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LJPC-501

Phase 3

Catecholamine-resistant Hypotension (CRH) | Small molecule | Infectious Disease |Innoviva, Inc.|Last Updated: Mar 27, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment344

FDA Designations

No designations recorded

Clinical trial landscape

LJPC-501 · 1 trial · 4 indications

Phase 3 1
NCT02338843A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant HypotensionCatecholamine-resistant Hypotension (CRH)
COMPLETED344 Analytics
PHASE3COMPLETED
A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension
Catecholamine-resistant Hypotension (CRH)Unlock trial analytics

Study Endpoints

Primary Endpoints

An Increased MAP, Defined as Achievement of a Day 1 MAP at 3 Hours Following the Initiation of Study Drug, of ≥ 75 mmHg OR a 10 mmHg Increase in Baseline MAP
Hour 3

Response with respect to mean arterial pressure (MAP) at hour 3 after the start of infusion was defined as an increase from baseline of at least 10 mm Hg or an increase to at least 75 mm Hg, without an increase in the dose of background vasopressors.

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LJPC-501 (angiotensin II)EXPERIMENTALTreatment arm
Placebo (0.9% sodium chloride solution)PLACEBO_COMPARATORPlacebo arm

Interventions

NameTypeDescription
LJPC-501DRUGTreatment arm
PlaceboDRUGPBO
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites115

Inclusion Criteria: 1. Adult patients ≥ 18 years of age with CRH, defined as those who require a total sum catecholamine dose of \> 0.2 mcg/kg/min for a minimum of 6 hours and a maximum of 48 hours, to maintain a MAP between 55-70 mmHg. 2. Patients are required to have central venous access and an ...

Countries:United StatesAustraliaBelgiumCanadaFinlandFranceGermanyNew ZealandSwitzerlandUnited Kingdom
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Frequently asked questions about LJPC-501

What is LJPC-501 used for?

LJPC-501 is an investigational small molecule being developed for the treatment of catecholamine-resistant hypotension (CRH), a condition of dangerously low blood pressure that does not respond to standard catecholamine therapy. It is also studied in related conditions including distributive shock, high output shock, and sepsis.

What does LJPC-501 target?

LJPC-501 is a small molecule designed to address catecholamine-resistant hypotension by providing an alternative vasopressor mechanism. Its specific molecular target is not disclosed in the available clinical trial information, but it is being studied in patients who do not respond to catecholamines.

Who makes LJPC-501?

LJPC-501 is being developed by Innoviva, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol INVA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with catecholamine-resistant hypotension.

What phase is LJPC-501 in?

LJPC-501 is in Phase 3 clinical development. It has completed a Phase 3 study, but it remains investigational and has not been approved by regulatory authorities. The drug is still undergoing clinical evaluation to determine its safety and effectiveness.

What clinical trials is LJPC-501 in?

LJPC-501 has one completed Phase 3 clinical trial, identified as NCT02338843. This randomized, double-blind, placebo-controlled study enrolled 344 patients with catecholamine-resistant hypotension and related conditions, including distributive shock, high output shock, and sepsis. The trial was conducted across multiple countries.

Is LJPC-501 the same as any other drug?

LJPC-501 is the primary name used in clinical trials and regulatory documents. No alternative names have been reported for this investigational drug. It is distinct from other vasopressor agents currently on the market or in development.