ANTIHEMOPHILIC FACTOR, PEGYLATED (MW 20000) HUMAN SEQUENCE RECOMBINANT
drug drugOn this page
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
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4594584 |
| Name | ANTIHEMOPHILIC FACTOR, PEGYLATED (MW 20000) HUMAN SEQUENCE RECOMBINANT |
| Type | Unknown |
| Max phase | 4 |
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).
| Indication | Phase | MONDO | EFO |
|---|---|---|---|
| hemophilia A | 4 | MONDO:0010602 | MONDO:0010602 |
Clinical trials
Total trials: 14.
Phase distribution
| Phase | Trials |
|---|---|
| Not specified | 6 |
| PHASE3 | 4 |
| PHASE1 | 2 |
| PHASE4 | 1 |
| PHASE2/PHASE3 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT04690322 | PHASE4 | WITHDRAWN | POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies |
| NCT01736475 | PHASE2/PHASE3 | COMPLETED | Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study) |
| NCT02210091 | PHASE3 | COMPLETED | BAX 855 Pediatric Study |
| NCT02585960 | PHASE3 | COMPLETED | BAX 855 PK-guided Dosing |
| NCT02615691 | PHASE3 | COMPLETED | A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A |
| NCT05707351 | PHASE3 | COMPLETED | A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A |
| NCT01599819 | PHASE1 | COMPLETED | BAX 855 Dose-Escalation Safety Study |
| NCT05042440 | PHASE1 | COMPLETED | Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A |
| NCT04158934 | Not specified | ACTIVE_NOT_RECRUITING | A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A |
| NCT02078427 | Not specified | COMPLETED | ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD) |
| NCT03006965 | Not specified | COMPLETED | Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT® |
| NCT03169972 | Not specified | COMPLETED | ADYNOVATE Drug Use-Results Survey |
| NCT03824522 | Not specified | COMPLETED | Post Marketing Surveillance Study for ADYNOVATE in South Korea |
| NCT04941898 | Not specified | COMPLETED | A 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.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Indicated for: hemophilia A