Eraxis, Ecalta(anidulafungin)
Ecalta, Eraxis (anidulafungin) is a small molecule pharmaceutical. Anidulafungin was first approved as Eraxis on 2006-02-17. It is used to treat abdominal abscess, candidemia, mycoses, and peritonitis in the USA. It has been approved in Europe to treat candidiasis.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Eraxis
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Anidulafungin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ERAXIS | Vicuron Pharmaceuticals | N-021632 RX | 2006-02-17 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| eraxis | New Drug Application | 2024-03-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| candidemia | EFO_1001282 | D058387 | — |
| mycoses | — | D009181 | B35-B49 |
| candidiasis | — | D002177 | B37 |
| peritonitis | EFO_0008588 | D010538 | K65 |
| abdominal abscess | EFO_1001753 | D018784 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0348 | Injection, anidulafungin, 1 mg |
Clinical
Clinical Trials
42 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Candidiasis | D002177 | — | B37 | — | 2 | 8 | 2 | 6 | 18 |
| Candidemia | D058387 | EFO_1001282 | — | — | — | 8 | 4 | 3 | 15 |
| Invasive candidiasis | D058365 | EFO_1001283 | B37 | — | 1 | 5 | 2 | 4 | 12 |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | 1 | 4 | 2 | — | 6 |
| Infections | D007239 | EFO_0000544 | — | 1 | 2 | 2 | 1 | 1 | 6 |
| Mycoses | D009181 | — | B35-B49 | 1 | — | — | 3 | 1 | 5 |
| Fungemia | D016469 | — | B49 | — | — | 2 | 1 | — | 3 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | — | — | 1 | 1 | 2 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neutropenia | D009503 | — | D70 | 2 | 2 | 1 | — | — | 3 |
| Invasive pulmonary aspergillosis | D055744 | — | B44.0 | — | — | 2 | — | — | 2 |
| Neuroaspergillosis | D020953 | EFO_0007393 | — | — | — | 1 | — | — | 1 |
| Pulmonary aspergillosis | D055732 | EFO_1001834 | — | — | — | 1 | — | — | 1 |
| Candida | D002175 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 2 | — | — | — | 2 |
| Leukemia | D007938 | — | C95 | — | 1 | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 1 | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | — | 1 | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | — | 1 | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | — | 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 kidney injury | D058186 | HP_0001919 | N17 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Invasive fungal infections | D000072742 | — | — | 1 | — | — | — | 1 | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Critical illness | D016638 | — | — | — | — | — | — | 2 | 2 |
| Hypoalbuminemia | D034141 | HP_0003073 | — | — | — | — | — | 1 | 1 |
| Peritonitis | D010538 | EFO_0008588 | K65 | — | — | — | — | 1 | 1 |
| Abdominal abscess | D018784 | EFO_1001753 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Anidulafungin |
| INN | anidulafungin |
| Description | Anidulafungin is a semisynthetic echinocandin anti-fungal drug. It is active against Aspergillus and Candida species and is used for the treatment of invasive candidiasis. It is an azamacrocycle, a heterodetic cyclic peptide, a semisynthetic derivative, an echinocandin and an antibiotic antifungal drug. |
| Classification | Small molecule |
| Drug class | antifungal antibiotics (undefined group) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCCOc1ccc(-c2ccc(-c3ccc(C(=O)N[C@H]4C[C@@H](O)[C@@H](O)NC(=O)[C@@H]5[C@@H](O)[C@@H](C)CN5C(=O)[C@H]([C@@H](C)O)NC(=O)[C@H]([C@H](O)[C@@H](O)c5ccc(O)cc5)NC(=O)[C@@H]5C[C@@H](O)CN5C(=O)[C@H]([C@@H](C)O)NC4=O)cc3)cc2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 166663-25-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL264241 |
| ChEBI ID | 55346 |
| PubChem CID | 166548 |
| DrugBank | DB00362 |
| UNII ID | 9HLM53094I (ChemIDplus, GSRS) |
Target
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Trends
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Safety
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Adverse Events
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1,059 adverse events reported
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