Xeris Biopharma outlines development for hypothyroidism drug XP-8121

Xeris Biopharma Holdings, Inc. has detailed its development strategy for XP-8121, an investigational once-weekly subcutaneous levothyroxine formulation designed to treat hypothyroidism. The company expects the drug to reach peak net revenue potential of $1 billion to $3 billion.

The clinical program includes the Cornerstone Phase 3 registrational study, a randomized 1:1 controlled study involving 500 adults and adolescents. The study aims to demonstrate that the once-weekly subcutaneous injection is therapeutically equivalent to daily oral levothyroxine.

Phase 3 study initiation is on track for the end of the year, with topline results anticipated in late 2028. Xeris expects U.S. FDA approval and a commercial launch by 2030.