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SHR-1918

Phase 2

Homozygous Familial Hypercholesterolemia | Small molecule | Metabolic |Co-Diagnostics, Inc.|Last Updated: Aug 21, 2025

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
UNCONTROLLED
Total Trials1
Total Enrollment55
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07133815Evaluate the Long-term Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial HypercholesterolemiaPHASE2 NOT YET_RECRUITING 55Aug 1, 2025Dec 1, 2027Aug 21, 20251 China
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Study Endpoints
Primary Endpoints
The incidence and severity of adverse events
during the study period About 48 months,
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SHR-1918EXPERIMENTAL -
Interventions
NameTypeDescription
SHR-1918DRUGSHR-1918
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Subjects who received and completed the SHR-1918-301 study treatment in previous studies and were deemed to have therapeutic benefits by the researchers Exclusion Criteria: 1. Known to be allergic to the investigatio...

Countries:China
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