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 | 2025-08-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| candidemia | EFO_1001282 | D058387 | — |
| mycoses | — | D009181 | B35-B49 |
| 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
43 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Candidemia | D058387 | EFO_1001282 | — | — | 1 | 5 | 3 | 4 | 13 |
| Candidiasis | D002177 | — | B37 | — | 2 | 4 | 1 | 3 | 10 |
| Invasive candidiasis | D058365 | EFO_1001283 | B37 | — | 1 | 3 | 2 | 2 | 8 |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | 1 | 3 | 2 | — | 5 |
| Mycoses | D009181 | — | B35-B49 | — | — | — | 2 | — | 2 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fungemia | D016469 | — | B49 | — | — | 2 | — | — | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | 2 | — | — | 2 |
| Neutropenia | D009503 | — | D70 | 1 | 1 | 1 | — | — | 2 |
| Invasive pulmonary aspergillosis | D055744 | — | B44.0 | — | — | 1 | — | — | 1 |
| Neuroaspergillosis | D020953 | EFO_0007393 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic neoplasms | D019337 | — | — | — | 1 | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | 1 | — | — | — | 1 |
| Respiratory tract infections | D012141 | — | J06.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| 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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No Black-box warning
Adverse Events
Top Adverse Reactions
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1,167 adverse events reported
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