Dalteparin sodium
Fragmin (dalteparin sodium) is an oligosaccharide pharmaceutical. Dalteparin sodium was first approved as Fragmin on 1994-12-22. It is used to treat myocardial infarction, postoperative complications, pulmonary embolism, thromboembolism, and thrombophlebitis amongst others in the USA. The pharmaceutical is active against antithrombin-III.
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Commercial
Trade Name
FDA
EMA
Fragmin
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dalteparin sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FRAGMIN | Mylan | N-020287 RX | 1994-12-22 | 9 products, RLD |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fragmin | New Drug Application | 2020-09-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myocardial infarction | EFO_0000612 | D009203 | I21 |
| postoperative complications | — | D011183 | — |
| pulmonary embolism | EFO_0003827 | D011655 | I26 |
| thromboembolism | HP_0001907 | D013923 | — |
| thrombophlebitis | HP_0004418 | D013924 | — |
| unstable angina | EFO_1000985 | D000789 | I20.0 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J1645 | Injection, dalteparin sodium, per 2500 iu |
Clinical
Clinical Trials
45 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | 8 | 1 | — | 9 |
| Spasm | D013035 | M62.83 | — | — | 1 | 1 | 1 | 3 | |
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | — | 2 | — | 3 |
| Low back pain | D017116 | HP_0003419 | M54.5 | — | — | 1 | 1 | — | 2 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | 1 | — | 1 | |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | 1 | — | 1 |
| Sleep | D012890 | GO_0030431 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 3 | 4 | — | — | 7 |
| Musculoskeletal pain | D059352 | — | — | 2 | — | — | 2 | ||
| Muscular diseases | D009135 | EFO_0002970 | G72.9 | — | — | 2 | — | — | 2 |
| Nervous system diseases | D009422 | G00-G99 | — | — | 2 | — | — | 2 | |
| Rheumatic diseases | D012216 | M79.0 | — | — | 2 | — | — | 2 | |
| Musculoskeletal diseases | D009140 | — | — | 2 | — | — | 2 | ||
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | 2 | — | — | 2 | |
| Neuromuscular diseases | D009468 | EFO_1001902 | G70.9 | — | — | 2 | — | — | 2 |
| Acute pain | D059787 | R52 | — | — | 1 | — | — | 1 | |
| Neck pain | D019547 | HP_0030833 | M54.2 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep initiation and maintenance disorders | D007319 | F51.01 | — | 1 | — | — | — | 1 | |
| Covid-19 | D000086382 | U07.1 | — | 1 | — | — | — | 1 | |
| Post-acute covid-19 syndrome | D000094024 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 1 | 1 |
| Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 1 | 1 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 1 | 1 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | — | — | — | 1 | 1 |
| Synovitis | D013585 | EFO_0008997 | M67.5 | — | — | — | — | 1 | 1 |
| Radiculopathy | D011843 | M54.1 | — | — | — | — | 1 | 1 | |
| Gout | D006073 | EFO_0004274 | M10 | — | — | — | — | 1 | 1 |
| Ankle fractures | D064386 | S82.5 | — | — | — | — | 1 | 1 | |
| Bunion | D000071378 | M21.61 | — | — | — | — | 1 | 1 | |
| Hammer toe syndrome | D037801 | EFO_1001336 | M21.53 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DALTEPARIN SODIUM |
| INN | dalteparin sodium |
| Description | Dalteparin is a low molecular weight heparin. It is marketed as Fragmin. Like other low molecular weight heparins, dalteparin is used for prophylaxis or treatment of deep vein thrombosis and pulmonary embolism to reduce the risk of a stroke or heart attack. Dalteparin acts by potentiating the activity of antithrombin III, inhibiting formation of both Factor Xa and thrombin. It is normally administered by self-injection.
|
| Classification | Oligosaccharide |
| Drug class | heparin derivatives and low molecular weight (or depolymerized) heparins |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | 67109 |
| ChEMBL ID | CHEMBL1201460 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06779 |
| UNII ID | 12M44VTJ7B (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
Clinical Variant
No data
Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 264 documents
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Safety
Black-box Warning
Black-box warning for: Fragmin
Adverse Events
Top Adverse Reactions
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9,511 adverse events reported
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