Minicircle sells unapproved klotho gene therapy
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- Minicircle is preparing to launch an injectable gene therapy at clinics in Honduras, the Bahamas, and Panama within six months, requiring no FDA or other major-regulator approval
- The therapy delivers circular DNA into abdominal fat cells, prompting them to produce the anti-aging protein klotho; the company estimates effects could last up to a year
- Minicircle conducted a 24-person, uncontrolled 'proof of concept' trial beginning October 2025 at partner clinics including the Honduran 'innovation city' Próspera, Panama City, and Paradise Island — but has not published results
- Founder and CEO Mac Davis told The New Republic he injected himself and experienced transient dizziness and altered time perception; he estimates an FDA trial application would cost $300,000+ and take up to three years
- Ethicists Christopher Rudge (University of Sydney) and Christopher Gyngell (University of Melbourne) called the rollout reckless, noting an infant with naturally excess klotho developed weak bones and growth problems
- Minicircle has sold a separate non-FDA-approved follistatin gene therapy at Próspera since 2022, priced at $25,000; longevity influencer Bryan Johnson claimed a 7% muscle gain after receiving it
- Miguel Chillón at the Autonomous University of Barcelona is developing a competing klotho therapy that extended mouse lifespan 20% but caused anal bleeding and skin ulcers, and plans to enter trials through standard regulatory channels
Why it matters: A single adverse event from Minicircle's 24-person, uncontrolled trial could derail the entire legitimate klotho research field, warns Alex John London of Carnegie Mellon. With gene-therapy effects lasting up to a year, unknown long-term risks loom — and patients paying for offshore treatments effectively become trial subjects without the safeguards regulators exist to provide.
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