Product Description
FBX-101 is being developed by Forge Biologics for the treatment of patients with Krabbe Disease. (Sourced from: https://clinicaltrials.gov/ct2/show/NCT04693598?term=FBX-101&draw=2&rank=1)
Mechanisms of Action: Gene Therapy,GALC
Novel Mechanism: Yes
Modality: Gene Therapy
Route of Administration: N/A
FDA Designation:
Fast Track - Krabbe Disease
Orphan Drug - Krabbe Disease *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Forge Biologics
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Spain, United States
Active Clinical Trial Count: 3
Highest Development Phases
Phase 2: Krabbe Disease|Leukodystrophy, Globoid Cell
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| RESKUE | P2 |
Active, not recruiting |
Leukodystrophy, Globoid Cell|Krabbe Disease |
2026-11-01 |
|
| REKLAIM | P2 |
Active, not recruiting |
Leukodystrophy, Globoid Cell|Krabbe Disease |
2026-11-01 |
|
| FBX-101-RESKUE | P2 |
Unknown Status |
Krabbe Disease |
2026-10-01 |