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LNA043

Phase 2

Osteoarthritis | Small molecule | Musculoskeletal |Novartis AG|Trials Updated: Apr 21, 2026

LNA043 development status

Highest phase Phase 2
Registered trials 6 across 1 sponsor since Jul 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment182

FDA Designations

No designations recorded

LNA043 clinical trials

LNA043 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT03275064Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.Osteoarthritis
COMPLETED142 Analytics
PHASE2COMPLETED
Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.
OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Articular Cartilage Collagen Organization in the Overall Cartilage (Femoral and Patellar Lesions) - Part A
Baseline up to Week 16, Week 28

Collagen fibril organization in articular cartilage evaluated by Magnetic Resonance Imaging (MRI) from the cartilage mean T2 relaxation time (with lower values indicative of higher quality). The area of interest is the focal cartilage lesion.

Change From Baseline in Articular Cartilage Collagen Organization in the Deep Cartilage Layer (Femoral and Patellar Lesions) - Part A
Baseline up to Week 16, Week 28

Collagen fibril organization in articular cartilage evaluated by MRI from the cartilage mean T2 relaxation time (with lower values indicative of higher quality). The area of interest is the focal cartilage lesion.

Change From Baseline in Articular Cartilage Collagen Organization in the Superficial Cartilage Layer (Femoral and Patellar Lesions) - Part A
Baseline up to Week 16, Week 28

Collagen fibril organization in articular cartilage evaluated by MRI from the cartilage mean T2 relaxation time (with lower values indicative of higher quality).The area of interest is the focal cartilage lesion.

Change From Baseline of LNA043 to Placebo in Cartilage Volume in the Femoral Medial Index Region (mm3) - Part B
Baseline, Week 29, Week 53

MRI based quantitative assessment using an automated segmentation algorithm

Change From Baseline of LNA043 to Placebo in Cartilage Thickness in the Femoral Medial Index Region (mm) - Part B
Baseline, Week 29, Week 53

MRI based quantitative assessment using an automated segmentation algorithm.

Overview of Number of Participants With Adverse Events and Serious Adverse Events for Part A and Part B
Baseline up to end of post treatment follow-up

Treatment emergent other and serious adverse events (TEAE and TESAE) period: Part A: Baseline up to Day 50 (included 30 day safety follow-up Part B: Baseline up to Day 113 (included 30 day safety follow-up) Long term Follow-UP period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365

Number of participants with adverse events
Up to Day 22

To assess the safety and tolerability of single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee

Safety endpoints (including number of adverse events CTC-AE, physical exam, vital signs, ECG, safety laboratory and pain measured using KOOS)
Up to and including 7 days post-dose

Safety and tolerability of LNA043 after one intra-articular injection into the knee of osteoarthritis patients scheduled for total knee replacement

Secondary Endpoints

Change From Baseline of LNA043 to Placebo in Cartilage Defect Volume (mm^3) for Both Groups of Patients (Femoral and Patellar Lesions) - Part A
Baseline up to Week 16, Week 28
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Overall Part B
Baseline, Week 29, Week 53
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Deep Part B
Baseline, Week 29, Week 53
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LNA043 40 mg Part BEXPERIMENTALLNA043 40 mg Part B
LNA043 20 mg Part BEXPERIMENTALLNA043 20 mg Part B
LNA043 20 mg Part AEXPERIMENTALLNA043 20 mg Part A
Placebo Part APLACEBO_COMPARATORPlacebo Part A
Placebo Part BPLACEBO_COMPARATORPlacebo Part B
LNA043EXPERIMENTALLNA043
placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
LNA043BIOLOGICALLNA043 intra-articular injection
PlaceboOTHERPlacebo intra-articular injection
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion criteria Part A * Patient was ≥18 and ≤55 years old at time of screening. * Patient had a body mass index (BMI) \<30 kg/m2 at screening, * Patient had a symptomatic, single, articular cartilage defect of one knee, grade II or IIIA according to the ICRS classification, localized to either ...

Countries:United StatesCzechiaDenmarkJapan
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Competitive Landscape -Osteoarthritis 143 trials

Frequently asked questions about LNA043

What is LNA043 used for?

LNA043 is an investigational small molecule being developed for osteoarthritis, including primary osteoarthritis in patients scheduled for total knee replacement surgery and articular cartilage lesions with knee osteoarthritis. It is administered via intra-articular injection and is currently in clinical development, not yet approved.

Who makes LNA043?

LNA043 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety, tolerability, and preliminary efficacy of LNA043 in patients with osteoarthritis.

What phase is LNA043 in?

LNA043 has completed Phase 2 clinical trials for osteoarthritis. It remains investigational and is not FDA approved. The drug has completed two trials, including a Phase 2 study, and is no longer in active clinical development according to available trial records.

What clinical trials has LNA043 been in?

LNA043 has been studied in three completed clinical trials. NCT02491281 was a Phase 1 first-in-human single ascending dose study in patients scheduled for total knee replacement. NCT03275064 was a Phase 2 study of intra-articular injections in patients with articular cartilage lesions and knee osteoarthritis. NCT04564053 was a Phase 1 study in Japanese participants with knee osteoarthritis.

Is LNA043 the same as any other drug?

No alternative names for LNA043 have been reported. The drug is identified solely by its code name LNA043 in clinical trial registries and development programs. It is a distinct investigational compound being developed by Novartis for osteoarthritis.