Ciclopirox
Ciclopirox, Loprox (ciclopirox) is a small molecule pharmaceutical. Ciclopirox was first approved as Loprox on 1982-12-30. It is used to treat cutaneous candidiasis, onychomycosis, tinea pedis, and tinea versicolor in the USA. It is known to target poly [ADP-ribose] polymerase 1.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Ciclopirox, Loprox (discontinued: Ciclopirox, Penlac)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ciclopirox
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LOPROX | Bausch Health Companies | N-021159 RX | 2003-02-28 | 1 products, RLD, RS |
| LOPROX | Medimetriks Pharmaceuticals | N-018748 RX | 1982-12-30 | 1 products, RLD, RS |
| LOPROX | Medimetriks Pharmaceuticals | N-019824 RX | 1988-12-30 | 1 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ciclodan | ANDA | 2020-12-21 |
| ciclopirox | ANDA | 2024-11-01 |
| ciclopirox 0.77% / salicylic acid 2% | unapproved drug other | 2019-05-16 |
| ciclopirox 1% / clobetasol propionate 0.05% | unapproved drug other | 2019-04-24 |
| ciclopirox 3% | unapproved drug other | 2019-05-20 |
| ciclopirox 3% / itraconazole 5% / urea 20% | unapproved drug other | 2019-05-20 |
| ciclopirox 8% / fluconazole 1% / terbinafine hcl 1% | unapproved drug other | 2019-04-24 |
| ciclopirox olamine | ANDA | 2024-10-30 |
| ciclopirox olamine 0.77% / clobetasol propionate 0.05% / salicylic acid 3%. | unapproved drug other | 2019-05-16 |
| ciclopirox olamine 1% / salicylic acid 2% | unapproved drug other | 2019-05-22 |
Show 2 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| onychomycosis | — | D014009 | B35.1 |
| tinea pedis | EFO_0007512 | D014008 | B35.3 |
| tinea versicolor | EFO_0007439 | D014010 | B36.0 |
| cutaneous candidiasis | — | D002179 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AE: Other antifungals for topical use in atc
— D01AE14: Ciclopirox
G: Genito urinary system and sex hormones
— G01: Gynecological antiinfectives and antiseptics
— G01A: Antiinfectives and antiseptics, excl. combinations with corticosteroids
— G01AX: Other gynecological antiinfectives and antiseptics in atc
— G01AX12: Ciclopirox
HCPCS
No data
Clinical
Clinical Trials
18 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Onychomycosis | D014009 | — | B35.1 | — | 1 | 2 | 4 | 2 | 9 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | — | 1 | 1 | — | 2 |
| Seborrheic dermatitis | D012628 | HP_0001051 | L21 | — | — | 1 | 1 | — | 2 |
| Skin diseases | D012871 | — | L00-L99 | — | — | — | 1 | 1 | 2 |
| Foot dermatoses | D005533 | — | — | — | — | — | 1 | — | 1 |
| Dermatomycoses | D003881 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tinea | D014005 | EFO_0007510 | B35.9 | — | — | 1 | — | 2 | 3 |
| Tinea pedis | D014008 | EFO_0007512 | B35.3 | — | — | 1 | — | 1 | 2 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 1 | — | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | — | — | — | — | 1 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | — | — | — | 1 |
| Hodgkin disease | D006689 | — | C81 | 1 | — | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tinea capitis | D014006 | — | B35.0 | — | — | — | — | 1 | 1 |
| Vulvar neoplasms | D014846 | — | C51 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Nail diseases | D009260 | HP_0001597 | L60 | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | — | 1 | 1 |
| Diabetic foot | D017719 | EFO_1001459 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ciclopirox |
| INN | ciclopirox |
| Description | Ciclopirox is a cyclic hydroxamic acid that is 1-hydroxypyridin-2(1H)-one in which the hydrogens at positions 4 and 6 are substituted by methyl and cyclohexyl groups, respectively. A broad spectrum antigfungal agent, it also exhibits antibacterial activity against many Gram-positive and Gram-negative bacteria, and has anti-inflammatory properties. It is used a a topical treatment of fungal skin and nail infections. It has a role as an antibacterial agent and an antiseborrheic. It is a pyridone, a cyclic hydroxamic acid and a hydroxypyridone antifungal drug. |
| Classification | Small molecule |
| Drug class | antimycotics (pyridone derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1cc(C2CCCCC2)n(O)c(=O)c1 |
Identifiers
| PDB | — |
| CAS-ID | 29342-05-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1413 |
| ChEBI ID | 453011 |
| PubChem CID | 2749 |
| DrugBank | DB01188 |
| UNII ID | 19W019ZDRJ (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
PARP1
PARP1
Organism
Homo sapiens
Gene name
PARP1
Gene synonyms
ADPRT, PPOL
NCBI Gene ID
Protein name
poly [ADP-ribose] polymerase 1
Protein synonyms
ADP-ribosyltransferase (NAD+; poly (ADP-ribose) polymerase), ADP-ribosyltransferase diphtheria toxin-like 1, ADP-ribosyltransferase NAD(+), ADPRT 1, ARTD1, DNA ADP-ribosyltransferase PARP1, NAD(+) ADP-ribosyltransferase 1, poly (ADP-ribose) polymerase family, member 1, poly(ADP-ribose) synthetase, poly(ADP-ribosyl)transferase, Poly[ADP-ribose] synthase 1, Protein poly-ADP-ribosyltransferase PARP1
Uniprot ID
Mouse ortholog
Parp1 (11545)
poly [ADP-ribose] polymerase 1 (P11103)
Variants
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Financial
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Estimated US medical usage
Ciclopirox
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Trends
PubMed Central
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Safety
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859 adverse events reported
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