Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Pitolisant - Bioprojet

Next Previous
Drug Profile

Pitolisant - Bioprojet

Alternative Names: BF-2.649; BF-2649; HBS-201; HBS-301; Ozawade; Pitolisant delayed-release (DR); Pitolisant High Dose; Pitolisant hydrochloride; Pitolisant-HD; Tiprolisant; Wakix

Latest Information Update: 22 Sep 2026

Price :
$50 *
Note:
  • Adis is an information provider. We do not sell or distribute actual drugs.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase.
  • A link to download a PDF version of the drug profile will be included in your email receipt.

At a glance

  • Originator Bioprojet; INSERM
  • Developer Aculys Pharma; AOP Orphan Pharmaceuticals AG; Bioprojet; Citrine Medicine; Ferox Therapeutics; Harmony Biosciences; Paladin Labs
  • Class Antiepileptic drugs; Antihyperglycaemics; Behavioural disorder therapies; Chlorobenzenes; Ethers; Nootropics; Obesity therapies; Piperidines; Sleep disorder therapies; Small molecules
  • Mechanism of Action Histamine H3 receptor antagonists; Histamine H3 receptor inverse agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Idiopathic hypersomnia; Narcolepsy; Prader-Willi syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Hypersomnia; Narcolepsy
  • Registered Cataplexy
  • Phase III Idiopathic hypersomnia; Prader-Willi syndrome
  • Phase II Attention-deficit hyperactivity disorder; Autism spectrum disorder; Myotonic dystrophy
  • Discontinued Epilepsy; Obesity; Type 1 diabetes mellitus

Most Recent Events

  • 16 Sep 2026 Registered for Hypersomnia in Japan (PO)
  • 16 Sep 2026 Registered for Narcolepsy in Japan (PO)
  • 16 Sep 2026 Pitolisant - Bioprojet receives Orphan Drug status for Narcolepsy in Japan

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top