An innovative injectable gene therapy promising to extend human lifespan is set to be available in several countries. However, it is important to note that this therapy has not undergone exhaustive clinical trials nor received approval from the U.S. Food and Drug Administration (FDA) or equivalent regulatory bodies.

Developed by Minicircle, a biotech company based in Austin, Texas, this therapy aims to enhance the production of klotho, an anti-aging protein, within human cells. To avoid lengthy FDA clinical trials, Minicircle plans to offer this largely unproven therapy to individuals traveling to Honduras, the Bahamas, and Panama. Interested parties can join a waiting list on their website to access treatments projected to commence within six months.

Medical ethicists caution that bypassing regulations meant to ensure patient safety could be dangerous. “This mirrors Silicon Valley’s attitude of ‘move fast and break things,’ posing a real risk of harm,” asserts Christopher Rudge from the University of Sydney, Australia.

Named after a Greek goddess believed to weave the fabric of life, the effects of klotho were first noted in studies involving mice devoid of this protein, which experienced accelerated aging and premature death. Subsequently, genetically modified mice producing excess klotho showed a lifespan increase of up to 30%. Additionally, injections of klotho have shown promise in enhancing memory in older primates.

As people age, klotho levels decrease, prompting Minicircle and others to seek methods for replenishing these levels. Rudge warns that although there are studies indicating potential lifespan extension in mice, the effects on humans remain unverified. Furthermore, a case of a child with naturally high klotho levels highlighted potential health risks, including bone fragility and growth disorders, suggesting that excessive intake might be detrimental.

According to Minicircle, their “life-extending” gene therapy utilizes a mini circular DNA structure, known as MiniCircle DNA, which instructs cells on how to produce the klotho protein. Administered via injection into abdominal fat, it is absorbed by fat cells, promoting klotho production that then circulates throughout the body. This DNA remains outside the chromosomes and does not integrate into the genome, eventually being degraded and eliminated. The company’s projections suggest effects could last for up to a year.

Minicircle has estimated that its therapy will cost over $300,000, allowing a three-year window for FDA approval. As an alternative, the company conducted a “proof of concept” trial in late 2025 with 24 participants in the U.S., treated at an “international partner clinic.” Notably, a clinic in Honduras allows developers to work within a flexible regulatory framework, also present in Panama City and Paradise Island, Bahamas.

While results from the klotho trial remain undisclosed, the company has indicated plans to publish clinical trial data soon. The founder and CEO, Mac Davis, shared personal experiences with the therapy, reporting improved immune response and reduced food sensitivities, though he also encountered transient effects. Nonetheless, the company has not responded to inquiries regarding clinical results.

Critics like Gyngell describe the small-scale trial conducted without a control group as insufficient for validating safety and efficacy. “Continuous protein production might yield adverse effects over time,” he notes. Additionally, prior gene therapy trials, even under strict supervision, have led to serious complications, underscoring the need for meticulous regulatory oversight.

Currently, no other klotho-enhancing gene therapy has been examined in human subjects. Researchers, including Miguel Chillon from Spain’s Autonomous University of Barcelona, have been exploring alternative klotho therapies through animal studies, reporting a 20% lifespan increase in rats, albeit with significant side effects. Chillon’s team is now investigating a smaller version of klotho, which appears to exhibit fewer adverse reactions, and aims to conduct trials under established regulations.

Experts, including Alex John London from Carnegie Mellon University, stress that premature efforts by companies like Minicircle could have detrimental effects on the entire field. “If risky treatments result in harmful outcomes, it could undermine years of diligent search for safer solutions,” he warns.

Although drug development is notoriously expensive, London emphasizes that the intricacies of human biology require thorough testing. Unregulated therapies risk repeating past mistakes that regulations aim to guard against, reminding us of the importance of patient safety.

In 2022, Minicircle introduced another non-FDA approved gene therapy targeting muscle growth through increased protein levels of follistatin. Preliminary results from a trial with 43 participants aged 23 to 88 indicated an average lean muscle increase of 770 grams after three months. However, due to the absence of a control group, the implications remain unclear. Notably, tech entrepreneur Brian Johnson underwent follistatin gene therapy, claiming a 7% increase in muscle mass for a cost of approximately $25,000.

“Individuals must have a clear understanding of risks and benefits if they choose to participate in these pioneering treatments,” Gyngell concludes. “Currently, the uncertainties surrounding these gene therapies are significant enough to warrant caution.”