Wednesday, July 8, 2026

Drug profile · INN

pitolisant

pitolisant (OZAWADE) is a histamine h3 receptor inverse agonist. Route of administration: film coated. Current US regulatory status: approved.

FDA: approved EMA: approved Nervous system (N07) N07XX11
US status approved
Patents linked 3
Pipeline programs 11
News articles 0
Drug details — pitolisant
US status
approved
Class
Nervous system (N07)
Route
FILM COATED
Patents
3
Programs
11
Data quality
0.84

Quick answer

pitolisant (OZAWADE) is a histamine h3 receptor inverse agonist. Route of administration: film coated. Current US regulatory status: approved.

Key facts

INN pitolisant
Brand OZAWADE
Mechanism Histamine H3 receptor inverse agonist
Target Histamine H3 receptor
Therapeutic class Nervous system (N07)
Route FILM COATED
Formulation TABLET
ATC code N07XX11

Mechanism of action

Histamine H3 receptor inverse agonist

Primary target: Histamine H3 receptor

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. HBS-101-CL-312 Phase 3 · Harmony Biosciences Holdings · Prader-Willi syndrome
  2. Open-label pitolisant Phase 3 · Harmony Biosciences Holdings · Idiopathic Hypersomnia
  3. P11-06 Phase 3 · Bioprojet · Narcolepsy
  4. Pitolisant Phase 3 · Harmony Biosciences Holdings · Idiopathic Hypersomnia
  5. Pitolisant Phase 3 · Harmony Biosciences Holdings · Prader-Willi Syndrome
  6. Pitolisant tablet Phase 3 · Harmony Biosciences Holdings · Prader-Willi Syndrome
  7. Pitolisant Oral Tablet Phase 2 · Harmony Biosciences Holdings · Myotonic Dystrophy 1
  8. Pitolisant oral tablets Phase 2 · Harmony Biosciences Holdings · Prader-Willi Syndrome

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)

Related patents

  1. EP 4681704

    NEUE FORMULIERUNGEN VON PITOLISANT

    Expires Tue Jan 16 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 2025120959

    NEW FORMULATIONS OF PITOLISANT AND METHODS OF USE

    Expires Wed Apr 12 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 2024327366

    POLYMORPH FORM OF PITOLISANT HYDROCHLORIDE

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

    granted

Frequently asked questions

What is pitolisant?

pitolisant (OZAWADE) is a histamine h3 receptor inverse agonist. Route of administration: film coated. Current US regulatory status: approved.

What is the brand name for pitolisant?

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

What is the US approval status of pitolisant?

pitolisant 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.