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Ibudilast

Phase 2

Pneumonia, Viral | Small molecule | Infectious Disease |MediciNova, Inc.|Last Updated: Oct 30, 2024

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04429555Efficacy, Safety, Tolerability, and Biomarkers of Ibudilast (MN-166) in Patients Hospitalized With COVID-19 at Risk for ARDSPHASE2 COMPLETED 34Jan 11, 2021Aug 7, 2024Oct 30, 20242 United States
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Study Endpoints
Primary Endpoints
Number of Participants Free From Respiratory Failure at Day 7
Day 7

Participants were considered "responders" if they did not meet the need for supplemental oxygen requirements (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at the end of the 7-day double-blind treatment.

Number of Participants With at Least a 1-point Improvement in Clinical Status on Day 7
Day 7

Number (percentage) of participants with at least a 1-point improvement in clinical status on Day 7. Clinical status is measured by the National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.

Secondary Endpoints
Number of Participants Receiving Mechanical Ventilation or Intubation
Days 7, 14, and 28
All-cause Mortality
Day 1 to Day 60
Number of Participants Discharged From Hospital at Days 7, 14, and 28
Days 7, 14, and 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active Treatment GroupEXPERIMENTAL -
Placebo Treatment GroupPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
IbudilastDRUG50 mg (5 x 10 mg capsules) twice daily for 7 days
PlaceboDRUG0 mg (5 matching capsules) twice daily for 7 days
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * SARS-CoV-2 infection confirmed with WHO criteria (including a positive PCR of any specimen, e.g., blood, respiratory, stool, urine, or any other body fluid) * Chest imaging (radiograph, computerized tomography (CT) scan or lung ultrasound) with abnormalities consistent with CO...

Countries:United States
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