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ALN-F1202

Phase 1

Healthy Volunteer | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Feb 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06669234Phase 1 Safety and Tolerability Study of ALN-F1202 in Healthy AdultsPHASE1 ACTIVE NOT_RECRUITING 56Mar 6, 2025Jul 30, 2026Feb 23, 20261 Belgium
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Study Endpoints
Primary Endpoints
Incidence of Treatment Emergent Adverse Events (TEAEs)
Up to 190 Days
Severity of TEAEs
Up to 190 Days
Secondary Endpoints
Change in activated Partial Thromboplastin Time (aPTT)
Baseline up to 190 Days
Change in Prothrombin Time (PT)
Baseline up to 190 Days
Concentration of combined ALN-F1202 and metabolites in plasma
Up to 190 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALN-F1202EXPERIMENTALRandomized as described in the protocol Escalating Cohorts including Optional Cohorts
PlaceboEXPERIMENTALRandomized as described in the protocol
Interventions
NameTypeDescription
ALN-F1202DRUGAdministered per the protocol
Matching PlaceboDRUGAdministered per the protocol
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: 1. Has a body mass index between 18 and 32 kg/m2, inclusive 2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of i...

Countries:Belgium
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06669234primaryCompletionDate: changed
LOWMay 24, 2026NCT06669234studyFirstPostDate: changed