Product Description
Lonoctocog alfa (rVIII-SingleChain; Afstyla®) is a novel single-chain recombinant factor VIII (FVIII) molecule, with a truncated B-domain and the heavy and light chains covalently linked to form a stable and homogenous drug that binds with high affinity to von Willebrand factor (VWF). Intravenous lonoctocog alfa is approved for the prophylaxis and treatment of bleeding in patients with haemophilia A in several countries worldwide. (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838207/)
Mechanisms of Action: FVIII Analogue
Novel Mechanism: Yes
Modality: Coagulation Factor
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Chile | Croatia | Cyprus | Denmark | France | Germany | Hong Kong | Hungary | Italy | Japan | Malaysia | Mexico | Netherlands | New Zealand | Norway | Poland | Portugal | Russia | Spain | Taiwan | Turkey | United Arab Emirates | United States
Approved Indications: None
Known Adverse Events: None
Company: CSL Behring
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China
Active Clinical Trial Count: 1
Highest Development Phases
Phase 3: Hemophilia A
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| CSL627_3003 | P3 |
Recruiting |
Hemophilia A |
2026-06-26 |