Wakix(pitolisant)
Ozawade, Wakix (pitolisant) is a small molecule pharmaceutical. Pitolisant was first approved as Wakix on 2016-03-31. It has been approved in Europe to treat narcolepsy and obstructive sleep apnea. The pharmaceutical is active against histamine H3 receptor. In addition, it is known to target histamine H4 receptor, histamine H1 receptor, and histamine H2 receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Wakix
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pitolisant hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| WAKIX | Harmony Biosciences Holdings | N-211150 RX | 2019-08-14 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| wakix | New Drug Application | 2025-12-01 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PITOLISANT HYDROCHLORIDE, WAKIX, HARMONY | |||
| 2027-10-13 | ODE-331 | ||
| 2026-08-14 | ODE-255 | ||
| 2024-08-14 | NCE | ||
HCPCS
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Clinical
Clinical Trials
35 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | — | — | — | 1 | — | 1 |
| Psychomotor agitation | D011595 | — | — | — | — | — | 1 | — | 1 |
| Syndrome | D013577 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disorders of excessive somnolence | D006970 | — | G47.1 | — | 1 | 3 | — | 1 | 5 |
| Prader-willi syndrome | D011218 | Orphanet_739 | Q87.11 | — | 1 | 2 | — | — | 3 |
| Sleepiness | D000077260 | — | R40.0 | — | 1 | 1 | — | 1 | 3 |
| Idiopathic hypersomnia | D020177 | — | G47.11 | — | — | 2 | — | — | 2 |
| Problem behavior | D000066553 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myotonic dystrophy | D009223 | — | G71.11 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Narcolepsy | D009290 | EFO_0000614 | G47.4 | 1 | — | — | — | 2 | 3 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cataplexy | D002385 | — | — | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pitolisant |
| INN | pitolisant |
| Description | Pitolisant is an organochlorine compound. |
| Classification | Small molecule |
| Drug class | histamine H3 receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Clc1ccc(CCCOCCCN2CCCCC2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 362665-56-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL462605 |
| ChEBI ID | — |
| PubChem CID | 9948102 |
| DrugBank | DB11642 |
| UNII ID | 4BC83L4PIY (ChemIDplus, GSRS) |
Target
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Safety
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Adverse Events
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845 adverse events reported
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