ANTIHEMOPHILIC FACTOR, PEGYLATED (MW 20000) HUMAN SEQUENCE RECOMBINANT

drug
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Also known as AdynovateAdynoviPegylated recombinant factor viiiPegylated rfviiiRurioctocog alfa pegol

Summary

Antihemophilic Factor, Pegylated (Mw 20000) Human Sequence Recombinant (CHEMBL4594584) is an approved unknown; indicated across 1 condition including hemophilia a.

At a glance

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

Identifiers

Drug identity and classification

FieldValue
ChEMBL IDCHEMBL4594584
NameANTIHEMOPHILIC FACTOR, PEGYLATED (MW 20000) HUMAN SEQUENCE RECOMBINANT
TypeUnknown
Max phase4

Also known as: Adynovate, Adynovi, Pegylated recombinant factor viii, Pegylated rfviii, Rurioctocog alfa pegol

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 approved indication. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

IndicationPhaseMONDOEFO
hemophilia A4MONDO:0010602MONDO:0010602

Clinical trials

Total trials: 14.

Phase distribution

PhaseTrials
Not specified6
PHASE34
PHASE12
PHASE41
PHASE2/PHASE31

Top trials by phase / activity

NCTPhaseStatusTitle
NCT04690322PHASE4WITHDRAWNPOCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies
NCT01736475PHASE2/PHASE3COMPLETEDStudy Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)
NCT02210091PHASE3COMPLETEDBAX 855 Pediatric Study
NCT02585960PHASE3COMPLETEDBAX 855 PK-guided Dosing
NCT02615691PHASE3COMPLETEDA Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A
NCT05707351PHASE3COMPLETEDA Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A
NCT01599819PHASE1COMPLETEDBAX 855 Dose-Escalation Safety Study
NCT05042440PHASE1COMPLETEDPharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A
NCT04158934Not specifiedACTIVE_NOT_RECRUITINGA Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A
NCT02078427Not specifiedCOMPLETEDADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)
NCT03006965Not specifiedCOMPLETEDPharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®
NCT03169972Not specifiedCOMPLETEDADYNOVATE Drug Use-Results Survey
NCT03824522Not specifiedCOMPLETEDPost Marketing Surveillance Study for ADYNOVATE in South Korea
NCT04941898Not specifiedCOMPLETEDA Study of TAK-660 in Surgical Procedures for 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.

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