Efanesoctocog Alfa

Summary

Efanesoctocog Alfa (CHEMBL5095275) is an approved protein; indicated across 2 conditions including hemophilia a and von willebrand disease (hereditary or acquired).

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• Indications: 2 conditions
• Clinical trials: 14

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL5095275
Name	Efanesoctocog Alfa
Type	Protein
Max phase	4

Also known as: Altuviiio, Altuvoct, Efanesoctocog alfa, Efanesoctocog alfa-ehtl, EFANESOCTOCOG ALFA

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

2 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
hemophilia A	4	MONDO:0010602	MONDO:0010602
von Willebrand disease (hereditary or acquired)	1	MONDO:0024574	MONDO:0024574

Clinical trials

Total trials: 14.

Phase distribution

Phase	Trials
PHASE3	5
PHASE4	3
PHASE1	3
Not specified	3

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06752850	PHASE4	ACTIVE_NOT_RECRUITING	A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis
NCT06940830	PHASE4	RECRUITING	Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa
NCT06941870	PHASE4	RECRUITING	Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy
NCT04644575	PHASE3	ACTIVE_NOT_RECRUITING	Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A
NCT05817812	PHASE3	ACTIVE_NOT_RECRUITING	A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa
NCT06716814	PHASE3	RECRUITING	Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa
NCT04161495	PHASE3	COMPLETED	A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A
NCT04759131	PHASE3	COMPLETED	Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A
NCT06579144	PHASE1	RECRUITING	Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A
NCT04770935	PHASE1	COMPLETED	To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)
NCT05042440	PHASE1	COMPLETED	Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A
NCT05911763	Not specified	ACTIVE_NOT_RECRUITING	A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A
NCT06684314	Not specified	RECRUITING	A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan
NCT06530030	Not specified	TERMINATED	Goal Attainment and Physical Activity in People With Hemophilia A

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).