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Sodium Enoxaparin clexane
Sodium Enoxaparin clexane is a Low-molecular-weight heparin (LMWH) Small molecule drug developed by Cristália Produtos Químicos Farmacêuticos Ltda.. It is currently in Phase 3 development for Prophylaxis of venous thromboembolism in surgical patients, Treatment of acute deep vein thrombosis, Treatment of acute pulmonary embolism. Also known as: clexane.
Enoxaparin is a low-molecular-weight heparin that inhibits blood clotting by enhancing the activity of antithrombin III against factors Xa and IIa.
Sodium Enoxaparin, also known as Lovenox, is a low molecular weight heparin used to treat conditions such as thrombosis, deep vein thrombosis, and pulmonary embolism. It is also being studied for its potential use in treating COVID-19.
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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.
| 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 | Sodium Enoxaparin clexane |
|---|---|
| Also known as | clexane |
| Sponsor | Cristália Produtos Químicos Farmacêuticos Ltda. |
| Drug class | Low-molecular-weight heparin (LMWH) |
| Target | Coagulation factors Xa and IIa (via antithrombin III) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Enoxaparin binds to and potentiates antithrombin III, a natural anticoagulant, leading to inactivation of coagulation factors Xa and IIa. This prevents thrombin generation and fibrin clot formation. It is administered subcutaneously and has predictable pharmacokinetics, making it suitable for both prophylaxis and treatment of thrombotic conditions.
Approved indications
- Prophylaxis of venous thromboembolism in surgical patients
- Treatment of acute deep vein thrombosis
- Treatment of acute pulmonary embolism
- Prophylaxis in medically ill patients at risk of thromboembolism
- Acute coronary syndrome
Common side effects
- Bleeding
- Thrombocytopenia
- Injection site hematoma
- Injection site pain
- Elevated transaminases
Key clinical trials
- A Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty (PHASE3)
- Dimolegin® (60 mg) Given Once Daily in Patients Undergoing Total Hip or Knee Replacement Compared to Enoxaparin (PHASE3)
- Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies (NA)
- Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum (NA)
- Edoxaban Steady-State PK/PD in Adults With Nephrotic Syndrome (NA)
- A Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery (PHASE2)
- Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients (PHASE4)
- Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury (NA)
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:
- Sodium Enoxaparin clexane CI brief — competitive landscape report
- Sodium Enoxaparin clexane updates RSS · CI watch RSS
- Cristália Produtos Químicos Farmacêuticos Ltda. portfolio CI
Frequently asked questions about Sodium Enoxaparin clexane
What is Sodium Enoxaparin clexane?
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What is Sodium Enoxaparin clexane used for?
Who makes Sodium Enoxaparin clexane?
Is Sodium Enoxaparin clexane also known as anything else?
What drug class is Sodium Enoxaparin clexane in?
What development phase is Sodium Enoxaparin clexane in?
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What does Sodium Enoxaparin clexane target?
Related
- Drug class: All Low-molecular-weight heparin (LMWH) drugs
- Target: All drugs targeting Coagulation factors Xa and IIa (via antithrombin III)
- Manufacturer: Cristália Produtos Químicos Farmacêuticos Ltda. — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Prophylaxis of venous thromboembolism in surgical patients
- Indication: Drugs for Treatment of acute deep vein thrombosis
- Indication: Drugs for Treatment of acute pulmonary embolism
- Also known as: clexane
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing