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LTP001

Phase 2

Pulmonary Arterial Hypertension | Small molecule | Cardiovascular |Novartis AG|Trials Updated: Jul 21, 2026

LTP001 development status

Highest phase Phase 2 (NCT05764265)
Phase scored for NVSPhase 1
Registered trials 3 across 1 sponsor since Nov 2021

LTP001 target and mechanism

ModalitySmall molecule

Also known as LTP

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment232

FDA Designations

No designations recorded

LTP001 clinical trials

LTP001 · 1 trial · 1 indication

Phase 1 1
NCT06649110A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)Healthy Volunteers, Pulmonary Arterial Hypertension
RECRUITING232 Analytics
PHASE1RECRUITING
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
Healthy Volunteers, Pulmonary Arterial HypertensionUnlock trial analytics

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 to 100 Years
SexALL
Healthy VolunteersYes
Study Sites87

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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Frequently asked questions about LTP001

What is LTP001?

LTP001 is an investigational small molecule drug being developed by Novartis AG for pulmonary arterial hypertension, a form of high blood pressure in the arteries of the lungs. It is in Phase 1 clinical development and has not been approved by the FDA. It is also known as LTP.

What is LTP001 used for?

LTP001 is being studied for the treatment of pulmonary arterial hypertension, a cardiovascular condition involving elevated pressure in the pulmonary arteries. The Phase 1 program also includes a healthy volunteer portion. Its safety and efficacy in patients have not yet been established.

Who makes LTP001?

LTP001 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the clinical program evaluating the drug in healthy participants and in patients with pulmonary arterial hypertension.

What phase is LTP001 in?

LTP001 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The single Phase 1 trial is currently recruiting participants.

What clinical trials is LTP001 in?

LTP001 is being evaluated in one Phase 1 trial, NCT06649110, titled A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B). The trial is recruiting, is randomized, double-blind, and placebo-controlled, and plans to enroll 232 participants across 18 countries.

Is LTP001 the same as LTP?

Yes, LTP001 is also referred to as LTP. Both names refer to the same investigational small molecule developed by Novartis AG for pulmonary arterial hypertension. Searches for either name point to the same Phase 1 program.