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
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Recorlev
Drug Products
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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 |
|---|---|---|
| nizoral | New Drug Application | 2025-08-21 |
| nizoral eczema relief cream | C200263 | 2025-01-27 |
| 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 | 2025-08-08 |
Indications
FDA
EMA
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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
212 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 21 | 4 | — | 2 | — | 27 |
| Seborrheic dermatitis | D012628 | — | L21 | — | 2 | 1 | 1 | 2 | 6 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 1 | 2 | 1 | — | 4 |
| Tinea versicolor | D014010 | EFO_0007439 | B36.0 | 1 | — | — | 3 | — | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | 1 | 1 | 3 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 2 | — | — | 1 | — | 3 |
| Thromboembolism | D013923 | — | — | — | 1 | — | 1 | — | 2 |
| Dermatitis | D003872 | — | L30.9 | — | — | — | 1 | 1 | 2 |
| Dyspnea | D004417 | — | R06.0 | — | — | — | 1 | — | 1 |
| Kidney transplantation | D016030 | — | — | — | — | — | 1 | — | 1 |
Show 5 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 3 | 18 | 5 | — | 4 | 28 |
| Tinea pedis | D014008 | EFO_0007512 | B35.3 | — | 1 | 5 | — | — | 6 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 3 | 3 | 1 | — | — | 5 |
| Tinea | D014005 | EFO_0007510 | B35.4 | — | 1 | 3 | — | — | 4 |
| Syndrome | D013577 | — | — | — | — | 4 | — | — | 4 |
| Cushing syndrome | D003480 | EFO_0003099 | E24 | — | — | 3 | — | 1 | 4 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | 1 | — | 2 | — | — | 3 |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | — | — | 2 | — | — | 2 |
| Candidiasis | D002177 | — | B37 | — | — | 1 | — | 1 | 2 |
| Scalp dermatoses | D012536 | — | — | — | — | 1 | — | 1 | 2 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | — | — | — | 3 |
| Hypogonadism | D007006 | — | E23.0 | 1 | 1 | — | — | 1 | 3 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | 2 | — | — | — | 3 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 2 | — | — | — | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 1 | — | — | — | 1 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | 1 | — | — | — | 1 |
| Granulosa cell tumor | D006106 | — | — | — | 1 | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | 1 | 1 | — | — | — | 1 |
Show 10 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 51 | — | — | — | 1 | 52 |
| Pharmacokinetics | D010599 | — | — | 6 | — | — | — | — | 6 |
| Lymphoma | D008223 | — | C85.9 | 5 | — | — | — | — | 5 |
| Drug interactions | D004347 | — | — | 4 | — | — | — | — | 4 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 3 | — | — | — | — | 3 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 2 | — | — | — | 1 | 3 |
| Hepatitis c | D006526 | — | B19.2 | 2 | — | — | — | — | 2 |
| Sleep deprivation | D012892 | — | F51.12 | 2 | — | — | — | — | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | — | — | — | — | 2 |
| Glioma | D005910 | EFO_0000520 | — | 2 | — | — | — | — | 2 |
Show 38 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 1 | 1 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Torsades de pointes | D016171 | EFO_0005307 | I47.21 | — | — | — | — | 1 | 1 |
| Gonadal disorders | D006058 | — | — | — | — | — | — | 1 | 1 |
| Kallmann syndrome | D017436 | Orphanet_478 | E23.0 | — | — | — | — | 1 | 1 |
| Dandruff | D063807 | — | L21.0 | — | — | — | — | 1 | 1 |
| Tinea capitis | D014006 | — | B35.0 | — | — | — | — | 1 | 1 |
| Esophagitis | D004941 | HP_0100633 | K20 | — | — | — | — | 1 | 1 |
| Cryptorchidism | D003456 | EFO_0004562 | Q53.1 | — | — | — | — | 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) |
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Recorlev – Xeris Biopharma Holdings
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Safety
Black-box Warning
Black-box warning for: Recorlev
Adverse Events
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2,828 adverse events reported
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