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New Antibiotic Is Effective Against Gonorrhea, Could Be First New Treatment Since 1990s, Study Says

CNN —

A new type of antibiotic for treatment of urinary tract infections in women could also work against gonorrhea infections, a new study finds. This could put the medication, called gepotidacin, on track to become the first new antibiotic for gonorrhea since the 1990s.

"Gepotidacin is a novel oral antibacterial treatment with the potential to become an alternative option for the treatment of gonococcal infections, supported by an acceptable safety and tolerability profile," the researchers wrote in the study published Monday in The Lancet, adding that the drug "could mark a meaningful advancement in patient care."

As an antibiotic, gepotidacin works by inhibiting bacteria from replicating in the body. In March, it was approved by the US Food and Drug Administration to treat uncomplicated urinary tract infections in women and girls ages 12 and older. Recurrent UTIs have become a bigger problem as the bacteria that cause them have become more resistant to the antibiotics available to treat them.

Now, there is new hope that gepotidacin may help fight drug-resistant gonorrhea.

"The big takeaway is that having additional treatment options for gonorrhea is fantastic," said Dr. Jason Zucker, an infectious disease and sexually transmitted infections expert and assistant professor of medicine at Columbia University Vagelos College of Physicians and Surgeons, who was not involved in the new study.

Effective treatments for gonorrhea have become increasingly limited in recent years due to the global rise of antimicrobial resistance in Neisseria gonorrhoeae, the bacteria that cause gonorrhea, rendering many previously used first-line antibiotics ineffective.

The current standard of care involves an intramuscular injection of the antibiotic ceftriaxone, which requires a visit to a care facility.

A key benefit of gepotidacin is that it would not involve an injection at the doctor's office, which could make treating gonorrhea more convenient for patients, Zucker said.

"Right now, patients come in, especially if they are not having symptoms, if they test positive, we have to ask them to come back. For some people, that's not so easy," he said. "So obviously, the ability to have the pharmacy send treatment to their house, or have them be able to pick it up, would really make things a lot easier for people and reduce the number of doctor visits they have, especially if they have jobs where they don't have a lot of time off."

Gonorrhea can lead to serious health problems if left untreated, and though rare, can even spread to the blood or joints. Among women, untreated gonorrhea can cause an infection of the reproductive organs called pelvic inflammatory disease, which can lead to a greater risk of pregnancy complications and infertility. In men, gonorrhea also can lead to infertility in rare cases.

In the United States, gonorrhea and other sexually transmitted infections or STIs have become more common. Reported cases of three nationally notifiable STIs – chlamydia, gonorrhea and syphilis – were up 90% in the US in 2023 compared with about two decades prior in 2004, according to data released last year by the US Centers for Disease Control and Prevention. More than 2.4 million cases of STIs were reported in 2023 nationally.

The Phase 3 trial, conducted between October 2019 and October 2023, included more than 600 people ages 12 and older who were diagnosed with gonorrhea in the urogenital area across six countries: Australia, Germany, Mexico, Spain, the United Kingdom and the United States.

The study was funded by the pharmaceutical company GSK, which developed the antibiotic, and the development of gepotidacin was funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, and the Defense Threat Reduction Agency, according to GSK.

About half of the study participants were treated with a gepotidacin regimen of two oral doses administered about 10 to 12 hours apart, at 3,000-milligrams per dose. The other participants were provided with the current standard treatment of administering a single dose of the antibiotic ceftriaxone as an injection paired with orally taking the antibiotic azithromycin.

The trial data, which is being presented at the European Society of Clinical Microbiology and Infectious Diseases conference, showed that gepotidacin was as effective as the current leading combination treatment, and was also effective against treatment-resistant infections, which occur when strains of gonorrhea are resistant to currently used antibiotics.

The gonorrhea infections were cured among 92.6% of the study participants who were administered gepotidacin compared with 91.2% of the study participants who were treated with ceftriaxone plus azithromycin.

Among the 7.4% of participants in the gepotidacin group who were not successfully treated, they all were due to missing data, according to GSK, which added that "in participants with complete data, there was no bacterial persistence at the urogenital body site."

While the study primarily assessed gepotidacin as a treatment for urogenital gonorrhea, some participants with rectal and throat infections were evaluated. Of those with complete data, the study showed that it was more difficult to treat gonorrhea in the throat compared with other body sites, as 14 out of 16 people with throat gonorrhea and complete data – 88% – were successfully treated.

The researchers wrote that the prevalence of throat infections "warrants further investigation" in a larger group of participants, as does studying the efficacy of geptodiacin in the treatment of gonorrhea in the throat.

"Pharyngeal gonorrhea is notoriously harder to treat and plays a key role in silent transmission and resistance development, so having reliable oral options at all anatomical sites is critical," Zucker, said.

The international team of researchers found no life-threatening nor fatal side effects associated with either treatment approach used in the study, but the gepotidacin group had higher rates of side effects compared with the ceftriaxone-plus-azithromycin group, which were mostly gastrointestinal, such as diarrhea and nausea, and almost all were mild or moderate, according to the study.

"One of the challenges is that a lot of oral antibiotics have GI side effects," Zucker said.

The researchers noted that it will be important to investigate the efficacy of gepotidacin for treating gonorrhea in groups not primarily represented in the study especially women and Black and Brown communities, as 92% of participants in the study were men, 74% were White and 71% were men who have sex with men.

If gepotidacin is approved for the treatment of gonorrhea in the United States, "the price will be disclosed when the product will be supplied in a market. Our approach would be for it to reflect the value and outcomes they bring to patients, providers and payers while being sensitive to market and societal expectations," according to a GSK spokesperson.

Bluejepa, the brand name for the version of gepotidacin approved in the United States to treat UTIs, is expected to be available in the second half of 2025.

The new study was "very well-done" with "rigorous data," and having more options to treat gonorrhea is critical for slowing down the bacteria's drug resistance, said Dr. Jeffrey Klausner, a clinical professor of public health at the University of Southern California's Keck School of Medicine in Los Angeles, who was not involved in the trial.

"The more options doctors have to treat gonorrhea means that they do not have to use the same drug over and over again, which is a recipe for disaster and more resistance. We know that using the same drug over and over again leads to drug resistance," Klausner said in the email. "If gepotidacin is approved and recommended for gonorrhea treatment, that is a true advance and will greatly help our efforts to slow down drug resistance in gonorrhea."

In the study, researchers noted that using gepotidacin to treat gonorrhea as an oral treatment option, not an injection, may be more efficient and reduces the risk of persistent, drug-resistant infections.

Yet there is some concern that strains of gonorrhea may eventually develop resistance to gepotidacin, according to a comment paper accompanying the new study in The Lancet.

"In our opinion, N gonorrhoeae will also develop gepotidacin resistance when the selective pressure increases and where compliance to the dual-dose regimen is suboptimal," Magnus Unemo of Örebro University in Sweden and Teodora Wi of the World Health Organization in Switzerland wrote in the paper.

"Due to the inherent ability of gonococci to develop resistance, difficulties in increasing the gepotidacin dose due to adverse events, and the lack of other treatment options, preclinical and clinical development of additional gonorrhoea treatments remains important," they wrote. "In conclusion, gepotidacin is promising for the treatment of gonorrhoea, but the challenges to retain gonorrhoea as a treatable infection will continue."

Newly FDA-approved Antibiotic Gepotidacin May Effectively Treat Gonorrhea

Gepotidacin could become the first new gonorrhea treatment since the 1990s. In an international study of more than 600 people, researchers found that it worked just as well as current standard treatments. Adobe stock/HealthDay

A newly approved antibiotic to treat urinary tract infections may also help fight drug-resistant gonorrhea, a new study shows.

The medication, called gepotidacin, could become the first new gonorrhea treatment since the 1990s. In an international study of more than 600 people, researchers found that it worked just as well as current standard treatments.

Gepotidacin works by stopping bacteria from multiplying. The U.S. Food and Drug Administration approved the drug in March to treat urinary tract infections in females age 12 and up. The rise of drug-resistant UTIs has made new treatments necessary, CNN reported.

This latest study looked at how well gepotidacin works against gonorrhea, a common sexually transmitted infection that has become harder to treat due to antibiotic resistance.

The study included people from the U.S., Australia, Germany, Mexico, Spain and the U.K. Half received two oral doses of gepotidacin, 10 to 12 hours apart. The other half received a shot of the antibiotic ceftriaxone plus an oral dose of azithromycin.

Cure rates were similar - 92.6% in the gepotidacin group and 91.2% in the group given ceftriaxone plus azithromycin.

While 88% of participants with gonorrhea of the throat had a harder time clearing the infection, most were successfully treated.

"The big takeaway is that having additional treatment options for gonorrhea is fantastic," Dr. Jason Zucker, an infectious disease and sexually transmitted infections expert who was not involved in the new study, told CNN.

Dr. Jeffrey Klausner, a professor of public health at the University of Southern California, welcomed the findings.

"The more options doctors have to treat gonorrhea means that they do not have to use the same drug over and over again, which is a recipe for disaster and more resistance," Klausner said in an email to CNN. "If gepotidacin is approved and recommended for gonorrhea treatment, that is a true advance and will greatly help our efforts to slow down drug resistance in gonorrhea."

The drug did cause mild or moderate side effects, mostly nausea and diarrhea, the study said.

Researchers said more work is needed to better understand how well gepotidacin works, especially in groups that were not well represented in the trial, including women and people of color.

In an accompanying commentary, two European experts warned that gonorrhea bacteria may eventually become resistant to gepotidacin, too.

"Due to the inherent ability of gonococci to develop resistance, difficulties in increasing the gepotidacin dose due to adverse events, and the lack of other treatment options, preclinical and clinical development of additional gonorrhoea treatments remains important," Magnus Unemo of Örebro University in Sweden and Teodora Wi of the World Health Organization in Switzerland wrote.

"In conclusion, gepotidacin is promising for the treatment of gonorrhoea, but the challenges to retain gonorrhea as a treatable infection will continue," they concluded.

More information

The Mayo Clinic has more on gonorrhea.

Alaska Records Spike In Rates Of Rare But Severe Complications From Gonorrhea

A flyer posted on a bulletin board at the University of Alaska Anchorage on April 20, 2024, gives information about tests for sexually transmitted infections. In the past two years, more Alaskans have been afflicted by medical problems caused by infections of the joints, heart and other body parts not usually affected by the pathogen that causes gonorrhea. (Photo by Yereth Rosen/Alaska Beacon)

Alaska has long had the distinction of having the nation's highest or nearly highest rates of gonorrhea.

Now there is another troublesome trend among those who contract the sexually transmitted infection. Cases of a rare but severe complication of gonorrhea have spiked in Alaska for reasons that are not yet fully understood, according to state health officials.

The Alaska Department of Health received 27 reports of patients with what is known as "disseminated gonococcal infection" last year, said a bulletin released by the department's epidemiology section. Those are infections in which the pathogen that causes gonorrhea passes beyond normally infected sites — the genital, rectal or mouth areas — into the bloodstream and other parts of the body.

Disseminated gonococcal infection, or DGI, can harm joints, tendons or body organs. The most serious potential effects, according to the bulletin, include endocarditis, a life-threatening infection of the heart's inner linings and valves, and meningitis, a potentially fatal inflammation of the brain and spinal cord.

The 27 cases of DGC reported last year represented 1.3% of the 2,079 reported cases of gonorrhea in Alaska in 2024, the bulletin said. That percentage is more than triple the rate in 2023, when eight DGI cases were reported among the 2,289 reported gonorrhea cases, and it is 10 times the rate in 2022, when only three DGI cases were reported out of the 2,304 reported gonorrhea cases that year, resulting in a rate of 0.13%, the bulletin said.

Additionally, Alaska's rate of DGI is far higher than the most recently reported national rates, the bulletin said.

While Alaska's rates of gonorrhea are high, that does not account for the increasing rates of the serious infections that go beyond the parts of the body usually infected by the disease, said Julia Rogers, an epidemiologist who co-authored the new bulletin.

The number of gonorrhea cases in Alaska actually decreased in recent years, dropping from 2,304 cases in 2022 to 2,079 last year, Rogers pointed out.

Rather, what might be happening is that a particular type of gonorrhea that makes patients more prone to these severe complications is spreading in Alaska, she said.

"Though the exact reason for this increase in disseminated cases is unclear at this time, several factors are likely contributing to the increase, including that certain characteristics of the new gonorrhea sequence types circulating in Alaska's population are more likely to result in disseminated infection and more likely to be asymptomatic upon initial infection (meaning they aren't detected and treated in a timely manner, allowing for severe manifestations like DGI in patients)," she said by email.

Sequences in epidemiology terms refer to genetic patterns, and different strains of pathogens have their own genetic sequences.

State health officials have been working since last fall to boost monitoring and have looked for a possible link between these cases, but they have not identified one yet, the bulletin said.

Of the 35 DGI patients identified in 2023 and 2024, most were in Anchorage, according to the epidemiology bulletin. The most common medical complication was septic arthritis, an infection of joint fluids and joint tissues, the bulletin said. Thirty-one patients were hospitalized, and most of those had to have invasive treatments, including two valve replacements, the bulletin said.

Originally published by the Alaska Beacon, an independent, nonpartisan news organization that covers Alaska state government.

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