Xeris targets Phase 3 start for once-weekly levothyroxine candidate XP-8121 by year-end
XERS•XP-8121 development plan for hypothyroidism
- Xeris outlined its XP-8121 development plan for hypothyroidism, targeting a Phase 3 start by year-end with results due in late 2028.
- Phase 3 results have not been presented; management expects U.S. FDA approval and a commercial launch in 2030.
- The pivotal study aims to show once-weekly subcutaneous dosing can match daily oral levothyroxine control in well-managed patients.
- A pediatric study and a special-population trial are planned to broaden use, including patients who struggle to stabilize on oral therapy.
- Peak net revenue potential was projected at USD 1 billion to USD 3 billion, framing XP-8121 as a major growth driver.
