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Drug

Fondaparinux sodium

Approved · EMA
Late-stage development

Also known as Arixtra.

1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Aspirin Versus Aspirin and Fondaparinux Prior to Early Invasive Strategy in Patients With NSTEMI

Clinical trial2026-05-04Results expected Q1 2029 · ClinicalTrials.gov

The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty

Clinical trial2017-05-15Results posted · ClinicalTrials.gov

The Use of Fondaparinux in Preventing Thromboembolism in High Risk Trauma Patients

Clinical trial2013-12-24Results posted · ClinicalTrials.gov

Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction

Clinical trial2013-02-01Completed · ClinicalTrials.gov

Approval: Arixtra (EMA)

Regulatory2002-03-20EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Fondaparinux sodium
Aliases & brands
Arixtra
RxNorm CUI
322154
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2002-03-20
Latest approval
2002-03-20
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2002-03-20Approval
Approval: Arixtra (EMA)
Indication: 1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injection Prevention of venous thromboembolic events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such asShow full indication

1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injection Prevention of venous thromboembolic events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. Prevention of VTE in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery. Prevention of VTE in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and / or acute respiratory disorders, and / or acute infectious or inflammatory disease. Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis. 2.5-mg/0.5-ml solution for injection Treatment of unstable angina or non-ST-segment-elevation myocardial infarction (UA/NSTEMI) in adult patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated. infarction (STEMI) in adult patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy. 5-mg/0.4-ml, 7.5-mg/0.6-ml and 10-mg/0.8-ml solution for injection Treatment of adults with acute deep-vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

14 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
14
registered trials across all phases
LATEST COMPLETION 2023
1
Active studies
1
Recruiting
10
Late-stage (III+)
11
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 14
Phase 11Phase 23Phase 2 / 31Phase 35Phase 43Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.