WASHINGTON — The U.S. Food and Drug Administration has approved a new oral combination antibiotic therapy for adults with complicated urinary tract infections, including infections involving antibiotic-resistant bacteria, providing a new treatment option for patients with limited alternatives, the agency said.
The approved drug, Utebzi (tebipenem pivoxil), is an oral carbapenem antibiotic developed by Spero Therapeutics and licensed globally by GSK for most markets. The FDA approved it for the treatment of complicated urinary tract infections (cUTIs), including kidney infections known as pyelonephritis, caused by susceptible microorganisms in adults who have limited or no alternative oral treatment options.
The approval marks the first FDA authorization of an oral carbapenem antibiotic, a class of medicines often reserved for serious infections involving bacteria that have developed resistance to other antibiotics. Carbapenems have traditionally been administered intravenously, meaning some patients with difficult-to-treat infections have required hospitalization or outpatient infusion care.
The FDA said the approval was supported by results from the phase 3 PIVOT-PO clinical trial, which compared tebipenem pivoxil with the intravenous antibiotic imipenem-cilastatin in hospitalized adults with complicated urinary tract infections. The agency reported that the oral therapy demonstrated comparable effectiveness to the intravenous treatment based on combined measures of clinical cure and microbiological response.
Complicated urinary tract infections can involve the kidneys or occur in patients with factors such as structural abnormalities or other conditions that make infections harder to treat. The FDA has identified antimicrobial resistance as a continuing public health concern, with resistant bacteria reducing the effectiveness of existing treatments.
The FDA said the most common side effects associated with Utebzi include diarrhea, headache, nausea, abdominal pain, increased liver enzymes and Clostridioides difficile infection. The agency also listed warnings related to allergic reactions and certain metabolic conditions.
GSK and Spero have said the therapy is intended for patients with infections caused by susceptible bacteria and should be used according to prescribing information and antimicrobial stewardship practices. The companies said availability in the United States is expected later in 2026.
The approval adds to recent regulatory efforts aimed at expanding antibiotic options as resistance limits the effectiveness of older treatments. The FDA’s latest drug approval listings include Utebzi among novel therapies approved in 2026.
