Recent Updates
Recently added Catalysts

S 44819 twice a day

Phase 2

Post Stroke Recovery | Small molecule | Neurology |Tango Therapeutics, Inc.|Last Updated: Mar 11, 2020

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment585
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02877615Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral EventPHASE2 COMPLETED 585Dec 19, 2016Mar 10, 2019Mar 11, 2020121 Australia, Belgium +13
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Modified Rankin Scale (mRS)
Up to 90 days
Secondary Endpoints
National Institutes of Health Stroke Scale (NIHSS) total score
Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105
Barthel Index (BI) total score
Day 30 Day 60 Day 90 Day 105
Montreal Cognitive Assessment scale (Moca) total score
Day 30 Day 90
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
S 44819 150 mg twice a dayEXPERIMENTAL -
S 44819 300 mg twice a dayEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
S 44819 150 mg twice a dayDRUGOne sachet of S 44819 150 mg and one sachet of placebo twice a day
S 44819 300 mg twice a dayDRUGTwo sachets of S 44819 150 mg twice a day
PlaceboDRUGTwo sachets of placebo twice a day
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites121

Inclusion criteria : * Patients aged between 18 and 85 years (both inclusive) * Acute ischemic stroke that occured between 72 hours (3 days) and 192 hours (8 days) (both inclusive) before inclusion Exclusion criteria : * Any non-selection criteria, which could have occurred after the selection vi...

Countries:AustraliaBelgiumBrazilCanadaCzechiaFranceGermanyHungaryItalyNetherlandsPolandSouth KoreaSpainSwedenUnited Kingdom
Unlock Eligibility Criteria