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LTP

Phase 1

Healthy Volunteers, Pulmonary Arterial Hypertension | Small molecule | Cardiovascular |Novartis AG|Last Updated: Apr 29, 2026

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment232
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06649110A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)PHASE1 RECRUITING 232Oct 24, 2024Dec 31, 2028Apr 29, 202685 United States, Argentina +16
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Study Endpoints
Primary Endpoints
Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Baseline to Day 35

Safety endpoints, including vital signs, ECG, clinical laboratory evaluations and adverse events up to and including the end-of-study visit.

Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR)
Baseline to Week 24

PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization.

Part B-Treatment Period 2: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
From Day 1 until Week 106

Safety endpoints, including vital signs, ECG, clinical laboratory evaluations, treatment-emergent adverse events and discontinuations due to adverse events.

Secondary Endpoints
Part A- Maximum observed plasma concentrations (Cmax)
Baseline to Day 35
Part A- Time to reach maximum plasma concentration (Tmax)
Baseline to Day 35
Part A- Area under plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
Baseline to Day 35
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LTP001 Dose 1EXPERIMENTAL -
LTP001 Dose 2EXPERIMENTAL -
LTP001 Dose 3EXPERIMENTAL -
PlaceboPLACEBO_COMPARATORmatching placebo
Interventions
NameTypeDescription
LTPDRUGLTP001
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersYes
Study Sites85

Part A Inclusion Criteria: * Healthy males and non-child-bearing potential females Part A Exclusion Criteria: * Clinically significant ECG or cardiac abnormalities, any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, o...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCzechiaFranceGermanyGreeceItalyLatviaMexicoPolandPortugalRomaniaSerbiaSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06649110primaryCompletionDate: changed
LOWMay 24, 2026NCT06649110studyFirstPostDate: changed