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LRX712

Phase 2

Osteoarthritis (OA) | Small molecule | Musculoskeletal |Novartis AG|Last Updated: Jan 30, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

LRX712 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT04097379Safety, Tolerability and Preliminary Efficacy of Multiple Intra-articular Injections of LRX712 in Patients With Knee OAOsteoarthritis (OA)
COMPLETED45 Analytics
PHASE2COMPLETED
Safety, Tolerability and Preliminary Efficacy of Multiple Intra-articular Injections of LRX712 in Patients With Knee OA
Osteoarthritis (OA)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Cartilage Volume in the Index Region Measured by 7 Tesla MRI
Baseline, Week 28

Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in the volume of cartilage in the index region. The index region was defined as the combination of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee. Change from baseline in cartilage volume was analyzed using the mixed effects model for repeated measures (MMRM). The model included baseline, treatment, timepoint and treatment-timepoints as fixed effects, and participant as random effect. Missing data was assumed to be Missing at Random (MAR).

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of LRX712 after a single intra-articular (i.a.) injection in Osteoarthritic (OA) patients
Day 29

To evaluate Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of LRX712 after a single i.a. injection in osteoarthritic patients

Secondary Endpoints

Time to Reach the Maximum Plasma Concentration (Tmax) of LRX712
Pre-dose, 0.5, 12, 24 and 168 hours after dose on Day 1; Pre-dose, 24 and 168 hours after dose on Day 29; Pre-dose, 24, 168, 1344 and 3360 hours after dose on Day 57
Maximum Observed Plasma Concentration (Cmax) of LRX712
Pre-dose, 0.5, 12, 24 and 168 hours after dose on Day 1; Pre-dose, 24 and 168 hours after dose on Day 29; Pre-dose, 24, 168, 1344 and 3360 hours after dose on Day 57
Minimum Observed Plasma Concentration (Cmin) of LRX712
Pre-dose on Day 29; Pre-dose, 1344 hours after dose on Day 57 (LRX712 15 mg arm) and 3360 hours after dose on Day 57 (LRX712 25 mg and 75 mg arms)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LRX712 15 mgEXPERIMENTALLRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
LRX712 25 mgEXPERIMENTALLRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
LRX712 75 mgEXPERIMENTALLRX712 75 mg was administered i.a. every four weeks, for a total of three administrations.
PlaceboPLACEBO_COMPARATORPlacebo was administered i.a. every four weeks, for a total of three administrations.
LRX712EXPERIMENTALLRX712 given intra-articularly

Interventions

NameTypeDescription
LRX712DRUGLRX712 intra-articular injections
PlaceboOTHERPlacebo intra-articular injections
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Eligibility Criteria

Age Range35 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Written informed consent must be obtained before any assessment is performed. To be eligible for inclusion in this study patients must meet all of the following criteria: * Patient must have a BMI between 18 -35 kg/m2 * Patient must have symptomatic knee osteoarthritis predomi...

Countries:Netherlands
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Frequently asked questions about LRX712

What is LRX712 used for?

LRX712 is an investigational small molecule being developed for osteoarthritis (OA), specifically for patients with moderate knee osteoarthritis aged 30 to 65 years. It is administered via intra-articular injection and is currently in clinical development, with studies completed in Phase 1 and Phase 2.

What does LRX712 target?

The molecular target of LRX712 is not disclosed in available information. It is a small molecule being studied for its safety, tolerability, and preliminary efficacy in knee osteoarthritis, but its specific mechanism of action has not been publicly detailed.

Who makes LRX712?

LRX712 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the drug's safety and efficacy in patients with knee osteoarthritis.

What phase is LRX712 in?

LRX712 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 study, NCT04097379, evaluated safety, tolerability, and preliminary efficacy of multiple intra-articular injections in patients with knee OA. The drug is not approved and remains investigational.

What clinical trials is LRX712 in?

LRX712 has been studied in two completed trials: NCT03355196, a Phase 1 first-in-human study in osteoarthritic patients, and NCT04097379, a Phase 2 study of multiple intra-articular injections in knee OA patients. Both trials were conducted in the Netherlands.

Is LRX712 the same as any other drug?

No alternative names for LRX712 have been reported. It is identified solely by its code name LRX712 in clinical trial registries and by its developer, Novartis AG.