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
Trade Name
FDA
EMA
Recorlev
Drug Products
FDA
EMA
New Drug Application (NDA)
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 |
|---|---|---|
| recorlev | New Drug Application | 2022-01-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| acanthamoeba keratitis | EFO_0007126 | D015823 | — |
| blastomycosis | EFO_0007174 | D001759 | B40 |
| chronic mucocutaneous candidiasis | Orphanet_1334 | D002178 | B37.2 |
| coccidioidomycosis | EFO_0007211 | D003047 | B38 |
| cutaneous candidiasis | — | D002179 | — |
| histoplasmosis | EFO_0007310 | D006660 | B39 |
| leishmaniasis | EFO_0005044 | D007896 | B55 |
| mycoses | — | D009181 | B35-B49 |
| oral candidiasis | EFO_0007406 | D002180 | B37.0 |
| paracoccidioidomycosis | EFO_0007417 | D010229 | B41 |
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LEVOKETOCONAZOLE, RECORLEV, STRONGBRIDGE | |||
| 2028-12-30 | ODE-385 | ||
ATC Codes
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AC: Imidazole and triazole derivatives, topical antifungals
— D01AC08: Ketoconazole
G: Genito urinary system and sex hormones
— G01: Gynecological antiinfectives and antiseptics
— G01A: Antiinfectives and antiseptics, excl. combinations with corticosteroids
— G01AF: Imidazole derivatives, gyncological antiinfectives
— G01AF11: Ketoconazole
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02C: Antiadrenal preparations
— H02CA: Anticorticosteroids
— H02CA03: Ketoconazole
J: Antiinfectives for systemic use
— J02: Antimycotics for systemic use
— J02A: Antimycotics for systemic use
— J02AB: Imidazole derivatives, antimycotic for systemic use
— J02AB02: Ketoconazole
HCPCS
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Clinical
Clinical Trials
172 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Seborrheic dermatitis | D012628 | L21 | — | 2 | 1 | 1 | 1 | 5 | |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 2 | — | — | 1 | — | 3 |
| Kidney transplantation | D016030 | — | — | — | 1 | — | 1 | ||
| Tinea versicolor | D014010 | EFO_0007439 | B36.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | C61 | 3 | 16 | 5 | — | 2 | 24 | |
| Tinea pedis | D014008 | EFO_0007512 | B35.3 | — | 1 | 5 | — | — | 6 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 3 | 3 | 1 | — | — | 5 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | — | 2 | — | — | 2 | |
| Candidiasis | D002177 | B37 | — | — | 1 | — | 1 | 2 | |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | — | — | 1 | — | — | 1 |
| Tinea | D014005 | EFO_0007510 | B35.4 | — | — | 1 | — | — | 1 |
| Pituitary acth hypersecretion | D047748 | EFO_1001110 | E24.0 | — | — | 1 | — | — | 1 |
| Burns | D002056 | T30.0 | — | 1 | 1 | — | — | 1 | |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 15 | 3 | — | — | — | 18 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Thromboembolism | D013923 | HP_0001907 | — | 1 | — | — | — | 1 | |
| Neoplasm metastasis | D009362 | EFO_0009708 | 1 | 1 | — | — | — | 1 | |
| Castration-resistant prostatic neoplasms | D064129 | — | 1 | — | — | — | 1 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | 1 | 1 | — | — | — | 1 | ||
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | — | — | — | 1 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | 1 | — | — | — | 1 |
| Femur head necrosis | D005271 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 43 | — | — | — | 1 | 44 | ||
| Pharmacokinetics | D010599 | 6 | — | — | — | — | 6 | ||
| Drug interactions | D004347 | 3 | — | — | — | — | 3 | ||
| Lymphoma | D008223 | C85.9 | 3 | — | — | — | — | 3 | |
| Neuroblastoma | D009447 | EFO_0000621 | 2 | — | — | — | 1 | 3 | |
| Hepatitis c | D006526 | B19.2 | 2 | — | — | — | — | 2 | |
| Hypogonadism | D007006 | E23.0 | 1 | — | — | — | 1 | 2 | |
| Glioma | D005910 | EFO_0000520 | 2 | — | — | — | — | 2 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 2 | — | — | — | — | 2 | |
| Asthma | D001249 | EFO_0000270 | J45 | 2 | — | — | — | — | 2 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gonadal disorders | D006058 | — | — | — | — | 1 | 1 | ||
| Kallmann syndrome | D017436 | Orphanet_478 | E23.0 | — | — | — | — | 1 | 1 |
| Tinea capitis | D014006 | B35.0 | — | — | — | — | 1 | 1 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 1 | 1 |
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) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
Recorlev - Xeris Biopharma Holdings
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Trends
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Safety
Black-box Warning
Black-box warning for: Recorlev
Adverse Events
Top Adverse Reactions
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