Enlivex receives FDA IND clearance to launch a Phase 2b trial of Allocetra™, an investigational immunotherapy for moderate-to-severe age-related knee osteoarthritis, evaluating pain, function, and quality-of-life outcomes.
Written By: Marka Sheshi, PharmaD
Reviewed By: Pharmacally Editorial Team
Enlivex Ltd. has received clearance from the U.S. Food and Drug Administration for its Investigational New Drug (IND) application for Allocetra™, enabling the company to initiate a Phase 2b clinical trial in patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis.
The planned global, multicenter, randomized, double-blind, placebo-controlled Phase 2b trial will evaluate the efficacy and safety of intra-articular injections of Allocetra™. The study will enroll patients with symptomatic knee osteoarthritis and assess changes from baseline in pain and physical function compared with placebo at three and six months following treatment. Additional endpoints include quality-of-life measures and functional mobility assessments.
Allocetra™ is an investigational immunotherapy designed to modulate inflammatory processes associated with aging. In an earlier clinical study (NCT06233474), the therapy demonstrated durable and clinically meaningful improvements lasting at least six months, with stronger benefits observed in older patient populations.
“This milestone represents an important step toward improving the quality of life of an aging population suffering from this debilitating disease with limited treatment options,” said Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex Ltd. The company expects to begin enrolling patients into the Phase 2b trial in the near term.
The regulatory clearance also marks the first milestone under Enlivex’s newly implemented dual-engine value creation strategy, which combines the development of longevity-focused therapeutics with a prediction-markets treasury strategy built around the RAIN protocol on the Arbitrum blockchain ecosystem.
Knee osteoarthritis is one of the most prevalent and disabling musculoskeletal disorders worldwide. More than 32 million people in the United States are currently affected, and the number is projected to reach 78 million by 2040. There are currently no approved disease-modifying therapies for the condition. Treatment typically focuses on symptom management through pain medications, intra-articular steroid injections, or surgical interventions. The disease burden increases with age, affecting roughly 30% of people by age 60, highlighting the need for new and durable treatment options.
Reference
Quality Longevity Company Enlivex Receives Investigational New Drug (IND) Clearance from the FDA for Phase 2b Trial of Allocetra in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis, 23 March 2026, Quality Longevity Company Enlivex Receives Investigational New Drug (IND) Clearance from the FDA for Phase 2b Trial of Allocetra in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis – Enlivex
Study of Intra-articular Allocetra in Knee Osteoarthritis, ClinicalTrials.gov ID NCT06233474, https://clinicaltrials.gov/study/NCT06233474
About the Writer
Marka Sheshi | Doctor of Pharmacy
Driven by a deep commitment to clinical excellence, research integrity, and impactful medical writing. With a strong foundation in pharmacotherapy and patient safety, specializes in transforming complex scientific evidence into authoritative, publication-ready content. Passionate about advancing healthcare through precise, evidence-based communication that informs practice, strengthens research visibility, and improves patient outcomes.