Friday, July 10, 2026

Drug profile · INN

pitolisant hydrochloride

pitolisant hydrochloride (WAKIX) is a histamine h3 receptor inverse agonist. Associated with Harmony Biosciences Holdings. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 3
Pipeline programs 4
News articles 0
Drug details — pitolisant hydrochloride
US status
approved
Class
Route
ORAL
Patents
3
Programs
4
Data quality
0.89

Quick answer

pitolisant hydrochloride (WAKIX) is a histamine h3 receptor inverse agonist. Associated with Harmony Biosciences Holdings. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN pitolisant hydrochloride
Brand WAKIX
Mechanism Histamine H3 receptor inverse agonist
Target Histamine H3 receptor
Route ORAL
Formulation TABLET

Mechanism of action

Histamine H3 receptor inverse agonist

Primary target: Histamine H3 receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. HBS-101-CL-312 Phase 3 · Harmony Biosciences Holdings · Prader-Willi syndrome
  2. P11-06 Phase 3 · Bioprojet · Narcolepsy
  3. P24-03 Phase 1 · Bioprojet · Narcolepsy, Narcolepsy with cataplexy
  4. P25-01 Phase 1 · Bioprojet · narcolepsy with cataplexy, Narcolepsy

Related & competitor drugs

  1. pitolisant Nervous system (N07)
  1. US 2024327366

    POLYMORPH FORM OF PITOLISANT HYDROCHLORIDE

    Expires Wed Sep 28 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 7625575

    Dermatological composition

    Expires Mon Nov 26 2029 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 7582307

    Dermatological composition

    Expires Mon Aug 27 2029 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is pitolisant hydrochloride?

pitolisant hydrochloride (WAKIX) is a histamine h3 receptor inverse agonist. Associated with Harmony Biosciences Holdings. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for pitolisant hydrochloride?

WAKIX is a marketed brand name for pitolisant hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of pitolisant hydrochloride?

pitolisant hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.