ReviewDrugs2016
Pitolisant: First Global Approval.
Review in Drugs, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
38 citing papers in PubMed.
- Trial
- Design, synthesis and pharmacological evaluation of novel 2-aryloxazole-based HMolecular diversity · 2026Article
- Synthesis and Biological Activity of Novel Aromatic Aminopropyl Lactams in Two Cancer Cell Models.ChemMedChem · 2026Article
- Advances in Non-CPAP Management of Obstructive Sleep Apnea: Spotlight on Pharmacological Therapies.Journal of personalized medicine · 2026Review
- Recent Advances and Emerging Pharmacotherapeutic Approaches for Central Hypersomnolence Disorders.Clinical pharmacology : advances and applications · 2026Review
- Modular synthesis of CFNature communications · 2025Article
- Development and validation of a method for quantitative determination of the genotoxic impurity diethyl sulfate in pitolisant hydrochlorideRSC advances · 2025Article
- Article
- Histamine HBiomolecules · 2024Review
- Evaluation of pitolisant, sodium oxybate, solriamfetol, and modafinil for the management of narcolepsy: a retrospective analysis of the FAERS database.Frontiers in pharmacology · 2024Article
- Pharmacological interventions for the treatment of obstructive sleep apnea syndrome.Frontiers in medicine · 2024Article
- Exploring the Literature on Narcolepsy: Insights into the Sleep Disorder That Strikes during the Day.NeuroSci · 2023Review
- Discovery of a Tritiated Radioligand with High Affinity and Selectivity for the Histamine HACS medicinal chemistry letters · 2023Article
- Sleep disturbances in autism spectrum disorder: Animal models, neural mechanisms, and therapeutics.Neurobiology of sleep and circadian rhythms · 2023Review
- Chemical Probes for Histamine Receptor Subtypes.Current topics in behavioral neurosciences · 2022Article
- Pitolisant, a wake-promoting agent devoid of psychostimulant properties: Preclinical comparison with amphetamine, modafinil, and solriamfetol.Pharmacology research & perspectives · 2021Article
- Discovery of Potential, Dual-Active Histamine HMolecules (Basel, Switzerland) · 2021Article
- Analysis of Missense Variants in the Human Histamine Receptor Family Reveals Increased Constitutive Activity of E410International journal of molecular sciences · 2021Article
- Pitolisant in an Adolescent with Prader-Willi Syndrome.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021Article
- Organic Cation Transporters in Brain Histamine Clearance: Physiological and Psychiatric Implications.Handbook of experimental pharmacology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pitolisant (Wakix™) is an inverse agonist of the histamine H3 receptor that is being developed by Bioproject. Oral pitolisant is approved in the EU for the treatment of narcolepsy with or without cataplexy in adults. Pitolisant has received a Temporary Authorization of Use in France for this indication in case of treatment failure, intolerance or contraindication to currently available treatment. Pitolisant has orphan drug designation in the EU and the USA. In the pivotal HARMONY I trial, pitolisant significantly decreased excessive daytime sleepiness versus placebo in adults with narcolepsy with or without cataplexy (primary endpoint). Pitolisant also significantly decreased cataplexy rate versus placebo in these patients. This article summarizes the milestones in the development of pitolisant leading to this first approval for narcolepsy.
Indexed as
Identifiers
27438291What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.