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EHL-FVIII
EHL-FVIII, developed by Federico II University, is a marketed small molecule with a unique mechanism of action targeting a specific biological pathway. The key composition patent for EHL-FVIII is set to expire in 2028, which may provide a period of market exclusivity and protection against generics. However, the lack of revenue data and key trial results poses a significant risk in assessing the drug's commercial viability and therapeutic efficacy.
At a glance
| Generic name | EHL-FVIII |
|---|---|
| Sponsor | Federico II University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Monitoring of Anti-TFPI in Hemophilia
- Real-World Joint Outcomes After Selective Transition to Low-Dose Emicizumab in Pediatric Hemophilia A (PHASE2,PHASE3)
- Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A (PHASE1)
- Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A (PHASE1)
- Association of Prophylactic Treatment With Treatment Burden and Psychosocial Variables in Patients With Hemophilia
- EVALUATION of the OVERALL HAEMOSTATIC CAPACITY of MIM8 with GLOBAL HAEMOSTASIS ASSAYS and FIBRIN CLOT ULTRASTRUCTURE
- Intensive Replacement Treatment in Haemophilia Patients With Synovitis (PHASE4)
- A Study in Children, Teenagers and Adults With Severe Hemophilia A Who Switched From Other Factor VIII Treatments to Adynovate
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:
- EHL-FVIII CI brief — competitive landscape report
- EHL-FVIII updates RSS · CI watch RSS
- Federico II University portfolio CI