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
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 | 2021-02-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| abdominal abscess | EFO_1001753 | D018784 | — |
| candidemia | EFO_1001282 | D058387 | — |
| mycoses | — | D009181 | B35-B49 |
| peritonitis | EFO_0008588 | D010538 | K65 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ANIDULAFUNGIN, ERAXIS, VICURON HOLDINGS | |||
| 2023-09-22 | NPP | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0348 | Injection, anidulafungin, 1 mg |
Clinical
Clinical Trials
34 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 | 4 | 1 | 1 | 8 | |
| Candidemia | D058387 | EFO_1001282 | — | — | 3 | 3 | — | 6 | |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | 1 | 3 | 2 | — | 5 |
| Mycoses | D009181 | B35-B49 | — | — | — | 3 | — | 3 | |
| Fungemia | D016469 | B49 | — | — | 2 | 1 | — | 3 | |
| Invasive candidiasis | D058365 | EFO_1001283 | B37 | — | — | 1 | 1 | 1 | 3 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | 1 | — | 1 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | 1 | — | 1 |
| Central nervous system fungal infections | D020314 | — | — | — | 1 | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | 1 | 2 | — | — | 1 | 3 | |
| Leukemia | D007938 | C95 | — | 1 | — | — | — | 1 | |
| Myelodysplastic syndromes | D009190 | D46 | — | 1 | — | — | — | 1 | |
| Myeloid leukemia acute | D015470 | C92.0 | — | 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 | |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 1 | — | — | — | 1 |
| Neoplasms | D009369 | C80 | 1 | 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 |
Indications Without Phase
No data
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 | 341018 |
| ChEMBL ID | CHEMBL264241 |
| ChEBI ID | 55346 |
| PubChem CID | 166548 |
| DrugBank | DB00362 |
| UNII ID | 9HLM53094I (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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147 adverse events reported
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