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Refludan (LEPIRUDIN)
Refludan (LEPIRUDIN) is a small molecule anti-coagulant that targets prothrombin. It was originally developed and is currently owned by an unspecified company. Refludan is FDA approved for the treatment of thrombosis in heparin-induced thrombocytopenia. The commercial status of Refludan is patented, and it is not yet off-patent. Key safety considerations include its potential for bleeding complications.
At a glance
| Generic name | LEPIRUDIN |
|---|---|
| Drug class | Anti-coagulant |
| Target | Prothrombin |
| Modality | Recombinant protein |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 1998 |
Approved indications
- Thrombosis in Heparin Induced Thrombocytopenia
Common side effects
Key clinical trials
- Study Evaluation of Recombinant Hirudin in Prophylaxis of Post-Operative Deep Vein Thrombosis (PHASE4)
- Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants (NA)
- Growth and Safety Study of an Infant Formula for Healthy Term Infants (NA)
- Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT) (PHASE4)
- Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II
- Lepirudin in Treating Patients With Recurrent or Advanced Small Cell Lung Cancer (PHASE1,PHASE2)
- Pharmacokinetic Studies of Tacrolimus in Transplant Patients (PHASE4)
- Argatroban Versus Lepirudin in Critically Ill Patients (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Refludan CI brief — competitive landscape report
- Refludan updates RSS · CI watch RSS