Recent Updates
Recently added Catalysts

VERU-111

Phase 3

SARS-CoV Infection | Small molecule | Infectious Disease |Veru Inc.|Last Updated: Apr 18, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment204
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04842747VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on StudyPHASE3 COMPLETED 204May 18, 2021Jul 6, 2022Apr 18, 202358 United States, Argentina +4
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Efficacy of Sabizabulin in the Treatment of SARS-CoV-2 Infection by Assessing Its Effect on the Proportion of Patients Who Died on Study.
Day 60

Efficacy of VERU-111 in the treatment of SARS-Cov- 2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60).

Secondary Endpoints
The Proportion of Subjects That Are Alive Without Respiratory Failure at Day 15, Day 22 and Day 29.
Day 15, Day 22, Day 29
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
9mg of VERU-111 Oral dailyEXPERIMENTAL9mg of VERU-111
Placebo Capsule once dailyNO_INTERVENTIONSubjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital.
Interventions
NameTypeDescription
VERU-111DRUGSubjects in the VERU-111 treatment groups will receive standard of care, plus oral daily VERU-111 9mg for 21 days or until released from hospital.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites58

Inclusion Criteria: * Provide informed consent from the subject or the subject's Legally Authorized Representative (LAR) * Aged ≥18 years * Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test * Patients with a WHO Ordinal Scale for ...

Countries:United StatesArgentinaBrazilBulgariaColombiaMexico
Unlock Eligibility Criteria