Recent Updates
Recently added Catalysts

LRX712

Phase 2

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

LRX712 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Nov 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment87

FDA Designations

No designations recorded

LRX712 clinical trials

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)
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Osteoarthritis 143 trials (matched to "Osteoarthritis (OA)")

Frequently asked questions about LRX712

What is LRX712 used for?

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

Who is developing LRX712?

LRX712 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker NVS. The drug is in clinical trials for knee osteoarthritis.

What phase is LRX712 in?

LRX712 is in Phase 2 clinical development for knee osteoarthritis. It has completed a Phase 1 first-in-human study and a Phase 2 study evaluating safety, tolerability, and preliminary efficacy of multiple intra-articular injections in patients with knee OA.

What clinical trials has LRX712 been in?

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

How is LRX712 administered?

LRX712 is administered via intra-articular injection, meaning it is injected directly into the knee joint. This route of administration was used in both the Phase 1 and Phase 2 clinical trials for knee osteoarthritis.

Is LRX712 FDA approved?

LRX712 is not FDA approved. It is an investigational drug currently in clinical development for knee osteoarthritis. Its clinical trials have been completed, but the drug has not received regulatory approval for any indication.