Unapproved Klotho Gene Therapy for Longevity Set to Launch at Offshore Clinics, Raising Safety and Ethics Concerns
Key Insights
Minicircle (search) plans to offer an unapproved klotho (search)-boosting gene therapy at clinics in Honduras, the Bahamas, and Panama within six months, bypassing FDA regulatory oversight.
The therapy uses nonviral minicircle (search) DNA injected into abdominal fat to prompt klotho (search) production, with effects estimated to last up to one year.
Ethicists and researchers warn that without rigorous clinical trials, the long-term safety profile remains unknown, citing risks seen in other gene therapy trials.
An injectable gene therapy that promises to extend human longevity by boosting levels of the anti-ageing protein klotho (search) will soon become available to consumers willing to travel outside the United States, despite lacking approval from the FDA or any other major regulatory body. The treatment, developed by Austin, Texas-based Minicircle (search), has opened a waitlist and is expected to launch within the next six months at partner clinics in Honduras, the Bahamas, and Panama.
The development has drawn sharp criticism from medical ethicists and researchers, who argue that sidestepping established regulatory frameworks places individuals at unnecessary risk and could undermine legitimate gene therapy research.
Klotho (search): The Biology Behind the Promise
Klotho (search), named after a Greek goddess who spins the thread of life, has been a target of anti-ageing research since the 1990s, when mice lacking the protein were found to age rapidly and die young. Subsequent studies demonstrated that mice genetically engineered to produce excess klotho lived up to 30 percent longer. More recently, injections of the protein improved memory in older monkeys.
In humans, klotho (search) levels naturally decline with age, providing the rationale for Minicircle (search)'s therapeutic approach. However, the translation from animal models to human application remains uncertain. "There have been so many things that have been found to extend lifespan in mice that don't work in humans," said Christopher Gyngell, a principal research fellow in biomedical ethics at the University of Melbourne.
Adding to safety concerns, a case report of an infant with excess klotho (search) levels due to a rare genetic condition documented weak bones and growth problems, suggesting that too much of the protein may be harmful.
How the Therapy Works
Minicircle (search)'s gene therapy employs small, circular DNA sequences called minicircle DNA that carry instructions for synthesizing the klotho (search) protein. The construct is injected into a person's abdominal fat, where it is absorbed into fat cells. The introduced DNA enters the nucleus but remains outside the chromosomes, meaning it does not integrate into the genome and eventually degrades and clears from the body. The company estimates the effects could last for up to one year.
Regulatory Workaround and Offshore Trials
Minicircle (search) has stated that filing an application with the FDA to conduct a clinical trial in the US would cost more than $300,000 and take up to three years to obtain approval. As a workaround, the company conducted a "proof of concept" trial in approximately 24 people who traveled to "international partner clinics" beginning in October 2025.
One of these partner clinics operates in Próspera, an experimental "innovation-friendly" city in Honduras that allows drug developers to "opt in to the regulations that most suit your business needs." Additional clinics are located in Panama City and Paradise Island in the Bahamas.
The company has not published results from this trial, though its website states it is "preparing clinical trial data for publication." Minicircle (search)'s founder and CEO, Mac Davis, told The New Republic that he personally received the therapy and experienced dizziness and odd, altered perceptions of time, though these symptoms resolved. He also reported feeling a stronger immune system and reduced food sensitivities. The company did not respond to requests from New Scientist for information about the study results or for general comment.
Ethical and Safety Concerns
A trial of just 24 people lasting less than a year and lacking a control group is inadequate to confirm safety or efficacy, according to Gyngell. "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. "People have died in trials of other gene therapies, even rigorously controlled ones with independent oversight, because it's still a novel area with a high risk of adverse effects."
Christopher Rudge at the University of Sydney characterized the approach as reflecting a "move fast and break things" mentality from Silicon Valley encroaching on medicine. "The risk is that moving fast with drug development may break people," he said.
Alex John London at Carnegie Mellon University warned that a serious adverse event from an unregulated therapy could have ripple effects across the entire field. "If you've been investing years trying to find an intervention that might be safe and effective, and then somebody else goes off and, without careful preparation and controls, they administer something like this gene therapy and there's a bad adverse effect, it could derail the whole thing and tarnish you as well," he said.
Parallel Research and Competing Approaches
No other klotho (search)-boosting gene therapy has been tested in humans to date. Miguel Chillón at the Autonomous University of Barcelona and colleagues developed another klotho gene therapy tested only in mice, which lived 20 percent longer but also experienced anal bleeding and skin ulcers. Chillón's team is now focusing on a smaller version of klotho that appears to have fewer side effects and, if it enters clinical trials, will proceed within the "normal regulatory framework."
Minicircle (search)'s Broader Portfolio
Since 2022, Minicircle (search) has also offered a non-FDA-approved follistatin (search) gene therapy at its offshore clinics, designed to build muscle by increasing levels of the follistatin protein. In preliminary testing, 43 people aged 23 to 88 received the therapy at the Próspera clinic. The company reported an average increase of 770 grams in lean muscle mass after three months without adverse effects, though the absence of a control group makes it unclear whether this represents a placebo effect. Tech millionaire Bryan Johnson, known for extreme longevity interventions, received the follistatin therapy and claimed a 7 percent increase in muscle mass. The treatment reportedly costs $25,000.
"The regulatory rules these companies complain of are not the red tape of overzealous bureaucrats," said Rudge. "They're the direct inheritance of past tragedies, and that's easy to forget when you're focused only on the opportunities."
Gyngell added a note of caution for potential consumers: "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."