Delving into the Latest Updates on Idrabiotaparinux sodium with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

Biotinylated idraparinux

+ [2]

Target

factor Xa

Mechanism

factor Xa inhibitors(Factor Xa inhibitors)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Atrial FibrillationPulmonary EmbolismStroke+ [2]

Originator Organization

Sanofi

Active Organization-

Inactive Organization

Sanofi SASanofi-Aventis Recherche et Développement SAAventis (China) Investment Co. Ltd.

+ [1]

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC53H88N4NaO51S8

InChIKeyDARDLXOMABZMLW-OWWFDHMYSA-N

CAS Registry405159-59-3

A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) With Oral Adjusted-dose Warfarin in the Prevention of Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).

Start Date01 Dec 2007

Sponsor / Collaborator

Sanofi SA

NCT00345618

/ CompletedPhase 3

An International, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Study of 3-month or 6-month Treatment With SSR126517E (3.0 mg s.c. Once-weekly) Versus Oral INR-adjusted Warfarin in the Treatment of Patients With Symptomatic Pulmonary Embolism With or Without Symptomatic Deep Venous Thrombosis

Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.

Start Date01 Jun 2006

Sponsor / Collaborator

Sanofi SA

NCT00311090

/ CompletedPhase 3

International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity

The three purposes of this study are the following:
To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment;
To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.

Start Date01 Apr 2006

Sponsor / Collaborator

Sanofi SA

100 Clinical Results associated with Idrabiotaparinux sodium

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100 Translational Medicine associated with Idrabiotaparinux sodium

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100 Patents (Medical) associated with Idrabiotaparinux sodium

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35

Literatures (Medical) associated with Idrabiotaparinux sodium

01 Apr 2020·Journal of Arrhythmia

Clinical outcomes associated with kidney function changes in anticoagulated atrial fibrillation patients: An ancillary analysis from the BOREALIS trial

Article

Author: Shantsila, Alena ; Bai, Ying ; Lip, Gregory Y. H.

AbstractBackgroundPatients with atrial fibrillation (AF) and chronic kidney disease represent a high‐risk group for thromboembolism and bleeding.AimsTo explore the relationship between kidney function changes and outcomes of stroke/systemic embolism (SE), major bleeding and all‐cause death in anticoagulated AF patients participating in the BOREALIS trial comparing efficacy and safety of once‐weekly s.c. idrabiotaparinux to that of warfarin.MethodsChanges in kidney function by estimated glomerular filtration rate (eGFR) were calculated using the Chronic Kidney Disease Epidemiology Collaboration equation in 2765 AF patients. Trial adjudicated outcomes were determined.ResultsAfter a mean follow‐up of 394 days, in 94.4% of the included patients kidney function changed ranging from −30 mL/min to 30 mL/min. The incidence of stroke/SE and major bleeding was similar between patients with deteriorated (reduction in eGFR from baseline over follow‐up) and preserved kidney function change (increase or no change in eGFR from baseline over follow‐up) [stroke/SE: incidence rate (IR): 1.33%/year vs 1.80%/year; hazard ratio (HR) 0.74, 95% confidence interval (CI) 0.41‐1.32, P = .30; major bleeding: IR 1.63%/year vs 1.49%/year, HR 1.10, 95% CI 0.61‐1.97, P = .76]. On Cox regression analysis, patients with deteriorated kidney function were at higher risk for all‐cause death, compared to patients with preserved kidney function (HR: 1.64, 95% CI: 1.02‐2.63, P = .04).ConclusionIn the BOREALIS trial, the risk of adjudicated stroke/SE, major bleedings, and all‐cause death was not related to mild‐moderate follow‐up changes in kidney function (±30 mL/min). The risk of all‐cause death was significantly increased in AF patients with abruptly deteriorating kidney function.

01 Sep 2014·Internal and Emergency MedicineQ3 · MEDICINE

The value of inhibitors of factor Xa for the treatment of pulmonary embolism

Q3 · MEDICINE

Review

Author: Alì Taher ; Raffaele Pesavento ; Sofia Barbar ; Sally Temraz ; Paolo Prandoni

The introduction of factor Xa inhibitors advocated the initiation of clinical trials that addressed the value of anticoagulation in patients with hemodynamically stable primary pulmonary embolism (PE). In the Matisse trial in patients with PE, fondaparinux administered at therapeutic doses followed by vitamin K antagonists (VKA) has shown a comparable efficacy and safety profile to that seen with intravenous adjusted-dose unfractionated heparin/VKA. A long-acting derivative of fondaparinux, idraparinux, failed to achieve similar results. On the other hand, the Cassiopea study revealed that once weekly injections of idrabiotaparinux, a slightly modified form of idraparinux, have similar efficacy and better safety profile compared to VKAs in the long-term treatment of patients with PE. However, the inconvenient parenteral administration of both fondaparinux and idrabiotaparinux limits their routine clinical use. The availability of antithrombotic compounds that can be administered orally in fixed dose, owing to their predictable pharmacokinetics and pharmacodynamics, and have a lower potential for drug and food interactions has opened new horizons for the treatment of patients with PE. The Einstein PE, Amplify and Hokusai studies, conducted with rivaroxaban, apixaban and edoxaban, respectively, showed that for the treatment of PE they possess a more favorable benefit-to-risk profile than the conventional antithrombotic drugs. In addition, rivaroxaban and apixaban make it possible to treat uncomplicated PE patients from the beginning, without the need for the parenteral administration of heparins or fondaparinux, and edoxaban allows the treatment of fragile patients with lower doses. All of them cover a wide spectrum of clinical presentations, including PE patients at intermediate risk.

01 Jun 2014·Journal of Thrombosis and HaemostasisQ2 · MEDICINE

Comparison of idrabiotaparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: the Borealis‐Atrial Fibrillation Study

Q2 · MEDICINE

Article

Author: G. Pillion ; M.H. Prins ; Graeme Hankey ; G.E. Raskob ; H.R. Büller ; J.L. Halperin

BACKGROUNDIdrabiotaparinux, a long-acting inhibitor of factor Xa, was shown to be effective in the treatment of patients with venous thromboembolism.OBJECTIVETo assess non-inferiority for the efficacy of idrabiotaparinux versus warfarin in patients with atrial fibrillation (AF) at risk of stroke and systemic embolism. Bleeding was also assessed.METHODSThis randomized, double-blind trial enrolled patients with electrocardiogram-documented AF. Idrabiotaparinux was administered weekly via subcutaneous injection, and warfarin was administered daily with dose adjustment to maintain the international normalized ratio between 2.0 and 3.0. Each idrabiotaparinux injection was 3 mg for the first 7 weeks, followed by 2 mg thereafter, except in patients with a creatinine clearance of 30-50 mL min(-1) or aged ≥ 75 years. The patients received 1.5 mg after the first 7 weeks. The efficacy outcome was the composite of all fatal or non-fatal strokes and systemic embolism. The safety outcome was clinically relevant bleeding (major and clinically relevant non-major bleeding).RESULTSThe study was terminated prematurely by the sponsor for strategic/commercial, not scientific, reasons, with 39% of the planned number of patients included and an average duration of treatment of 240 days. Of the 1886 idrabiotaparinux recipients, 20 developed stroke or systemic embolism (1.5% per year), whereas this occurred in 22 of the 1887 warfarin patients (1.6% per year, hazard ratio 0.98, 95% confidence interval 0.49-1.66). The annual incidence of bleeding was 6.1% in the idrabiotaparinux and 10.0% in the warfarin group (hazard ratio 0.61, 95% confidence interval 0.46-0.81).CONCLUSIONIf anything, despite its early termination, the idrabiotaparinux regimen studied suggested a comparable efficacy to dose-adjusted warfarin, with a lower bleeding risk.

100 Deals associated with Idrabiotaparinux sodium

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External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Venous Thrombosis	Phase 3	BR	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	IT	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	ZA	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	BR	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	IL	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	AR	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	IT	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	IL	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	ZA	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	AR	Sanofi SA	01 Apr 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00580216 (Pubmed \| J Thromb Haemost)	Phase 3	Atrial Fibrillation	3,773	Idrabiotaparinux	qcqfbfhtcb(ukthheebls) = urablfmluv zjdpuislue (tctjkctzhr )	Positive	01 Jun 2014
				Warfarin	qcqfbfhtcb(ukthheebls) = dumzzcckvp zjdpuislue (tctjkctzhr )
NCT00311090 (EQUINOX, Pubmed \| Br J Clin Pharmacol)	Phase 1	Venous Thrombosis	757	idrabiotaparinux	evvxwvfozu(dgazwlsrmi): ratio estimate = 0.95 (90% CI, 0.87 - 1.04) View more	-	01 May 2013
				idraparinux
NCT00311090 (Pubmed \| J Thromb Haemost)	Phase 3	Venous Thrombosis	757	Idrabiotaparinux (3 mg)	hubtrbolwh(lfcuabpdlr) = pcqkftpwvc oeyiljujty (xnunxjggqo ) View more	-	01 Jan 2011
				Idraparinux (2.5 mg)	hubtrbolwh(lfcuabpdlr) = eyeiscktah oeyiljujty (xnunxjggqo ) View more