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dalteparin

Phase 4FDA approved

Venous Thromboembolism | Small molecule | Cardiovascular |Pfizer, Inc.|Trials Updated: Apr 16, 2019

dalteparin development status

FDA approval on record Mar 30, 1999 as Fragmin
Approval holderPfizer
ApplicationNDA020287
Highest phase Phase 4 (NCT00942968)
Phase scored for PFEPhase 2
Registered trials 4 across 2 sponsors since Jun 2009

Label indication FRAGMIN is a low molecular weight heparin (LMWH) indicated for • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction ( 1.1 ) • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness ( 1.2 ) • Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the… FDA label

dalteparin target and mechanism

Molecular targetSERPINC1
Target classActivator
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

dalteparin clinical trials

dalteparin · 1 trial · 1 indication

Phase 2 1
NCT00952380Fragmin for the Treatment of Acute VTE in Pediatric Cancer PatientsVenous Thromboembolism
COMPLETED38 Analytics
PHASE2COMPLETED
Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
Venous ThromboembolismUnlock trial analytics

Study Endpoints

Primary Endpoints

Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level
4 hours post-dose at each Day 1 to 7 in dose adjustment phase

Prespecified therapeutic anti-factor Xa level was 0.5-1.0 international unit per milliliter (IU/mL). Cumulative data of Day 1 to 7 has been reported.

Secondary Endpoints

Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels
Day 1 to 7 in dose adjustment phase
Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE)
Baseline up to 28 days after the last dose of study drug (up to Day 132)
Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)
Baseline up to 28 days after the last dose of study drug (up to Day 132)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single ArmOTHERSingle arm open-label

Interventions

NameTypeDescription
dalteparinDRUGdalteparin subcutaneous injection
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Eligibility Criteria

Age RangeN/A to 18 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: \- Exclusion Criteria: \-

Countries:United StatesNorwayRussiaSloveniaSpain
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Frequently asked questions about dalteparin

What is dalteparin used for in venous thromboembolism?

Dalteparin is being studied for the treatment of venous thromboembolism, including in pediatric cancer patients. It is an anticoagulant developed by Pfizer, Inc. under the ticker PFE. The research focuses on managing acute VTE in this specific patient population.

What does dalteparin target?

Dalteparin targets SERPINC1, also known as antithrombin III. It acts as an activator of this target. By activating antithrombin, dalteparin enhances the inhibition of thrombin and factor Xa, which are key enzymes in the blood clotting cascade.

Who makes dalteparin?

Dalteparin is developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is a global pharmaceutical company involved in the research and development of various therapeutic products.

What phase is dalteparin in?

Dalteparin is in Phase 2 clinical development for venous thromboembolism. It is an investigational drug and has not been approved by the FDA for this indication. The Phase 2 trial has been completed.

What clinical trials is dalteparin in?

Dalteparin has been studied in a completed Phase 2 trial, NCT00952380, titled "Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients." This trial enrolled 38 participants and was conducted in the United States, Norway, Russia, Slovenia, and Spain.