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Lonoctocog alfa - CSL

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Drug Profile

Lonoctocog alfa - CSL

Alternative Names: Afstyla; CSL-627; NBP-601; Recombinant-factor-VIII-single-chain-CSL; rFVIII - CSL; rVIII-SC - CSL; rVIII-single chain - CSL; rVIII-SingleChain - CSL; Single-chain-recombinant-factor-VIII-CSL

Latest Information Update: 10 Feb 2025

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At a glance

  • Originator SK Chemicals
  • Developer CSL
  • Class Antihaemorrhagics; Blood coagulation factors; Recombinant proteins
  • Mechanism of Action Blood coagulation factor replacements; Factor X stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Haemophilia A
  • New Molecular Entity No

Highest Development Phases

  • Marketed Haemophilia A

Most Recent Events

  • 09 Jan 2025 Phase-III clinical trials in Haemophilia A (In infants, In children, In adolescents, In adults, In the elderly, Treatment-experienced) in China (IV) (NCT06738485), (EudraCT2023-001026-34)
  • 17 Dec 2024 CSL Behring plans a phase III trial for Haemophilia A (In infants, In children, In adolescents, In adults, In the elderly) (IV, Infusion) (NCT06738485), (EudraCT2023-001026-34)
  • 19 Jan 2021 CSL completes a phase III extension trial in Haemophilia A in USA, Australia, Austria, Canada, Czech Republic, France, Georgia, Germany, Hungary, Ireland, Italy, Japan, Lebanon, Malaysia, Netherlands, Philippines, Poland, Portugal, Romania, South Africa, Spain, Switzerland, Thailand and Ukraine (NCT02172950) (EudraCT2013-003262-13)

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