New Oral Treatments Approved for Gonorrhea Offer Hope Amidst Rising Drug Resistance

The U.S. Food and Drug Administration has recently authorized two new oral medications designed to combat gonorrhea, a prevalent sexually transmitted infection. These approvals come at a critical time, as global rates of drug-resistant gonorrhea continue to rise, potentially limiting existing treatment options. The new therapies offer additional choices for patients diagnosed with uncomplicated urogenital gonorrhea, a localized infection that can lead to serious reproductive health complications if left untreated.

One of the newly approved treatments, Nuzolvence (zoliflodacin) granules, which dissolve in water, has received approval for the treatment of uncomplicated urogenital gonorrhea in individuals aged 12 and older who weigh at least 77 pounds. This medication was evaluated in a clinical study involving 930 patients, where a single 3-gram dose demonstrated comparable effectiveness to the standard treatment of an injection of ceftriaxone combined with an oral azithromycin. The study reported a cure rate of 91% for Nuzolvence, versus 96% for the standard treatment, indicating its efficacy in clearing the bacteria. Common side effects observed during Nuzolvence trials included low white blood cell counts, headache, dizziness, nausea, and diarrhea. Importantly, animal studies have raised concerns about potential risks such as birth defects, pregnancy loss, or male fertility issues, necessitating adherence to specific safety precautions outlined in the drug’s labeling. Individuals with known allergies to Nuzolvence or those taking certain interacting medications should avoid this treatment.

The second oral therapy, Blujepa (gepotidacin) oral tablets, was approved the day prior to Nuzolvence and is indicated for the same condition in patients aged 12 and older weighing at least 99 pounds. Blujepa is particularly relevant for patients with limited alternative treatment options due to scarce clinical safety data for other therapies. Notably, Blujepa had previously been approved in March 2025 for the treatment of urinary tract infections. Its effectiveness was assessed in a study of 628 patients, where a regimen of two 3,000 mg doses taken 10 to 12 hours apart achieved comparable bacterial clearance rates to the standard treatment. The Blujepa study showed a 93% cure rate, compared to 91% for the standard treatment. Identified side effects of Blujepa include diarrhea, nausea, stomach pain, vomiting, gas, dizziness, soft stools, headache, tiredness, and excessive sweating. The drug carries specific warnings concerning potential effects on heart rhythm and certain brain chemicals, as well as the possibility of allergic reactions. Patients should be aware of these precautions, including those related to QTc prolongation, acetylcholinesterase inhibition, and allergic responses.

Both Nuzolvence and Blujepa received Fast Track, Qualified Infectious Disease Product, and Priority Review designations from the FDA for their intended use in treating uncomplicated urogenital gonorrhea. Entasis Therapeutics received approval for Nuzolvence, while GSK secured approval for Blujepa.

Article by Mel Anara, based upon information from the U.S. Food and Drug Administration.

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