At a panel in Boston, senior officials announced plans to include aging in the agency’s regulatory science agenda and discussed how therapies could move toward approval.
Longevity has a partner
The 2026 edition of the Aging Research and Drug Discovery Meeting (ARDD) kicked off yesterday. This is one of the biggest and longest-running longevity conferences, and it has been traditionally held in Copenhagen. This year, it arrived in Boston instead, with a slightly truncated schedule (three days versus the usual five) but with an equally impressive lineup and program.
Day 1 was all about longevity going mainstream, with discussions centered on policy, regulation, and clinical translation. Gone are the days when longevity events were largely ignored by the people calling the shots. This time, a panel titled “Matching Clinical Trials of Therapeutics & Regulatory Mandates” boasted four FDA heavyweights. Prompted by moderator Andrew Brack, Program Manager at ARPA-H, they described the agency’s growing interest in aging and longevity and discussed how gerotherapeutics could progress toward approval.
“This is an important topic for the agency and HHS at large,” said Lowell Zeta, Deputy Commissioner for Strategic Initiatives. “It’s a defining moment, an inflection point for the future of FDA and how we adapt to the rapidly evolving science in this space.”
The most tangible announcement was that aging and longevity will feature in the forthcoming update to FDA’s Focus Areas of Regulatory Science (FARS). Drawing applause from the crowd, Steven Kozlowski, the agency’s Chief Scientist, described FARS as “high-level principles on areas that are very, very important to us; aging and longevity will be one of those topics.” Kozlowski gave a tentative release target of the 2027 fiscal year, which also began yesterday. The document’s previous version was released several years ago.
Seeking approval
Beyond that announcement, the panelists drilled down into what an approval process for longevity therapies could look like. Jeffrey Siegel, Director of the Office of Drug Evaluation Sciences, outlined two possible approaches to demonstrating broader effects on aging. One would involve accumulating evidence that a treatment benefits several age-related conditions; another, drawing on the concept of intrinsic capacity, would measure deterioration across multiple physical and mental capacities in a defined population and show that treatment slows it.
Justin Penzenstadler, Acting Associate Director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology, expects early trials that could support approval to focus on age-related comorbidities or mortality. Collecting functional assessments alongside those outcomes could help establish additional metrics for later trials.
One obvious caveat is that a broader aging claim needs evidence beyond a drug’s established benefits. If a cardiometabolic treatment extends survival through its known cardiovascular effects, that alone does not demonstrate broader geroprotective activity, Penzenstadler noted.
Safety also shapes the choice of trial population. Decades of treatment, potentially modest benefits, and relatively low baseline risk make for a demanding benefit–risk calculation. As Penzenstadler put it, “We’re thinking about potentially treating somebody for thirty years to derive a couple-year benefit.” Consequently, he favors initial trials in older, higher-risk populations, where the calculation “is a bit more straightforward.”
Biomarkers could help shorten trials by serving as proxies for clinical outcomes – but only with evidence that they reliably reflect benefit. The panel discussed collecting both clinical outcomes and candidate biomarkers in trials to build that evidence.
Siegel distinguished prognostic biomarkers, which predict future risk, from surrogate endpoints. “A surrogate endpoint biomarker may also be prognostic, but it has the additional feature that it changes with treatment, and that change reflects the clinical benefit downstream,” he said.
Collaboration and convergence
Asked how the longevity community could advance regulatory progress, Penzenstadler’s main recommendation was to establish a pre-competitive consortium to work out “a cookbook of biomarkers” to include in trials. Agreeing on compatible trial designs up front would allow different companies to pool their results and build evidence for biomarker validation. “I think that’s probably the number one thing that is actionable that will push the field,” he said.
His second recommendation was to hold regular, structured meetings between regulators, researchers, and industry, helping both sides understand emerging evidence and the challenges of developing therapies.
Several recommendations voiced during the panel echoed initiatives that are already underway. For instance, the proposed Targeting Aging with Metformin (TAME) trial would examine multiple age-related diseases, while XPRIZE Healthspan focuses on muscle, cognitive, and immune function. These correspond to the two approaches described by Siegel. Likewise, the Biomarkers of Aging Consortium reflects the field’s recognition that developing better measurements requires collaboration.
This convergence comes amid growing engagement between FDA officials and the longevity field, which seems to have intensified further this year. FDA participation in events such as A4LI’s June DC summit provided ample opportunities for cross-pollination. What we heard at ARDD suggests that this dialogue may be beginning to bear fruit.
The panel also gave longevity sponsors a concrete address: Penzenstadler identified his clinical review office as being responsible for aging as an indication. He encouraged sponsors to submit actual protocols and supporting evidence through the Investigational New Drug (IND) process, giving FDA something specific to assess and respond to.
View the article at lifespan.io
