Innoviva Gets FDA Approval for Gonorrhea Drug

Dow Jones12-13

By Katherine Hamilton

Innoviva received approval from the Food and Drug Administration for Nuzolvence, a treatment of gonorrhea.

Nuzolvence has been approved as a single-dose oral medication to treat uncomplicated urogenital gonorrhea in patients 12 years and older, the biopharmaceutical company said Friday.

Innoviva plans to commercialize the drug in the second half of 2026, either in collaboration with a commercialization partner or independently.

The approval comes after Nuzolvence demonstrated non-inferiority compared with other treatments in a phase 3 trial of 930 patients.

Gonorrhea is the second-most common sexually transmitted bacterial infection in the world, with more than 82 million new cases a year, according to the company. Without timely treatment, it can lead to serious and potentially permanent health complications.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

December 12, 2025 17:14 ET (22:14 GMT)

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