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ARIXTRA infusion
ARIXTRA infusion is a Factor Xa inhibitor Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Prophylaxis of venous thromboembolism in patients undergoing hip fracture surgery, hip replacement surgery, or knee replacement surgery, Treatment of acute deep vein thrombosis, Treatment of acute pulmonary embolism.
ARIXTRA (fondaparinux) selectively inhibits Factor Xa in the coagulation cascade, preventing thrombin generation and blood clot formation.
Arixtra is an oligosaccharide used to treat conditions such as Non-Small Cell Lung Cancer, Venous Thromboembolism, and Acute Coronary Syndromes, often in combination with chemotherapy. It is administered through infusion, although specific dosing and administration details are not provided in the given facts.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care. -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | ARIXTRA infusion |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Factor Xa inhibitor |
| Target | Factor Xa (Coagulation Factor X, activated) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Fondaparinux is a synthetic pentasaccharide that binds to antithrombin III, enhancing its ability to inactivate Factor Xa, a critical enzyme in the intrinsic and common pathways of blood coagulation. By blocking Factor Xa, it prevents the conversion of prothrombin to thrombin, thereby inhibiting clot formation without directly affecting thrombin itself. This selective mechanism provides anticoagulation with a predictable pharmacokinetic profile and subcutaneous bioavailability.
Approved indications
- Prophylaxis of venous thromboembolism in patients undergoing hip fracture surgery, hip replacement surgery, or knee replacement surgery
- Treatment of acute deep vein thrombosis
- Treatment of acute pulmonary embolism
- Prophylaxis of thromboembolism in patients with acute coronary syndrome
Common side effects
- Bleeding (major and minor)
- Thrombocytopenia
- Injection site reactions
- Anemia
- Elevated liver enzymes
Key clinical trials
- Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (PHASE3)
- Enhanced Platelet Inhibition in Critically Ill Patients With COVID-19 (PHASE2)
- Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT) (PHASE4)
- OASIS-6 : The Safety and Efficacy of Fondaparinux Versus Control Therapy in Patients With ST Segment Elevation Acute Myocardial Infarction (PHASE3)
- Fondaparinux (Arixtra) With Chemotherapy for Advanced Non-Small Cell Lung Cancer (PHASE1)
- Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI (PHASE3)
- ARIXTRA Local Study For Registration In China. (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ARIXTRA infusion CI brief — competitive landscape report
- ARIXTRA infusion updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about ARIXTRA infusion
What is ARIXTRA infusion?
How does ARIXTRA infusion work?
What is ARIXTRA infusion used for?
Who makes ARIXTRA infusion?
What drug class is ARIXTRA infusion in?
What development phase is ARIXTRA infusion in?
What are the side effects of ARIXTRA infusion?
What does ARIXTRA infusion target?
Related
- Drug class: All Factor Xa inhibitor drugs
- Target: All drugs targeting Factor Xa (Coagulation Factor X, activated)
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Prophylaxis of venous thromboembolism in patients undergoing hip fracture surgery, hip replacement surgery, or knee replacement surgery
- Indication: Drugs for Treatment of acute deep vein thrombosis
- Indication: Drugs for Treatment of acute pulmonary embolism
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing