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QTI571

Phase 3

Severe Pulmonary Arterial Hypertension | Small molecule | Cardiovascular |Novartis AG|Last Updated: Jun 18, 2019

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
UNCONTROLLED
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02042014Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in JapanPHASE3 COMPLETED 8Jan 22, 2014Oct 17, 2016Jun 18, 20193 Japan
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Study Endpoints
Primary Endpoints
Serious Adverse Events
Approximately 2.9 years

All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
QTI571EXPERIMENTALParticipants will receive QTI571 during 3 years.
Interventions
NameTypeDescription
QTI571DRUGQTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * patient is receiving QTI571 for the treatment of Pulmonary Arterial Hypertension (PAH) and is currectly enrolled in a long-term extension study (CQTI571A2301E1) in Japan. * Patient is currently benifitting form the treatment with QTI571 in the opinion of the investigator. Exc...

Countries:Japan
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