Kris DeVault is desperate.

His son, Brody, was born in March 2023. It wasn’t long before he started to show signs of developmental delay, says DeVault. As time went on, Brody started missing key milestones in speech, movement, and coordination, he says.

When Brody was around two and a half years old, a genetic test revealed creatine transporter deficiency—a rare condition in which the brain and muscles lack the energy they need to develop.

There are no cures for Brody’s condition. But DeVault has learned of a company developing a drug that might help. That drug is still in the early stages of development and has only been tested in animals and a small number of healthy adults. Doctors can’t prescribe it.

DeVault knows the drug might not work. But he’s doing all he can to access it regardless. And a new law in Montana could make it easier for people in his position to get access to treatments—at least in theory.

Today, Brody is three years old. His dad describes him as a happy, curious, and loving little boy who wants to learn. But Brody struggles to communicate. “He’s got no words, really,” says DeVault. “He wants to communicate more than he’s able to … which then turns into frustration.”

It’s difficult for Brody to tell his parents whether he’s hot, cold, hungry, thirsty, uncomfortable, or even in pain, says DeVault. He recently found Brody standing on an anthill in the backyard, being bitten by red ants. “These fire ants were just going to town on his feet … and he was just looking,” he says.

Brody has muscle weakness too. “He can’t move very fast, he doesn’t have a ton of strength … and it takes a lot of energy for him to walk balanced,” says DeVault. “His arms are skinnier than [those of] his nine-month-old sister.”

It’s concerning, but DeVault is most worried about Brody’s neurological development. Toddlers’ brains are exceptionally “plastic”—the first years of a child’s life are thought to be crucial for long-term brain development.

A biotechnology company in France is working on a drug to help people like Brody. Creatine usually provides brain cells with energy. People with creatine transporter deficiency (CTD) can’t get creatine into the brain.

The team at Ceres Brain Therapeutics is developing a treatment designed to bypass this issue and effectively deliver creatine directly to the brain. So far, the team has seen promising results in mice, says Ceres CEO Thomas Joudinaud.

The company also recently completed a phase I clinical trial that involved testing various doses of the drug, which is delivered as a nasal spray, in 48 healthy adult volunteers. That trial has not yet been published, says Joudinaud. The drug has not been tested in people with CTD, or in children.

“I look at this, and I’m like, that is my one shot for Brody,” says DeVault.

Joudinaud is planning a phase II trial in people with CTD, as well as others with amyotrophic lateral sclerosis. But that trial will take place in France, and it’s unlikely that Brody will be able to take part, says DeVault.

Ceres can’t make the drug available to Brody under an expanded access scheme run by the US Food and Drug Administration either, because the drug has not been registered with the FDA, and because it is currently manufactured in a way that does not comply with FDA regulations, says Joudinaud.

Even if that phase II trial is successful, and if the drug is ultimately approved, it is unlikely to reach the US market for at least a few years. DeVault is worried that will be too late for Brody—he’ll be “past his plasticity window” by then, he says.

Now, with the adoption of a new law in Montana, he theoretically has another option. Montana has had a “right to try” law—which allows terminally ill people to apply for access to unapproved drugs—in place since 2015. In 2023, a new law technically expanded this option to people who were not terminally ill, providing the drugs have been through preliminary phase I clinical trials. A second law aimed to clarify how clinics could sell and administer those treatments to patients. And last weekend, the state’s department of Health and Human Services finalized a set of rules for those clinics.

An experimental treatment review board (ETRB) has been established to review applications for access to experimental, unproven, and unapproved drugs. And it is set to review its first two applications in the coming weeks.

Ceres could also apply to Montana’s ETRB to sell its experimental treatment to Brody’s parents via a clinic in the state. But Joudinaud is reluctant, at least for the time being. While he thinks that Montana’s setup is “very interesting and very pragmatic” and “suitable for our drug,” he’s worried about getting on the wrong side of the FDA.

DeVault has been pleading with FDA staffers for a written statement essentially promising that biotech companies participating in Montana’s program won’t be penalized later on, especially when they eventually try to get their drugs approved in the US. But he hasn’t made any progress.

Now he’s looking beyond Montana. He’s considering accessing treatment in Próspera, a private city and “special economic zone” in Roatán, Honduras, where a clinic sells unproven stem-cell and gene therapies, among others.

Many scientists have cautioned against the use of such “offshore” clinics. Even when it comes to Montana, scientists, bioethicists, and health law experts will caution that phase I clinical trials don’t prove a drug is safe. And they certainly don’t prove a drug’s efficacy, either.

When I spoke to Aaron Kesselheim, a professor of medicine at Harvard Medical School with expertise in health policy and drug regulation, about the Montana law earlier this week, he made his concerns clear. “Patients who want these kinds of treatments deserve them to be rigorously assessed so that [they] can better understand what they’re getting themselves into, and what they’re paying their hard-earned money for.”

But DeVault pushes back on these arguments. “I’m a full-grown human being,” he says. “I’m capable of going to Vegas right now … blowing it all on the poker table, [or] I can go to the gun shop and buy a silenced [semi-automatic rifle] … how come I can’t make a decision to purchase a potential treatment that might change the entire trajectory of my son’s life?”

This article first appeared in The Checkup, MIT Technology Review’s weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here.

As of this week in Montana, any biotech company with an experimental drug has a clear path to selling it to consumers. Companies whose drugs have been through preliminary testing—sometimes in as few as 10 healthy people—can pay $12,500 to apply to a newly established review board for approval. Once its treatment is rubber-stamped, the company can set the price of the drug and sell it via experimental treatment clinics, the first of which is likely to be up and running around the end of this year.  

Montana’s latest right-to-try legislation is unique. While other jurisdictions with similar laws limit access to drugs to people with terminal illness, in Montana access is theoretically available to anyone who gives informed consent and can pay. That includes people desperate for treatments for rare diseases. It also includes those who are interested in longevity and want to try out drugs pitched as preventive therapies.

The state’s Department of Health and Human Services recently finalized rules to implement the law. The rules stipulate that patient consumers provide fully informed consent and that each application be reviewed by a board that includes a Montana-certified doctor, expert scientists, and an ethicist. Supporters of the law stress that they want the process to be responsible. “It will be done in a very rigorous way, with qualified medical professionals and appropriate oversight,” says Matt Kaeberlein, a scientist on the first board, which was formed independently of the state health department.

But other experts are worried about the potential for harm in selling unproven treatments to people without oversight from the US Food and Drug Administration. “I would be concerned,” says Aaron Kesselheim, a professor of medicine at Harvard Medical School with expertise in health policy and drug regulation.

There has been a growing movement to make unapproved drugs more accessible in the US. But the story of Montana’s law is unique. It’s been driven and drafted by longevity enthusiasts instead of the usual libertarian and patient groups.

An unusual origin story

Montana first passed a right-to-try law in 2015. In 2023, with the support of state senator Ken Bogner, the state expanded the law to include all patients, not those just with terminal disease. Last year, Bogner told MIT Technology Review that his vision was to focus “more on preventative medicine” rather than “just treating diseases once they show up.”

Bogner says he had “started working on a bill” that would become the 2023 law when the Alliance for Longevity Initiatives (A4LI), a nonprofit “dedicated to advancing legislation and policies aimed at increasing healthy human lifespan,” got in touch. A4LI connected Bogner with others who helped draft the bill and testified in support of it.

Once that law was in place, the tech entrepreneur and longevity enthusiast Niklas Anzinger got involved. Anzinger has been working to establish a jurisdiction to fast-track the search for drugs that might deliver radical life extension. He is based in Próspera—a private city and “special economic zone” in Roatán, Honduras, which is already home to a separate clinic that sells experimental stem-cell and gene therapies. Anzinger founded a community there called Infinita City; he has also founded an investment company and a “service providing” company, both of which include the name Infinita.

Over the last couple of years, Anzinger has switched his focus to the US. “Now we think that Montana is a better model, because it’s building on … existing regulatory precedents,” he says. Once Montana’s 2023 law was passed, he adds, he worked with a handful of unnamed biotech companies to draft a second bill—one that laid out the specific terms under which clinics can offer unapproved drugs. That law was passed in April 2025 and adopted the following month.

Since then, Anzinger, Bogner, and others have been waiting for the state’s Department of Health and Human Services to finalize specific rules for treatment centers—a set of operational guidelines and requirements that any clinic offering treatments unapproved by the FDA must meet under Montana’s law. “The rules have been taking a very long time,” says Anzinger. “Then on Friday, we heard they were effective … from Saturday [July 25].” The rules have since been published online.

Following the rules

With the new rules in hand, Anzinger and his colleague Stephen Martin, Infinita’s US lead, got to work. The first step was to establish an independent experimental treatment review board—a panel of five experts to evaluate applications for access. Anzinger and Martin started recruiting candidates months ago.

The state’s first board, named the Montana ETRB, was officially announced by Infinita earlier this week. For the time being, it is the state’s only review board, although Anzinger says that other groups are free to establish their own. After Bogner raised concerns that the board’s website wrongly implied that it was an official state body, the site was updated to note that “It is a private service run by Montana Governance Services Inc.” That company is “a local Montana registered entity, but it is under the Infinita umbrella,” says Anzinger. 

Infinita will pay board members a flat fee, funded by the $12,500 companies will have to pay to have their applications reviewed. Anzinger stresses that the board members, and their decisions, will be independent of Infinita.

In accordance with the rules, the board includes a Montana-licensed doctor: James Burke, an oncologist. It also includes a bioethicist: Jessica Flanigan, a libertarian who is known for her strong views in support of self-medication and her book Pharmaceutical Freedom.

The other three members are familiar faces in the longevity community—all of whom are well respected in the field. “When we looked at our own network, these were some of the best guys,” says Martin. They include Felipe Sierra, who formerly held a senior role at the National Institutes of Health’s arm focused on aging. More recently, Sierra served as chief scientific officer at Hevolution Foundation, a nonprofit that funds research into extending healthy lifespan with the support of the government of Saudi Arabia.

Matt Kaeberlein, who formerly led the Dog Aging Project and has studied the potential for rapamycin as a longevity therapeutic, also features. So does Jamie Justice, a gerontologist who is also executive director of the X Prize Healthspan competition, which has $101 million in prize money up for grabs for researchers who find ways to treat the signs of aging.

“I saw an opportunity to help build a safe, transparent, and scientifically rigorous process for implementing Montana’s newly expanded right-to-try legislation, particularly as it applies to longevity medicines and aging-related interventions,” says Justice. “Science is moving quickly, and I wanted to help ensure that as it develops, it does so with real rigor and accountability.”

Kaeberlein, who has a prominent media presence, has long raised his own concerns about access to other unproven treatments, including peptides and stem-cell therapies. He sees Montana’s setup as offering a more regulated environment—one that offers scientific oversight, ensures informed consent, and allows for data collection.

Applications incoming 

While many of the bill’s original supporters were interested in longevity, the initial interest in making drugs more accessible in Montana is coming from companies and individuals looking to treat specific diseases.

“We were actually surprised that much of the interest … is actually more from oncology [and] neurodegenerative disease,” says Anzinger. This focus, he says, is “very compatible” with Infinita’s mission. “We’re not trying to convince everyone … to support radical life extension,” he says. Anything that extends health and human life, including treating cancer and neurodegenerative disease, is part of what longevity means to him, he says.

Martin says that two applications have already been submitted to the newly formed review board. They’ve come from biotech companies that are developing drugs for neuropathy and hearing loss, he says. “I expect we’re going to get started on them this week,” he says.

One of the applications was submitted by Stanley Kim, CEO of WinSanTor. His company is developing a treatment for peripheral neuropathy, a painful nerve condition that can be a consequence of cancer treatment or diabetes. The drug is currently in phase II trials, but Kim says he regularly receives messages from people who are desperate to access it, to the point of being suicidal. He hopes that not only will he be able to make the drug accessible to those people, but he’ll also be able to collect data from them—data that might help accelerate the drug’s approval process.

“We have a newsletter [that is sent to] around 15,000 patients,” says Kim. “Not all of them will be able to go to Montana, but many of them, I think, will.” His company still plans to continue with regular clinical trials as well.

But not all biotech companies with early-stage drugs feel comfortable submitting an application—at least not yet. Thomas Joudinaud, CEO of a French biotechnology company called Ceres Brain Therapeutics, has fielded a request from a person keen to access the company’s experimental drug in Montana. He says that while Montana’s system is “very interesting and very pragmatic” and “suitable for our drug,” he won’t be submitting an application for the time being. He is concerned that if anything goes wrong in Montana, it may jeopardize the company’s standing with the FDA, which wields the power to approve or reject the sale of its treatments to broader populations.  

Martin and others have asked the FDA for some kind of assurance that biotech companies participating in Montana’s program won’t be penalized later on. But the agency hasn’t provided them with more than a restatement of the federal Right to Try Act.

“As a matter of policy, the FDA does not comment on state legislation,” an FDA spokesperson wrote in response to a request for clarification from MIT Technology Review.

Even if the FDA were to provide some kind of assurance, it wouldn’t necessarily protect biotech companies in the long term, cautions Chris Robertson, a specialist in health law at Boston University. The FDA’s position could change with a new presidential administration, he says: “I wouldn’t bet on anything that the FDA is saying today being applicable when the rubber hits the road later.” 

Companies that want to stay on good terms with the FDA would be safest taking the expanded-access route, says Robertson. That’s the pathway the FDA already uses for people who are seriously or terminally ill, have run out of options, and want to try experimental drugs that have not yet been through clinical trials. The FDA approves over 99% of these applications, says Harvard’s Kesselheim. 

“The FDA isn’t a bottleneck but in fact exists to help ensure that expanded-access programs are aboveboard and that patients who receive [the drugs] are able to contribute knowledge about [them],” says Kesselheim. He says he doesn’t think that any “legitimate manufacturer” should fear having to go through the FDA’s expanded-access process, which the agency says takes “less than 45 minutes” to fill out.

The cost of experimenting

There are some key differences between expanded access, which allows seriously ill people to apply for access to experimental drugs that might not have been through any human trials, and Montana’s approach. In theory, a person doesn’t need to be seriously ill to access experimental drugs in Montana. 

“In Montana, patients may be eligible for preventive or earlier-stage interventions if they provide informed consent and meet the program’s requirements, so the breadth of potential therapies and situations is much broader,” says Kaeberlein, the Montana ETRB member, who is an affiliate professor at the University of Washington in Seattle.

Kaeberlein also highlights another key difference, which is cost. Companies that make their treatments available through expanded access are only able to charge for the costs of making, transporting, and monitoring the drug, and they must justify the eventual price to the FDA. In Montana, they can charge whatever price they want. Stanley of WinSanTor says he plans to sell his drugs “at cost.” But Ceres’s Joudinaud says that he’d be more interested in selling his at a market price. When asked what that might be, he hinted that the prices of new drugs for rare diseases can be high. In recent years, the median price of such drugs was $218,872. 

“Instead of simply creating a legal pathway for patients, it also creates a business model that companies may actually be willing to use,” says Kaeberlein.

Beyond the financial cost, there will be risks associated with any experimental drug. Phase I trials don’t conclusively reveal whether a drug is safe. Around 17% of drugs are found to be inadequately safe during phase III trials. “The idea that a drug has been proven safe because it’s been subject to a phase I study is very, very wrong,” says Kesselheim. Bioethicists have raised concerns about the ethics of promoting and selling unproven treatments and the risk of harm should something go wrong.

But the moment when people start spending money on these treatments is already fast approaching. While Montana’s first ETRB prepares to review its first applications, clinics that hope to be part of the program are busy addressing the requirements laid out in the state’s new rules. Treatment rooms are being outfitted. Medical directors are being hired. And experimental treatments should be reaching patients in the coming months.