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Live News REGULATION ARTICLE H impact

XERS XP-8121 enters Phase 3, targeting 2030 FDA approval

XP-8121, a once-weekly injectable levothyroxine, will enter Phase 3 trials by year-end 2026. The program targets FDA approval and launch in 2030, aiming for $1—3B peak net revenue.

XERS

XP-8121, a once-weekly injectable levothyroxine, is entering Phase 3 trials by year-end 2026, with FDA approval and launch targeted for 2030. The program is aimed at unmet needs in hypothyroidism, and multiple supporting studies are underway. Peak net revenue potential is put at $1—3 billion.