A controversial anti-aging gene therapy designed to increase levels of the longevity protein klotho could soon become available to paying customers, even though it has not been approved by the U.S. Food and Drug Administration. Instead of offering the treatment in the United States, the Texas-based company behind it plans to market the therapy through clinics in Honduras, Panama, and the Bahamas, allowing customers to travel overseas to receive it.
What Is Klotho?
Klotho is a naturally occurring protein that has attracted the attention of aging researchers for decades. Named after the Greek goddess who spun the thread of life, the protein plays an important role in healthy aging. Scientists first became interested in klotho during the 1990s after discovering that mice lacking the protein aged rapidly and died young. Later studies found that mice engineered to produce extra klotho lived as much as 30 percent longer than normal. Other research found that injections of klotho improved memory in older monkeys.
Humans also produce klotho naturally, but levels gradually decline with age. Researchers believe that falling klotho levels may contribute to muscle loss, declining brain function, and other age-related conditions. Exercise appears to naturally increase klotho production. Studies have shown that even a single session of high-intensity exercise can temporarily raise blood klotho levels, while regular exercise helps maintain higher levels over time. Diet may also play a role, with vitamin C, folate, and fiber associated with higher klotho levels.
How the Gene Therapy Works
The therapy, developed by Austin-based Minicircle, does not permanently alter a person’s DNA. Instead, it uses small circular pieces of DNA called minicircle DNA that carry instructions telling fat cells to manufacture additional klotho protein.
The treatment is injected into abdominal fat. Once inside the cells, the minicircle DNA enters the cell nucleus but remains outside the chromosomes. Because it does not integrate into the genome, the DNA eventually breaks down and is cleared from the body. The company estimates the effects may last for up to one year before another treatment would be needed.
The goal is simple: increase circulating klotho levels in hopes of slowing aspects of biological aging.
Avoiding the FDA
Rather than seeking immediate FDA approval, Minicircle plans to sell the therapy through overseas clinics. The company says obtaining FDA approval to begin a clinical trial would cost more than $300,000 and could take up to three years before testing could even begin.
Instead, Minicircle has established partnerships with clinics in Próspera, Honduras, Panama City, and Paradise Island in the Bahamas. The company has already opened a waiting list and expects to begin offering the treatment within six months. According to company materials, customers will travel to these international clinics to receive the injections.
What Human Testing Has Shown
So far, evidence in humans remains extremely limited.
Minicircle conducted what it describes as a proof-of-concept study involving approximately 24 participants who traveled to international partner clinics beginning in late 2025. However, the company has not yet published the study’s results in a peer-reviewed journal and says it is still preparing the clinical data for publication.
Company founder and CEO Mac Davis said he personally received the treatment. He reported experiencing dizziness and unusual perceptions of time that later disappeared. He also claimed his immune system felt stronger and that some food sensitivities had diminished. These observations remain personal experiences rather than scientific proof of effectiveness.
Experts emphasize that a small, uncontrolled study lasting less than one year cannot establish either safety or effectiveness.
Results in Mice Offer Promise and Warnings
Animal studies have produced encouraging but mixed results.
Researchers in Spain reported that a one-time klotho gene therapy increased the lifespan of male mice by approximately 19.7 percent. The treated mice also showed improvements in muscle regeneration, stronger bones, healthier brain cells, and better physical performance. Scientists observed higher numbers of neurons, astrocytes, and other brain cells associated with healthy aging.
However, the research also uncovered potential safety concerns. Female mice developed skin ulcers and anal bleeding, forcing researchers to end that portion of the study before determining whether the treatment would have extended their lives. Earlier studies have also suggested that excessively high klotho levels may cause bone weakness and growth abnormalities.
Bryan Johnson’s Connection
Tech entrepreneur Bryan Johnson, who has become famous for spending millions of dollars pursuing longer life through intensive medical monitoring and experimental therapies, has not publicly received Minicircle’s klotho therapy.
However, Johnson did receive the company’s earlier follistatin gene therapy, which is designed to increase muscle mass. Featured in the documentary Don’t Die, Johnson claimed the treatment increased his muscle mass by about 7 percent. That therapy reportedly costs approximately $25,000 and also remains outside FDA approval.
While Johnson’s experience has drawn attention to Minicircle’s work, it does not provide evidence regarding the effectiveness of the company’s newer klotho treatment.
Experts Urge Caution
Many scientists and medical ethicists believe the company is moving too quickly.
Christopher Rudge of the University of Sydney warned, “This is the ‘move fast and break things’ mentality of Silicon Valley encroaching on medicine, but the risk is that moving fast with drug development may break people.”
Christopher Gyngell of the University of Melbourne also questioned whether the available evidence is sufficient. “If you’ve got this thing in your body that is continuously producing a protein, maybe in five years’ time you’ll start to see serious adverse effects,” he said, noting that previous gene therapy trials have resulted in deaths despite careful oversight. He added, “If people want to be guinea pigs for these kinds of things, then I’m actually sympathetic to that, but only if they have a good understanding of the potential risks and benefits. In the case of these gene therapies, I think there’s too much uncertainty to meet that benchmark.”
Alex John London of Carnegie Mellon University warned that if an unregulated treatment produces serious side effects, it could damage the reputation of the entire field of gene therapy and slow development of safer treatments.
For now, Minicircle’s klotho therapy represents one of the boldest attempts yet to commercialize anti-aging medicine before traditional regulatory approval. Whether it ultimately proves to be a breakthrough or a cautionary tale will likely depend on the rigorous clinical evidence that has yet to be produced.
LLH Editor: We like that these therapies are getting out there faster, even without the snail-like FDA approvals. We are less excited about this particular treatment since we have seen dozens of mouse studies that have different ways of increasing the lifespan of mice by 20% or more in different ways. They do not always translate into human benefits.