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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Abelcet, Ambisome (generic drugs available since 1992-04-29, discontinued: Amphotec, Fungizone)
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New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amphotericin b
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AMBISOME | Astellas Pharma | N-050740 RX | 1997-08-11 | 1 products, RLD, RS |
| ABELCET | Leadiant Biosciences | N-050724 RX | 1995-11-20 | 1 products, RLD, RS |
Show 4 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| abelcet | New Drug Application | 2023-11-21 |
| ambisome | New Drug Application | 2020-08-14 |
| amphotec | 2006-02-27 | |
| amphotericin b | ANDA | 2022-11-17 |
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Agency Specific
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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
Clinical
Clinical Trials
173 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cryptococcal meningitis | D016919 | EFO_0007228 | B45.1 | 4 | 7 | 5 | 2 | 11 | 26 |
| Visceral leishmaniasis | D007898 | — | B55.0 | 1 | 5 | 7 | 3 | 1 | 17 |
| Mycoses | D009181 | — | B35-B49 | — | 2 | 5 | 3 | 2 | 12 |
| Invasive pulmonary aspergillosis | D055744 | — | B44.0 | 1 | 3 | 3 | 2 | 1 | 10 |
| Candidiasis | D002177 | — | B37 | — | — | 4 | 1 | 1 | 6 |
| Neutropenia | D009503 | — | D70 | — | 1 | 2 | 1 | 1 | 5 |
| Invasive candidiasis | D058365 | EFO_1001283 | B37 | — | 2 | 1 | 1 | — | 4 |
| Leukemia | D007938 | — | C95 | — | 1 | 1 | 1 | — | 3 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | — | 1 | 1 | — | 2 |
| Blastomycosis | D001759 | EFO_0007174 | B40 | — | — | 1 | 1 | — | 2 |
Show 12 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | 4 | 5 | — | 9 | 19 |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | 4 | 4 | — | — | 6 |
| Invasive fungal infections | D000072742 | — | — | 1 | — | 1 | — | 3 | 5 |
| Infections | D007239 | EFO_0000544 | — | — | — | 3 | — | 1 | 4 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | 1 | — | 1 | — | 2 | 4 |
| Neoplasms | D009369 | — | C80 | — | 1 | 2 | — | — | 3 |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | — | 2 | 1 | — | — | 3 |
| Lung transplantation | D016040 | — | — | — | — | 3 | — | — | 3 |
| Allergic bronchopulmonary aspergillosis | D001229 | EFO_0007140 | B44.81 | — | 2 | 1 | — | — | 2 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | — | — | 2 | — | — | 2 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | — | 4 | — | — | — | 4 |
| Leishmaniasis | D007896 | EFO_0005044 | B55 | 2 | 4 | — | — | — | 4 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | 2 | — | — | — | 2 |
| Mucormycosis | D009091 | EFO_0007380 | B46.5 | — | 2 | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | — | 2 | — | — | — | 2 |
| Vulvovaginitis | D014848 | EFO_1001240 | N76.0 | — | 2 | — | — | — | 2 |
| Fever | D005334 | HP_0001945 | R50.9 | — | 1 | — | — | — | 1 |
| Hiv | D006678 | — | O98.7 | — | 1 | — | — | — | 1 |
| Meningitis | D008581 | HP_0001287 | G03 | — | 1 | — | — | — | 1 |
| Meningoencephalitis | D008590 | EFO_0007364 | A69.22 | — | 1 | — | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic foot | D017719 | EFO_1001459 | — | 1 | — | — | — | — | 1 |
| Foot ulcer | D016523 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | — | — | 1 | 1 |
| Critical illness | D016638 | — | — | — | — | — | — | 1 | 1 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | — | — | — | 1 | 1 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | — | — | 1 | 1 |
| Acute-on-chronic liver failure | D065290 | — | — | — | — | — | — | 1 | 1 |
| Pharmacokinetics | D010599 | — | — | — | — | — | — | 1 | 1 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | — | — | 1 | 1 |
| Zika virus infection | D000071243 | — | A92.5 | — | — | — | — | 1 | 1 |
| Drug evaluation | D004341 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Amphotericin b |
| INN | amphotericin 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) |  |
| 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-ID | 1397-89-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL267345 |
| ChEBI ID | 2682 |
| PubChem CID | 14956 |
| DrugBank | DB00681 |
| UNII ID | 7XU7A7DROE (ChemIDplus, GSRS) |
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Ambisome – Gilead Sciences
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Amphotericin b
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Safety
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10,337 adverse events reported
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