Octocog Alfa
drug drugOn this page
Also known as AdvateAntihemophilic factorhuman recombinantBAY W 6240BAY-W-6240Factor viii (rdna)Factor viii octocog alfaFactor viiirecombinantHelixate fsHelixate nexgenHelixate nextgenIbliasKogenateKogenate bayerKogenate fsKovaltryRecombinate
Summary
Octocog Alfa (CHEMBL4297873) 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: 23
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4297873 |
| Name | Octocog Alfa |
| Type | Protein |
| Max phase | 4 |
Also known as: Advate, Antihemophilic factor, human recombinant, BAY W 6240, BAY-W-6240, Factor viii (rdna), Factor viii octocog alfa, Factor viii, recombinant, Helixate fs, Helixate nexgen, Helixate nextgen
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 |
1 disease in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.
| Disease (in trials) | Phase | MONDO | EFO |
|---|---|---|---|
| von Willebrand disease (hereditary or acquired) | 3 | MONDO:0024574 | Orphanet:903 |
Clinical trials
Total trials: 23.
Phase distribution
| Phase | Trials |
|---|---|
| Not specified | 7 |
| PHASE1 | 5 |
| PHASE3 | 4 |
| PHASE4 | 3 |
| PHASE2 | 3 |
| PHASE2/PHASE3 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00586521 | PHASE4 | COMPLETED | BAY14-2222 Prophylaxis and Joint Function Improvement (Adults) |
| NCT01085344 | PHASE4 | COMPLETED | Canadian Hemophilia Prophylaxis Study |
| NCT04985682 | PHASE4 | COMPLETED | A Study of ADVATE in People With Hemophilia A in India |
| NCT05582993 | PHASE3 | RECRUITING | A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD) |
| NCT07129343 | PHASE3 | RECRUITING | A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD) |
| NCT00606060 | PHASE3 | COMPLETED | BAY14-2222 Continuous Infusion in Surgeries |
| NCT01486927 | PHASE2/PHASE3 | COMPLETED | An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A |
| NCT02306694 | PHASE3 | COMPLETED | Prospective Biomarkers of Bone Metabolism in Hemophilia A |
| NCT00245297 | PHASE2 | COMPLETED | Study of the Efficacy of Human Recombinant Factor VIII (Kogenate FS) Reconstituted in Pegylated Liposomes. |
| NCT00717626 | PHASE2 | COMPLETED | Once-A-Day Prophylaxis for Youth and Young Adults With Severe Hemophilia A |
| NCT00989196 | PHASE2 | COMPLETED | Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A |
| NCT02483208 | PHASE1 | COMPLETED | Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate |
| NCT02716194 | PHASE1 | COMPLETED | BAX 826 Dose-Escalation Safety Study |
| NCT04864743 | PHASE1 | COMPLETED | A Study to Evaluate the Pharmacokinetics，Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection |
| NCT05042440 | PHASE1 | COMPLETED | Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A |
| NCT05251090 | PHASE1 | COMPLETED | A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection |
| NCT07446010 | Not specified | NOT_YET_RECRUITING | Post Approval Observational Study to Learn More About How Safe Octocog Alfa is and How Well it Works in Patients With Severe Hemophilia A in India |
| NCT00864552 | Not specified | COMPLETED | International PMS Study - KOGENATE Bayer |
| NCT02078427 | Not specified | COMPLETED | ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD) |
| NCT02282410 | Not specified | UNKNOWN | Evaluate Efficacy and Safety of ADVATE in the Standard Prophylaxis Treatment of Severe or Moderately Severe Hemophilia A |
| NCT02830477 | Not specified | COMPLETED | Study Evaluating Real World Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis |
| NCT03006965 | Not specified | COMPLETED | Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT® |
| NCT03747653 | Not specified | UNKNOWN | A Study to Evaluate the Pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection |
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
- In clinical trials for: von Willebrand disease (hereditary or acquired)