FOXO4-DRI: What It Is and Its U.S. Regulatory Status

What is FOXO4-DRI?

FOXO4-DRI is an experimental, laboratory-designed peptide studied in research on aging cells. It is not FDA-approved, it has not been tested in any published human trial, and no approved medicine in the United States contains it.

The letters DRI stand for D-retro-inverso, a chemical design in which the amino acids are the mirror-image form and are arranged in the reverse sequence. This design makes the peptide harder for the body to break down.

How it is thought to work

Senescent cells are cells that have stopped dividing but do not die off normally, and they build up with age. Inside these cells, a protein called FOXO4 binds to p53, a protein that can trigger cell death. FOXO4-DRI was designed to disrupt that interaction, so that p53 pushes senescent cells into programmed cell death (apoptosis). Compounds meant to clear senescent cells are called senolytics.

Research history

The key study was published in 2017 in the journal Cell by researchers at Erasmus University Medical Center in Rotterdam, led by Peter de Keizer. In mice, the peptide reduced damage from the chemotherapy drug doxorubicin, and the authors reported restored fitness, fur density and kidney function in both fast-aging and naturally aged mice.

A company called Cleara Biotech has since worked on senolytic peptides based on this research. As of September 2026, no clinical trial of FOXO4-DRI was registered on ClinicalTrials.gov, and no human results have been published.

Results in mice often do not carry over to people. The safety and effects of FOXO4-DRI in humans have not been established.

U.S. regulatory status

Current status: Not FDA-approved.

FOXO4-DRI has not gone through the FDA review that a drug must pass before it can be marketed for use in people. It does not appear in any category of the FDA's 503A nomination lists (as updated May 14, 2026) and is not on the 503A bulks list, so it does not meet the conditions for 503A compounding.

It is also not a dietary supplement. Products labeled "for research purposes only" or "not for human consumption" are not approved medicines, and the FDA has not reviewed their contents, purity or quality.

Documented safety information

Because no human trials have been published, there is no established safety profile. The FDA has not published a safety assessment of FOXO4-DRI. For other synthetic peptides it has reviewed, the agency has pointed to risks such as unwanted immune responses and peptide-related impurities.

A peptide designed to trigger cell death in one type of cell raises questions about effects on healthy cells, and those questions have not been studied in people.

Sport

FOXO4-DRI is not named on the World Anti-Doping Agency (WADA) 2026 Prohibited List. The list's S0 class covers any pharmacological substance not addressed elsewhere on the list that has no current approval by any government health authority for human therapeutic use. Athletes should confirm the status of any substance with their anti-doping organization.

Why Peptide Labs does not sell FOXO4-DRI

Peptide Labs does not sell this compound. This page is general information, not medical advice. We are not a pharmacy, we do not supply FOXO4-DRI, and we do not point readers to anyone who does.

For personal medical questions, including questions about healthy aging, the right person to ask is a licensed healthcare provider.

Related reading

See the full list of compound profiles in the Peptide Guide. Other compounds discussed in aging research include epitalon, humanin and MOTS-c. You can also read what peptides are.