In early 2026, the FDA accepted Levicept’s IND application for LEVI-04. Following positive FDA feedback on its development plans, Levicept is now preparing for further clinical development.
Levicept does not currently have any clinical studies open to new patients.
Phase II (Completed)
Levicept’s Phase II trial enrolled over 500 patients with osteoarthritis pain in the knee. Completed in July 2024, the randomised, double-blind, placebo-controlled study evaluated five monthly intravenous infusions of LEVI-04 at three doses:
- LEVI-04 met its primary endpoint at every dose, with significant improvements across key secondary endpoints
- At Week 17, average WOMAC [1] pain scores fell by more than half from baseline, significantly more than with placebo
- Patients saw significant improvements in function, stiffness, overall wellbeing and daily pain, with gains in function and stiffness beyond what pain relief alone would predict
- LEVI-04 was well tolerated, with no increase in rapidly progressive osteoarthritis compared with placebo
- An exploratory MRI analysis at Week 20 also found dose-dependent reductions in bone marrow lesions compared with placebo. These lesions are found in around 70% of people with osteoarthritis and are linked to pain and disease progression.
The results were published in The Lancet in March 2026 (DOI: 10.1016/S0140-6736(26)00131-5).
clinicaltrials.gov ID: NCT05618782
[1] The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain index: a recognised standard pain scale
Phase I (Completed)
In March 2021, Levicept completed a Phase I trial of LEVI-04 in healthy volunteers and patients with osteoarthritis. The trial confirmed LEVI-04’s favourable safety and tolerability, and pharmacokinetics profile.
clinicaltrials.gov ID: NCT03227796