Narcolepsy
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CLINICAL_TRIALS trial_result · 2026-08-27Clinical Trial Results: A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy [Phase 4]
Phase 4 trial investigating the effect of XYWAV on sleepiness, polysomnography, and functional outcomes in idiopathic hypersomnia and narcol…
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EMA approval · 2026-08-06EMA Authorised: Wakix (pitolisant) — Bioprojet Pharma
Wakix (pitolisant) has been authorised by the EMA for narcolepsy.
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CLINICAL_TRIALS trial_result · 2026-06-30Clinical Trial Results: Narcolepsy Nightmare Study [NA]
Completed clinical trial results for Narcolepsy-related conditions; results posted.
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CLINICAL_TRIALS trial_result · 2026-04-24Clinical Trial Update: A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With Narcolepsy [Phase 4]
Phase 4 switch study evaluated blood pressure changes when narcolepsy patients moved from high-sodium oxybate (Xyrem) to Xywav, with results…
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FDA approval · 2026-04-23FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application from Prasco Laboratories for the four mixed amphetamine salt components: dextroamphetamine saccharat…
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FDA approval · 2026-04-21FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for methylphenidate hydrochloride from Amneal Pharmaceuticals of New York LLC.
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CLINICAL_TRIALS other · 2026-04-20Clinical Trial Update: A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy [Phase 3]
Clinical trial update on a Phase 3 study evaluating Samelisant for narcolepsy; status is not yet recruiting.
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CLINICAL_TRIALS trial_result · 2026-04-14Clinical Trial Update: Study of MK-6552 in Participants With Narcolepsy Type 1 (MK-6552-004) [Phase 1]
A Phase 1 study of MK-6552 in participants with narcolepsy has been terminated, with results posted on 2026-04-14.
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EMA approval · 2026-03-27EMA Authorised: Wakix (pitolisant) — Bioprojet Pharma
EMA authorised Wakix (pitolisant) for narcolepsy with Bioprojet Pharma as the marketing authorisation holder; it is designated an orphan med…
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FDA approval · 2026-03-25FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals Inc.'s supplemental application for methylphenidate hydrochloride granules (generic methylphenidate hy…
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CLINICAL_TRIALS trial_result · 2026-03-25Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy [Phase 2]
A Phase 2 clinical trial to evaluate the efficacy and safety of the investigational drug E2086 in adults with narcolepsy; the study status i…
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CLINICAL_TRIALS research · 2026-03-24Clinical Trial Update: Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy
This clinical trial investigates proteomics and metabolomics of body fluids in patients with Narcolepsy and is currently recruiting. Sponsor…
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CLINICAL_TRIALS research · 2026-03-10Clinical Trial Update: Decreasing Nightmares in Adults With Narcolepsy [NA]
A clinical trial to evaluate approaches to reduce nightmares in adults with narcolepsy, including Narcolepsy Type 1.
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FDA approval · 2026-02-13FDA Approved: WAKIX — Supplemental Application (Harmony Biosciences, LLC)
FDA approved a supplemental application for Wakix (pitolisant hydrochloride) from Harmony Biosciences, LLC. The action typically updates lab…
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CLINICAL_TRIALS research · 2026-02-13Clinical Trial Update: Observational Study of LUMRYZ in Narcolepsy
This clinical trial update describes a completed observational study evaluating LUMRYZ for narcolepsy.
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FDA approval · 2026-01-15FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved Amneal Pharmaceuticals of New York LLC's supplemental application for methylphenidate hydrochloride.
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FDA approval · 2026-01-09FDA Approved: METHYLPHENIDATE — Supplemental Application (KVK-Tech, Inc.)
FDA granted supplemental approval for a methylphenidate hydrochloride product developed by KVK-Tech, Inc. This is a routine supplemental app…
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CLINICAL_TRIALS research · 2025-12-19Clinical Trial Update: Metabolism Characteristics in the Children With Narcolepsy [NA]
This entry reports on a completed clinical trial studying metabolism characteristics in children with narcolepsy.
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CLINICAL_TRIALS trial_result · 2025-12-12Clinical Trial Update: A Study of HBS-201 (Pitolisant Delayed-release) [Phase 1]
A Phase 1 study evaluating HBS-201 (delayed-release pitolisant) for narcolepsy has completed.
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CLINICAL_TRIALS trial_result · 2025-11-13Clinical Trial Update: A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE) [Phase 3]
A Phase 3 study (ENCORE) evaluating the long-term efficacy and safety of AXS-12 (reboxetine) in narcolepsy with cataplexy and excessive dayt…
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FDA approval · 2025-10-07FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental ANDA for methylphenidate hydrochloride by SpecGx LLC. The action formalizes a change under the generic drug appr…
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CLINICAL_TRIALS trial_result · 2025-10-02Clinical Trial Update: An Open Label Study of FT218 in Subjects With Narcolepsy [Phase 3]
This open-label Phase 3 trial of FT218 in narcolepsy with cataplexy has completed, providing results on safety and efficacy in this populati…
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FDA approval · 2025-09-26FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma LLC)
FDA granted supplemental approval for a generic Amphetamine Sulfate product by Epic Pharma LLC.
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FDA approval · 2025-09-23FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application from Prasco Laboratories for four amphetamine salt formulations (dextroamphetamine saccharate, a…
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FDA approval · 2025-09-23FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA granted a supplemental approval for Dexedrine Spansule (dextroamphetamine sulfate) to Amneal Pharmaceuticals LLC.