In late 2025, the U.S. Food and Drug Administration (FDA) approved two new drugs to treat gonorrhea, a significant development occurring just weeks after the World Health Organization (WHO) raised concerns about increasing antibiotic resistance. The new treatments – gepotidacin and zoliflodacin – represent the first entirely new classes of antibiotics for gonorrhea in over thirty years.
Gonorrhea is a common bacterial sexually transmitted infection (STI), with an estimated 82 million cases globally each year. In the United States, the Centers for Disease Control and Prevention (CDC) estimates approximately 1.6 million cases annually. A key challenge in controlling the spread of gonorrhea is that many infected individuals experience no symptoms, unknowingly transmitting the infection to others. Untreated gonorrhea can lead to serious health complications, including infertility in both men and women.
The Growing Challenge of Antibiotic Resistance
While gonorrhea remains curable, the bacterium Neisseria gonorrhoeae has demonstrated a remarkable ability to evolve and develop resistance to antibiotics. Over time, it has become resistant to sulfanilamides, penicillins, tetracyclines, and fluoroquinolones. This left cephalosporins, specifically ceftriaxone administered via injection, as the primary effective treatment option. The emergence of resistance to cephalosporins prompted urgent calls for new therapeutic approaches.
The newly approved antibiotics offer a crucial advantage: they belong to novel classes, distinct from those to which the bacteria have already developed resistance. Both gepotidacin and zoliflodacin are administered orally, simplifying treatment and improving accessibility compared to injectable medications.
Introducing Blujepa (Gepotidacin)
Gepotidacin, marketed under the brand name Blujepa, received FDA approval in March for treating uncomplicated urinary tract infections (UTIs) in females and subsequently for urogenital gonorrhea. This proves available in tablet form. A standard course of treatment involves eight pills taken in two doses.
A study involving 628 patients with gonorrhea demonstrated that Blujepa achieved comparable cure rates to the current standard treatment. Specifically, 92.6% of patients treated with Blujepa were cured, compared to 91.2% of those receiving ceftriaxone injection followed by a single dose of azithromycin. While patients taking Blujepa reported a higher incidence of side effects, such as diarrhea and nausea, these were generally mild in nature.
Nuzolvence (Zoliflodacin): A Single-Dose Option
Zoliflodacin, sold under the name Nuzolvence, is administered as a single dose of granules that dissolve in water. Research indicates that it also achieves similar cure rates to existing treatments. In a study of 930 patients with gonorrhea, 91% of those treated with Nuzolvence were cured at the one-week follow-up, compared to 96% of patients receiving the standard ceftriaxone and azithromycin regimen.
Nuzolvence was developed through a collaborative effort between the Global Antibiotic Research and Development Partnership (GARDP), a nonprofit organization established by the WHO, and Innoviva Specialty Therapeutics Inc. GARDP’s mission is to foster the development of new antibiotics, recognizing that the potential for profit in this area is often limited, hindering investment from traditional pharmaceutical companies.
A deliberate strategy guided the development of Nuzolvence: it is specifically indicated for the treatment of gonorrhea, aiming to prevent overuse and minimize the development of further antibiotic resistance. This focused approach is intended to preserve the effectiveness of this new treatment option for as long as possible.
Expert Perspectives and Public Health Implications
Public health experts have expressed considerable enthusiasm for these new drugs. Edward Hook, MD, an emeritus professor of medicine at the University of Alabama and former ASHA board member, who served as the protocol chair for studies of Nuzolvence, stated, “It’s been more than 30 years since the FDA approved a new antibiotic for gonorrhea treatment. At a time when antibiotic resistance is increasing worldwide, having new oral antibiotics effective against antibiotic resistant gonorrhea is a great addition to care for persons with an at risk for STIs.”
The approval of gepotidacin and zoliflodacin represents a critical step forward in combating the growing threat of antibiotic-resistant gonorrhea. These new oral treatments offer healthcare providers and patients additional options for effectively managing this common and potentially serious STI. Continued surveillance of antibiotic resistance patterns and responsible antibiotic stewardship will be essential to preserving the effectiveness of these and future treatments.
