Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LNA043 · 3 trials · 3 indications
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.
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.
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.
MRI based quantitative assessment using an automated segmentation algorithm
MRI based quantitative assessment using an automated segmentation algorithm.
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
To assess the safety and tolerability of single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee
Safety and tolerability of LNA043 after one intra-articular injection into the knee of osteoarthritis patients scheduled for total knee replacement
| Arm | Type | Description |
|---|---|---|
| LNA043 40 mg Part B | EXPERIMENTAL | LNA043 40 mg Part B |
| LNA043 20 mg Part B | EXPERIMENTAL | LNA043 20 mg Part B |
| LNA043 20 mg Part A | EXPERIMENTAL | LNA043 20 mg Part A |
| Placebo Part A | PLACEBO_COMPARATOR | Placebo Part A |
| Placebo Part B | PLACEBO_COMPARATOR | Placebo Part B |
| LNA043 | EXPERIMENTAL | LNA043 |
| placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| LNA043 | BIOLOGICAL | LNA043 intra-articular injection |
| Placebo | OTHER | Placebo intra-articular injection |
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 ...
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 by the FDA.
LNA043 is being developed by Novartis AG, traded on the New York Stock Exchange under the ticker NVS. The company has sponsored clinical trials of LNA043 in the United States, Czechia, Denmark, and Japan.
LNA043 is in Phase 2 clinical development for osteoarthritis. It has completed Phase 1 and Phase 2 trials, including a Phase 2 study of intra-articular injections in patients with articular cartilage lesions and knee osteoarthritis. It remains investigational and is not FDA approved.
LNA043 has completed three clinical trials: NCT02491281, a Phase 1 first-in-human single ascending dose study in patients scheduled for total knee replacement; NCT03275064, a Phase 2 study of intra-articular injections in patients with articular cartilage lesions and knee osteoarthritis; and NCT04564053, a Phase 1 study in Japanese osteoarthritis participants.
No alternative names for LNA043 have been disclosed. It is identified solely by the code name LNA043 in clinical trial registrations and is not known to be marketed under any other brand name.