Montana is poised to become a pioneering hub for experimental medical treatments, with its expanded "right to try" legislation gaining significant momentum. The state has established a clear pathway for biotech companies to offer their experimental drugs directly to consumers, marking a significant shift in the accessibility of unproven therapies. This initiative, driven by a unique coalition of longevity enthusiasts and biotech entrepreneurs, aims to accelerate the development and availability of novel treatments, particularly for rare diseases and aging-related conditions.

At the core of Montana’s new framework is a streamlined application process for companies seeking to provide their experimental drugs. For a fee of $12,500, biotech firms whose drugs have undergone preliminary testing—even as little as testing on 10 healthy individuals—can apply to a newly formed review board for approval. Once a treatment receives the board’s endorsement, the company can set its own price and market the drug through specialized experimental treatment clinics, with the first such facilities anticipated to be operational by the end of the year.

What sets Montana’s approach apart from other "right to try" laws is its broad scope. Unlike jurisdictions that restrict access to drugs solely for individuals with terminal illnesses, Montana’s legislation theoretically allows any patient who provides informed consent and can afford the treatment to access these experimental therapies. This inclusive approach opens doors for individuals seeking treatments for rare diseases, as well as those interested in longevity and preventative medicine.

The Montana Department of Health and Human Services has finalized the rules governing this new law, ensuring that patients provide comprehensive informed consent. Each application will undergo a rigorous review by a dedicated board comprised of a Montana-certified physician, expert scientists, and an ethicist. Proponents of the law, such as Matt Kaeberlein, a scientist on the first review board, emphasize the commitment to a responsible and scientifically sound process. "It will be done in a very rigorous way, with qualified medical professionals and appropriate oversight," Kaeberlein stated. However, concerns linger among some experts, like Dr. Aaron Kesselheim of Harvard Medical School, regarding the potential for harm when unproven treatments are made available without the oversight of the U.S. Food and Drug Administration (FDA).

The movement to increase access to unapproved drugs in the United States has been growing, but Montana’s initiative has a distinctive origin. Spearheaded by longevity advocates rather than traditional libertarian or patient advocacy groups, the legislation’s trajectory is noteworthy. Montana initially enacted a "right to try" law in 2015. In 2023, with the support of State Senator Ken Bogner, the law was expanded to encompass all patients, not just those with life-threatening conditions. Senator Bogner articulated a vision focused on "preventative medicine" rather than solely treating diseases once they manifest.

Bogner’s legislative efforts in 2023 were significantly influenced by the Alliance for Longevity Initiatives (A4LI), a nonprofit dedicated to advancing policies that promote healthy human lifespan. A4LI facilitated connections that helped shape the bill and garnered support for its passage.

Following the 2023 law, tech entrepreneur and longevity enthusiast Niklas Anzinger became a key figure. Anzinger has been actively involved in establishing jurisdictions that can expedite the search for life-extending drugs. Previously based in Próspera, a special economic zone in Honduras, where he co-founded Infinita City and related ventures focused on experimental stem cell and gene therapies, Anzinger has now shifted his focus to the U.S. He views Montana as a more viable model due to its foundation in existing regulatory precedents. Anzinger collaborated with several unnamed biotech companies to draft a subsequent bill in 2025, which outlined the specific operational terms for clinics offering unapproved drugs. This bill was passed in April 2025 and adopted the following month, paving the way for the current regulatory framework.

Since the passage of the 2025 law, Anzinger and his colleagues have been awaiting the finalization of operational guidelines for treatment centers by the state’s Department of Health and Human Services. These rules, which specify the requirements for clinics offering treatments not approved by the FDA, were recently published online and became effective on July 25, 2026.

With the new rules in place, Anzinger and Stephen Martin, Infinita’s U.S. lead, have moved forward with establishing the Montana Experimental Treatment Review Board (ETRB). This independent board, comprising five experts, will evaluate applications for access to experimental drugs. While other review boards may emerge, the Montana ETRB is currently the state’s sole entity. Concerns about the board’s initial website implying official state status led to an update clarifying that it is a private service managed by Montana Governance Services Inc., an entity under the Infinita umbrella. Infinita will fund the board members through the application fees paid by companies.

The Montana ETRB includes Dr. James Burke, a board-certified oncologist, and bioethicist Jessica Flanigan, known for her advocacy of self-medication and pharmaceutical freedom. The remaining three members are highly respected figures in the longevity community: Felipe Sierra, former senior role at the National Institutes of Health’s aging arm and former chief scientific officer at Hevolution Foundation; Matt Kaeberlein, who led the Dog Aging Project and studies rapamycin for longevity; and Jamie Justice, a gerontologist and executive director of the X Prize Healthspan competition. Justice stated her motivation as helping to build a "safe, transparent, and scientifically rigorous process" for Montana’s legislation, particularly concerning longevity and aging interventions. Kaeberlein sees the Montana setup as offering a more regulated environment with scientific oversight, informed consent, and data collection capabilities, addressing his prior concerns about unproven treatments.

While the initial impetus for Montana’s law came from longevity advocates, the first wave of interest in accessing experimental drugs is originating from companies and individuals focused on treating specific diseases. Anzinger noted a surprising level of interest from oncology and neurodegenerative disease sectors, which he views as compatible with Infinita’s broader mission of extending healthy human life.

Two applications have already been submitted to the Montana ETRB: one from a biotech company developing a treatment for neuropathy and another for hearing loss. Martin anticipates these applications will be reviewed promptly. Stanley Kim, CEO of WinSanTor, which is developing a treatment for peripheral neuropathy, has submitted an application. He cited desperate pleas from patients, some with suicidal ideation, as a driving force. Kim believes the Montana program will not only provide access but also generate valuable data to accelerate FDA approval. His company plans to continue its regular clinical trials alongside this initiative.

However, not all biotech companies are eager to participate. Thomas Joudinaud, CEO of Ceres Brain Therapeutics, while finding Montana’s system "very interesting and very pragmatic," has reservations. He worries that any adverse events in Montana could jeopardize his company’s standing with the FDA. The FDA has not offered assurances that companies participating in Montana’s program will be protected from potential penalties, merely restating the federal Right to Try Act.

Chris Robertson, a health law specialist at Boston University, cautions that even FDA assurances could be transient, subject to shifts in policy with new administrations. He suggests that the FDA’s expanded-access pathway, which approves over 99% of applications for seriously ill patients with no other options, remains the safest route for companies seeking to maintain good standing with the agency. Dr. Kesselheim concurs, stating that the FDA’s expanded-access process is designed to ensure programs are legitimate and patients can contribute valuable knowledge, and that "legitimate manufacturers" should not fear this established pathway.

A key distinction between Montana’s approach and the FDA’s expanded-access program lies in the breadth of eligibility and cost. In Montana, patients do not need to be seriously ill, opening the door for preventive or earlier-stage interventions. Furthermore, while expanded access allows companies to charge only for the costs of manufacturing, transportation, and monitoring, Montana allows companies to set market prices, which could be substantial, as exemplified by the median price of $218,872 for new rare disease drugs. This business model, as Kaeberlein notes, may incentivize companies to utilize the program.

Beyond financial costs, experimental drugs carry inherent risks. Phase I trials do not conclusively establish safety, and a significant percentage of drugs fail in later trial phases. Kesselheim emphasizes that a drug’s passage through early trials does not guarantee safety, and bioethicists have voiced concerns about the ethical implications of promoting and selling unproven treatments.

Despite these concerns, the operationalization of Montana’s experimental treatment framework is rapidly advancing. The Montana ETRB is preparing to review its first applications, and clinics involved in the program are actively working to meet the state’s new regulatory requirements. Treatment facilities are being equipped, medical directors are being hired, and the delivery of experimental treatments to patients is anticipated in the coming months.