Drugs / Human Coagulation Factor VIII
last change May 2026 re-read 9 days ago

Human Coagulation Factor VIII

also known as Optivate

Protein / enzyme biologic

Developed for
hemophilia A
Investigated by
Bio Products Laboratory

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Voncento — 2013-08-12 europa.eu ↗

Trials 1

today
EU approved 2013
NCT02246868 · Ph 3
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 31 trial
Phase 3 NCT02246868 Sep 2001 → Aug 2004 hemophilia A Bio Products Laboratory Completed No outcome recorded
Comparator or background therapy1 trial
Phase 3 NCT07416526 Comparator May 2026 → Sep 2027 expected hemophilia A Hoffmann-La Roche Recruiting No outcome recorded

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as Human Coagulation Factor VIII ClinicalTrials.gov intervention name — accepted as the source's own label NCT02246868 ↗
1

NCT07416526 ↗

Known as Optivate “Optivate® (Human Coagulation Factor VIII)” NCT02246868 ↗
Action Restore “whether haemostasis was achieved with Optivate® when treating a bleed” NCT02246868 ↗
Modality Protein / enzyme biologic “Optivate® (Human Coagulation Factor VIII)” NCT02246868 ↗