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Drug ReportsAmphotericin b
Amphotericin b
Abelcet, Ambisome, Amphotericin B (amphotericin b) is a small molecule pharmaceutical. Amphotericin b was first approved as Fungizone on 1982-01-01. It is used to treat aids-related opportunistic infections, aspergillosis, blastomycosis, chronic mucocutaneous candidiasis, and coccidioidomycosis amongst others in the USA.
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Safety
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
respiratory tract diseasesD012140
nervous system diseasesD009422
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Abelcet, Ambisome, Amphotericin b (discontinued: Amphotec, Amphotericin b, Fungizone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amphotericin b
Tradename
Company
Number
Date
Products
AMBISOMEAstellas PharmaN-050740 RX1997-08-11
1 products, RLD, RS
ABELCETLeadiant BiosciencesN-050724 RX1995-11-20
1 products, RLD, RS
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
abelcetNew Drug Application2023-11-21
ambisomeNew Drug Application2020-08-14
amphotec2006-02-27
amphotericin bANDA2022-11-17
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
A01: Stomatological preparations
A01A: Stomatological preparations
A01AB: Antiinfectives and antiseptics for local oral treatment
A01AB04: Amphotericin b
A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
A07A: Intestinal antiinfectives
A07AA: Antibiotics, intestinal
A07AA07: Amphotericin b
G: Genito urinary system and sex hormones
G01: Gynecological antiinfectives and antiseptics
G01A: Antiinfectives and antiseptics, excl. combinations with corticosteroids
G01AA: Antibiotics, gynecological
G01AA03: Amphotericin b
J: Antiinfectives for systemic use
J02: Antimycotics for systemic use
J02A: Antimycotics for systemic use
J02AA: Antibiotics for systemic use
J02AA01: Amphotericin b
HCPCS
Code
Description
J0285
Injection, amphotericin b, 50 mg
J0287
Injection, amphotericin b lipid complex, 10 mg
J0288
Injection, amphotericin b cholesteryl sulfate complex, 10 mg
J0289
Injection, amphotericin b liposome, 10 mg
Clinical
Clinical Trials
183 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MycosesD009181B35-B492697832
LeishmaniasisD007896EFO_0005044B55515104231
MeningitisD008581HP_0001287G03410621129
Cryptococcal meningitisD016919EFO_0007228B45.1410621129
InfectionsD007239EFO_000054424103725
AspergillosisD001228EFO_0007157B44110112223
Visceral leishmaniasisD007898B55.02974122
Invasive fungal infectionsD0000727422233818
CandidiasisD002177B37662317
Communicable diseasesD0031411341412
Show 25 more
Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MucormycosisD009091EFO_0007380B46.51516
ZygomycosisD020096B461516
Myeloid leukemia acuteD015470C92.044
Myeloid leukemiaD007951C9244
Cutaneous leishmaniasisD016773B55.12314
Hematopoietic stem cell transplantationD01838033
VulvovaginitisD014848EFO_1001240N76.022
Cystic fibrosisD003550EFO_0000390E84112
RhinosinusitisD00009682511
Varicose ulcerD01464711
Show 6 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients112
Therapeutic equivalencyD01381022
Diabetic footD017719EFO_100145911
Wound infectionD01494611
Foot ulcerD01652311
FibrosisD00535511
Indications Without Phase
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAmphotericin b
INNamphotericin b
Description
Amphotericin B is an antifungal medication used for serious fungal infections and leishmaniasis. The fungal infections it is used to treat include mucormycosis, aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, and cryptococcosis. For certain infections it is given with flucytosine. It is typically given intravenously (injection into a vein).
Classification
Small molecule
Drug class
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@@H]1OC(=O)C[C@H](O)C[C@H](O)CC[C@@H](O)[C@H](O)C[C@H](O)C[C@]2(O)C[C@H](O)[C@@H](C(=O)O)[C@H](C[C@@H](O[C@@H]3O[C@H](C)[C@@H](O)[C@H](N)[C@@H]3O)/C=C/C=C/C=C/C=C/C=C/C=C/C=C/[C@H](C)[C@@H](O)[C@H]1C)O2
Identifiers
PDB
CAS-ID1397-89-3
RxCUI
ChEMBL IDCHEMBL267345
ChEBI ID2682
PubChem CID14956
DrugBankDB00681
UNII ID7XU7A7DROE (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Ambisome Gilead Sciences
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Estimated US medical usage
Amphotericin b
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 90,285 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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13,116 adverse events reported
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