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Lovenox® (enoxaparin)
Lovenox® (enoxaparin) is a Low-molecular-weight heparin (LMWH) Small molecule drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 3 development for Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip or knee replacement surgery, Prophylaxis of DVT in patients with acute illness, Treatment of acute DVT and pulmonary embolism.
Enoxaparin is a low-molecular-weight heparin that inhibits blood clotting by enhancing the activity of antithrombin III against factors Xa and IIa.
Enoxaparin is a low-molecular-weight heparin that inhibits blood clotting by enhancing the activity of antithrombin III against factors Xa and IIa. Used for Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip or knee replacement surgery, Prophylaxis of DVT in patients with acute illness, Treatment of acute DVT and pulmonary embolism.
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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 | Lovenox® (enoxaparin) |
|---|---|
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Drug class | Low-molecular-weight heparin (LMWH) |
| Target | Factor Xa and Factor 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 more predictable pharmacokinetics than unfractionated heparin.
Approved indications
- Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip or knee replacement surgery
- Prophylaxis of DVT in patients with acute illness
- Treatment of acute DVT and pulmonary embolism
- Acute coronary syndrome (unstable angina and non-ST-segment elevation myocardial infarction)
Common side effects
- Bleeding
- Thrombocytopenia
- Injection site hematoma
- Elevated liver enzymes
Key clinical trials
- Dimolegin® (60 mg) Given Once Daily in Patients Undergoing Total Hip or Knee Replacement Compared to Enoxaparin (PHASE3)
- Effect of Montelukast Versus Co Enzyme in Sepsis (PHASE2, PHASE3)
- : Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery (PHASE4)
- Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients (PHASE3)
- Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With COVID-19 (PHASE3)
- Bioequivalence Study of a Generic Enoxaparin Sodium to Clexane® After Single Subcutaneous Dose in Healthy Human Subjects (PHASE1)
- Hydroxychloroquine in Unexplained Recurrent Pregnancy Loss (PHASE1)
- Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox® (PHASE4)
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:
- Lovenox® (enoxaparin) CI brief — competitive landscape report
- Lovenox® (enoxaparin) updates RSS · CI watch RSS
- Assistance Publique - Hôpitaux de Paris portfolio CI
Frequently asked questions about Lovenox® (enoxaparin)
What is Lovenox® (enoxaparin)?
How does Lovenox® (enoxaparin) work?
What is Lovenox® (enoxaparin) used for?
Who makes Lovenox® (enoxaparin)?
What drug class is Lovenox® (enoxaparin) in?
What development phase is Lovenox® (enoxaparin) in?
What are the side effects of Lovenox® (enoxaparin)?
What does Lovenox® (enoxaparin) target?
Related
- Drug class: All Low-molecular-weight heparin (LMWH) drugs
- Target: All drugs targeting Factor Xa and Factor IIa (via antithrombin III)
- Manufacturer: Assistance Publique - Hôpitaux de Paris — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip or knee replacement surgery
- Indication: Drugs for Prophylaxis of DVT in patients with acute illness
- Indication: Drugs for Treatment of acute DVT and pulmonary embolism
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing