pitolisant (Wakix) Report issue

Small molecule Orphan Drug FDA Approved FDA Fast Track FDA Priority Review FDA
AACT ChEMBL Drug Central MeSH PubChem

Active Ingredient History

NOW
  • Now
Pitolisant (INN) or tiprolisant (USAN) is a histamine receptor inverse agonist/antagonist selective for the H3 subtype. It has stimulant and nootropic effects in animal studies and may have several medical applications, having been researched for the treatment of narcolepsy, for which it has been granted orphan drug status in the EU and US. It is currently in clinical trials for schizophrenia and Parkinson’s disease. Pitolisant hydrochloride was approved by European Medicine Agency (EMA) on Mar 31, 2016. It was developed and marketed as Wakix® by Bioprojet in EU. Wakix® is available as the tablet for oral use, containing 4.5 mg and 18 mg of Pitolisant hydrochloride. The initial dose of 9 mg (two 4.5 mg, tablets) per day, and it should be used at the lowest effective dose, depending on individual patient response and tolerance, according to an up-titration scheme, without exceeding the dose of 36 mg/day. Pitolisant was the first clinically used H3 receptor inverse agonist.   NCATS

Chemistry

More Chemistry

Pharmacology

  • Mechanism of Action:
  • Multi-specific: Missing data
  • Black Box: No
  • Availability: Prescription Only
  • Delivery Methods: Oral
  • Pro Drug: No

Drug Pricing (per unit)

United States

$70.0613 - $140.3003
More Pricing Detail

Note: This drug pricing data is preliminary, incomplete, and may contain errors.

Alternative names

1-(3-(3-(4-chlorophenyl)propoxy)propyl)piperidine | b.249 | bf 2.649 | bf2.649 | modiodal | pitolisant | pitolisant hydrochloride | tiprolisant | tiprolisant hydrochloride | wakix

Organizations (15)

Research & Development (15)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Marketing (2)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Indications (21)

Approved Indications (2)


 

Disorders of Excessive Somnolence

Narcolepsy

Experimental Indications - Clinical Trial Phases 1-4 (21)


 

Alcohol Drinking (Phase 1)

Alcohol-Induced Disorders, Nervous System (Phase 2)

Alcoholism (Phase 1)

Autism Spectrum Disorder (Phase 2)

Cataplexy (Phase 3)

Diabetes Mellitus, Type 1 (Phase 1)

Disorders of Excessive Somnolence (Phase 3)

Healthy Volunteers (Phase 1)

Hypoglycemia (Phase 1)

Idiopathic Hypersomnia (Phase 3)

Kidney Failure, Chronic (Phase 1)

Myotonic Dystrophy (Phase 2)

Narcolepsy (Phase 3)

Parkinson Disease (Phase 3)

Prader-Willi Syndrome (Phase 2)

Restless Legs Syndrome (Phase 4)

Schizophrenia (Phase 2)

Sleep Apnea, Obstructive (Phase 3)

Sleep Disorders, Intrinsic (Phase 3)

Sleep Wake Disorders (Phase 3)

Substance-Related Disorders (Phase 1)

Overview

  • Highest Phase: Phase 4
  • # of Trials: 31
  • # of Trial Organizations: 15

Trials by Phase

Trial Phase Start Date Organizations Indications

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