Efanesoctocog Alfa
Hemophilia A
Floatz Rating
BBB72/100
Confidence
Indicative
Sponsor
Sanofi
Modality
protein_peptide
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
71High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06941870CT.gov Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy | — | Recruiting | — | — | — |
NCT06940830CT.gov Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa | — | Recruiting | — | — | — |
NCT06716814CT.gov Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa | — | Recruiting | — | — | — |
NCT06579144CT.gov Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A | — | Recruiting | — | — | — |
NCT06752850CT.gov A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis | — | Active Not Recruiting | — | — | — |
NCT06530030CT.gov Goal Attainment and Physical Activity in People With Hemophilia A | — | Terminated | — | — | — |
NCT06684314CT.gov A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan | — | Recruiting | — | — | — |
NCT05911763CT.gov A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A | — | Active Not Recruiting | — | — | — |
NCT05042440CT.gov Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A | — | Completed | — | — | — |
NCT04644575CT.gov Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A | — | Active Not Recruiting | — | — | — |
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NCT04759131CT.gov Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A | — | Completed | — | — | — |
NCT04161495CT.gov A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
73High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Hemophilia A
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Efanesoctocog Alfa (this asset) | Sanofi | Approved | BBB · 72 |
| Turoctocog Alfa | Novo Nordisk A/S | P4 | A |
| Eptacog Alfa (Activated) | AryoGen Pharmed Co. | P4 | A |
| Rurioctocog Alfa Pegol | Takeda | P4 | BBB |
| N8-GP | Novo Nordisk A/S | P3 | BBB |
| Immunoglobulin G4 [230-Proline,De-449-Lysine], Anti-(Human Blood-Coagulation Factor Ix)(Human Clone 0365-0001-9985 ?4-Chain), Disulfide With Human Clone 0365-0001-9985 ?-Chain, (228?226?),(231?229?)-Bis(Disulfide) With Anti-(Human Blood-Coagulation Factor X) Immunoglobulin G4 [228-Proline,405-Leucine,409-Lysine,De-447-Lysine] (Human Clone 0365-0001-8174 ?4-Chain) Disulfide With Human Clone 0365-0001-8174 ?-Chain | Novo Nordisk A/S | P3 | BBB |
| bay94-9027 | Bayer | P4 | BBB |
| Emicizumab | Emory University | P4 | BBB |
| Fitusiran | Sanofi | P4 | BBB |
+36 more in the Hemophilia A cohort
Other indications for Efanesoctocog Alfa
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Hemophilia | — | P4 | BB · 65 |
| Synovitis | — | P4 | BB · 65 |
| Severe Hemophilia A | — | P3 | BB · 64 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Citation
Floatz Terminal. Efanesoctocog Alfa in Hemophilia A. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 13, 2026. https://terminal.floatz.ai/assets/efanesoctocog-alfa-hemophilia-a
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