drugset
Drugs / LONOCTOCOG ALFA
last change Jan 2021 re-read 2 minutes ago

LONOCTOCOG ALFA

also known as rVIII-SingleChain · Afstyla · CSL627 · Recombinant VIII (rVIII)-SingleChain

Protein / enzyme biologic targets F8

Developed for
hemophilia A · severe hemophilia A
Investigated by
CSL Behring

Trials 3 · a red edge is where a trial was stopped

today NCT02172950 · Ph 3 NCT02093897 · Ph 3 NCT01486927 · Ph 2/3
2012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2/31 trial
Phase 2/3 NCT01486927 Feb 2012 → Dec 2014 hemophilia A CSL Behring Completed No outcome recorded
Phase 32 trials
Phase 3 NCT02172950 Oct 2014 → Jan 2021 severe hemophilia A CSL Behring Completed No outcome recorded
Phase 3 NCT02093897 Mar 2014 → Aug 2015 hemophilia A CSL Behring Completed No outcome recorded

Press releases naming this drug 19 releases

DateIssuerRelease
2017-09-28 CSL Behring Japan’s Ministry of Health, Labour and Welfare Approves AFSTYLA® - CSL Behring’s Novel Recombinant Haemophilia A Treatment csl.com ↗
2017-07-10 CSL Behring New Findings Show AFSTYLA® Provides Long-lasting Efficacy without Increased Product Consumption for Prophylactic and On-Demand Treatment of Haemophilia A csl.com ↗
2017-07-06 CSL Behring New Data for Two Leading Haemophilia Medicines -- AFSTYLA® and IDELVION® -- to be Presented at the International Society on Thrombosis and Haemostasis Congress 2017 csl.com ↗
2017-04-19 CSL Behring Therapeutic Goods Administration Approves AFSTYLA® - CSL Behring’s Novel Recombinant Haemophilia A Treatment csl.com ↗
2017-01-09 CSL Behring AFSTYLA®, for Haemophilia A, Receives European Commission Approval csl.com ↗
2016-12-14 CSL Behring Health Canada Approves CSL Behring’s AFSTYLA™ for the Treatment of Hemophilia A csl.com ↗
2016-11-14 CSL Behring AFSTYLA®, for Haemophilia A, Receives Positive Opinion from European Medicines Agency CHMP csl.com ↗
2016-07-27 CSL Behring CSL Behring Presents Pivotal Efficacy Data for AFSTYLA® In Adolescents and Children with Hemophilia A at the World Federation of Hemophilia 2016 World Congress csl.com ↗
2016-07-19 CSL Behring CSL Behring to Present New Data for IDELVION® and AFSTYLA® at the World Federation of Hemophilia 2016 World Congress csl.com ↗
2016-06-20 CSL Behring AFSTYLA® – CSL Behring’s Novel Recombinant Factor VIII Single Chain Therapy for Hemophilia A – Now Available in the U.S. csl.com ↗
2016-05-26 CSL Behring 20 U.S. FDA Approves CSL Behring’s AFSTYLA®-- The First and Only Recombinant Factor VIII Single Chain Therapy for Hemophilia A csl.com ↗
2015-12-22 CSL Behring CSL Behring Submits Marketing Authorization Application to the European Medicines Agency for rVIII-SingleChain for Patients with Hemophilia A csl.com ↗

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as LONOCTOCOG ALFA ChEMBL registry synonym — accepted as the source's own label CHEMBL4594603 ↗
Known as Afstyla ChEMBL registry synonym — accepted as the source's own label CHEMBL4594603 ↗
Known as CSL627 “rVIII-SingleChain, CSL627” NCT02172950 ↗
Known as Recombinant VIII (rVIII)-SingleChain “Recombinant VIII (rVIII)-SingleChain is a novel B-domain-truncated recombinant factor VIII (rFVIII), comprised of covalently bonded factor VIII (FVIII) heavy and light chains.” PMID 27330001 ↗ Jun 2016
Known as rVIII-SingleChain ClinicalTrials.gov intervention name — accepted as the source's own label NCT02172950 ↗
2

NCT02093897 ↗

NCT01486927 ↗
Modality Protein / enzyme biologic “Recombinant VIII (rVIII)-SingleChain is a novel B-domain-truncated recombinant factor VIII (rFVIII), comprised of covalently bonded factor VIII (FVIII) heavy and light chains.” PMID 27330001 ↗ Jun 2016
Route Intravenous “single intravenous infusion” NCT01486927 ↗
Target F8 “Coagulation factor VIII exogenous protein” CHEMBL4594603 ↗