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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Ambisome, Amphotericin b (discontinued: Abelcet, Amphotec, Amphotericin b, Fungizone)
Drug Products
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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 |
|---|---|---|---|---|
| AMBISOME | Astellas Pharma | N-050740 RX | 1997-08-11 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ambisome | New Drug Application | 2025-06-11 |
| amphotec | 2006-02-27 | |
| amphotericin b | ANDA | 2026-04-20 |
| amphotericin b liposome | ANDA | 2025-06-06 |
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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
210 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 | 2 | 5 | 9 | 7 | 10 | 33 |
| Invasive fungal infections | D000072742 | — | — | 2 | 1 | 4 | 4 | 18 | 29 |
| Cryptococcal meningitis | D016919 | EFO_0007228 | B45.1 | 4 | 10 | 6 | 2 | 11 | 29 |
| Meningitis | D008581 | EFO_0000584 | G03 | 4 | 7 | 4 | 2 | 11 | 26 |
| Infections | D007239 | EFO_0000544 | — | 2 | 4 | 11 | 3 | 6 | 25 |
| Leishmaniasis | D007896 | EFO_0005044 | B55 | 5 | 13 | 6 | 4 | 2 | 25 |
| Visceral leishmaniasis | D007898 | — | B55.0 | 2 | 8 | 7 | 4 | 3 | 23 |
| Aspergillosis | D001228 | EFO_0007157 | B44 | 1 | 10 | 9 | 2 | 3 | 22 |
| Candidiasis | D002177 | — | B37 | — | 5 | 5 | 2 | 3 | 15 |
| Invasive pulmonary aspergillosis | D055744 | — | B44.0 | 1 | 4 | 3 | 2 | 1 | 11 |
Show 28 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 | 3 | 4 | 5 | — | 11 | 22 |
| Communicable diseases | D003141 | — | — | 1 | 3 | 3 | — | 3 | 9 |
| Myeloid leukemia acute | D015470 | — | C92.0 | — | 4 | 1 | — | 1 | 6 |
| Fever | D005334 | — | R50.9 | — | 1 | 3 | — | — | 4 |
| Neoplasms | D009369 | — | C80 | — | 1 | 3 | — | — | 4 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | — | 1 | — | 3 | 4 |
| Lung transplantation | D016040 | — | — | — | 1 | 3 | — | — | 4 |
| Histoplasmosis | D006660 | EFO_0007310 | B39 | — | 1 | 3 | — | — | 4 |
| Allergic bronchopulmonary aspergillosis | D001229 | EFO_0007140 | B44.81 | — | 2 | 1 | — | 1 | 3 |
| Multiple myeloma | D009101 | — | C90.0 | — | — | 2 | — | 1 | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematopoietic stem cell transplantation | D018380 | — | — | — | 3 | — | — | 2 | 5 |
| Myeloid leukemia | D007951 | — | C92 | — | 4 | — | — | — | 4 |
| Cutaneous leishmaniasis | D016773 | — | B55.1 | 2 | 3 | — | — | 1 | 4 |
| Vulvovaginitis | D014848 | EFO_1001240 | N76.0 | — | 2 | — | — | — | 2 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 1 | — | — | — | 2 |
| Rhinosinusitis | D000096825 | — | — | — | 1 | — | — | — | 1 |
| Varicose ulcer | D014647 | — | — | — | 1 | — | — | — | 1 |
| Leg ulcer | D007871 | — | — | — | 1 | — | — | — | 1 |
| Meningoencephalitis | D008590 | EFO_0007364 | A69.22 | — | 1 | — | — | — | 1 |
| Chronic mucocutaneous candidiasis | D002178 | Orphanet_1334 | B37.2 | — | 1 | — | — | — | 1 |
Show 6 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | 1 | 2 |
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Diabetic foot | D017719 | EFO_1001459 | — | 1 | — | — | — | — | 1 |
| Wound infection | D014946 | — | — | 1 | — | — | — | — | 1 |
| Foot ulcer | D016523 | — | — | 1 | — | — | — | — | 1 |
| Fibrosis | D005355 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Critical illness | D016638 | — | — | — | — | — | — | 2 | 2 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | — | — | 2 | 2 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | — | — | 1 | 1 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | — | — | 1 | 1 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | — | — | — | 1 | 1 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
| Coinfection | D060085 | — | — | — | — | — | — | 1 | 1 |
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | — | — | — | — | 1 | 1 |
| Liver failure | D017093 | — | K72.9 | — | — | — | — | 1 | 1 |
Show 14 more
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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15,728 adverse events reported
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