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Amphotericin b
Abelcet, Ambisome (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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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 (generic drugs available since 1992-04-29, discontinued: Amphotec, 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 Application2020-11-19
ambisomeNew Drug Application2020-08-14
amphotec2006-02-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
aids-related opportunistic infectionsD017088
aspergillosisEFO_0007157D001228B44
blastomycosisEFO_0007174D001759B40
chronic mucocutaneous candidiasisOrphanet_1334D002178B37.2
coccidioidomycosisEFO_0007211D003047B38
cryptococcal meningitisEFO_0007228D016919B45.1
cutaneous candidiasisD002179
cystitisEFO_1000025D003556N30
fungemiaD016469B49
histoplasmosisEFO_0007310D006660B39
Show 8 more
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
130 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cryptococcal meningitisD016919EFO_0007228B45.147411023
Visceral leishmaniasisD007898B55.01473116
MycosesD009181B35-B49253111
Invasive pulmonary aspergillosisD055744B44.013329
CandidiasisD002177B374116
Invasive candidiasisD058365EFO_1001283B372114
NeutropeniaD009503D701214
Liver transplantationD016031EFO_0010682112
BlastomycosisD001759EFO_0007174B40112
SepsisD018805A41.9112
Show 7 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B20245818
AspergillosisD001228EFO_0007157B44335
InfectionsD007239EFO_0000544314
Vulvovaginal candidiasisD002181EFO_0007543B37.3213
Lung transplantationD01604033
Allergic bronchopulmonary aspergillosisD001229EFO_0007140B44.81212
NeoplasmsD009369C8022
Bacterial vaginosisD016585EFO_000393222
Myelodysplastic syndromesD009190D46112
Acquired immunodeficiency syndromeD000163EFO_0000765B20112
Show 9 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.044
MucormycosisD009091EFO_0007380B46.522
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.022
VulvovaginitisD014848EFO_1001240N76.022
LeishmaniasisD007896EFO_0005044B55122
Hematopoietic stem cell transplantationD01838011
FeverD005334HP_0001945R50.911
CryptococcosisD003453EFO_0007229B45111
HivD006678O98.711
MeningitisD008581EFO_0000584G0311
Show 5 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients11
Therapeutic equivalencyD01381011
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory distress syndromeD012128EFO_1000637J8011
Critical illnessD01663811
Ventilator-associated pneumoniaD053717EFO_1001865J95.85111
Respiratory tract infectionsD012141J06.911
PneumoniaD011014EFO_0003106J1811
Healthy dietD00007200111
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAMPHOTERICIN B
INNamphotericin b
Description
Amphotericin B is a macrolide antibiotic used to treat potentially life-threatening fungal infections. It has a role as an antiprotozoal drug, a bacterial metabolite and an antiamoebic agent. It is a macrolide antibiotic, a polyene antibiotic and an antibiotic antifungal drug.
Classification
Small molecule
Drug class
Image (chem structure or protein)
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
RxCUI732
ChEMBL IDCHEMBL267345
ChEBI ID2682
PubChem CID5280965
DrugBankDB00681
UNII ID7XU7A7DROE (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Ambisome - Gilead Sciences
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 71,688 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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20,292 adverse events reported
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