Overview:
Joel Stanley explains that he left Charlotte's Web to start Ajna Biosciences to help get FDA approval for natural botanical medicines.
When Joel Stanley co-founded Charlotte’s Web in 2011, he saw firsthand how plant-based medicines could change lives. That work, sparked by families searching for alternatives to treat debilitating epilepsy in children, convinced him of the healing potential of cannabinoids but also showed him the limits of access without FDA approval. Even with promising results, most doctors and patients couldn’t fully trust treatments that hadn’t cleared regulatory hurdles.
Now Stanley is taking the next step. As founder and CEO of Ajna BioSciences, he has joined forces with Charlotte’s Web and British American Tobacco in a joint venture called DeFloria. Together, they are advancing AJA001, a full-spectrum cannabinoid drug designed to treat the symptoms of autism spectrum disorder. Unlike supplements or state-based cannabis programs, this candidate is moving through the FDA’s rigorous process so it could eventually be prescribed, covered by insurance, and trusted by clinicians.
Phase 1 trials, completed in Australia last year, showed AJA001 was safe and well-tolerated across a range of doses. The findings, presented at the American College of Neuropsychopharmacology, also helped define the dosing parameters for the next stage. Two Phase 2 trials are planned for 2025, aiming to measure the treatment’s effectiveness for children, adolescents, and adults with ASD.
In our conversation for 5 Questions, Stanley spoke about the evolution of botanical drug development, why microdosing isn’t yet a one-size-fits-all solution and how regulatory attitudes toward psychedelics and cannabinoids have shifted dramatically in the past decade. His goal now is to combine the rigor of modern science with the promise of plant medicine to create therapies that are both innovative and accessible.
You’re a pioneer in the area of botanical drugs. What do you wish people knew about their healing potential, and should we all start microdosing?
What most people don’t realize is just how effective botanical medicines can be. For a long time, they’ve been dismissed because we haven’t had clinical data to support them, or they’ve been lumped into categories like unregulated dietary supplements or fringe plant medicines like ayahuasca that lack Western medical validation.
But what’s changing now is that we finally have the tools to partner with nature, to take plant-based medicines and apply the same level of rigor and repeatability you see in synthetic pharma. Just one hundred years ago, all of our medicines came from nature. What we’re doing now is essentially reintroducing plants into modern medicine, but with precision and control. A lot of people don’t trust plant medicine simply because their doctors can’t yet trust it, and that’s the trust gap we’re closing.
As for microdosing, no, not everyone should start microdosing. Many would benefit so long as they have a standardized supply and a proper dosing protocol. Unfortunately, standardized microdoses and care are out of reach for most people, which is why we’re advancing a microdose option that, once FDA approved, can be legally prescribed and monitored by a physician. We believe this candidate, AJA002, may offer a better alternative to traditional antidepressants, with fewer side effects. That said, it’s not one-size-fits-all. It needs to be evaluated on a case-by-case basis.
You founded Charlotte’s Web in 2011 and developed a cannabinoid treatment for Charlotte Figi and other children dealing with crippling epilepsy. It’s been almost 15 years. What have you learned from that time?
That experience changed my life. Charlotte’s Web, and Charlotte Figi herself, showed me the profound healing potential of plant medicine. It was the first time I truly saw what these therapies could do for people who were out of options.
But it also taught me a hard truth: without FDA approval, access remains limited. Even with compelling results, most patients and providers aren’t willing or able to take the risk. Without FDA approval, therapies that could change lives end up reaching only a fraction of the people who need them.
That’s why I left Charlotte’s Web to start Ajna Biosciences. Our mission now is to bring these proven natural medicines through the FDA pathway so they can be legally prescribed, covered by insurance, and trusted by both patients and clinicians. It’s the next evolution, combining the power of nature with the rigor of science to make these therapies truly accessible.
What results are you seeing in FDA trials using cannabinoids to treat autism?
To clarify, Phase 1 trials aren’t conducted in the specific condition we’re studying, in this case, autism. Phase 1 is about safety, not efficacy. Our Phase 1 trial for AJA001 was conducted in healthy adults to demonstrate the drug’s safety, determine the maximum tolerated dose, and assess how the body metabolizes the drug. Phase 1 was a success, as we achieved our safety endpoints and gained a clear understanding of the drug’s bioavailability.
That said, we do have meaningful observational data. Through a research registry we created with the Realm of Caring Foundation and Johns Hopkins, we’ve seen statistically significant improvements in anxiety and depression symptoms in children with autism. These results are very encouraging and point to the potential we’re now working to validate through formal clinical studies.
Psilocybin is being used to treat depression, anxiety and PTSD. Why should we trust psychedelics rather than other tried and true medications?
Let’s start with the phrase “tried and true.” Yes, SSRIs are widely used, but millions of people are stuck on them long-term, and for many, the efficacy diminishes over time. They also come with a physiological trap: they can disrupt the body’s serotonin production, making it hard to get off them without severe consequences.
With our microdose approach, we’re introducing an exogenous molecule that targets serotonin receptors directly without manipulating the body’s natural serotonin metabolism. Additionally, the natural serotonergic molecules from fungi are not known to possess the same level of toxicity as serotonin itself, such as serotonin syndrome, which can be a serious side effect caused by drug and food interactions with current antidepressants. This represents a significant advantage and, we believe, a much safer, more sustainable approach.
On the larger-dose, psychedelic-assisted therapy side, the early data is incredibly promising. In trials from Johns Hopkins and others, and even in Lykos’s MDMA trial, we’ve seen people go in with full-blown PTSD and come out without meeting the diagnostic criteria. And they’re still doing better at follow-ups months later. That kind of durable, transformative outcome just hasn’t been achieved with conventional treatments. This isn’t just incremental improvement—this is potentially revolutionary.
How challenging has it been to get government organizations like the FDA to work with you to research cannabinoid and psilocybin pharmaceuticals?
Not challenging at all. The tides have shifted. Stories like Charlotte Figi’s helped change public and political perception, and we’re now operating in a very different landscape than we were a decade ago.
Back when I was building in the CBD space, we couldn’t even get a DEA Schedule 1 license. We had to go state by state, lobbying legislatures and asking parents to advocate for their children. Fast forward to today—the DEA is granting licenses to qualified labs, and the FDA is supporting the progression of these compounds through the clinical trial process.
I think this phenomenon will only compound on itself with the current administration regularly promoting the importance of creating safe access to psychedelic therapies. This simply wouldn’t have been possible ten years ago. We’re living in an unprecedented moment for the field—lawmakers and regulators are engaged, open and genuinely interested in seeing where this science can go.