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Drug ReportsPosaconazole
Noxafil(posaconazole)
Noxafil, Posaconazole (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
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
stomatognathic diseasesD009057
Trade Name
FDA
EMA
Noxafil, Posaconazole (discontinued: Noxafil, Posaconazole)
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
NOXAFILMerck & CoN-205596 RX2014-03-13
1 products, RLD, RS
NOXAFIL POWDERMIX KITMerck & CoN-214770 RX2021-05-31
1 products, RLD, RS
NOXAFILMerck & CoN-022003 RX2006-09-15
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
noxafilNew Drug Application2024-10-25
posaconazoleANDA2025-06-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mycoses—D009181B35-B49
oral candidiasisEFO_0007406D002180B37.0
Agency Specific
FDA
EMA
Expiration
Code
POSACONAZOLE, NOXAFIL, MERCK SHARP DOHME
2028-06-17ODE-355
2024-06-17I-881
2024-05-31NPP
POSACONAZOLE, NOXAFIL POWDERMIX KIT, MSD MERCK CO
2024-05-31NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Posaconazole, Noxafil, Merck Sharp Dohme
94935822033-02-27DP
90237902031-07-04DPU-1698, U-3160, U-3171
93582972031-06-24DPU-3160, U-3171
84100772029-03-13DP
97508222029-03-13DP
101179512029-03-13DP
ATC Codes
J: Antiinfectives for systemic use
— J02: Antimycotics for systemic use
— J02A: Antimycotics for systemic use
— J02AC: Triazole and tetrazole derivatives
— J02AC04: Posaconazole
HCPCS
No data
Clinical
Clinical Trials
104 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MycosesD009181—B35-B495674628
Invasive fungal infectionsD000072742——4242416
InfectionsD007239EFO_0000544—4324215
Communicable diseasesD003141——4112210
AspergillosisD001228EFO_0007157B44—12216
Invasive pulmonary aspergillosisD055744—B44.0—111—3
CandidiasisD002177—B37—111—3
NeutropeniaD009503—D701—11—3
Myeloid leukemia acuteD015470—C92.0——11—2
Myeloid leukemiaD007951—C92——11—2
Show 5 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190—D46—11——2
Hiv infectionsD015658EFO_0000764B20—11——2
Oral candidiasisD002180EFO_0007406B37.0—11——2
Pulmonary aspergillosisD055732EFO_1001834———1——1
LeukopeniaD007970EFO_0004233D72.819——1——1
CoccidioidomycosisD003047EFO_0007211B38——1——1
CoccidiosisD003048EFO_0007212———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnemiaD000740EFO_0004272D64.9—1———1
Aplastic anemiaD000741—D61.9—1———1
PreleukemiaD011289———1———1
SyndromeD013577———1———1
Chagas diseaseD014355EFO_0008559B57—1———1
LeukemiaD007938—C95—1———1
OnychomycosisD014009—B35.1—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung transplantationD016040——————11
Covid-19D000086382—U07.1————11
Respiratory tract infectionsD012141—J06.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePosaconazole
INNposaconazole
Description
Posaconazole, sold under the brand name Noxafil among others, is a triazole antifungal medication.
Classification
Small molecule
Drug classsystemic antifungals (miconazole type)
Image (chem structure or protein)Loading
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-ID171228-49-2
RxCUI—
ChEMBL IDCHEMBL1397
ChEBI ID64355
PubChem CID147912
DrugBankDB01263
UNII ID6TK1G07BHZ (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
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Noxafil – Merck & Co
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Estimated US medical usage
Posaconazole
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,380 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,815 adverse events reported
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