Unapproved Gene Therapy for Longevity: Upcoming Release Promises Anti-Aging Breakthrough

An innovative injectable gene therapy that promotes longevity is set to launch in select countries. This development occurs despite a lack of rigorous clinical trials and absence of approval from renowned regulatory bodies like the U.S. Food and Drug Administration (FDA).

Developed by Minicircle, based in Austin, Texas, this gene therapy stimulates the body’s cells to produce an anti-aging protein known as klotho. To bypass the extensive clinical trials mandated by the FDA, Minicircle intends to offer the under-researched therapy to individuals willing to travel to countries such as Honduras, the Bahamas, and Panama. The company is currently maintaining a waiting list on its website and anticipates that treatments will be available in the next six months.

<p>Experts in medical ethics have cautioned that skirting regulations intended to protect patients from potentially harmful or ineffectual treatments is perilous. "This approach reflects Silicon Valley's reckless 'move fast and break things' mentality in medicine," warns <a href="https://profiles.sydney.edu.au/christopher.rudge">Christopher Rudge</a> from the University of Sydney, Australia.</p>
<p>Named after the Greek goddess associated with the thread of life, klotho's anti-aging properties were first observed in mice lacking this protein, which experienced <a href="https://www.nature.com/articles/36285">accelerated aging and early death</a>. Conversely, genetically altered mice producing higher levels of klotho have been shown to <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC2536606/">live up to 30% longer</a>. Additionally, injections of klotho have been found to enhance memory in older primates.</p>
<p>As people naturally experience a <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC9101232/">decline in klotho levels with age</a>, Minicircle and other companies aim to rejuvenate these levels. However, <a href="https://findanexpert.unimelb.edu.au/profile/811748-christopher-gyngell">Christopher Gyngell</a> from the University of Melbourne asserts, "Numerous studies indicate that while klotho may extend lifespan in mice, there's no evidence supporting a similar effect in humans." A case involving an infant with excessive klotho levels due to a rare genetic disorder revealed concerning symptoms such as <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC2265125/">brittle bones and growth issues</a>, indicating that high levels of this protein could be detrimental.</p>
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<p>According to information on Minicircle’s website, the therapy comprises a small circular DNA fragment known as MiniCircle DNA, which instructs the body on synthesizing klotho. This DNA is injected into abdominal fat, promoting its absorption by fat cells and leading to increased klotho production. Importantly, the introduced DNA enters the nucleus of the fat cell but remains outside the chromosomes, ensuring it does not integrate into the individual’s genome, leading to eventual breakdown and removal from the body. The company estimates that the beneficial effects may last up to one year.</p>
<p>Minicircle indicated that the treatment costs over $300,000 and that navigating the FDA approval process for clinical trials could take up to three years. As an alternative, the company recently conducted a "proof of concept" trial involving <a href="https://clinicaltrials.gov/study/NCT07216781">24 participants</a> who visited an “international partner clinic” to receive gene therapy starting in October 2025. Partner clinics include one in Prospera, Honduras, known for its lenient regulatory environment, alongside others in Panama City and Paradise Island in the Bahamas.</p>
<p>Though the results from the klotho gene therapy trial have not yet been disclosed, the company states it is "preparing to publish clinical trial findings." Minicircle's founder and CEO, <a href="https://minicircle.io/about/">Mac Davis</a>, mentioned in an interview with <em>New Republic</em> that he personally underwent the treatment and experienced vertigo and altered perceptions of time — symptoms that reportedly resolved. He also noted an improved immune response and reduced food sensitivities. However, the company did not provide further comments to <em>New Scientist</em> regarding research results or general inquiries.</p>
<p>Gyngell criticized the trial's rapid execution on only 24 individuals without a control group, asserting it fails to establish adequate safety or efficacy. "Introducing a substance that continually produces a protein might lead to severe side effects within five years," he argues. "Previous gene therapy trials have faced fatalities, even with rigorous control and supervision, highlighting the inherent risks of this emerging field."</p>

<p>No other gene therapies aimed at increasing klotho levels have been tested in human subjects. A team led by <a href="https://portalrecerca.uab.cat/en/persons/miguel-chill%C3%A3n-rodriguez/">Miguel Chillon</a> at Spain's Autonomous University of Barcelona has developed another klotho gene therapy, which has only been evaluated in mice. These mice reportedly <a href="https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(25)00120-0">exhibited a 20% longer lifespan</a> but also suffered from conditions like anal bleeding and skin ulcers. Chillon’s team is now exploring gene therapy based on a smaller version of klotho, which seems to have fewer side effects. Clinical trials for this therapy will proceed within the standard regulatory framework, according to Chillon.</p>
<p>If a company like Minicircle moves too hastily and encounters complications, the repercussions could adversely impact others in the field striving to follow regulations, warns <a href="https://www.cmu.edu/dietrich/philosophy/people/faculty/london.html">Alex John London</a> from Carnegie Mellon University, Pittsburgh, Pennsylvania. "If you pour years into safe and effective interventions and someone rushes developmental processes, the backlash from negative outcomes could jeopardize everyone involved.”</p>
<p>While developing new medications is indeed expensive, London notes, this stems from the complexity of human biology and the challenges associated with creating safe, effective treatments. Large clinical trials are essential, as drugs that appear promising in early studies often fail in extensive trials.</p>
<p>“Regulatory measures concerning companies like Minicircle stem from past tragedies, which often get overlooked when we focus solely on potential opportunities,” Rudge adds.</p>

<p>Since <a href="https://portal.garmclinic.com/gene-therapy/">2022</a>, Minicircle has also introduced a separate non-FDA-approved gene therapy targeting muscle growth through the enhancement of a protein named follistatin. In preliminary tests, 43 participants aged 23 to 88 received follistatin gene therapy at Prospera Clinic, showing an average increase of \ <a href="https://www.rapamycin.news/uploads/short-url/jlJjB748AdNFUJQSMj7dSeROC5i.pdf">770 grams</a> in lean muscle mass after three months. While there were no recorded side effects, the absence of a control group raises questions about whether this outcome was purely a placebo effect. Notably, tech billionaire Brian Johnson, who has publicly declared his efforts to extend his lifespan, underwent follistatin gene therapy featured in the documentary <em>Don't Die</em>, claiming a 7% increase in muscle mass as a result. Reports indicate the treatment costs around <a href="https://www.businessinsider.com/tech-millionaire-live-forever-25k-gene-therapy-bryan-johnson-2023-12">$25,000</a>.</p>
<p>"If individuals wish to serve as subjects for such treatments, I understand their motivations, provided they are fully informed regarding the potential risks and benefits," Gyngell states. "However, I believe the existing uncertainties surrounding these gene therapies do not meet that standard."</p>

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