Narcolepsy
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-12-17FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application from Granules Pharmaceuticals Inc. for methylphenidate hydrochloride granules, adding a new dosage f…
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FDA approval · 2024-11-18FDA Approved: XYWAV — Supplemental Application (Jazz Pharmaceuticals, Inc.)
FDA approved a supplemental application for XYWAV (calcium, magnesium, potassium, and sodium oxybates) submitted by Jazz Pharmaceuticals.
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CLINICAL_TRIALS trial_result · 2024-10-30Clinical Trial Update: A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005) [Phase 1]
Phase 1 clinical trial assessing MK-6552 in combination with Modafinil in healthy men and individuals with narcolepsy; the study status is c…
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CLINICAL_TRIALS research · 2024-10-26Clinical Trial Update: Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Test
Investigating psychological, sociological, and professional factors associated with maintenance of wakefulness test performance in individua…
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FDA approval · 2024-10-25FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved Actavis Pharma, Inc.'s supplemental application for dextroamphetamine sulfate, confirming continued approval and updating label…
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FDA approval · 2024-10-16FDA Approved: LUMRYZ — Supplemental Application (Avadel CNS Pharmaceuticals, LLC)
The FDA approved a supplemental application for LUMRYZ (sodium oxybate) from Avadel CNS Pharmaceuticals, LLC.
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CLINICAL_TRIALS trial_result · 2024-10-04Clinical Trial Update: A Study to Collect Information of People With Narcolepsy in Spain
Takeda-sponsored observational study to collect information on people with narcolepsy in Spain has completed and posted results.
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CLINICAL_TRIALS trial_result · 2024-10-01Clinical Trial Update: A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003) [Phase 1]
This Phase 1 trial of MK-6552 (MK-6552-003) in sleep-deprived healthy participants and participants with narcolepsy has completed, with Merc…
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FDA approval · 2024-09-26FDA Approved: LUMRYZ — Supplemental Application (Avadel CNS Pharmaceuticals, LLC)
The FDA approved a supplemental application for LUMRYZ (sodium oxybate) submitted by Avadel CNS Pharmaceuticals, LLC.
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FDA approval · 2024-09-10FDA Approved: DEXMETHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)
FDA approved a supplemental application for a generic Dexmethylphenidate hydrochloride product from Nivagen Pharmaceuticals, expanding acces…
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FDA approval · 2024-08-30FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for a four-salt amphetamine combination (dextroamphetamine saccharate, amphetamine aspartate monohyd…
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FDA approval · 2024-08-30FDA Approved: METHYLPHENIDATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for methylphenidate submitted by Mylan Pharmaceuticals Inc. The approval covers the changes describe…
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FDA approval · 2024-08-30FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for Accord Healthcare's methylphenidate hydrochloride under an ANDA, adjusting the regulatory status…
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FDA approval · 2024-08-16FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride from Actavis Pharma, Inc., updating the product under an ANDA.
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CLINICAL_TRIALS research · 2024-08-15Clinical Trial Update: Child and Adolescent Registry for Participants With Narcolepsy
Jazz Pharmaceuticals is conducting a child and adolescent registry for participants with narcolepsy, and the study is currently recruiting.
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CLINICAL_TRIALS trial_result · 2024-06-26Clinical Trial Update: This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation. [Phase 1]
A completed Phase 1 study evaluating the safety and tolerability of multiple oral doses of an investigational drug in adults with narcolepsy…
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FDA approval · 2024-06-14FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Sandoz Inc)
FDA approved a Supplemental Application from Sandoz Inc for a generic combination product containing dextroamphetamine saccharate, amphetami…
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CLINICAL_TRIALS trial_result · 2024-06-12Clinical Trial Update: Narcolepsy Nightmare Study [NA]
A completed clinical trial update for the Narcolepsy Nightmare Study (NA) reported status as completed, with listed narcolepsy-related condi…
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FDA approval · 2024-06-03FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (KVK-TECH, INC.)
The FDA approved a supplemental application for methylphenidate hydrochloride from KVK-Tech, Inc., authorizing their generic product under a…
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FDA approval · 2024-05-30FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for a generic formulation containing four amphetamine salt components (dextroamphetamine saccharate,…
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CLINICAL_TRIALS research · 2024-05-29Clinical Trial Update: Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence [NA]
This clinical trial compares a spectrometry-based method (MRM) to the I-125 radioimmunoassay for quantifying Orexin-A in patients with hyper…
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FDA approval · 2024-05-22FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc., resulting in changes to the product …
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CLINICAL_TRIALS research · 2024-05-14Clinical Trial Update: SUNOSI® (Solriamfetol) Pregnancy Registry
A pregnancy registry for SUNOSI (solriamfetol) is recruiting to collect safety information on pregnant women exposed to the drug and outcome…
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CLINICAL_TRIALS withdrawal · 2024-05-14Clinical Trial Update: Feasibility Study of At-Home EEG Monitoring for Hypersomnia [NA]
A feasibility study on at-home EEG monitoring for hypersomnia and narcolepsy was withdrawn.
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FDA approval · 2024-05-13FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Cranbury Pharmaceuticals, LLC)
FDA granted a supplemental approval for methylphenidate hydrochloride from Cranbury Pharmaceuticals, LLC, updating the approved generic prod…