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 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 36 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03100123 Comparator | Nov 2017 → Oct 2019 | antiphospholipid syndrome, pregnancy disorder with abortive outcome | Ottawa Hospital Research Institute | Terminated | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT05189002 Comparator | May 2019 → Aug 2021 | venous thromboembolism | PharmaDiall Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT03178864 Comparator | Mar 2019 → Oct 2022 | cerebral sinovenous thrombosis | University of British Columbia | Completed | No outcome recorded |
| Phase 2 | NCT03139487 Comparator | Aug 2017 → Sep 2021 | ampulla of vater cancer, esophageal cancer, gastric cancer, gastroesophageal cancer +3 | Asan Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT01648036 Comparator | Jul 2012 → Jan 2014 | infectious disease with sepsis | University of Manitoba | Completed | No outcome recorded |
| Phase 2 | NCT00239980 Comparator | Oct 2005 → Jan 2010 | ovarian carcinoma | Ontario Clinical Oncology Group (OCOG) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00260988 Comparator | Oct 2003 → Nov 2008 | thrombotic disease | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 316 trials | ||||||
| Phase 3 | NCT07228663 Comparator | Dec 2025 → Jul 2027 expected | venous thromboembolism | McMaster University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06370273 Comparator | Nov 2024 → Aug 2028 expected | thrombotic disease | Queen Mary University of London | Recruiting | No outcome recorded |
| Phase 3 | NCT06153394 Comparator | Jun 2024 → Feb 2025 overdue | liver disorder, thrombophilia, thrombotic disease | Western University, Canada | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05171075 Comparator | Sep 2022 → Apr 2026 | pulmonary embolism, venous thromboembolism | Anthos Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT04536272 Comparator | Oct 2020 → Mar 2025 | heart failure, hemorrhagic disease, respiratory failure, thrombotic disease | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 3 | NCT03559114 Comparator | Jul 2018 → Dec 2026 expected | traumatic brain injury | Sunnybrook Health Sciences Centre | Recruiting | No outcome recorded |
| Phase 3 | NCT03045406 Comparator | Apr 2017 → Jun 2019 | venous thromboembolism | Fadoi Foundation, Italy | Completed | No outcome recorded |
| Phase 3 | NCT02746185 Comparator | Sep 2016 → Apr 2018 | neoplasm, venous thromboembolism | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT02583191 Comparator | Mar 2016 → Jun 2019 | cancer, venous thromboembolism | AIO-Studien-gGmbH | Terminated | No outcome recorded |
| Phase 3 | NCT02073682 Comparator | Jul 2015 → Sep 2017 | cancer, pulmonary embolism, venous thromboembolism | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT01164046 Comparator | Aug 2010 → Jul 2014 | neoplasm, venous thromboembolism | University Medical Center Groningen | Terminated | No outcome recorded |
| Phase 3 | NCT00421538 Comparator | Jan 2008 → May 2015 | venous thromboembolism | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 3 | NCT00432796 Comparator | Dec 2006 → Mar 2019 | stroke disorder | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Unknown | No outcome recorded |
| Phase 3 | NCT00182143 Comparator | May 2006 → Jun 2010 | venous thromboembolism | McMaster University | Completed | No outcome recorded |
| Phase 3 | NCT00238667 Comparator | Nov 2005 → May 2014 | carotid artery dissection, stroke disorder, vertebral artery dissection | St George's, University of London | Completed | No outcome recorded |
| Phase 3 | NCT00967382 Comparator | Jul 2000 → Mar 2014 | pregnancy disorder, thrombophilia | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT06020560 Comparator | Mar 2023 → Mar 2025 | venous thromboembolism | Herlev Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01828697 Comparator | Apr 2013 → Oct 2021 | pulmonary embolism, venous thromboembolism | Academic Medical Center - University of Amsterdam | Completed | No outcome recorded |
| Phase 4 | NCT01245998 Comparator | Dec 2010 → Dec 2012 | thrombophlebitis | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 4 | NCT01714297 Comparator | Jan → Jun 2008 | infectious disease | Vestre Viken Hospital Trust | Completed | No outcome recorded |
| Phase 4 | NCT00655122 Comparator | Apr → Dec 2003 | hyperheparinemia, venous thromboembolism | Pfizer | Terminated | No outcome recorded |
| Phase 4 | NCT00264381 Comparator | Oct 2002 → Sep 2009 | thrombophlebitis | University of Oklahoma | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT05058924 Comparator | Aug 2021 → Feb 2024 | venous thromboembolism | Mount Sinai Hospital, Canada | Completed | No outcome recorded |
| — | NCT03671174 Background | Aug 2019 → Sep 2021 | habitual spontaneous abortion, undifferentiated connective tissue syndrome | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT03465735 Background | Jan 2017 → Aug 2019 | venous thromboembolism | Mayo Clinic | Terminated | No outcome recorded |
| — | NCT02744092 Comparator | Dec 2016 → Oct 2020 | cancer, pulmonary embolism, thrombotic disease, venous thromboembolism | Alliance Foundation Trials, LLC. | Completed | No outcome recorded |
| — | NCT01050153 Comparator | Mar 2010 → Dec 2011 | venous thromboembolism | Denver Health and Hospital Authority | Completed | No outcome recorded |
| — | NCT00726570 Background | Aug 2008 → Nov 2010 | blood coagulation disease | University of Parma | Terminated | No outcome recorded |
| — | NCT00681785 Comparator | Jun 2006 → Dec 2007 | — | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
Evidence & citations 28 cited values
Every value below carries the sentence it was read from. 95 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 ↗ “Dalteparin sodium (Fragmin)” NCT01050153 ↗ “Fragmin (Dalteparin Sodium)” NCT00564174 ↗ |
| 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 ↗ “LMWH options include: Tinzaparin, Enoxaparin, or Dalteparin.” NCT04444700 ↗ “LMWH options include: Tinzaparin, Enoxaparin or Dalteparin.” NCT04362085 ↗ “Dalteparin, Enoxaparin, Nadroparin, Tinzaparin” NCT06494878 ↗ “Dalteparin: 5000 IU subcutaneously OD” NCT07228663 ↗ “Dalteparin 200 I.E./kg BW once daily” NCT02583191 ↗ “dalteparin 5000-7500IU o.d.” NCT07140211 ↗ “Fragmin (Dalteparin Sodium)” NCT00564174 ↗ “Dalteparin (Fragmin®)” NCT01817257 ↗ “Dalteparin (Fragmin)” NCT03465735 ↗ “Dalteparin” NCT01419977 ↗ “dalteparin” NCT01164046 ↗ “Dalteparin” NCT03100123 ↗ |
| 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 ↗ “dalteparine (Fragmin)” NCT00681785 ↗ “Dalteparin ( Fragmin)” NCT00435487 ↗ “Dalteparin (Fragmin)” NCT00445328 ↗ “Dalteparin (Fragmin)” NCT00041782 ↗ |
| 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 ↗ |
| Known as | nadroparine | “Nadroparine 2850 UI” NCT06845423 ↗ |
| Known as | nadroparine calcium | “Once-daily injection of 171 U/Kg/day of nadroparine calcium for 6 weeks.” NCT00421538 ↗ |
| 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 ↗ |