Pitolisant

Pitolisant
Clinical data
Pronunciation/pɪˈtɒlɪsənt/
pi-TOL-i-sənt
Trade namesWakix, Ozawade
Other namesTiprolisant; Ciproxidine; BF2.649
AHFS/Drugs.comMonograph
MedlinePlusa619055
License data
Routes of
administration		By mouth
Drug classHistamine H3 receptor inverse agonist
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life10–12 hours
Identifiers
IUPAC name
  • 1-[3-[3-(4-chlorophenyl)propoxy]propyl]piperidine
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC17H26ClNO
Molar mass295.85 g·mol−1
3D model (JSmol)
SMILES
  • C1CCN(CC1)CCCOCCCC2=CC=C(C=C2)Cl
InChI
  • InChI=1S/C17H26ClNO/c18-17-9-7-16(8-10-17)6-4-14-20-15-5-13-19-11-2-1-3-12-19/h7-10H,1-6,11-15H2 Y
  • Key:NNACHAUCXXVJSP-UHFFFAOYSA-N Y
 NY (what is this?)  (verify)

Pitolisant, sold under the brand name Wakix among others, is a medication used for the treatment of excessive daytime sleepiness in adults with narcolepsy.[3] It is an inverse agonist of the histamine H3 receptor.[3] It represents the first commercially available medication in its class, so that the U.S. Food and Drug Administration (FDA) declares it a first-in-class medication.[7][8] Pitolisant enhances the activity of histaminergic neurons in the brain that function to improve a person's wakefulness.[9] It was approved by the European Medicines Agency (EMA) in March 2016 for narcolepsy with or without cataplexy, and for excessive daytime sleepiness by the FDA in August 2019.[10] The most common side effects include difficulty sleeping, nausea, and feeling worried.[11]

  1. ^ "Summary Basis of Decision (SBD) for Wakix". Health Canada. 23 October 2014. Archived from the original on 22 December 2022. Retrieved 29 May 2022.
  2. ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Archived from the original on 25 March 2024. Retrieved 25 March 2024.
  3. ^ a b c "Wakix- pitolisant hydrochloride tablet, film coated". DailyMed. 6 November 2019. Archived from the original on 11 August 2020. Retrieved 18 August 2020.
  4. ^ Cite error: The named reference Wakix EPAR was invoked but never defined (see the help page).
  5. ^ Cite error: The named reference Ozawade EPAR was invoked but never defined (see the help page).
  6. ^ "Ozawade Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
  7. ^ "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration (FDA). 31 December 2019. Archived from the original on 16 September 2020. Retrieved 15 September 2020.
  8. ^ "FDA Approves Pitolisant for Daytime Sleepiness in Patients with Narcolepsy". Pharmacy Times. 16 August 2019. Archived from the original on 12 August 2020. Retrieved 18 August 2020.
  9. ^ Syed YY (September 2016). "Pitolisant: First Global Approval". Drugs. 76 (13): 1313–1318. doi:10.1007/s40265-016-0620-1. PMID 27438291. S2CID 42684839.
  10. ^ Giliberto S, Shishodia R, Nastruz M, Brar C, Bulathsinhala S, Terry J, Pemminati S, Shenoy SK (March 2024). "A Comprehensive Review of Novel FDA-Approved Psychiatric Medications (2018-2022)". Cureus. 16 (3): e56561. doi:10.7759/cureus.56561. PMC 11028406. PMID 38646400.
  11. ^ Cite error: The named reference FDA snapshot was invoked but never defined (see the help page).
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