Dalteparin sodium
Other / unclassified targets SERPINC1 via activation
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | FRAGMIN | — | 1996-03-18 – 2024-10-15 | fda.gov ↗ |
| Approved | US (FDA) | FRAGMIN | — | 1994-12-22 | fda.gov ↗ |
Trials 57
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2017-12-13 | Daiichi Sankyo | Results Once-Daily, Oral LIXIANA® (edoxaban) Met Primary Endpoint in Investigational Hokusai-VTE CANCER Study daiichisankyo.com ↗
Hokusai-VTE CANCER is the first study with a direct oral anticoagulant (DOAC), edoxaban, to meet pre-specified non-inferiority criteria versus the standard of care dalteparin in this patient population. |
| 2007-05-07 | Eisai Inc. | Regulatory FDA Approves FRAGMIN®, an Injectable Anti-Clotting Agent, for Extended Treatment to Reduce the Recurrence of Blood Clots in Patients with Cancer eisai.com ↗
With this approval, FRAGMIN® is the first low-molecular-weight heparin (LMWH) approved in the U.S. for the extended treatment of recurrent VTE in patients with cancer. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-12-13 | Daiichi Sankyo | Once-Daily, Oral LIXIANA® (edoxaban) Met Primary Endpoint in Investigational Hokusai-VTE CANCER Study daiichisankyo.com ↗ |
| 2007-05-07 | Eisai Inc. | FDA Approves FRAGMIN®, an Injectable Anti-Clotting Agent, for Extended Treatment to Reduce the Recurrence of Blood Clots in Patients with Cancer eisai.com ↗ |
Evidence & citations 26 cited values
Every value below carries the sentence it was read from. 94 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dalteparin Sodium | “BACKGROUND: Dalteparin sodium, a low-molecular-weight heparin, is indicated for prevention of clotting in the extracorporeal circuit during hemodialysis (HD).” PMID 30542622 ↗ Nov 20188“Dalteparin sodium was administered at a daily dosage of 5,000 UI anti-Xa by subcutaneous route.” NCT00655122 ↗ “Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium.” NCT00662831 ↗ “Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium” NCT00765063 ↗ “Fragmin (Dalteparin Sodium)” NCT00564174 ↗ “Dalteparin sodium (Fragmin)” NCT01050153 ↗ |
| Known as | .alpha.-heparin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201460 ↗ |
| Known as | B01AB04 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201460 ↗ |
| Known as | Boxol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201460 ↗ |
| Known as | dalteparin | “The initial dose will be a twice daily therapeutic dose of 1.35U/kg (pregnancy weight) of enoxaparin or 135 U/kg (pregnancy weight) of dalteparin using prefilled syringes...” NCT07658989 ↗79“Enoxaparin, dalteparin, or tinzaparin are acceptable LMWHs to be used for patients in the investigational arm and dose should be based on measured or estimated weight of the patient.” NCT05848713 ↗ “BACKGROUND: Dalteparin sodium, a low-molecular-weight heparin, is indicated for prevention of clotting in the extracorporeal circuit during hemodialysis (HD).” PMID 30542622 ↗ Nov 2018 “LMWHs like Nadroparin and Dalteparin are no experimental pharmaceuticals; both have been registered in the Netherlands for these indications since 1989.” NCT01542762 ↗ “Enoxaparin 40mg once daily subcutaneous or dalteparin 5000IU once daily subcutaneous or nadroparin calcium 4100U once daily subcutaneous” NCT03671174 ↗ “Low-molecular-weight heparin (dalteparin or enoxaparin) was administered subcutaneously at a dose of 100 IU/kg every 12 hours (n = 352).” PMID 16926353 ↗ Aug 2006 “dalteparin, 200 IU/kg subcutaneously once daily for one month followed by 150 IU/kg subcutaneously once daily for 2 months” NCT02746185 ↗ “Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight \<100 kg for 6 weeks.” NCT05058924 ↗ “or dalteparin (200 IU/kg subcutaneous once daily or 100 IU/kg subcutaneous twice a day)” NCT04372589 ↗ “Dalteparin 5000 units daily or Enoxaparin 40 mg subcutaneous daily” NCT03200613 ↗ “Low-molecular weight heparin (dalteparin, enoxaparin, tinzaparin)” NCT03178864 ↗ |
| Known as | Dalteparin (Fragmin) | “Dalteparin (Fragmin®)” NCT01817257 ↗1“Dalteparin (Fragmin)” NCT03465735 ↗ |
| Known as | Dalteparin sodium (Fragmin) | “Dalteparin sodium (Fragmin)” NCT01050153 ↗ |
| Known as | DALTEPARIN SODIUM INJECTION | “A THREE MONTH PROSPECTIVE OPEN LABEL STUDY OF THERAPY WITH FRAGMIN(REGISTERED) (DALTEPARIN SODIUM INJECTION) IN CHILDREN WITH VENOUS THROMBOEMBOLISM WITH OR WITHOUT MALIGNANCIES” NCT00952380 ↗ |
| Known as | Dalteparin Sodium(DIN 02132648/NDC# 62856-500) | “Dalteparin Sodium(DIN 02132648/NDC# 62856-500)” NCT01274637 ↗ |
| Known as | Dalteparina de sodio | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201460 ↗ |
| Known as | dalteparine | “Dalteparine 5000 UI” NCT06845423 ↗ |
| Known as | Dalteparine sodique | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201460 ↗ |
| Known as | FR-860 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201460 ↗ |
| Known as | Fragmin | “The FRAGMATIC trial will assess the effect of adding dalteparin (FRAGMIN), a type of LMWH, to standard treatment for patients with lung cancer.” PMID 19807917 ↗ Oct 200915“Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium.” NCT00662831 ↗ “Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients” NCT00952380 ↗ “Dalteparin (Fragmin®) 5000 IU (International Unit) once daily” NCT01741506 ↗ “Fragmin (Dalteparin) LMWH verus Unfractionated Heparin (UFH)” NCT00182364 ↗ “Fragmin (Dalteparin Sodium)” NCT00564174 ↗ “Drug: Fragmin (dalteparin)” NCT00260988 ↗ “Dalteparin ( Fragmin)” NCT00435487 ↗ “dalteparine (Fragmin)” NCT00681785 ↗ “Dalteparin (Fragmin)” NCT00041782 ↗ “Dalteparin (Fragmin)” NCT00445328 ↗ |
| Known as | Fragmin (Dalteparin Sodium) | “Fragmin (Dalteparin Sodium)” NCT00564174 ↗ |
| Known as | Fragmin P Forte | “Fragmin P Forte (dalteparin sodium)” NCT00400387 ↗ |
| Known as | FRAGMIN(REGISTERED) | “A THREE MONTH PROSPECTIVE OPEN LABEL STUDY OF THERAPY WITH FRAGMIN(REGISTERED) (DALTEPARIN SODIUM INJECTION) IN CHILDREN WITH VENOUS THROMBOEMBOLISM WITH OR WITHOUT MALIGNANCIES” NCT00952380 ↗ |
| Known as | Fragmine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201460 ↗ |
| Known as | HEPARIN FRAGMENT KABI 2165 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201460 ↗ |
| Known as | KABI-2165 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201460 ↗ |
| Known as | Low liquemine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201460 ↗ |
| Action | Activate | “Antithrombin-III activator” CHEMBL1201460 ↗ |
| Action | Inhibit | “Dalteparin may be effective in inhibiting the growth of blood vessels in tumors” NCT00003674 ↗ |
| Modality | Other / unclassified | “Dalteparin Low Molecular Weight Heparin” NCT00135876 ↗ |
| Route | Subcutaneous | “dalteparin by subcutaneous injection once daily” NCT00003674 ↗ |
| Target | SERPINC1 | “Antithrombin-III activator” CHEMBL1201460 ↗ |