Entera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis
Entera Bio received positive FDA feedback on the Phase 3 registrational protocol for EB613, an oral anabolic tablet for postmenopausal osteoporosis. The agency accepted a plan for a single, randomized, double-blind trial in approximately 750 women with a primary endpoint of total hip BMD at 12 months, with topline data expected in the second half of 2028.
Key figures
- Drug Name
- EB613 (oral PTH(1-34), teriparatide)
- Phase Of Trial
- Phase 3
- Phase 2 patients
- 161
- Phase 3 patients
- approximately 750
- Phase 3 initiation
- late 2026
- Topline data timing
- second half of 2028
AI analysis
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