Noxafil(posaconazole)
Noxafil (posaconazole) is a small molecule pharmaceutical. Posaconazole was first approved as Noxafil on 2005-10-25. It is used to treat mycoses and oral candidiasis in the USA. It has been approved in Europe to treat aspergillosis, candidiasis, coccidioidomycosis, and mycoses.
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Commercial
Trade Name
FDA
EMA
Noxafil (generic drugs available since 2019-08-21)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Posaconazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NOXAFIL | Merck Sharp & Dohme | N-205053 RX | 2013-11-25 | 1 products, RLD, RS |
| NOXAFIL | Merck Sharp & Dohme | N-205596 RX | 2014-03-13 | 1 products, RLD, RS |
| NOXAFIL POWDERMIX KIT | Merck Sharp & Dohme | N-214770 RX | 2021-05-31 | 1 products, RLD, RS |
| NOXAFIL | Merck Sharp & Dohme | N-022003 RX | 2006-09-15 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| noxafil | New Drug Application | 2020-09-17 |
| posaconazole | NDA authorized generic | 2023-04-11 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| mycoses | — | D009181 | B35-B49 |
| oral candidiasis | EFO_0007406 | D002180 | B37.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
POSACONAZOLE, NOXAFIL, MERCK SHARP DOHME | |||
| 2028-06-17 | ODE-355 | ||
| 2024-06-17 | I-881 | ||
| 2024-05-31 | NPP | ||
POSACONAZOLE, NOXAFIL POWDERMIX KIT, MSD MERCK CO | |||
| 2024-05-31 | NP | ||
HCPCS
No data
Clinical
Clinical Trials
73 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mycoses | D009181 | B35-B49 | 7 | 5 | 6 | 4 | 6 | 28 | |
| Myeloid leukemia acute | D015470 | C92.0 | 5 | 4 | 1 | 4 | 2 | 12 | |
| Myelodysplastic syndromes | D009190 | D46 | 2 | 3 | 1 | 2 | — | 6 | |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | 1 | 2 | 1 | 2 | 5 |
| Invasive pulmonary aspergillosis | D055744 | B44.0 | 1 | 1 | 1 | 1 | — | 4 | |
| Invasive fungal infections | D000072742 | — | 1 | 1 | 1 | 1 | 4 | ||
| Neutropenia | D009503 | D70 | 1 | — | 1 | 1 | — | 3 | |
| Invasive candidiasis | D058365 | EFO_1001283 | B37 | — | — | 1 | 1 | — | 2 |
| Pharmacokinetics | D010599 | 1 | — | — | 1 | — | 2 | ||
| Aplastic anemia | D000741 | HP_0001915 | D61.9 | — | 1 | — | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 1 | 1 | — | — | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | 1 | — | 1 | 2 |
| Chronic granulomatous disease | D006105 | EFO_0000338 | D71 | — | 1 | 1 | — | — | 2 |
| Oral candidiasis | D002180 | EFO_0007406 | B37.0 | — | 1 | 1 | — | — | 2 |
| Candidemia | D058387 | EFO_1001282 | — | — | 1 | — | — | 1 | |
| Fungemia | D016469 | B49 | — | — | 1 | — | — | 1 | |
| Pneumocystis | D011010 | — | — | 1 | — | — | 1 | ||
| Aspergillus | D001230 | — | — | 1 | — | — | 1 | ||
| Invasive hydatidiform mole | D002820 | D39.2 | — | — | 1 | — | — | 1 | |
| Leukopenia | D007970 | EFO_0004233 | D72.819 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | C95 | 1 | 2 | — | — | — | 2 | |
| Onychomycosis | D014009 | B35.1 | — | 1 | — | — | 1 | 2 | |
| Chagas disease | D014355 | EFO_0008559 | B57 | — | 2 | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | 1 | — | — | — | 1 | |
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 1 | 1 | — | — | — | 1 | |
| Mucormycosis | D009091 | EFO_0007380 | B46.5 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 2 | — | — | — | — | 2 | |
| Myeloid leukemia | D007951 | C92 | 1 | — | — | — | — | 1 | |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | 1 | — | — | — | — | 1 | |
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Glioblastoma | D005909 | EFO_0000515 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fungal lung diseases | D008172 | EFO_0007278 | — | — | — | — | 1 | 1 | |
| Candidiasis | D002177 | B37 | — | — | — | — | 1 | 1 | |
| Genetic predisposition to disease | D020022 | — | — | — | — | 1 | 1 | ||
| Fusariosis | D060585 | EFO_1001795 | — | — | — | — | 1 | 1 | |
| Respiratory tract infections | D012141 | J06.9 | — | — | — | — | 1 | 1 | |
| Critical illness | D016638 | — | — | — | — | 1 | 1 | ||
| Drug monitoring | D016903 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | POSACONAZOLE |
| INN | posaconazole |
| Description | Posaconazole is an N-arylpiperazine that consists of piperazine carrying two 4-substituted phenyl groups at positions 1 and 4. A triazole antifungal drug. It has a role as a trypanocidal drug. It is a member of triazoles, a N-arylpiperazine, an organofluorine compound, a member of oxolanes, an aromatic ether, a conazole antifungal drug and a triazole antifungal drug. |
| Classification | Small molecule |
| Drug class | systemic antifungals (miconazole type) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@@H]([C@H](C)O)n1ncn(-c2ccc(N3CCN(c4ccc(OC[C@@H]5CO[C@@](Cn6cncn6)(c6ccc(F)cc6F)C5)cc4)CC3)cc2)c1=O |
Identifiers
| PDB | — |
| CAS-ID | 171228-49-2 |
| RxCUI | 282446 |
| ChEMBL ID | CHEMBL1397 |
| ChEBI ID | 64355 |
| PubChem CID | 468595 |
| DrugBank | DB01263 |
| UNII ID | 6TK1G07BHZ (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
No data
Variants
Clinical Variant
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Financial
Noxafil - Merck Sharp & Dohme
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Trends
PubMed Central
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Additional graphs summarizing 9,578 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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13 adverse events reported
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