Lorecivivint
Lorecivivint (SM04690)
Also known as: SM04690
An injected Wnt-pathway small molecule for knee osteoarthritis, given once or twice a year, with an NDA submitted to the FDA in January 2026 after multi-year cartilage-preservation data.
Overview
Lorecivivint inhibits CLK and DYRK1A kinases to modulate Wnt signaling in the joint, aiming to slow cartilage loss rather than only relieve pain. After a mixed Phase 3 history, Biosplice's long-term OA-07 data showed preservation of joint-space width over several years, and the company submitted a New Drug Application on January 6, 2026. If approved it would be the first structure-modifying osteoarthritis drug.
Mechanism of action
Intra-articular CLK/DYRK1A inhibition that modulates Wnt signaling, reducing inflammation and promoting chondrocyte health.
Key studies & citations
- Human2026
Biosplice submits NDA for lorecivivint in knee osteoarthritis
Filing based on joint-space-width preservation.
Biosplice press release - Human2021
Lorecivivint in knee osteoarthritis: Phase 2 and 3 trials
Pain and function improvement with a structural signal in subgroups.
PubMed
Frequently asked questions
How is this different from BPC-157 for joints?
Lorecivivint has completed regulated Phase 3 trials with imaging endpoints and is under FDA review. BPC-157 has animal data only.