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Hydronidone

Phase 3

Chronic Hepatitis B With Hepatic Fibrosis | Small molecule | Infectious Disease |Co-Diagnostics, Inc.|Last Updated: Mar 31, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07343778A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver CirrhosisPHASE3 RECRUITING 300Mar 16, 2026Oct 30, 2026Mar 31, 20261 China
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Study Endpoints
Primary Endpoints
Any adverse events occurring in study participants following drug administration.
28 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Hydronitone Capsules groupEXPERIMENTALEligible subjects who passed screening were enrolled sequentially in this study and received Hydronidone Capsules 120mg TID for 28 consecutive days.
Interventions
NameTypeDescription
Hydronidone CapsulesDRUG120mg TID for 28 consecutive days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Participants fully understand the study, voluntarily participate, and have signed the informed consent form (ICF). * Aged ≥18 years, regardless of gender. * Have a confirmed diagnosis of hepatic fibrosis or cirrhosis based on either: A prior percutaneous liver biopsy (results...

Countries:China
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