Collaborative Risk-stratified Investigation in Teen Inpatients With Critical Illness: Anticoagulation With LMWH in Kids for ThromboProphylaxis (CRITICAL-Kids-TP)

Critically ill adolescents are at greatest risk for developing hospital-acquired venous thromboembolism. To date, no phase 3 randomized controlled trials have been conducted for pharmacological thromboprophylaxis as primary venous thromboembolism prevention in children. The investigators will perform a United States definitive multicenter phase 3 randomized controlled trial of the low molecular weight heparin dalteparin as primary venous thromboembolism prophylaxis among critically ill adolescents who are classified a priori as high risk based upon the investigators validated risk prediction models.

Start Date31 Oct 2025

Sponsor / Collaborator

Johns Hopkins All Children's Hospital

[+1]

NCT06370273

/ RecruitingPhase 3

Thromboprophylaxis in Lower Limb Immobilisation (TiLLI): a Multicentre Study Comprising Two Linked Open Label Phase III Randomised Controlled Trials Evaluating the Effectiveness and Cost Effectiveness of Different Methods of Pharmacological Prophylaxis for Patients With Temporary Lower Limb Immobilisation.

The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury.
The main questions it aims to answer are:
* whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care)
* whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots.
Participants will be assessed to be high risk (TiLLI High) or low risk (TiLLI Low). People who are at high risk of clots will have either tablets or injections to reduce their risk. People at low risk will receive tablets, injections or no medication.
Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidelines. The participants will be followed up for 90 days following randomisation.

Start Date12 Nov 2024

Sponsor / Collaborator

Queen Mary University of London

NCT06583330

/ Not yet recruitingNot ApplicableIIT

A Multicenter, Open-Label, Non-Inferiority Randomized Controlled Trial of Postoperative VTE Prevention in Chinese Patients After Colorectal Cancer Surgery

research objective
1. Optimize VTE prevention management after CRC surgery.
2. Improve the prevention and treatment level of VTE in current perioperative patients.
3. Reduce the social burden of VTE related diseases.
Participants will:
1. start low molecular weight heparin prophylaxis within 24 hours post-surgery.
2. The prophylactic regimen for the experimental group lasted 14 days, while the control group received it for 28 days. Low molecular weight heparin is given subcutaneously at a dose of 0.3ml once daily.
3. atients underwent lower limb color Doppler ultrasound on postoperative days 7 ± 2, 14 ± 3, and 28 ± 5, which included screening for thrombosis in the proximal deep veins (femoral, popliteal), distal deep veins (posterior tibial, fibular, and muscular veins), and their perforating branches.

Start Date01 Oct 2024

Sponsor / Collaborator

Beijing Friendship Hospital

100 Clinical Results associated with Dalteparin Sodium

100 Translational Medicine associated with Dalteparin Sodium

100 Patents (Medical) associated with Dalteparin Sodium

1,340

Literatures (Medical) associated with Dalteparin Sodium

01 Dec 2025·European Journal of Trauma and Emergency Surgery

Anti-xa guided enoxaparin thromboprophylaxis is associated with less thromboembolism than fixed dose dalteparin in trauma patients admitted to intensive care

Article

Author: Rizoli, Sandro ; Kanbar, Ahad ; Khan, Naushad Ahmad ; Alaieb, AbuBaker ; Kloub, Ahmad ; Abumusa, Suha ; Abulkhair, Tarik ; El-Menyar, Ayman ; Al-Thani, Hassan ; Alishaq, Fajer ; Hinawi, Yazan ; Asim, Mohammad

Abstract:

Background:

Venous Thromboembolism (VTE) is a common, preventable complication in trauma. Low-molecular-weight heparin (LMWH) is recommended for VTE prophylaxis (VTEp). We investigated whether switching from fixed-dose dalteparin to anti-Xa-guided enoxaparin prophylaxis reduces VTE without increasing the risk of bleeding among hospitalized trauma patients.

Methods:

This observational study compared injured patients admitted one year before (pre-P) and after (post-P) implementing a new VTEp protocol. The protocol was introduced as a performance improvement project (subcutaneous enoxaparin 30 mg twice daily), with dose calibration to peak plasma Anti-Xa level measured after the 3rd dose. The primary outcomes were the rate of VTE and bleeding.

Results:

After protocol implementation (post-P), 305 patients were compared to 350 pre-protocol patients (pre-P). Anti-Xa levels were measured in 83% of post-P and none in the pre-P. 40% had low levels of anti-Xa, suggesting inadequate prophylaxis, and enoxaparin doses were accordingly increased. 51% attained the desired anti-Xa levels, 9% had higher levels, and LMWH doses were subsequently reduced. VTE incidence after protocol implementation decreased from 4 to 1.3% (OR 0.31; 95% CI 0.1–0.9, P = 0.03) without increasing the bleeding rate. The time intervals between two consecutive PE events were significantly longer after protocol implementation. Among TBI patients, the rate of VTE was lower. However, it did not reach statistical significance. 75% of patients with VTE had low anti-Xa levels, while 20% of those with bleeding had high anti-Xa levels.

Conclusion:

Among adult patients in the trauma ICU, compared to a fixed dose dalteparin, enoxaparin prophylaxis with dose calibration according to peak anti-Xa levels was associated with lower VTE rates without increasing the risk of bleeding. About 40% of patients who received initial enoxaparin doses of 30 mg twice daily had anti-Xa levels suggestive of inadequate prophylaxis. Calibrating LMWH dosing may improve VTEp following traumatic injury.

21 Oct 2025·NEUROLOGY

Intracranial Hemorrhage With Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin in Brain Tumors

Review

Author: Fuse, Kenshiro ; Rhee, John Y. ; Goulart, Thiago Oscar ; Wang, Chen ; Zambrano, Daniela ; Bukhari, Yasir

BACKGROUND AND OBJECTIVES:

Patients with brain tumors face an increased risk of arterial and venous thromboembolic events. However, owing to risk of intracranial hemorrhage (ICH), clinician practice patterns vary on preference for anticoagulation treatment. This meta-analysis evaluates the safety of direct oral anticoagulants (DOACs) vs low-molecular-weight heparin (LMWH) on the development of ICH in patients with brain tumor.

METHODS:

We searched MEDLINE, Embase, Web of Science, and Cochrane Central Register of Controlled Trials (January 2010-June 2025) for randomized-controlled trials or cohort studies enrolling adults (age ≥18 years) with primary or metastatic brain tumors receiving therapeutic DOACs (apixaban, rivaroxaban, edoxaban, betrixaban, and dabigatran) vs LMWH (enoxaparin, dalteparin, nadroparin, and tinzaparin). Studies limited to prophylactic dosing or non-brain tumor patients were excluded. Pooled risk ratios (RRs) with 95% CIs were calculated using a restricted random-effects model. Heterogeneity (I²) and bias were evaluated, with prespecified subgroups (tumor type, follow-up duration, and study quality) and sensitivity analyses. The study protocol was registered on PROSPERO (CRD42025635334).

RESULTS:

Among 762 publications identified, 10 retrospective cohort studies (1,572 patients: 645 DOAC, 895 LMWH) were included. Patients' mean or median age ranged 60.4-67 years (DOAC) vs 53-64 years (LMWH), with follow-up durations ranging from 3 to 12 months. Patients with primary or metastatic brain tumors receiving DOACs had a statistically significantly lower risk of any ICH compared with LMWH (RR = 0.50, 95% CI 0.29-0.87; p = 0.01, I² = 49.50%). Reduction was more pronounced in 3 studies with three-month follow-up (RR = 0.23, 95% CI 0.09-0.57; p < 0.01, I² < 0.01%). Stratified analyses showed reduced ICH risk with DOACs in primary brain tumors (5 studies, RR = 0.20, 95% CI 0.08-0.54; p < 0.01, I² < 0.01%) but not in metastatic brain tumors (5 studies, RR = 0.86, 95% CI 0.44-1.68; p = 0.66, I² = 36.04%). Leave-one-out analyses confirmed robustness, and cumulative meta-analysis demonstrated stable estimates with narrowing CIs. Egger (p = 0.19) and Begg (p = 0.59) tests showed no statistical evidence of publication bias.

DISCUSSION:

In the current meta-analysis, DOACs were associated with significantly lower ICH risk than LMWH in patients with anticoagulated brain tumor, particularly those with primary brain tumors. Findings support DOACs as a safe anticoagulant in arterial and venous thromboembolism. Given observational designs with inherent confounding, findings warrant cautious interpretation.

01 Oct 2025·JOURNAL OF THROMBOSIS AND HAEMOSTASIS

The risk of bleeding in pregnant women with acute venous thromboembolism treated with anticoagulants: an international multidatabase cohort study

Article

Author: Douros, Antonios ; Simard, Camille ; Filion, Kristian B ; Tagalakis, Vicky ; Enders, Dirk ; Malhamé, Isabelle ; Vivirito, Annika ; Filliter, Christopher ; Abenhaim, Haim

BACKGROUND:

Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism, is a major cause of maternal mortality. Low-molecular-weight heparin (LMWH) is the mainstay of therapy for VTE during pregnancy. However, the effects of different LMWH types and dosing regimens on bleeding risk remain unclear.

OBJECTIVES:

To compare the risk of major bleeding among pregnant women with acute VTE treated with the most used therapeutic dose LMWH, dalteparin in Québec and enoxaparin in Germany, vs other LMWHs. We also examined the impact of once-daily vs. twice-daily LMWH dosing on bleeding outcomes.

METHODS:

This multinational retrospective cohort study used population-level healthcare data from Québec, Canada, and Germany and included women with acute VTE during pregnancy who initiated therapeutic doses of LMWH within 15 days of an incident VTE. We used Cox proportional hazards models to compare the risk of major bleeding associated with different LMWHs.

RESULTS:

The study cohort included 567 pregnant women (Germany: n = 308; Québec: n = 259) with VTE treated with LMWH. Major bleeding occurred in 6.5% to 7.7% of patients in both cohorts. The hazard ratios (95% CIs) for the most prescribed LMWH vs other LMWHs were 0.9 (0.3-2.5) in Québec and 1.4 (0.5-4.1) in Germany. No significant differences in bleeding risk were found between once-daily and twice-daily dosing schedules.

CONCLUSION:

Our multinational cohort study provided population-based incidence rates for bleeding related to LMWH use during VTE treatment in pregnancy. Moreover, while hypothesis-generating, our findings suggest that the LMWH type and dosing frequency may not influence bleeding risk in pregnant women with VTE. Further research is necessary to explore anticoagulation strategies to optimize outcomes and minimize bleeding complications.

News (Medical) associated with Dalteparin Sodium

11 Feb 2025

·pipelinereview.com

Novartis bolsters late-stage cardiovascular pipeline with agreement to acquire Anthos Therapeutics for USD 925 million upfront

BASEL, Switzerland I February 11, 2025 I Novartis today announced that it has entered into an agreement to acquire Anthos Therapeutics, Inc., a Boston-based, privately held, clinical-stage biopharmaceutical company with abelacimab, a late-stage medicine in development for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The transaction, which is subject to customary closing conditions, is fully in line with Novartis’ growth strategy and therapeutic area focus, leveraging the company’s strength and expertise in the cardiovascular area. Anthos Therapeutics, launched by Blackstone Life Sciences and Novartis in 2019, has advanced abelacimab through clinical development under a license from Novartis. Abelacimab is a novel, highly selective, fully human monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation through Factor XI inhibition. Phase 2 data showed a significant reduction in bleeding events in patients taking abelacimab versus a standard of care direct-oral anticoagulant in patients with atrial fibrillation (AZALEA 1,2 ). Three Phase 3 clinical trials are ongoing for patients at risk of arterial and venous clots, one in patients with atrial fibrillation (LILAC-TIMI 76 3 ) and two in cancer associated thrombosis (ASTER 4 ) and (MAGNOLIA 5 ). “We are excited to join forces to advance the development of abelacimab, a potential first-in-class treatment and safer approach for stroke prevention in atrial fibrillation as well as cancer-associated thrombosis,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “Welcoming Anthos Therapeutics strengthens our focus in the cardiovascular space and complements our portfolio of life-changing treatments, comprehensive clinical programs, and strategic collaborations that help thousands of patients with heart disease around the world.” In July 2022 abelacimab received a Fast Track Designation from the FDA for the treatment of thrombosis associated with cancer. In September 2022 abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation. “Abelacimab is a potential first-in-class medicine, which promises to be an effective and safer approach to preventing thrombosis and stroke than the current standards of care.” said David Soergel, M.D., Global Head, Cardiovascular, Renal and Metabolism Development Unit, Novartis. “We are proud that this medicine originated at Novartis and have been impressed with the Anthos Therapeutics team’s expertise and dedication and with the great progress they have made on the program. Now is the right time to bring abelacimab back into the Novartis CRM pipeline.” Transaction Details Under the terms of the agreement, Novartis will make an upfront payment of USD 925 million upon closing of the transaction, subject to certain customary adjustments, and potential additional payments of up to USD 2.15 billion upon achievement of specified regulatory and sales milestones. The transaction is expected to close in the first half of 2025, subject to satisfaction of customary closing conditions. About Abelacimab Abelacimab is a novel, investigational, highly selective, fully human monoclonal antibody that binds tightly to Factor XI to block its activation and prevent the generation of the activated form (Factor XIa). This mimics natural Factor XI deficiency, which is associated with protection from thromboembolic disease. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn , Facebook , X/Twitter and Instagram . References 1. Samer Al Said, et al. Bleeding with the FXI Inhibitor Abelacimab compared with Rivaroxaban in Patients on Antiplatelet therapy: A Prespecified Analysis of the AZALEA-TIMI 71 Trial. Available from: https://timi.org/wp-content/uploads/2024/11/Samer-Al-Said-Bleeding-with-the-FXI-Inhibitor-Abelacimab-compared-with-Rivaroxaban-in-Patients-on-Antiplatelet-therapy-A-Prespecified-Analysis-of-the-AZALEA-TIMI-71-Trial-.pdf . Accessed February 2024. 2. Ruff C, Patel S, et al. Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation. N Engl J Med. 2025; 392 (4):361-371.doi:10.1056/NEJMoa2406674 3. ClinicalTrials.gov . NCT05712200. Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76) (LILAC-TIMI 76). Available from: https://clinicaltrials.gov/study/NCT05712200?term=NCT05712200&rank=1 . Accessed February 2024. 4. ClinicalTrials.gov . NCT05171049. A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE. Available from: https://clinicaltrials.gov/study/NCT05171049 . Accessed February 2024. 5. ClinicalTrials.gov . NCT05171075. A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/ Genitourinary Cancer and Associated VTE (MAGNOLIA). Available from: https://clinicaltrials.gov/study/NCT05171075. Accessed February 2024 . SOURCE: Novartis

Clinical ResultFast TrackPhase 2Phase 3Acquisition

11 Feb 2025

·endpts.com

Novartis returns for its anticoagulant in up to $3.1B buy of Blackstone’s Anthos

Nearly six years to the day after offloading its factor XI inhibitor to Blackstone Life Sciences, Novartis is swooping up the monoclonal antibody for $925 million upfront and up to $3.1. billion total if certain regulatory and commercial milestones are met. The Wednesday move for Anthos Therapeutics’ abelacimab marks a key moment for multiple parties. The deal adds to the Swiss pharma giant’s late-stage cardiovascular pipeline with three Phase 3 trials underway. It brings another large pharma to the factor XI table, joining Bayer, the duo of Johnson & Johnson and Bristol Myers Squibb, and Regeneron, among others. It also lines up a successful exit for Blackstone Life Sciences just in time for it to pitch the story to investors: The alternative asset manager is currently fundraising another pool of capital to back late-stage clinical development companies, with a target that at a minimum matches its last fund of $5 billion. And for one individual, Bill Meury, it marks the second multibillion-dollar M&A exit in 14 months. Meury served as CEO of Karuna Therapeutics when Bristol Myers swarmed in with $14 billion to gain access to its schizophrenia medicine, which was subsequently approved. He joined Anthos as CEO last April and quickly brought in his right-hand man Will Kane — the former Karuna chief commercial officer — for the same role, plus the title of president. He had also tapped former Turnstone Biologics and Seagen executive Venkat Ramanan as chief financial officer. Novartis said it anticipates the deal will close before the second half of the year. It marks a potentially long sale process for the biotech, as Reuters reported in December 2023 that Blackstone was exploring an M&A exit for Anthos, according to unnamed sources. The “natural home for this has always been Novartis,” Nicholas Galakatos, Anthos chair and global leader of Blackstone Life Sciences, told Endpoints News on Wednesday morning. While “stroke prevention was not the highest priority” six years ago, it returned to favor, Galakatos said. Anthos means “flower” in Greek. “It blossomed and Novartis picked it,” he said. “We are proud that this medicine originated at Novartis and have been impressed with the Anthos Therapeutics team’s expertise and dedication and with the great progress they have made on the program,” David Soergel, who leads Novartis’ cardiovascular, renal and metabolism (CRM) drug development, said in a statement. “Now is the right time to bring abelacimab back into the Novartis CRM pipeline.” It follows another $3 billion deal from last week. Bain Capital said it would buy centuries-old Mitsubishi Tanabe Pharma to help boost the Japanese pharmaceutical industry. J&J , Eli Lilly and GSK also disclosed M&A moves during the JP Morgan Healthcare Conference. Aside from J&J’s $14 billion takeover of commercial drugmaker Intra-Cellular Therapies, all the deals have fallen into the tuck-in range that pharmas favored last year . While Anthos launched with $250 million from Blackstone, a behemoth with the firepower to provide additional capital, the biotech would likely eventually need a large pharma company to help it launch into a massive market that other top-tier drugmakers also seek to enter. Novartis, which had retained a minority stake in Anthos when it split ties with the antibody, has the capabilities of launching medicines worldwide and the wherewithal to finalize those three pivotal trials and regulatory interactions needed to get approval. Novo Holdings also held a minority stake. “With its deep roots in the cardiovascular space, Novartis is especially well positioned to advance abelacimab’s clinical development and bring this innovative product to healthcare providers and patients,” Meury said in a release. Anthos, Regeneron, Bayer and BMS-allied J&J are all developing forms of factor XI inhibitors, which seek to take advantage of genetic studies showing factor XI deficiency could reduce rates of myocardial infarction, stroke and other cardiovascular problems. For Anthos, the initial focus is on patients with atrial fibrillation and cancer-associated thrombosis. It has FDA fast track tags across both areas. All three Phase 3 trials are slated to wrap up in 2026, according to the federal clinical trial database. Blackstone said the trials should have data in the second half of 2026. The atrial fibrillation trial is comparing abelacimab to placebo on the rate of ischemic stroke or systemic embolism. It’s estimated to enroll 1,900 patients. Meanwhile, one of the late-stage cancer studies is comparing abelacimab to BMS and Pfizer’s factor Xa inhibitor Eliquis in 1,655 patients with cancer-associated venous thromboembolism (VTE). The other is testing Anthos’ candidate against the blood thinner dalteparin in 1,020 patients with gastrointestinal/genitourinary cancer-associated VTE. Editor’s note: This story was updated to include comments from Anthos chair Nicholas Galakatos.

Executive ChangePhase 3AcquisitionDrug Approval

08 Dec 2023

·synapse.patsnap.com

What are factor Xa inhibitors and how do you quickly get the latest development progress?

Factor Xa inhibitors are a class of anticoagulant drugs that work by inhibiting Factor Xa, a key enzyme in the coagulation cascade. The development of Factor Xa inhibitors began in the early 1980s, with the first inhibitor, antistasin, being isolated from the salivary glands of the Mexican leech Haementeria officinalis in 1987. Four drugs from this class are currently marketed worldwide. Rivaroxaban (Xarelto) was the first approved Factor Xa inhibitor, becoming commercially available in Europe and Canada in 2008. This was followed by the approval of apixaban (Eliquis) in Europe in 2011 and in the United States in 2012. Edoxaban (Lixiana, Savaysa) was approved in Japan in 2011 and in Europe and the US in 2015. The most recent addition to this class is betrixaban (Bevyxxa), which was approved in the US in 2017¹ Looking ahead, Factor Xa inhibitors are expected to continue to play a significant role in anticoagulant therapy. They are just as efficacious as low molecular weight heparin (LMWH) and warfarin but are given orally and don't need as strict monitoring. However, the emergence of resistance and the lack of an effective reversal drug when bleeding occurs are challenges that need to be addressed. Ongoing research and development efforts are focused on addressing these issues and expanding the clinical applications of Factor Xa inhibitors The analysis of target factor Xa in the pharmaceutical industry reveals a competitive landscape with multiple companies focusing on its development. Pfizer Inc., Bristol Myers Squibb Co., AstraZeneca PLC, Daiichi Sankyo Co., Ltd., and Bayer AG are among the companies growing the fastest under this target. The indications for drugs targeting factor Xa cover a wide range of cardiovascular and thrombotic conditions, indicating their potential in treating these diseases. Small molecule drugs, chemical drugs, and recombinant coagulation factors are progressing rapidly under this target. The European Union, the United States, and Japan are leading in terms of drug development, but China has also shown progress. Further analysis is required to understand the specific progress in China and its impact on the future development of target factor Xa. Overall, target factor Xa presents a promising opportunity in the pharmaceutical industry with a diverse range of companies, indications, drug types, and countries/locations involved in its development. The mechanism of action of factor Xa inhibitorsFactor Xa inhibitors are a type of medication that specifically target and inhibit the activity of factor Xa, which is a key enzyme involved in the blood clotting process. From a biomedical perspective, factor Xa is a crucial component of the coagulation cascade, a series of reactions that leads to the formation of blood clots. By inhibiting factor Xa, these medications prevent the formation of blood clots and reduce the risk of conditions such as deep vein thrombosis, pulmonary embolism, and stroke. Factor Xa inhibitors work by binding to factor Xa and blocking its ability to activate other clotting factors, ultimately preventing the formation of a stable blood clot. This mechanism of action makes them anticoagulant drugs, meaning they help to prevent the excessive formation of blood clots. These inhibitors are commonly used in the treatment and prevention of thromboembolic disorders, such as atrial fibrillation, venous thromboembolism, and post-operative prophylaxis. Examples of factor Xa inhibitors include rivaroxaban, apixaban, and edoxaban. It's important to note that factor Xa inhibitors carry a risk of bleeding, as they interfere with the normal clotting process. Therefore, their use should be carefully monitored, and patients may require regular blood tests to assess their coagulation status. Additionally, factor Xa inhibitors should be used with caution in individuals with certain medical conditions or those taking other medications that increase the risk of bleeding. Catalog of factor Xa InhibitorsThe currently marketed factor Xa inhibitors include: Andexanet alfaHuman Coagulation Factor X(Bio Products)ApixabanEdoxaban TosylateRivaroxabanArdeparin SodiumCertoparin sodiumParnaparin SodiumDanaparoid SodiumDalteparin SodiumFor more information, please click on the image below. What is the purpose of using factor Xa inhibitors?Factor Xa inhibitors that are used to prevent and treat thromboembolic disorders. For more information, please click on the image below to log in and search. How can I get the most recent advancements in factor Xa inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of factor Xa inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

100 Deals associated with Dalteparin Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D03353	Dalteparin Sodium	B01AB04	DBSALT002488

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Angina, Unstable	United States	Pfizer Inc.	16 May 2019
Venous Thromboembolism	United States	Pfizer Inc.	16 May 2019
Myocardial Infarction	United States	Pfizer Inc.	10 Dec 2003
Coronary Artery Disease	China	Pfizer NV/SA	19 Mar 1999
Thrombosis	China	Pfizer NV/SA	19 Mar 1999
Venous Thrombosis	United States	Pfizer Inc.	22 Dec 1994
Disseminated Intravascular Coagulation	Japan	Pfizer Inc.	21 Jan 1992
Disseminated Intravascular Coagulation	Japan	Kissei Pharmaceutical Co., Ltd.	21 Jan 1992

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Kidney Failure, Chronic	Phase 3	Canada	Pfizer Inc.	01 Oct 2013
Peripheral arterial occlusive disease	Phase 3	Austria	Pfizer Inc.	01 Oct 2008
Peripheral arterial occlusive disease	Phase 3	Belgium	Pfizer Inc.	01 Oct 2008
Peripheral arterial occlusive disease	Phase 3	Canada	Pfizer Inc.	01 Oct 2008
Peripheral arterial occlusive disease	Phase 3	Czechia	Pfizer Inc.	01 Oct 2008
Peripheral arterial occlusive disease	Phase 3	Denmark	Pfizer Inc.	01 Oct 2008
Peripheral arterial occlusive disease	Phase 3	Germany	Pfizer Inc.	01 Oct 2008
Peripheral arterial occlusive disease	Phase 3	Greece	Pfizer Inc.	01 Oct 2008
Peripheral arterial occlusive disease	Phase 3	Italy	Pfizer Inc.	01 Oct 2008
Peripheral arterial occlusive disease	Phase 3	Norway	Pfizer Inc.	01 Oct 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04362085 (CTgov)	Phase 3	Post Acute COVID 19 Syndrome	465	Therapeutic Anticoagulation (Therapeutic Anticoagulation)	uvgnzhpvxv = cubzubpjar atfcxxkeaj (xrdibzqskf, jatoakwxsz - uvtpumtpzz) View more	-	30 Jan 2025
				LMWH+fondaparinux+UFH (Standard Care)	uvgnzhpvxv = qjilhywwbw atfcxxkeaj (xrdibzqskf, jmsvoyccse - rnbsymzsaz) View more
NCT02744092 (CANVAS, CTgov)	Not Applicable	Solid tumor \| Advanced Malignant Solid Neoplasm \| Pulmonary Embolism ... View more	811	rivaroxaban+Edoxaban+Apixaban+Dabigatran (Randomized Arm 1 (DOACs))	ugazoglrzb = vnewzsxnos hzjowiqxpe (jklapkxzux, tfmqdavdbd - zcjnewnllo) View more	-	03 Oct 2023
				Warfarin+Fondaparinux+Enoxaparin+Dalteparin (Randomized Arm 2 (LMWH))	ugazoglrzb = qplbegqozs hzjowiqxpe (jklapkxzux, hapipkpksc - pqfhliugkv) View more
NCT02583191 \| NCT03139487 \| NCT02744092 \| NCT02746185 (Pubmed \| Mayo Clin Proc)	Phase 2/3	Thrombosis	2,894	Direct oral anticoagulants (DOACs)	diimjmecao(btauwdxner): P-Value = 1.34	Positive	01 Feb 2022
				Dalteparin
RIETECAT cohort study (ISTH2021)	Not Applicable	Venous Thromboembolism	-	Enoxaparin	zlzwlsyowu(eulfvujjis) = nstmtafimf xpopemejzb (tagxyjywui ) View more	Positive	17 Jul 2021
				Tinzaparin or Dalteparin	zlzwlsyowu(eulfvujjis) = ybfzixoxyi xpopemejzb (tagxyjywui ) View more
NCT00432796 (PERIOP2, Pubmed \| BMJ) Manual	Phase 3	Arterial embolism	1,471	dalteparin	nrrkanfdht(ehyvlxjbfo) = biiyscydha clxcscmgsk (dswwweimgd ) View more	Negative	09 Jun 2021
				Placebo	nrrkanfdht(ehyvlxjbfo) = ezutnnuvol clxcscmgsk (dswwweimgd ) View more
NCT00525057 (CTgov)	Not Applicable	Femoral Fractures \| Neoplasm Metastasis \| Multiple Myeloma ... View more	65	Dalteparin (Interventional (Dalteparin, Metastatic))	tvweuvtqvk = pstqedavxy evpchxqbmg (mxiriaohar, jdqqbinczj - mfxwhwrbud) View more	-	22 Jan 2021
				Dalteparin (Interventional (Dalteparin, Sarcoma))	tvweuvtqvk = blkohszzlm evpchxqbmg (mxiriaohar, lzyqsxthly - stzsnpmvfh) View more
NCT02585713 (CTgov)	Phase 3	Thrombosis of cerebral veins \| Neoplasm Metastasis \| Pulmonary Embolism ... View more	300	Apixaban (Arm A (Apixaban))	gadfxwcdve = crdcyinzjk zaeukivgic (pqeikkgrku, jiztgzkcah - reegcjezue) View more	-	24 Dec 2019
				Dalteparin (Arm B (Dalteparin))	gadfxwcdve = kuuxaboosr zaeukivgic (pqeikkgrku, sujkvwcxwt - xfmeellcmn) View more
NCT00952380 (CTgov)	Phase 2	Acute Lymphoblastic Leukemia \| Venous Thromboembolism	38	Dalteparin Sodium (Dalteparin Sodium: All Participants (>= 0 to < 19 Years))	vapbrbhtne(pfjzzixyhr) = ungrmhnzrw dunkdyqyjn (zzduynrasd, fwptlbtigb - noumyntuol) View more	-	16 Apr 2019
				Dalteparin Sodium (Dalteparin Sodium: Group 1 (>=0 to <8 Weeks))	tanjqxihsx = fbzovpiwql wdsruaehoz (adldanyuzg, zvkfninmlq - zicpccfrpx) View more
NCT01879618 (PARROT, Pubmed \| Can J Kidney Health Dis) Manual	Phase 3	Kidney Failure, Chronic	152	dalteparin	roppijyqnu(tcjzbuojag) = htlhmujrwz pticfnbeko (sawagzgpgd, 99.7 - 100) View more	Positive	04 Nov 2018
NCT00876915 (Pubmed \| Thromb Res)	Phase 3	Venous Thromboembolism	117	Dalteparin 5000units daily	wfhswuvktd(kmpdvzskei): HR = 0.69 (95% CI, 0.23 - 1.89) View more	-	01 Mar 2017
				Dalteparin (Observation)

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Dalteparin Sodium

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