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QTI571

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

QTI571 · 1 trial · 1 indication

Phase 3 1
NCT02042014Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in JapanSevere Pulmonary Arterial Hypertension
COMPLETED8 Analytics
PHASE3COMPLETED
Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan
Severe Pulmonary Arterial HypertensionUnlock trial analytics

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 to 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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Frequently asked questions about QTI571

What is QTI571 used for?

QTI571 is an investigational small molecule being developed for severe pulmonary arterial hypertension, a condition of high blood pressure in the arteries of the lungs. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.

Who makes QTI571?

QTI571 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with severe pulmonary arterial hypertension.

What phase is QTI571 in?

QTI571 is in Phase 3 clinical development for severe pulmonary arterial hypertension. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its potential as a treatment for this condition.

What clinical trials is QTI571 in?

QTI571 has been studied in a completed Phase 3 clinical trial registered as NCT02042014. This open-label, multi-center study was designed to provide QTI571 to patients with severe pulmonary arterial hypertension in Japan who had participated in a prior extension study. The trial enrolled 8 participants.

Is QTI571 the same as any other drug?

QTI571 is the investigational name for this drug candidate developed by Novartis. No alternative names have been reported in the available clinical trial information, and it is identified solely by the designation QTI571 in the context of its development for severe pulmonary arterial hypertension.