Drug

Efmoroctocog alfa

Established medicine

ClassCoagulation factor VIII exogenous proteinResearchOngoing clinical research

Also known as Eloctate, antihemophilic factor (FVIII) rec, Fc fusion prot, rFVIIIFc, (1-743)-(1638-2332)-blood-coagulation factor VIII (synthetic human) fusion protein with immunoglobulin G1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin G1 (synthetic human fc domain fragment)+5 more

Eloctate, antihemophilic factor (FVIII) rec, Fc fusion prot, rFVIIIFc, (1-743)-(1638-2332)-blood-coagulation factor VIII (synthetic human) fusion protein with immunoglobulin G1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin G1 (synthetic human fc domain fragment), Antihemophilic Factor (Recombinant BDD), FC Fusion Protein, Antihemophilic Factor VIII (Recombinant), Fc Fusion Protein, Antihemophilic factor (recombinant, FC fusion protein), Coagulation factor VIII recombinant immunoglubulin g1 fusion protein, antihemophilic factor, recombinant Fc fusion protein.

RxNorm1543095 ChEMBLCHEMBL4297945UNII7PCM518YLR

Coagulation factor VIII

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Clinical trial2023-02-20Completed · ClinicalTrials.gov

An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia A

Clinical trial2022-04-11Results posted · ClinicalTrials.gov

A Non-controlled, Open-Label, Multicenter, Study of Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Subjects With Inhibitors Undergoing the First ITI Treatment

Clinical trial2022-03-28Results posted · ClinicalTrials.gov

A Randomized, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) Manufactured at 15K Scale and at Different Vial Strengths in Previously Treated Subjects With Severe Hemophilia A

Clinical trial2020-12-19Results posted · ClinicalTrials.gov

A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetics of 2 Vial Strengths of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in Previously Treated Subjects With Severe Hemophilia A

Clinical trial2020-12-19Results posted · ClinicalTrials.gov

An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A

Clinical trial2020-12-19Results posted · ClinicalTrials.gov

Approval: Elocta (EMA)

Regulatory2015-11-18EMA

An Open-Label, Crossover, Dose-Escalation, and Multi-Center Study to Determine the Safety, Tolerability, and Pharmacokinetic of a Single Intravenous Injection of rFVIIIFc in Previously Treated Patients With Severe Hemophilia A

Clinical trial2011-05-01Completed · ClinicalTrials.gov

POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies

Clinical trial2027-07-01Withdrawn · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Efmoroctocog alfa

Aliases & brands

Eloctateantihemophilic factor (FVIII) rec, Fc fusion protrFVIIIFc(1-743)-(1638-2332)-blood-coagulation factor VIII (synthetic human) fusion protein with immunoglobulin G1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin G1 (synthetic human fc domain fragment)Antihemophilic Factor (Recombinant BDD), FC Fusion ProteinAntihemophilic Factor VIII (Recombinant), Fc Fusion ProteinAntihemophilic factor (recombinant, FC fusion protein)Coagulation factor VIII recombinant immunoglubulin g1 fusion proteinantihemophilic factor, recombinant Fc fusion protein

RxNorm CUI

1543095

ChEMBL ID

CHEMBL4297945

UNII

7PCM518YLR

Primary mechanism

Coagulation factor VIII exogenous protein

Regulatory jurisdictions

ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Coagulation factor VIII

F8 · P00451

EXOGENOUS PROTEINCoagulation factor VIII exogenous protein

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2015-11-18

Latest approval

2015-11-18

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2015-11-18Approval

Approval: Elocta (EMA)

Indication: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Elocta can be used for all age groups.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

8 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2023

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 8

Phase 12Phase 33Phase 43

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies

WithdrawnPH IVUniversity of Texas Southwestern Medical Center2027

CompletedPH IVThe League of Clinical Research, Russian=302023

A Non-controlled, Open-Label, Multicenter, Study of Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Subjects With Inhibitors Undergoing the First ITI Treatment

CompletedPH IVBioverativ, a Sanofi companyn=162021

CompletedPH IIIBioverativ, a Sanofi companyn=1082019

CompletedPH IIIBioverativ Therapeutics Inc.n=2402017

Recent completions

Trials that read out recently, adding to the completed evidence base.

CompletedPH IVThe League of Clinical Research, Russian=302023

A Non-controlled, Open-Label, Multicenter, Study of Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Subjects With Inhibitors Undergoing the First ITI Treatment

CompletedPH IVBioverativ, a Sanofi companyn=162021

CompletedPH IIIBioverativ, a Sanofi companyn=1082019

CompletedPH IIIBioverativ Therapeutics Inc.n=2402017

CompletedPH IIIBioverativ Therapeutics Inc.n=242017

CompletedPH IBioverativ Therapeutics Inc.n=192015

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.