Levoketoconazole
Recorlev (levoketoconazole) is a small molecule pharmaceutical. Levoketoconazole was first approved as Recorlev on 2021-12-30. It is used to treat acanthamoeba keratitis, blastomycosis, chronic mucocutaneous candidiasis, coccidioidomycosis, and cutaneous candidiasis amongst others in the USA.
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Commercial
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Recorlev
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New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Levoketoconazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RECORLEV | Strongbridge Biopharma | N-214133 RX | 2021-12-30 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nizoral | New Drug Application | 2024-12-30 |
| nizoral eczema relief cream | C200263 | 2024-12-12 |
| nizoral psoriasis | C200263 | 2024-09-18 |
| nizoral psoriasis relief | C200263 | 2024-01-05 |
| nizoral scalp itch relief | C200263 | 2024-01-05 |
| recorlev | New Drug Application | 2024-12-02 |
Indications
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LEVOKETOCONAZOLE, RECORLEV, STRONGBRIDGE | |||
| 2028-12-30 | ODE-385 | ||
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Clinical
Clinical Trials
209 clinical trials
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Indications Phases 4
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tinea | D014005 | EFO_0007510 | B35.9 | 1 | — | — | — | — | 1 |
| Tinea versicolor | D014010 | EFO_0007439 | B36.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Levoketoconazole |
| INN | levoketoconazole |
| Description | (2S,4R)-ketoconazole is a cis-1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine which dioxolane moiety has (2S,4R)-configuration. It is an enantiomer of a (2R,4S)-ketoconazole. |
| Classification | Small molecule |
| Drug class | systemic antifungals (miconazole type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)N1CCN(c2ccc(OC[C@@H]3CO[C@@](Cn4ccnc4)(c4ccc(Cl)cc4Cl)O3)cc2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 142128-57-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL295698 |
| ChEBI ID | 47518 |
| PubChem CID | 47576 |
| DrugBank | DB05667 |
| UNII ID | 2DJ8R0NT7K (ChemIDplus, GSRS) |
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Recorlev – Xeris Biopharma Holdings
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Safety
Black-box Warning
Black-box warning for: Recorlev
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6,580 adverse events reported
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