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LNA043

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment154
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03275064Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.PHASE2 COMPLETED 142 — — Sep 12, 2017Sep 6, 2022Apr 21, 202619 United States, Czechia +1
NCT04564053Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis ParticipantsPHASE1 COMPLETED 12 — — Sep 23, 2020Dec 10, 2020Aug 10, 20222 Japan
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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

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 — 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 115 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY3PHASE3Eloralintide, Orforglipron, LY3016859 ISA, LY3556050 ISA, LY3526318 ISA
Pacira Biosciences, Inc.PCRX4PHASE3ZILRETTA, Enekinragene Inzadenovec, FX201
Novo Nordisk A/S Sponsored ADR Class BNVO1PHASE3NNC0487-0111
Bioventus, Inc. Class ABVS1PHASE2PTP-001
Enlivex Ltd.ENLV2PHASE1Allocetra, Allocetra-OTS
Smith & Nephew plc Sponsored ADRSNN10 — Undisclosed
Stryker CorporationSYK11NAUndisclosed
Zimmer Biomet Holdings, Inc.ZBH57NAUndisclosed
Merit Medical Systems, Inc.MMSI1NACorticosteroid
Johnson & JohnsonJNJ1NAUndisclosed
Abbott LaboratoriesABT1NAUndisclosed
Enovis CorporationENOV1NAUndisclosed
Teleflex IncorporatedTFX1 — Undisclosed
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