Roatán Island Pushes Regulatory Boundaries for Anti-Aging Gene Therapies

December 02, 2025-Próspera, a charter city on Roatán island in Honduras, is positioning itself as a deregulated haven for longevity-focused biotechnology firms, attracting companies developing experimental gene therapies aimed at combating human aging. The city’s “flexible” regulatory jurisdiction is a key draw for developers seeking to fast-track novel treatments, but the approach raises significant questions from industry experts regarding scientific validity and regulatory acceptability.

Biotechs Fast-Track Experimental Aging Treatments

Two prominent biotechs are now operating in Próspera:

• Minicircle: Established a clinical site in 2021 to study its circular RNA therapy for cognitive and health benefits in a Phase I trial (NCT07216781).

• Unlimited Bio: Incorporated last year, the company plans to create a regimen of gene therapies to address aging. Unlimited’s CEO, Ivan Morgunov, explained that the city’s lax regulations are essential for testing such treatments on healthy individuals.

Unlimited is preparing its first clinical trial in Próspera, which will study a combined regimen of plasmid gene therapies targeting two proteins: VEGF (vascular endothelial factor, involved in blood vessel formation) and follistatin (an inhibitor of the myostatin gene, which limits muscle growth).

Morgunov plans to market Unlimited’s therapy directly after Phase I and II studies, admitting that data gathered in Próspera is unlikely to be accepted by major agencies like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). This is particularly true for preventative therapies not aimed at widely recognized diseases.

The Appeal of Deregulation

Próspera was incorporated in 2017 as one of Honduras’s Zones for Employment and Economic Development (ZEDEs). The city, which is now home to over 300 companies, offers a “regulatory system designed for entrepreneurs to build better, cheaper, and faster than anywhere else in the world,” according to its website.

Thibault Serlet, co-founder of the think tank Startup Societies Foundation, notes that the city provides secure property rights, reliable rule of law, attractive tax structures (as low as 1% business tax), and, crucially for biopharma, a more permissive regulatory environment than major global markets.

However, critics warn that this environment may lead to medical tourism rather than drug approval. Morgunov admits that most of Unlimited’s patients currently come from outside Honduras.

Industry Experts Question Scientific and Regulatory Viability

Fellow gene therapy developers express strong skepticism regarding the Próspera model:

• Scientific Plausibility: Lubor Gaal, CFO of circular RNA developer Circio, stated that combining gene therapies “sounds like science fiction,” given the complexity and inherent issues of a single gene therapy.

• Defining Aging: Miguel Forte, CEO of Kiji Therapeutics and president of the International Society for Cell & Gene Therapy, cautioned that “Age is not a disease.” He emphasized that aging is a multifactorial process, and scientists still have much to learn about how to safely target it, warning of the risk of “playing with fire before we know how to control fire.”

• Regulatory Acceptability: The consensus among experts is that regulatory agencies are unlikely to accept data gathered under such permissive rules for broad approvals. While the FDA is showing flexibility for rare disease platforms, experts do not expect a significant relaxation of regulations for broad, non-rare indications like aging.

Unlimited plans to begin dosing participants (healthy individuals over 45 years old) in its Phase I/II combination trial in January 2026, with data expected by April 2026. The trial’s results will feed into the XPrize Healthspan competition, with efficacy measured via biomarkers, including VO₂ max and cognitive function tests.