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Wakix (PITOLISANT)
Wakix works by blocking histamine H3 receptors in the brain, allowing more histamine to be available to regulate sleep-wake cycles.
Wakix (Pitolisant) is a small molecule modality developed by Harmony, targeting the histamine H3 receptor. It was FDA-approved in 2019 for the treatment of narcolepsy. Wakix is a patented medication with no generic manufacturers available. Key safety considerations include its potential to increase heart rate and blood pressure. As a histamine H3 receptor antagonist, Wakix works by increasing the levels of histamine in the brain, which helps regulate sleep-wake cycles.
At a glance
| Generic name | PITOLISANT |
|---|---|
| Sponsor | Harmony |
| Target | Histamine H3 receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2019 |
| Annual revenue | 700 |
Mechanism of action
The mechanism of action of pitolisant in excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy is unclear. However, its efficacy could be mediated through its activity as an antagonist/inverse agonist at histamine-3 (H3) receptors.
Approved indications
- Narcolepsy
Common side effects
- Insomnia
- Nausea
- Anxiety
- Headache
- Upper respiratory tract infection
- Musculoskeletal pain
- Abdominal pain
- Heart rate increased
- Hallucinations
- Irritability
- Sleep disturbance
- Decreased appetite
Key clinical trials
- A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) (PHASE3)
- A Study of Pitolisant in Participants With Prader-Willi Syndrome (PHASE3)
- A Study of Pitolisant in Patients With Prader-Willi Syndrome (PHASE3)
- A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension (PHASE2)
- A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia (PHASE3)
- A Study of HBS-201 (Pitolisant Delayed-release) (PHASE1)
- Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents (PHASE2)
- WAKIX® (Pitolisant) Pregnancy Registry
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |