Amid continuing challenges for companies developing antibiotics, a new report highlights some bright spots in efforts to tackle drug-resistant infections.

Among the highlights of the 2026 Antimicrobial Resistance (AMR) Benchmark Report, released yesterday by the Access to Medicine Foundation, are the recent Food and Drug Administration approvals of two new antibiotics—zoliflodacin and gepotidacin—for uncomplicated gonorrhea infections. The two drugs are the first new oral treatment options for gonorrhea in decades, and they’ve arrived at a time when gonorrhea cases are rising and current treatment options are becoming less effective.

Zoliflodacin and gepotidacin (also approved for uncomplicated urinary tract infections in March 2025) are two of the seven approved and late-stage products highlighted in the report, which evaluates the efforts of 25 large, small, and generic pharmaceutical companies involved in antibiotic development. Others include a new antibiotic for serious infections caused by resistant gram-negative bacteria, currently undergoing regulatory review, and new drugs for multidrug-resistant tuberculosis and invasive fungal infections that are currently in phase 3 trials. 

These products are important, the authors of the report note, because they’re novel drugs targeting high-priority pathogens that need new treatment options. Of note, the companies developing these drugs also have plans in place to make them accessible in low- and middle-income countries (LMICs), where AMR is a bigger problem but newer antibiotics are often unavailable.

Report co-author Martijn van Gerven, MSc, said it was important to highlight these projects because their impact could be “massive for people with resistant infections.”

“We know the landscape for antibiotic development is really bad…so we really wanted to highlight these projects that are in the pipeline and can really make a change for global health,” van Gerven told CIDRAP News. 

A dwindling pipeline

The bright spots illuminate an otherwise cloudy picture for antibiotic development, which faces the same challenges that have concerned global health officials for the past decade. At a time when the toll of drug-resistant bacterial infections is rising, new resistant threats are emerging, and current antibiotics are losing their effectiveness, the pipeline of new antibiotics continues to contract. 

“Overall, the Benchmark identifies hopeful spots of progress from companies still engaged in the antimicrobial space, but industry-wide efforts are being outpaced by drug resistance,” the report states.

Since the last AMR Benchmark report was released in 2021, the number of pipeline candidates from large research-based companies has fallen by 35%, from 92 to 60. Of the seven large pharmaceutical companies assessed, much of the antibiotic research and development is being driven by just three companies—GSK, Pfizer, and Shionogi. GSK is by far the most active, with 30 products in the pipeline, compared with eight each for Pfizer and Shionogi.

Because antibiotics don’t bring in much revenue, many large drugmakers have abandoned antibiotic development in favor of more lucrative drugs. That’s left small- and medium-sized enterprises (SMEs) to pick up the slack, despite the economic challenges they face. Of the seven new antibiotics highlighted in the report, four originated with SMEs. 

Van Gerven says these companies, which don’t have a large global reach and often have to fight for financing just to get their products through clinical trials, are “punching above their weight.” 

With a small pipeline, it really is essential that these products reach the people who need them the most.

But their existence is tenuous. Van Gerven noted that when the Access to Medicine Foundation first began assessing the antibiotic pipeline in 2018, there were several small companies with promising products in the pipeline. “And a lot of those names don’t exist anymore, so that tells you something,” he said.

Although van Gerven and his colleagues found that the makers of the seven highlighted products have plans in place to make them available in the LMICs where they are most needed, the plans still vary in their depth and specificity. Only Innoviva, which makes zoliflodacin, and Ostuka, the developer of the TB drug quabodepistat, have detailed plans that address availability, affordability, and supply in LMICs.

The report warns that the gaps in access planning could leave millions in LMICs with delayed treatment, or no access at all.

“With a small pipeline, it really is essential that these products reach the people who need them the most,” van Gerven said. “Without access, these innovations are pretty useless for global health, and I think that’s something we really need to understand.”

Lack of child-friendly formulations

Another concern highlighted in the report is the lack of child-friendly antibiotic formulations, such as liquid suspensions, particularly in countries where children are highly vulnerable to drug-resistant bacterial infections with high mortality rates. Of the 35 projects from large and small companies that were assessed in the report, only five are designed to specifically meet the needs of children under five years. And across all companies assessed, none have registered child-friendly versions of their products in 17 countries in sub-Saharan African, where the AMR burden is high.

The lack of child-friendly formulations for antibiotics means children in these countries often receive suboptimal treatment. And approval of child-specific versions of antibiotics can often take years. Take the drug-resistant tuberculosis (TB) drug bedaquiline, originally approved by the FDA for adults in 2012, for example. An estimated 30,000 children a year develop drug-resistant TB, yet a pediatric formulation of bedaquiline wasn’t approved until 2020.

“We saw an eight-year gap from adults receiving this drug and children under five receiving it,” said Claudia Duarte, MSc, research coordinator at the Access to Medicine Foundation. And the gap is even bigger for antibiotics needed to treat newborns with severe drug-resistant infections, she added.

The report suggests companies could narrow this gap by initiating pediatric studies of new antibiotics in parallel with adult formulations early in the development process. 

“Beginning that development alongside the adult formulation is exactly what’s needed in order to ensure that the gap between adult access and pediatric access is minimized as much as possible,” Duarte said.

Ultimately, the challenges highlighted in the report circle back to the solutions that antibiotic development advocates have been promoting for years. Namely, more action from policymakers to make antibiotic development more financially viable and sustainable.

“Until antibiotic discovery is funded at a scale that matches the threat posed by AMR, efforts will be reactive instead of proactive, costing money and lives,” the report states. “Governments and policymakers play a crucial role in shaping sustainable markets to support continued industry innovation and investment—without which global efforts to save people from drug-resistant infections cannot succeed.”