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 H1 receptor, histamine H2 receptor, and histamine H4 receptor.
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FDA Novel Drug Approvals 2019
Commercial
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 | 2021-03-12 |
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 | ||
| 2023-10-13 | I-846 | ||
HCPCS
No data
Clinical
Clinical Trials
31 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 |
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 | — | 3 | 9 | — | — | 12 | |
| Narcolepsy | D009290 | EFO_0000614 | G47.4 | — | — | 7 | — | 2 | 9 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | 1 | 4 | — | — | 5 |
| Cataplexy | D002385 | — | — | 3 | — | — | 3 | ||
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | 2 | — | — | 3 |
| Idiopathic hypersomnia | D020177 | G47.11 | — | — | 2 | — | — | 2 | |
| Sleep wake disorders | D012893 | G47 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prader-willi syndrome | D011218 | Orphanet_739 | Q87.11 | — | 1 | — | — | — | 1 |
| Nervous system alcohol-induced disorders | D020268 | — | 1 | — | — | — | 1 | ||
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | — | — | — | 1 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 2 | — | — | — | — | 2 | ||
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | — | 1 |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | 1 | — | — | — | — | 1 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 1 | — | — | — | — | 1 |
| Alcohol drinking | D000428 | EFO_0004329 | 1 | — | — | — | — | 1 | |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| 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 | 2197878 |
| ChEMBL ID | CHEMBL462605 |
| ChEBI ID | — |
| PubChem CID | 9948102 |
| DrugBank | DB11642 |
| UNII ID | 4BC83L4PIY (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 429 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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27,099 adverse events reported
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