Positive FDA Feedback on Phase 3 Brings Entera Bio's Oral Osteoporosis Pill One Step Closer to Market

Entera Bio received positive FDA feedback on its Phase 3 protocol for EB613, an oral osteoporosis tablet based on teriparatide. The FDA accepted the company's proposed single-study registrational strategy with approximately 750 postmenopausal women, using total hip bone mineral density at 12 months as the primary endpoint. Phase 3 is expected to initiate in late 2026 with topline results anticipated in H2 2028. The approval could represent the first oral anabolic osteoporosis treatment, addressing a market where injectable therapies have limited adoption despite high efficacy.