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BAY94-9027
BAY94-9027 is a Long-acting recombinant factor VIII (PEGylated) Biologic drug developed by Bayer. It is currently in Phase 3 development for Hemophilia A (routine prophylaxis and treatment of bleeding episodes).
BAY94-9027 is a long-acting factor VIII replacement therapy that extends the half-life of clotting factor VIII through PEGylation, reducing dosing frequency in hemophilia A patients.
BAY94-9027 is a long-acting factor VIII replacement therapy that extends the half-life of clotting factor VIII through PEGylation, reducing dosing frequency in hemophilia A patients. Used for Hemophilia A (routine prophylaxis and treatment of bleeding episodes).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Bayer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | BAY94-9027 |
|---|---|
| Sponsor | Bayer |
| Drug class | Long-acting recombinant factor VIII (PEGylated) |
| Target | Coagulation factor VIII |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
BAY94-9027 is a recombinant human coagulation factor VIII conjugated with polyethylene glycol (PEG), which increases its circulating half-life compared to conventional factor VIII products. This extended half-life allows for less frequent dosing while maintaining therapeutic factor VIII levels, improving convenience and compliance in hemophilia A management. The drug functions as a direct replacement of the deficient clotting factor in the intrinsic coagulation pathway.
Approved indications
- Hemophilia A (routine prophylaxis and treatment of bleeding episodes)
Common side effects
- Inhibitor development (factor VIII antibodies)
- Injection site reactions
- Headache
- Hypersensitivity reactions
Key clinical trials
- Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa (PHASE4)
- A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health
- Phase 3 Study for Efficacy and Safety Outcomes Data in Japanese Patients With Severe Hemophilia A (PHASE3)
- Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a "Shuttle" (PHASE1, PHASE2)
- An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
- A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease (PHASE3)
- An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
- Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BAY94-9027 CI brief — competitive landscape report
- BAY94-9027 updates RSS · CI watch RSS
- Bayer portfolio CI
Frequently asked questions about BAY94-9027
What is BAY94-9027?
How does BAY94-9027 work?
What is BAY94-9027 used for?
Who makes BAY94-9027?
What drug class is BAY94-9027 in?
What development phase is BAY94-9027 in?
What are the side effects of BAY94-9027?
What does BAY94-9027 target?
Related
- Drug class: All Long-acting recombinant factor VIII (PEGylated) drugs
- Target: All drugs targeting Coagulation factor VIII
- Manufacturer: Bayer — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Hemophilia A (routine prophylaxis and treatment of bleeding episodes)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing