Fondaparinux sodium
Arixtra, Fondaparinux (fondaparinux sodium) is an oligosaccharide pharmaceutical. Fondaparinux sodium was first approved as Arixtra on 2001-12-07. It is used to treat pulmonary embolism and venous thrombosis in the USA. It has been approved in Europe to treat myocardial infarction, pulmonary embolism, unstable angina, and venous thrombosis. The pharmaceutical is active against antithrombin-III.
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Commercial
Therapeutic Areas
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FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| arixtra | New Drug Application | 2020-08-20 |
| fondaparinux sodium | ANDA | 2024-11-05 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J1652 | Injection, fondaparinux sodium, 0.5 mg |
Clinical
Clinical Trials
93 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thromboembolism | D013923 | HP_0001907 | — | 1 | 2 | 15 | 4 | 15 | 36 |
| Thrombosis | D013927 | — | — | 2 | 5 | 9 | 1 | 13 | 29 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | 1 | 1 | 9 | 2 | 13 | 25 |
| Embolism | D004617 | — | — | 1 | 3 | 3 | 1 | 7 | 14 |
| Pulmonary embolism | D011655 | HP_0002204 | I26 | 1 | 2 | 3 | 1 | 7 | 13 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | 1 | 3 | 2 | 7 |
| Covid-19 | D000086382 | — | — | — | 1 | 2 | 1 | 1 | 5 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | 1 | 1 | — | 2 | 1 | 5 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | — | 2 | 1 | 1 | 4 |
| Thrombophlebitis | D013924 | HP_0004418 | — | — | — | 2 | 1 | 1 | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | 1 | 4 | 8 | — | 12 | 24 |
| Neoplasms | D009369 | — | C80 | — | — | 1 | — | 4 | 5 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | 1 | — | 1 | 3 |
| Infarction | D007238 | EFO_0009463 | — | — | 1 | 1 | — | 1 | 3 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 1 | 1 | — | — | 2 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | 2 | — | — | 2 |
| Hemostatic disorders | D020141 | — | — | — | — | 2 | — | — | 2 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | 2 | — | — | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | 1 | — | — | 1 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 1 | — | — | 3 | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 2 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | 1 | — | — | — | 1 |
| Embolism and thrombosis | D016769 | — | — | — | 1 | — | — | — | 1 |
| Pneumonia | D011014 | EFO_0003106 | — | — | 1 | — | — | — | 1 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 1 | — | — | — | 1 |
| Coronary disease | D003327 | — | — | — | 1 | — | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | 1 | — | — | — | 1 |
| Sarcoma | D012509 | — | — | — | 1 | — | — | — | 1 |
| Fallopian tube neoplasms | D005185 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | — | — | — | 1 | 2 |
| Morbid obesity | D009767 | EFO_0001074 | — | 1 | — | — | — | 1 | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | — | 1 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 2 | 2 |
| Ataxia | D001259 | — | R27.0 | — | — | — | — | 2 | 2 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | — | 2 | 2 |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | — | — | — | 1 | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 1 | 1 |
| St elevation myocardial infarction | D000072657 | — | — | — | — | — | — | 1 | 1 |
| Drug therapy | D004358 | — | — | — | — | — | — | 1 | 1 |
| Percutaneous coronary intervention | D062645 | — | — | — | — | — | — | 1 | 1 |
| Esophageal neoplasms | D004938 | — | C15 | — | — | — | — | 1 | 1 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fondaparinux sodium |
| INN | fondaparinux sodium |
| Description | Fondaparinux is a synthetic pentasaccharide which, apart from the O-methyl group at the reducing end of the molecule, consists of monomeric sugar units which are identical to a sequence of five monomeric sugar units that can be isolated after either chemical or enzymatic cleavage of the polymeric glycosaminoglycans heparin and heparan sulfate. It has a role as an anticoagulant. It is an amino sugar, an oligosaccharide sulfate and a pentasaccharide derivative. It is functionally related to a normethylfondaparinux. It is a conjugate acid of a fondaparinux(10-). |
| Classification | Oligosaccharide |
| Drug class | antihrombotic indirect selective synthetic factor Xa inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CO[C@H]1O[C@H](COS(=O)(=O)[O-])[C@@H](O[C@@H]2O[C@@H](C(=O)[O-])[C@@H](O[C@H]3O[C@H](COS(=O)(=O)[O-])[C@@H](O[C@@H]4O[C@H](C(=O)[O-])[C@@H](O[C@H]5O[C@H](COS(=O)(=O)[O-])[C@@H](O)[C@H](O)[C@H]5NS(=O)(=O)[O-])[C@H](O)[C@H]4O)[C@H](OS(=O)(=O)[O-])[C@H]3NS(=O)(=O)[O-])[C@H](O)[C@H]2OS(=O)(=O)[O-])[C@H](O)[C@H]1NS(=O)(=O)[O-].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+] |
Identifiers
| PDB | — |
| CAS-ID | 104993-28-4 |
| RxCUI | 321208 |
| ChEMBL ID | CHEMBL1200644 |
| ChEBI ID | — |
| PubChem CID | 5282448 |
| DrugBank | DB00569 |
| UNII ID | J177FOW5JL (ChemIDplus, GSRS) |
Target
Agency Approved
SERPINC1
SERPINC1
Organism
Homo sapiens
Gene name
SERPINC1
Gene synonyms
AT3
NCBI Gene ID
Protein name
antithrombin-III
Protein synonyms
serine (or cysteine) proteinase inhibitor, clade C (antithrombin), member 1, Serpin C1, serpin peptidase inhibitor clade C member 1, serpin peptidase inhibitor, clade C (antithrombin), member 1
Uniprot ID
Mouse ortholog
Serpinc1 (11905)
antithrombin-III (P32261)
Alternate
No data
Variants
No data
Financial
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Arixtra, Fondaparinux sodium
Adverse Events
Top Adverse Reactions
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8,429 adverse events reported
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