Entera Bio (ENB) Secures FDA Alignment for 12-Month Phase 3 EB613 Study

Entera Bio (ENB) announced on June 22, 2026, it has received U.S. Food and Drug Administration (FDA) alignment for a 12-month Phase 3 study of EB613, its investigational oral anabolic tablet for osteoporosis. This milestone advances the potential for the first oral anabolic treatment for the condition. The Phase 3 trial will evaluate EB613 in hypogonadal men with osteoporosis. This follows positive Phase 2 results that demonstrated significant increases in bone mineral density (BMD) and bone formation markers. The company plans to submit an Investigational New Drug (IND) application and commence the study upon FDA clearance. EB613 aims to offer a convenient oral alternative to current injectable anabolic therapies, potentially expanding treatment options for patients.