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Ravidasvir

Phase 2

Chronic Hepatitis C | Small molecule | Infectious Disease |Co-Diagnostics, Inc.|Last Updated: Oct 22, 2020

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03020095Efficacy and Safety of Ravidasvir + Danoprevir/r 12-week Oral Therapy in Treatment-Naive Non Cirrhotic G1 CHC TaiwanPHASE2 COMPLETED 38Aug 1, 2015Feb 1, 2017Oct 22, 2020 -
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Study Endpoints
Primary Endpoints
Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
12 weeks

SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ravidasvir,Danoprevir/r,RBVEXPERIMENTALParticipants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks.
Interventions
NameTypeDescription
RavidasvirDRUGRavidasvir 200mg tablet administered orally once daily
DanoprevirDRUGDanoprevir 100mg tablet administered orally twice daily
RitonavirDRUGRitonavir 100mg tablet administered orally twice daily
RibavirinDRUGRibavirin(RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)administered orally
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Willing and able to provide written informed consent * Chronic HCV infection (≥6 months) , HCV RNA ≥ 1 × 104 IU/mL * Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV * Chronic liver disease consistent with...

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