{"disease":{"id":"narcolepsy","name":"Narcolepsy","therapeutic_area":"","data":{},"enrichment_level":0,"last_enriched_at":null,"visit_count":0,"created_at":"2026-04-19T18:31:21.150Z","updated_at":"2026-04-19T18:39:44.960Z","meddra_pt":null,"meddra_code":null,"icd10_codes":null,"synonyms":[],"prevalence_global":null,"prevalence_us":null,"marketed_drug_count":11,"pipeline_drug_count":0,"trial_count":3},"drugs":{"marketed":[{"drug_id":"pitolisant","indication_name":"Narcolepsy","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Wakix","generic_name":"PITOLISANT","company_name":"Harmony","drug_phase":"marketed","molecular_target":"Histamine H3 receptor","drug_class":"","quality_score":65,"revenue":"700","mechanism":"Wakix works by blocking histamine H3 receptors in the brain, allowing more histamine to be available to regulate sleep-wake cycles."},{"drug_id":"amphetamine-sulfate","indication_name":"Narcolepsy","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Amphetamine Sulfate","generic_name":"AMPHETAMINE SULFATE","company_name":"Azurity","drug_phase":"marketed","molecular_target":"Sodium-dependent dopamine transporter","drug_class":"Central Nervous System Stimulant","quality_score":10,"revenue":"172.0","mechanism":""},{"drug_id":"dexamfetamine","indication_name":"Narcolepsy","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Xelstrym","generic_name":"dexamfetamine","company_name":"UCB","drug_phase":"marketed","molecular_target":"Sodium-dependent noradrenaline transporter","drug_class":"Central Nervous System Stimulant [EPC]","quality_score":10,"revenue":"172.0","mechanism":"Xelstrym works by blocking the reuptake of noradrenaline, allowing it to stay in the brain for longer and increasing alertness and focus."},{"drug_id":"amfetamine","indication_name":"Narcolepsy","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Amphetamine Sulfate","generic_name":"amfetamine","company_name":"UCB","drug_phase":"marketed","molecular_target":"Sodium-dependent dopamine transporter","drug_class":"Central Nervous System Stimulant","quality_score":66,"revenue":"172.0","mechanism":""},{"drug_id":"methylphenidate","indication_name":"Narcolepsy","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Ritalin","generic_name":"methylphenidate","company_name":"Novartis","drug_phase":"marketed","molecular_target":"Alpha-2A adrenergic receptor, Alpha-2B adrenergic receptor, Alpha-2C adrenergic receptor","drug_class":"","quality_score":20,"revenue":null,"mechanism":null},{"drug_id":"concerta","indication_name":"Narcolepsy","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":null,"generic_name":"Concerta","company_name":"Lei Lei, MD","drug_phase":"marketed","molecular_target":"Alpha-2A adrenergic receptor, Alpha-2B adrenergic receptor, Alpha-2C adrenergic receptor","drug_class":"","quality_score":16,"revenue":null,"mechanism":null},{"drug_id":"amfetaminil","indication_name":"Narcolepsy","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Aponeuron","generic_name":"AMFETAMINIL","company_name":"","drug_phase":"phase_2","molecular_target":"","drug_class":"amfetaminil","quality_score":null,"revenue":null,"mechanism":"Aponeuron works by increasing the levels of certain neurotransmitters in the brain, such as dopamine and norepinephrine, to enhance alertness and wakefulness."},{"drug_id":"dextroamphetamine","indication_name":"Narcolepsy","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":null,"generic_name":"DEXTROAMPHETAMINE","company_name":"","drug_phase":"marketed","molecular_target":"Dopamine transporter (DAT), Norepinephrine transporter (NET)","drug_class":"Central nervous system stimulant","quality_score":10,"revenue":null,"mechanism":""},{"drug_id":"dextroamphetamine-sulfate","indication_name":"Narcolepsy","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":null,"generic_name":"DEXTROAMPHETAMINE SULFATE","company_name":"","drug_phase":"marketed","molecular_target":"","drug_class":"","quality_score":20,"revenue":null,"mechanism":null},{"drug_id":"modafinil","indication_name":"Narcolepsy","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Provigil","generic_name":"modafinil","company_name":"Nuvo Pharms","drug_phase":"marketed","molecular_target":"D(2) dopamine receptor","drug_class":"Sympathomimetic-like Agent [EPC]","quality_score":80,"revenue":null,"mechanism":"Provigil works by increasing the activity of certain neurotransmitters in the brain, such as dopamine, to help regulate sleep-wake cycles."},{"drug_id":"xyrem","indication_name":"Cataplexy and narcolepsy","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":null,"generic_name":"Xyrem","company_name":"Jazz Pharmaceuticals","drug_phase":"marketed","molecular_target":"Calcium/calmodulin-dependent protein kinase type II subunit alpha, GABA-B receptor, Gamma-hydroxybutyrate receptor","drug_class":"","quality_score":16,"revenue":null,"mechanism":null},{"drug_id":"xyrem","indication_name":"Narcolepsy","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":null,"generic_name":"Xyrem","company_name":"Jazz Pharmaceuticals","drug_phase":"marketed","molecular_target":"Calcium/calmodulin-dependent protein kinase type II subunit alpha, GABA-B receptor, Gamma-hydroxybutyrate receptor","drug_class":"","quality_score":16,"revenue":null,"mechanism":null},{"drug_id":"armodafinil","indication_name":"Narcolepsy","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Nuvigil","generic_name":"ARMODAFINIL","company_name":"Nuvo Pharms","drug_phase":"marketed","molecular_target":"D(2) dopamine receptor","drug_class":"armodafinil","quality_score":54,"revenue":null,"mechanism":"Nuvigil works by selectively targeting the D(2) dopamine receptor to increase wakefulness and alertness."}],"pipeline":[],"offLabel":[],"totalMarketed":13,"totalPipeline":0},"trials":{"data":[{"nct_id":"NCT04806620","title":"Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research","phase":"","overall_status":"RECRUITING","enrollment_count":10000,"lead_sponsor_name":"Brain Inflammation Collaborative","has_results":false},{"nct_id":"NCT03765892","title":"Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)","phase":"","overall_status":"COMPLETED","enrollment_count":1605,"lead_sponsor_name":"Hospices Civils de Lyon","has_results":false},{"nct_id":"NCT02769780","title":"A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy","phase":"","overall_status":"COMPLETED","enrollment_count":1500,"lead_sponsor_name":"Jazz Pharmaceuticals","has_results":false},{"nct_id":"NCT05536011","title":"WAKIX® (Pitolisant) Pregnancy Registry","phase":"","overall_status":"RECRUITING","enrollment_count":1329,"lead_sponsor_name":"Harmony Biosciences Management, Inc.","has_results":false},{"nct_id":"NCT04827329","title":"Anesthetic Management of Patients With Chronic Sleep Disorders","phase":"","overall_status":"COMPLETED","enrollment_count":700,"lead_sponsor_name":"University Hospital, Montpellier","has_results":false},{"nct_id":"NCT04330963","title":"International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study","phase":"","overall_status":"RECRUITING","enrollment_count":600,"lead_sponsor_name":"Insel Gruppe AG, University Hospital Bern","has_results":false},{"nct_id":"NCT04141891","title":"Advancing Understanding of Transportation Options","phase":"NA","overall_status":"COMPLETED","enrollment_count":529,"lead_sponsor_name":"University of Colorado, Denver","has_results":true},{"nct_id":"NCT05321355","title":"Mainz Register of Patients With Sleep Disorders","phase":"","overall_status":"RECRUITING","enrollment_count":500,"lead_sponsor_name":"Johannes Gutenberg University Mainz","has_results":false},{"nct_id":"NCT04899947","title":"Child and Adolescent Registry for Participants With Narcolepsy","phase":"","overall_status":"RECRUITING","enrollment_count":500,"lead_sponsor_name":"Jazz Pharmaceuticals","has_results":false},{"nct_id":"NCT05816382","title":"A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions","phase":"PHASE2, PHASE3","overall_status":"RECRUITING","enrollment_count":500,"lead_sponsor_name":"Takeda","has_results":false},{"nct_id":"NCT04667338","title":"A Study to Collect Information of People With Narcolepsy in Spain","phase":"","overall_status":"COMPLETED","enrollment_count":214,"lead_sponsor_name":"Takeda","has_results":true},{"nct_id":"NCT05373979","title":"Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale","phase":"","overall_status":"COMPLETED","enrollment_count":212,"lead_sponsor_name":"Boston Children's Hospital","has_results":false},{"nct_id":"NCT02720744","title":"Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy","phase":"PHASE3","overall_status":"COMPLETED","enrollment_count":212,"lead_sponsor_name":"Avadel","has_results":true},{"nct_id":"NCT05875974","title":"A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy","phase":"PHASE4","overall_status":"COMPLETED","enrollment_count":207,"lead_sponsor_name":"Jazz Pharmaceuticals","has_results":false},{"nct_id":"NCT04316286","title":"TElemedicine for NARcolepsy","phase":"NA","overall_status":"COMPLETED","enrollment_count":202,"lead_sponsor_name":"Azienda Usl di Bologna","has_results":false},{"nct_id":"NCT03030599","title":"A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy","phase":"PHASE3","overall_status":"COMPLETED","enrollment_count":201,"lead_sponsor_name":"Jazz Pharmaceuticals","has_results":true},{"nct_id":"NCT06586138","title":"Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Test","phase":"","overall_status":"RECRUITING","enrollment_count":200,"lead_sponsor_name":"Hospices Civils de Lyon","has_results":false},{"nct_id":"NCT06786377","title":"Genetic and Clinical Characterization of Type 1 and 2 Narcolepsy in Adult and Pediatric Black and North African Populations","phase":"","overall_status":"NOT_YET_RECRUITING","enrollment_count":200,"lead_sponsor_name":"Assistance Publique - Hôpitaux de Paris","has_results":false},{"nct_id":"NCT01792583","title":"The Nuvigil and Provigil Pregnancy Registry","phase":"","overall_status":"TERMINATED","enrollment_count":191,"lead_sponsor_name":"Cephalon, Inc.","has_results":false},{"nct_id":"NCT04072380","title":"A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy","phase":"PHASE2","overall_status":"COMPLETED","enrollment_count":190,"lead_sponsor_name":"Suven Life Sciences Limited","has_results":true},{"nct_id":"NCT04451668","title":"An Open Label Study of FT218 in Subjects With Narcolepsy","phase":"PHASE3","overall_status":"COMPLETED","enrollment_count":184,"lead_sponsor_name":"Avadel","has_results":false},{"nct_id":"NCT06457945","title":"Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions","phase":"NA","overall_status":"RECRUITING","enrollment_count":180,"lead_sponsor_name":"Hospices Civils de Lyon","has_results":false},{"nct_id":"NCT06470828","title":"A Study of TAK-861 for the Treatment of Narcolepsy Type 1","phase":"PHASE3","overall_status":"COMPLETED","enrollment_count":168,"lead_sponsor_name":"Takeda","has_results":false},{"nct_id":"NCT05869773","title":"A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy","phase":"PHASE4","overall_status":"COMPLETED","enrollment_count":160,"lead_sponsor_name":"Jazz Pharmaceuticals","has_results":false},{"nct_id":"NCT03173378","title":"Evaluation of Academic and Professional Trajectories of Narcoleptic Patients","phase":"","overall_status":"COMPLETED","enrollment_count":149,"lead_sponsor_name":"Hospices Civils de Lyon","has_results":false},{"nct_id":"NCT04561427","title":"Pediatric Cohort Study","phase":"","overall_status":"UNKNOWN","enrollment_count":120,"lead_sponsor_name":"Hospices Civils de Lyon","has_results":false},{"nct_id":"NCT05615584","title":"Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence","phase":"NA","overall_status":"RECRUITING","enrollment_count":117,"lead_sponsor_name":"University Hospital, Montpellier","has_results":false},{"nct_id":"NCT05687903","title":"A Study of TAK-861 in Participants With Narcolepsy Type 1","phase":"PHASE2","overall_status":"COMPLETED","enrollment_count":112,"lead_sponsor_name":"Takeda","has_results":true},{"nct_id":"NCT02611687","title":"Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period","phase":"PHASE3","overall_status":"COMPLETED","enrollment_count":110,"lead_sponsor_name":"Bioprojet","has_results":true},{"nct_id":"NCT04803786","title":"A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy","phase":"","overall_status":"COMPLETED","enrollment_count":110,"lead_sponsor_name":"Jazz Pharmaceuticals","has_results":false},{"nct_id":"NCT06505031","title":"A Study of TAK-861 in People With Narcolepsy Type 1","phase":"PHASE3","overall_status":"COMPLETED","enrollment_count":105,"lead_sponsor_name":"Takeda","has_results":false},{"nct_id":"NCT03376568","title":"Investigation of Clinical Feature and Brain Function in Narcoleptic Patients","phase":"","overall_status":"UNKNOWN","enrollment_count":100,"lead_sponsor_name":"Tang-Du Hospital","has_results":false},{"nct_id":"NCT07299097","title":"Epidemiology of Narcolepsy Type 1 and Type 2 in Spain","phase":"","overall_status":"RECRUITING","enrollment_count":100,"lead_sponsor_name":"Takeda","has_results":false},{"nct_id":"NCT04096560","title":"A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy","phase":"PHASE2","overall_status":"TERMINATED","enrollment_count":97,"lead_sponsor_name":"Takeda","has_results":true},{"nct_id":"NCT06555783","title":"A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2","phase":"PHASE2","overall_status":"COMPLETED","enrollment_count":93,"lead_sponsor_name":"Alkermes, Inc.","has_results":false},{"nct_id":"NCT06358950","title":"A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)","phase":"PHASE2","overall_status":"COMPLETED","enrollment_count":92,"lead_sponsor_name":"Alkermes, Inc.","has_results":false},{"nct_id":"NCT07096674","title":"A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia","phase":"PHASE2","overall_status":"RECRUITING","enrollment_count":90,"lead_sponsor_name":"Centessa Pharmaceuticals (UK) Limited","has_results":false},{"nct_id":"NCT05059223","title":"A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy","phase":"PHASE3","overall_status":"COMPLETED","enrollment_count":90,"lead_sponsor_name":"Axsome Therapeutics, Inc.","has_results":false},{"nct_id":"NCT05375890","title":"Clinical and Neurophysiological Characteristics of Narcolepsy","phase":"","overall_status":"COMPLETED","enrollment_count":89,"lead_sponsor_name":"I.M. Sechenov First Moscow State Medical University","has_results":false},{"nct_id":"NCT06952699","title":"A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)","phase":"PHASE2","overall_status":"RECRUITING","enrollment_count":88,"lead_sponsor_name":"Takeda","has_results":false},{"nct_id":"NCT07363720","title":"A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy","phase":"PHASE3","overall_status":"RECRUITING","enrollment_count":88,"lead_sponsor_name":"Takeda","has_results":false},{"nct_id":"NCT00001664","title":"Sleep Disorders of Patients With Diseases of the Nervous System","phase":"","overall_status":"COMPLETED","enrollment_count":83,"lead_sponsor_name":"National Institute of Neurological Disorders and Stroke (NINDS)","has_results":false},{"nct_id":"NCT04026958","title":"Clarithromycin Mechanisms in Hypersomnia Syndromes","phase":"PHASE2","overall_status":"COMPLETED","enrollment_count":83,"lead_sponsor_name":"Emory University","has_results":false},{"nct_id":"NCT06531876","title":"Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy","phase":"","overall_status":"COMPLETED","enrollment_count":78,"lead_sponsor_name":"Beacon Biosignals","has_results":false},{"nct_id":"NCT03754348","title":"Microglial Activation in Narcolepsy Type 1 and Kleine-Levin Syndrome: Positron Emission Tomography (PET) Study in [18F] DPA-714","phase":"NA","overall_status":"COMPLETED","enrollment_count":78,"lead_sponsor_name":"University Hospital, Montpellier","has_results":false},{"nct_id":"NCT05687916","title":"A Study of TAK-861 in Participants With Narcolepsy Type 2","phase":"PHASE2","overall_status":"COMPLETED","enrollment_count":71,"lead_sponsor_name":"Takeda","has_results":true},{"nct_id":"NCT06792708","title":"Observational Study of LUMRYZ in Narcolepsy","phase":"","overall_status":"COMPLETED","enrollment_count":71,"lead_sponsor_name":"Avadel","has_results":false},{"nct_id":"NCT04419792","title":"'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'","phase":"","overall_status":"SUSPENDED","enrollment_count":70,"lead_sponsor_name":"University of Dublin, Trinity College","has_results":false},{"nct_id":"NCT05113745","title":"A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)","phase":"PHASE3","overall_status":"COMPLETED","enrollment_count":68,"lead_sponsor_name":"Axsome Therapeutics, Inc.","has_results":false},{"nct_id":"NCT04923594","title":"Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy","phase":"PHASE2","overall_status":"COMPLETED","enrollment_count":67,"lead_sponsor_name":"NLS Pharmaceutics","has_results":false}],"total":50},"guidelines":[],"source":"Drug Landscape verified database"}