X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
0
Canada
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
0
Details:
Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Product Name: Wakix
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 03, 2024
Details:
Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Product Name: Wakix
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 20, 2024
Details:
Wakix (pitolisant HCl) is a 5-HT3 receptor Inhibitor Small molecule drug candidate, which is currently being evaluated for the treatment of adult patients with myotonic dystrophy type 1.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Product Name: Wakix
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2023
Details:
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for idiopathic hypersomnia.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2023
Details:
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for idiopathic hypersomnia.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2023
Details:
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for Prader-Willi Syndrome.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Product Name: Wakix
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2023
Details:
Wakix (pitolisant) is a selective histamine 3 (H3) receptor antagonist/inverse agonist, which was granted orphan drug designation for the treatment of narcolepsy by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 04, 2023
Details:
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse, which is used for Prader-Willi Syndrome.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Product Name: Wakix
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2023
Details:
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2023
Details:
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse, which is used for Prader-Willi Syndrome.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Product Name: Wakix
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2023
Details:
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2023
Details:
Wakix (pitolisant) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2023
Details:
BF2.649 (pitolisant hydrochloride) is an antagonist/inverse agonist that binds to the histamine H3 receptor, an autoreceptor located in the presynaptic region of the histamine-containing neurons in the human brain that plays a critical role in regulating sleep and wake rhythm.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: BF2.649
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2023
Details:
Pitolisant is marketed as WAKIX in U.S. and is FDA approved to treat excessive daytime sleepiness or cataplexy in adults with narcolepsy. Pitolisant is not approved for use in patients with PWS and is currently being evaluated as an agent in this patient population.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Product Name: Wakix
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2022
Details:
WAKIX (pitolisant), a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy and has been commercially available in the U.S. since Q4 2019.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2022
Details:
WAKIX® (pitolisant) Tablets, a first-in-class medication, is a selective histamine 3 (H3) receptor antagonist/inverse agonist, is approved by U.S.FDA for treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
Ozawade (pitolisant hydrochloride) enhances the activity of histaminergic neurons, promotes wakefulness by blocking H3 autoreceptors and increases the levels of histamine transmitters at the synapse, and is used for Prader-Willi Syndrome.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Ozawade
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2021
Details:
Wakix (pitolisant hydrochloride), a selective histamine H3-receptor antagonist/inverse agonist, is approved by the EMA and the FDA to treat adults suffering from narcolepsy, a serious, chronic disorder characterized by excessive daytime sleepiness, with or without cataplexy.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2021
Details:
New analysis evaluating number needed to treat (NNT) and effect sizes for treatment with WAKIX® (pitolisant) that demonstrates the magnitude of its clinical effectiveness for excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2021
Details:
The findings reported in this publication highlight that WAKIX® (pitolisant) was efficacious for reducing the symptom burden for both EDS and cataplexy, even in patients with a high burden of the two most common symptoms in narcolepsy.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2021
Details:
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of pitolisant for the treatment of excessive daytime sleepiness (EDS) and other key symptoms in patients with Prader-Willi Syndrome (PWS).
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Product Name: Wakix
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2020
Details:
The partnership provides Citrine with exclusive rights to develop, register, market, and manufacture Wakix® (pitolisant) in China for the treatment of narcolepsy and obstructive sleep apnea.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Citrine Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 28, 2020
Details:
WAKIX is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult patients with narcolepsy .
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2020
Details:
The company expects to initiate a Phase 3 trial for EDS and cataplexy in pediatric patients in the 2H21. It also plans to start Phase 2 trials for EDS and other key symptoms in patients with Prader-Willi Syndrome and in adult patients with myotonic dystrophy in the 1H21.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Product Name: Wakix
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 27, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
