3 FDA-approved drugs tested in new longevity trial: Inside the clinical debate
Industry Buzz
We want the FDA to recognize intrinsic capacity as a meaningful, regulatory-grade endpoint.
—Elena Volpi, MD, PhD
Semaglutide and dapagliflozin improve specific chronic conditions—diabetes, heart failure, obesity, chronic kidney disease—for which they have FDA indications as a result of large-scale clinical trials. In these populations, they likely increase longevity.
—Michael Blyumin, PharmD
An upcoming $38 million trial will examine whether existing FDA-approved drugs can help boost healthspan.[]
The drugs being studied in the VITAL-H trial are rapamycin, dapagliflozin, and semaglutide. Researchers will examine how the drugs impact trial participants aged in their 60s.
Related: People are taking this cancer drug to extend their lifespan—does it work, and what else can it do?“The concept in geroscience is that aging modifies a relatively small number of core biological mechanisms that drive most diseases. If we target those mechanisms, one intervention could influence many outcomes,” Elena Volpi, MD, PhD, FGSA, principal investigator of the VITAL-H trial, said in a press statement.[]
About the trial
The trial will include just over 700 adults aged in their 60s. One of the key factors will be to determine if the drugs impact intrinsic capacity, a measure of both physical and mental functionality. “We want the FDA to recognize intrinsic capacity as a meaningful, regulatory-grade endpoint,” Dr. Volpi said.[]
Michael Blyumin, PharmD, is a clinical pharmacist at Stanford Healthcare. He says some of the drugs being studied likely do boost longevity; however, this may only be the case for certain populations.
“Semaglutide and dapagliflozin improve specific chronic conditions—diabetes, heart failure, obesity, chronic kidney disease—for which they have FDA indications as a result of large-scale clinical trials. In these populations, they likely increase longevity. However, moving outside of these specific populations, it is difficult to determine the longevity benefits for a general, healthy population,” he tells MDLinx.
The rapidly evolving field of longevity medicine
The UT San Antonio research team has 50 years of experience in longevity research on the biological mechanisms of aging of the cellular systems in fruit flies and rodents. Taking this research into human trials, experts say, is an intriguing development.
Sean Curran, PhD, a professor of gerontology at the University of Southern California, explains some of the lines of inquiry to MDLinx.
“Although mechanistically different,” he says, “all of these drugs can influence metabolism; and modulating diet and nutrition are established regulators of lifespan and healthspan. Although evidence for these drugs influencing aging in humans is limited, this remains an intriguing idea, but it will be important to look at whether the known targets of these drugs are responsible, or if the potential aging-related outcomes are a result of a different mode of action.”
Repurposing FDA-approved drugs for treatment of another condition is an important strategy that can accelerate approval, since the drug have already been deemed safe.
—Sean Curran, PhD
The trial adds to a rapidly evolving field of longevity research.
Dr. Curran notes that as research progresses, the challenge will be to improve actual health in older age, rather than just extend the life span.
“In non-human studies, medications have been used to extend longevity across organisms, from simple yeast cells to more complex mammals. Although this is the question everyone wants the answer to, perhaps the more important question we should be asking is, To what extent can a medication influence health across the lifespan, including in older adults? Maximizing the health, especially at older ages, is far more important than extending longevity.”
Related: The gym as a longevity clinic? How medically supervised services could reshape patient care