Coagulation Factor Ix Recombinant Human

Summary

Coagulation Factor Ix Recombinant Human (CHEMBL2109205) is an approved protein; indicated across 1 condition including hemophilia b.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• Indications: 1 condition
• Clinical trials: 14

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2109205
Name	Coagulation Factor Ix Recombinant Human
Type	Protein
Max phase	4

Also known as: Benefix, Coagulation factor ix recombinant human, Factor ix, recombinant, Nonacog alfa, Nonacog gamma, Recombinant factor ix, Rixubis, COAGULATION FACTOR IX RECOMBINANT HUMAN

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

1 indication (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 B	4	MONDO:0010604	MONDO:0010604

Clinical trials

Total trials: 14.

Phase distribution

Phase	Trials
PHASE3	5
Not specified	3
PHASE4	2
PHASE1	2
PHASE2/PHASE3	1
PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT02336178	PHASE4	COMPLETED	Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China
NCT04286412	PHASE4	COMPLETED	Nonacog Alfa Prophylaxis And Treatment Of Bleeding Episodes In Previously Treated Patients With Hemophilia B
NCT00037557	PHASE3	COMPLETED	Study Evaluating rFIX; BeneFIX in Severe Hemophilia B
NCT00768287	PHASE2/PHASE3	COMPLETED	Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B
NCT00866606	PHASE3	COMPLETED	Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
NCT01174446	PHASE3	COMPLETED	Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients
NCT01335061	PHASE3	COMPLETED	Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B
NCT01507896	PHASE3	COMPLETED	BAX 326 Surgery Study in Hemophilia B Patients
NCT03091751	PHASE2	COMPLETED	Efficacy and Safety of AlphaNine Versus BeneFIX in Patients With Severe Hereditary Haemophilia B
NCT02213250	PHASE1	COMPLETED	An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B
NCT03186677	PHASE1	COMPLETED	Dose-escalation Study to Investigate the Safety, PK, and PD of ISU304/CB2679d in Hemophilia B Patients
NCT00714415	Not specified	COMPLETED	Registry For Patients Treated With BeneFix In Usual Care Setting In Germany
NCT02922231	Not specified	COMPLETED	Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
NCT02937831	Not specified	COMPLETED	RIXUBIS Drug Use-Result Survey (Japan)

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).