Narcolepsy
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-09-23FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for methylphenidate from Sandoz Inc, updating the product's approval under the existing NDA.
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FDA approval · 2025-09-23FDA Approved: METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE — Supplemental Application (KVK-Tech, Inc.)
The FDA-approved supplemental application approves a generic extended-release methylphenidate hydrochloride product from KVK-Tech, Inc. for …
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FDA approval · 2025-09-10FDA Approved: SODIUM OXYBATE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved the original ANDA for sodium oxybate by Amneal Pharmaceuticals LLC, establishing a generic version of the drug. The approved in…
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EMA approval · 2025-09-05EMA Authorised: Sunosi (solriamfetol hydrochloride) — Atnahs Pharma Netherlands B.V.
Sunosi (solriamfetol hydrochloride) has been authorised in the European Union for the treatment of narcolepsy and obstructive sleep apnea; d…
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CLINICAL_TRIALS research · 2025-08-05Clinical Trial Update: WAKIX® (Pitolisant) Pregnancy Registry
A pregnancy registry for WAKIX (pitolisant) to monitor pregnancy outcomes in people with narcolepsy; recruitment is currently ongoing.
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CLINICAL_TRIALS trial_result · 2025-07-17Clinical Trial Update: A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy [Phase 4]
A Phase 4 study evaluating XYWAV for sleepiness, polysomnography metrics, and functional outcomes in idiopathic hypersomnia and narcolepsy h…
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FDA approval · 2025-07-16FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Wilshire Pharmaceuticals, Inc.)
The FDA approved a supplemental application for dextroamphetamine sulfate by Wilshire Pharmaceuticals, Inc., enabling continued marketing of…
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CLINICAL_TRIALS research · 2025-06-29Clinical Trial Update: Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments
A Mayo Clinic-sponsored clinical trial is examining cardiovascular and cognitive effects of central disorders of hypersomnolence (narcolepsy…
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FDA approval · 2025-06-03FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for methylphenidate hydrochloride, a generic stimulant used to treat attent…
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FDA approval · 2025-05-23FDA Approved: WAKIX — Supplemental Application (Harmony Biosciences, LLC)
FDA approved a supplemental application for WAKIX (pitolisant hydrochloride) from Harmony Biosciences, LLC.
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EMA approval · 2025-05-12EMA Authorised: Xyrem (sodium oxybate) — UCB Pharma Ltd
The European Medicines Agency authorised Xyrem (sodium oxybate) for cataplexy and narcolepsy. The marketing authorization holder is UCB Phar…
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FDA approval · 2025-04-01FDA Approved: AMPHETAMINE EXTENDED-RELEASE — Supplemental Application (Neos Therapeutics, LP)
The FDA approved a supplemental application for AMPHETAMINE EXTENDED-RELEASE from Neos Therapeutics, LP, updating the product through a supp…
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CLINICAL_TRIALS trial_result · 2025-03-19Clinical Trial Update: A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy [Phase 3]
Phase 3 trial of AXS-12 (Reboxetine) in narcolepsy with cataplexy has completed.
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FDA approval · 2025-03-18FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for methylphenidate hydrochloride (ANDA204115), a generic ADHD medication.
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FDA approval · 2025-03-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for a generic combination of dextroamphetamine and amphetamine salts developed by Camber Pharmaceuti…
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FDA approval · 2025-03-10FDA Approved: LUMRYZ — Supplemental Application (Avadel CNS Pharmaceuticals, LLC)
FDA approved a supplemental NDA for LUMRYZ (sodium oxybate) from Avadel CNS Pharmaceuticals, LLC.
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FDA approval · 2025-03-05FDA Approved: MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for Mixed Salts of a Single Entity Amphetamine Product XR, a generic extended-release amphetamine pr…
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CLINICAL_TRIALS trial_result · 2025-02-28Clinical Trial Update: A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy [Phase 2]
Phase 2 study evaluating the safety and efficacy of TS-091 in patients with narcolepsy has completed.
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CLINICAL_TRIALS research · 2025-02-14Clinical Trial Update: The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders [NA]
Clinical trial evaluating light, electrical, and magnetic neuroregulation interventions for sleep-wake disorders, currently recruiting at th…
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CLINICAL_TRIALS research · 2025-02-13Clinical Trial Update: Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale
This trial update describes the development and validation of a pediatric patient-reported outcomes scale for narcolepsy. The study has comp…
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FDA approval · 2025-01-29FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' supplemental application for methylphenidate hydrochloride, a generic stimulant used to treat attention-de…
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CLINICAL_TRIALS research · 2025-01-22Clinical Trial Update: Genetic and Clinical Characterization of Type 1 and 2 Narcolepsy in Adult and Pediatric Black and North African Populations
This clinical trial aims to genetically and clinically characterize Type 1 and Type 2 narcolepsy in both adults and children from Black and …
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CLINICAL_TRIALS trial_result · 2025-01-13Clinical Trial Update: A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy [Phase 2]
Phase 2 study evaluating the safety and efficacy of Samelisant (SUVN-G3031) in narcolepsy patients with and without cataplexy has completed …
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FDA approval · 2024-12-18FDA Approved: LUMRYZ — Supplemental Application (Avadel CNS Pharmaceuticals, LLC)
FDA approved a supplemental application for Lumryz (sodium oxybate) from Avadel CNS Pharmaceuticals, LLC.
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FDA approval · 2024-12-17FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals, Inc.)
FDA approved a Teva supplemental application for a generic combination of four amphetamine salts (dextroamphetamine saccharate, amphetamine …