Cataplexy, a sudden and transient loss of muscle tone often triggered by strong emotions, is a key symptom of narcolepsy. According to Jan Hlodak et al., 2025, the prevalence and incidence of narcolepsy disease may vary by region, but it is considered rare, affecting approximately 30 individuals per 100,000. Current therapies focus on symptom management, including sodium oxybate and selective serotonin-norepinephrine reuptake inhibitors. The cataplexy drug pipeline is witnessing a growing focus on targeted therapies and novel treatment mechanisms. According to the cataplexy pipeline analysis by Expert Market Research, the market is expected to experience significant growth in the coming years, driven by rising awareness, advanced clinical research, and unmet medical needs.
Major companies involved in the cataplexy pipeline analysis include Axsome Therapeutics, Takeda, and others.
Leading drugs currently in the pipeline include AXS-12, TAK-861, ALKS 2680, and others.
The cataplexy drug pipeline is expected to expand significantly due to increasing clinical trials of novel therapies, rising investment in targeted treatments, and growing demand for safer, more effective options.
The Cataplexy Pipeline Analysis Report by Expert Market Research gives comprehensive insights into cataplexy therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for cataplexy. The cataplexy report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The cataplexy pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with cataplexy treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to cataplexy.
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Cataplexy is a neurological disorder characterized by sudden, brief episodes of muscle weakness or paralysis triggered by strong emotions such as laughter, surprise, or anger. It occurs due to abnormal signaling in the brain’s hypocretin system, which regulates wakefulness and muscle tone, often associated with narcolepsy.
Cataplexy treatment includes sodium oxybate, antidepressants, and emerging therapies targeting hypocretin pathways to reduce the frequency and severity of attacks while improving daytime alertness. In October 2024, sodium oxybate (LUMRYZ) was FDA-approved for children aged seven and above with narcolepsy, offering a once-a-day bedtime dosing option that improves muscle control and reduces excessive daytime sleepiness.
Cataplexy, most commonly associated with narcolepsy type 1, remains a rare neurological condition with considerable geographic variation in prevalence. According to Jan Hlodak et al., 2025, approximately 30 per 100,000 individuals are diagnosed globally. In the United States, prevalence is estimated at 79.4 per 100,000, while global prevalence ranges from 25 to 50 per 100,000, as reported by Christopher N. Kaufmann et al., 2025.
This section of the report covers the analysis of cataplexy drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
By Drug Class
The cataplexy pipeline analysis report covers 50+ drug analyses based on drug classes:
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration.
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase III and II, with around 50% cover a major share of the total cataplexy clinical trials. This highlights advanced development and strong clinical evidence for efficacy and safety, and ongoing innovation and early-stage promise. This balanced distribution indicates a robust pipeline, poised to expand treatment options, enhance patient outcomes, and drive growth in the cataplexy market.
The drug molecule categories covered under the cataplexy pipeline analysis include small molecules, monoclonal antibodies, gene therapies, polymers, and peptides. The cataplexy report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for cataplexy. Oxybate-based therapies remain a cornerstone in cataplexy management. For instance, Xywav® (calcium, magnesium, potassium, and sodium oxybates), developed by Jazz Pharmaceuticals, has demonstrated clinical benefits with reduced sodium burden. Moreover, emerging investigational compounds in the central nervous system depressant class are being evaluated to improve safety profiles while maintaining efficacy in reducing cataplexy episodes in narcolepsy patients.
The EMR report for the cataplexy pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed cataplexy therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in cataplexy clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for cataplexy. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of cataplexy drug candidates.
Axsome Therapeutics is developing AXS-12 (reboxetine) as a potent, highly-selective norepinephrine reuptake inhibitor and cortical dopamine modulator. The ongoing Phase 3 SYMPHONY trial is examining its efficacy and safety in reducing cataplexy attacks in patients with narcolepsy. This randomized, double-blind, placebo-controlled study is evaluating weekly cataplexy frequency, excessive daytime sleepiness, inadvertent naps, and cognitive function. AXS-12 is showing promising reductions in cataplexy attacks and improvements in wakefulness and cognition, with a favorable safety profile.
Oveporexton (TAK-861) is an investigational oral orexin receptor 2 (OX2R) agonist being developed by Takeda to restore orexin signaling in people with narcolepsy type 1 (NT1). The ongoing Phase 3 study is examining its ability to improve wakefulness, reduce cataplexy events, and enhance overall quality of life. Oveporexton targets the underlying orexin deficiency causing NT1 and has demonstrated significant improvements in sleep latency, excessive daytime sleepiness, and disease severity in prior Phase 2b trials.
ALKS 2680, developed by Alkermes plc, is a novel oral orexin 2 receptor (OX2R) agonist currently being evaluated as a once-daily treatment for narcolepsy type 1. The ongoing study is examining its safety, tolerability, and efficacy in improving wakefulness and reducing cataplexy. ALKS 2680 is designed to target the underlying orexin deficiency in narcolepsy, enhancing alertness and sleep latency. Early Phase 1b results have demonstrated dose-dependent improvements in mean sleep latency and patient-reported alertness, with favorable tolerability across tested doses.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Cataplexy Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for cataplexy. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into cataplexy collaborations, regulatory environments, and potential growth opportunities.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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