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SR-90107 (Sanofi-Synthélabo).

F Liu1, W P Bagley, R C Carroll

  • 1Graduate School of Medicine, 1924 Alcoa Highway, Knoxville, TN 37920, USA.

Idrugs : the Investigational Drugs Journal
|July 29, 2005
PubMed
Summary

SR-90107, a synthetic pentasaccharide, is being developed for deep vein thrombosis (DVT), pulmonary embolism, and coronary artery diseases. Clinical trials are progressing, with anticipated NDA submissions for various indications.

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Area of Science:

  • Pharmacology and Therapeutics
  • Cardiovascular Medicine
  • Hematology

Background:

  • SR-90107 is a synthetic pentasaccharide heparinoid developed as a Factor Xa antagonist and thrombokinase inhibitor.
  • It is jointly developed by Sanofi-Synthelabo and Organon for treating and preventing deep vein thrombosis (DVT) and pulmonary embolism (PE).
  • The compound is also being investigated for potential applications in coronary artery diseases.

Purpose of the Study:

  • To evaluate the efficacy and safety of SR-90107 in the prevention and treatment of DVT and PE.
  • To assess the potential of SR-90107 in managing coronary artery diseases, including unstable angina and acute myocardial infarction.
  • To support regulatory submissions for SR-90107 in multiple indications.

Main Methods:

  • Phase III clinical trials for DVT and PE prevention were underway, involving thousands of patients undergoing orthopedic surgery.
  • Phase III trials for DVT and PE treatment were planned, comparing SR-90107 with enoxaparin sodium and unfractionated heparin.
  • Phase IIb trials in cardiology indications, such as acute myocardial infarction and unstable angina, were conducted.

Main Results:

  • Four Phase III trials for DVT/PE prevention were active, with data expected by June 2000.
  • Phase III trials for DVT/PE treatment were initiated in early 2000.
  • Phase IIb trials in cardiology showed a favorable safety/efficacy profile.

Conclusions:

  • SR-90107 demonstrated potential as a treatment and prophylaxis for DVT and PE.
  • The compound showed promise in managing acute coronary syndromes.
  • Anticipated NDA submissions in Europe and the US were planned for 2000-2004.

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