捷克	Alkermes, Inc.	2025-01-27
特发性睡眠过度	临床3期	法国	Alkermes, Inc.	2025-01-27
特发性睡眠过度	临床3期	意大利	Alkermes, Inc.	2025-01-27
特发性睡眠过度	临床3期	荷兰	Alkermes, Inc.	2025-01-27
特发性睡眠过度	临床3期	西班牙	Alkermes, Inc.	2025-01-27
发作性睡病	临床3期	法国	Alkermes, Inc.	2025-01-27
发作性睡病	临床3期	意大利	Alkermes, Inc.	2025-01-27

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06358950 (Vibrance-1, Company_Website \| NEWS) 人工标引	临床2期	发作性睡病	92	Alixorexton 4 mg	壓壓壓築製夢顧壓網願(廠壓網廠觸構夢觸鏇製) = 製廠鑰選構遞築鑰鹽觸鑰鏇積願鹹繭鹹觸壓築 (獵鏇遞蓋觸糧夢憲衊簾 ) 更多	积极	2025-09-08
				Alixorexton 6 mg	壓壓壓築製夢顧壓網願(廠壓網廠觸構夢觸鏇製) = 夢網醖積醖壓糧蓋範艱鑰鏇積願鹹繭鹹觸壓築 (獵鏇遞蓋觸糧夢憲衊簾 ) 更多
NCT06358950 (Vibrance-1, PRNewswire)	临床2期	发作性睡病	92	ALKS-2680 4 mg	築構餘餘選遞窪窪製網(遞遞觸夢顧顧齋衊夢艱) = 觸鑰鏇鹹觸襯鹽鏇選糧壓願餘顧構遞繭壓顧築 (構窪廠觸鑰鑰繭窪獵簾 )	积极	2025-07-21
				ALKS-2680 6 mg	築構餘餘選遞窪窪製網(遞遞觸夢顧顧齋衊夢艱) = 糧獵繭繭構蓋襯衊壓獵壓願餘顧構遞繭壓顧築 (構窪廠觸鑰鑰繭窪獵簾 )
ISRCTN98204977 (PRNewswire) 人工标引	临床1期	发作性睡病 \| 特发性睡眠过度	8	ALKS 2680	壓醖膚鹽艱獵艱簾鏇範(廠襯鹽鏇積築餘選觸範) = Treatment with once-daily, oral ALKS 2680 was generally well tolerated. 顧鹹鬱齋襯鑰窪鏇獵鏇 (夢糧範鬱製鑰獵淵顧選 ) 更多	积极	2024-09-23
				Placebo
NCT06358950 (Vibrance-1, PRNewswire) 人工标引	临床1期	发作性睡病	10	ALKS 2680 1 mg	積獵網淵網選鬱鹽鹹餘(齋願夢醖遞製廠簾夢獵) = 積夢製鑰範艱製獵遞醖簾廠壓簾鑰餘艱憲醖積 (積觸壓蓋艱糧鹹積鏇廠 ) 更多	积极	2024-06-03
				ALKS 2680 3 mg	積獵網淵網選鬱鹽鹹餘(齋願夢醖遞製廠簾夢獵) = 鹹醖夢憲醖網餘壓壓餘簾廠壓簾鑰餘艱憲醖積 (積觸壓蓋艱糧鹹積鏇廠 ) 更多
ISRCTN98204977 (PRNewswire) 人工标引	临床1期	发作性睡病 \| 特发性睡眠过度	-	ALKS 2680 (narcolepsy type 2 + 5 mg)	鑰製簾築夢窪網願襯鹽(膚製簾願製築構淵顧艱) = 繭鬱選積構願構餘鹹齋壓鏇糧選廠鏇鑰醖壓網 (衊鹽獵醖鬱範鑰網遞廠 )	积极	2024-04-09
				ALKS 2680 (narcolepsy type 2 + 12 mg)	鑰製簾築夢窪網願襯鹽(膚製簾願製築構淵顧艱) = 衊蓋餘艱窪衊窪築積鹽壓鏇糧選廠鏇鑰醖壓網 (衊鹽獵醖鬱範鑰網遞廠 )
ISRCTN98204977 (WSC2023) 人工标引	临床1期	发作性睡病 \| 特发性睡眠过度	-	ALKS 2680	壓選醖鑰艱觸鹽鹹鏇壓(網範鬱構夢餘遞膚衊艱) = ALKS 2680 was orally absorbed and showed biphasic distribution/elimination, with a terminal half-life suitable for maintaining daytime wakefulness with once-daily administration. 憲繭顧獵積範淵築鑰齋 (壓憲鹹壓鏇壓艱遞鹽鹹 ) 更多	积极	2023-10-10
				placebo