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Ruxolitinib

Phase 1

Coronavirus | Small molecule | Infectious Disease |Rigel Pharmaceuticals, Inc.|Last Updated: Nov 18, 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
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment185
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04581954Inflammatory Signal Inhibitors for COVID-19 (MATIS)PHASE1 COMPLETED 185Oct 2, 2020Sep 2, 2023Nov 18, 20255 United Kingdom
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Study Endpoints
Primary Endpoints
Progression from mild to severe COVID-19 pneumonia within 14 days in hospitalised patients
Day 14

Patients are recruited at a WHO COVID-19 Severity Score of 3 and 4 and the primary endpoint is the comparison of patients whose COVID-19 pneumonia progresses to a severity score ≥ 5 on the modified WHO Ordinal Scale. Specifically, the primary endpoint is met when the following are recorded within 14 days: * Death * Requirement for invasive ventilation * Requirement for non-invasive ventilation including CPAP or high flow nasal oxygen * O2 saturation \< 90% on ≥60% inspired oxygen

Secondary Endpoints
Mortality
Day 14
Invasive ventilation
Day 14
Non-invasive ventilation including CPAP and high flow nasal oxygen
Day 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Standard of careACTIVE_COMPARATOR -
FostamatinibACTIVE_COMPARATOR -
RuxolitinibACTIVE_COMPARATOR -
Interventions
NameTypeDescription
RuxolitinibDRUGRuxolitinib is a Janus kinase 1 (JAK1)/Janus kinase 2 (JAK2) inhibitor approved for clinical use in the treatment of splenomegaly, myelofibrosis, polycythaemia vera and graft-versus-host disease. It is an oral agent with a rapid mode of action.
FostamatinibDRUGFostamatinib is a tyrosine kinase inhibitor with activity against spleen tyrosine kinase (SYK). It has approved for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP).
Standard of careOTHERStandard of care treatment as per site-level policies and guidelines.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patients age ≥ 18 years at screening * Patients with mild or moderate C19 pneumonia, defined as Grade 3 or 4 severity by the WHO COVID-19 Ordinal Scale by * Patients meeting criteria: Hospitalization AND SARS-CoV2 infection (clinically suspected\* or laboratory-confirmed) AND ...

Countries:United Kingdom
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