U.S. Approves Two New Antibiotics for Treating Gonorrhea, Expanding Limited Options

Washington, D.C.; December 24th, 2025

A long-narrowed treatment field widened this month, as federal regulators approved two new antibiotics for use in treating uncomplicated gonorrhea in the United States, marking the first such expansion in years for a disease increasingly shaped by antibiotic resistance.

The approvals were issued by U.S. Food and Drug Administration, which formally authorized two oral therapies for the treatment of uncomplicated urogenital gonorrhea in adolescents and adults. The decision places both medications into lawful clinical use under defined age and weight thresholds, expanding the federally approved toolkit available to clinicians.

According to the FDA’s official regulatory announcements, the newly approved therapies are Nuzolvence (zoliflodacin) and Blujepa (gepotidacin). Nuzolvence was approved for patients 12 years of age and older who weigh at least 77 pounds, while Blujepa was approved for patients 12 years of age and older who weigh at least 99 pounds. Both are indicated specifically for uncomplicated urogenital gonorrhea.

The approvals represent a notable regulatory milestone. Gonorrhea has developed resistance to multiple antibiotic classes over recent decades, steadily reducing effective treatment options and elevating public health concern. Until now, new approved therapies for the infection had been scarce, leaving clinicians with a narrowing range of federally sanctioned treatments.

The FDA’s action constitutes a formal regulatory determination that the submitted clinical data met the agency’s standards for safety and effectiveness for the approved indication. While the agency did not publish full trial datasets in its public announcements, the approvals themselves reflect completion of the FDA’s review process through its Center for Drug Evaluation and Research.

Both therapies are oral, distinguishing them from injectable treatments that have often formed the backbone of gonorrhea care. Oral administration may offer practical advantages in certain clinical settings, particularly where access to injections or follow-up visits can be limited.

The approvals do not alter public health guidance or treatment protocols beyond the legal authorization of these drugs for their approved indication. Decisions about prescribing, patient selection, and integration into clinical practice remain subject to professional judgment, existing guidelines, and future recommendations from public health authorities.

The FDA emphasized that these approvals are specific to uncomplicated urogenital gonorrhea and do not imply broader indications beyond those defined in the regulatory authorization. As with all approved medications, post-approval monitoring and reporting requirements apply under federal law.

With these decisions, the federal regulatory record now reflects two additional approved options in a treatment area long marked by constraint. The approvals stand as documented regulatory acts, expanding what is legally available to treat a common infection whose management has grown more complex over time.

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Sources

Primary First-Hand Sources

• U.S. FOOD AND DRUG ADMINISTRATION, official press announcements approving Nuzolvence (zoliflodacin) and Blujepa (gepotidacin) for the treatment of uncomplicated urogenital gonorrhea, December 2025