“Nobody Wants A Synthetic-Only Future”: Filament Health Is Formulating Natural Psilocybin And Standardizing Ayahuasca
Last reviewed and updated: July 3, 2026.
Key Takeaways
| Natural vs. synthetic | Compass COMP360 (synthetic) → rolling NDA Q4 2026; Filament PEX010 (natural extract) → earlier stage but argues commercial + potential clinical differentiation |
| Entourage effect | Baeocystin, norbaeocystin, aeruginascin may modulate effects alongside psilocybin — biologically plausible, clinically unproven; no head-to-head RCT published |
| Filament pipeline | PEX010 (natural psilocybin extract) + standardized ayahuasca; publicly traded TSX Venture: FH / OTC: FLHLF |
| Ayahuasca standardization | DMT + MAOI two-plant combination; pharma-grade consistency technically demanding; no approved ayahuasca drug anywhere in the world |
| FDA natural product path | Epidiolex (plant-derived CBD) approved 2018 — established botanical NDA precedent; natural psilocybin path is viable but slower and costlier than synthetic |
Up until recently, all clinical studies involving psilocybin relied on a synthetic iteration of the drug for standardization purposes. When the second wave of psychedelic research began picking up in the late 2010s, Filament Health CEO Ben Lightburn and his colleagues asked themselves why no one had thought to create a natural version of the drug.
“We looked at what people were already consuming, and 99.99 percent of all psilocybin that’s been consumed has been natural. And yet, all the research, all the clinical studies, everything was done with synthetic psilocybin,” said Lightburn in an interview with Healing Maps at the company’s Burnaby, B.C. office.
“And that’s because making natural psilocybin is hard.”
Lightburn, who is also the co-founder of Filament Health, has a long history in the natural extracts industry. He and several Filament team members sold their extraction start-up, Mazza Innovation, in 2018. The company produced multiple tons of extracts per day — identifying an opportunity in psychedelics and the growing mental health crisis.
“There’s not a lot of people out there who have been plugging away for their whole careers making botanical extracts,” he said. “We wanted to take all of those skills, all of that experience, and apply it to an industry where we could potentially have an opportunity to do a lot of good.”
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Filament Health’s Mission To Supply Natural Psychedelics
Today, Filament ships naturally derived psychedelics to clinical trials around the world. This includes the likes of North America, the United Kingdom, and Europe.
In 2021, the company received FDA approval for the first-ever clinical trial using naturally sourced psychedelics. Additionally, the University of California San Francisco is conducting a phase 1 trial on Filament’s IP-protected oral and sublingual psilocin and oral psilocybin.
At Filament Health, the focus is on developing naturally derived medicines and not on the indications for those medicines. So the company’s primary role in the emerging psychedelic space is as a supplier for both academic and commercial researchers looking into their medical potential. Though small, the company’s lab has the capacity to manufacture up to 10,000 doses of psilocybin per month. This is more than enough to meet the current demand for clinical trials.
*Outside of supplying trials, the company is one of the current suppliers of psilocybin for Canada’s federal Special Access Program. This program provides patients in Canada legal access to psilocybin. Lightburn says it feels good to know that “there are actual patients consuming our products in the real world.”
*Note: A previous version of this story incorrectly noted that Filament was the only supplier of psilocybin to Health Canada’s Special Access Program.
“The Special Access Program is only for experimental medicines that haven’t been approved, but many of the applications with our drug are being approved by Health Canada,” he says. “To be already working with doctors and patients? It’s happened a lot more quickly than we thought was possible.”
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Encapsulated Psilocybin
So, what does a legal dose of psilocybin look like from a Filament Health lab? Lightburn was able to show me: A 25-milligram capsule of psilocybin looks just like any other dietary supplement or pharmaceutical product that one might consume.
But it doesn’t just contain psilocybin: “It also contains the secondary metabolites in the same ratio and proportion as if you were to consume the magic mushroom naturally, including psilocin, baeocystin, norbaeocystin, and norpsilocin,” he says.
“This makes our manufacturing work more challenging because we essentially have to standardize a dozen or more different compounds. But we believe over time, we can show that the presence of these other compounds can work together to have some kind of benefit relative to pure synthetic psilocybin, or even isolated natural psilocybin.”
From a medical perspective, there are many reasons why encapsulating naturally derived psilocybin makes sense. The amount of psilocybin in any given mushroom can vary from stem to cap, making it hard to judge dose, even by weight. Filament Health’s capsules remove the variability, and they also decrease the form factor — from five grams of dried magic mushrooms to one tiny capsule.
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Filament Health Hopes To Standardize Ayahuasca
Psilocybin is getting a lot of attention in the current research landscape. However, Ben Lightburn and his Filament Health team want to ensure that other natural psychedelic medicines receive similar acceptance.
“There’s no rule that psilocybin is the best psychedelic, even the best psychedelic in the magic mushroom,” he says. “We’re working on different natural psychedelics, and one of those is ayahuasca.”
Consumption of ayahuasca traditionally combines a mixture of two different plant extracts — Banisteriopsis caapi, the ayahuasca vine, and the Psychotria viridis, the chacruna shrub. The latter is rich in the classic psychedelic DMT. The former is rich in beta-carboline alkaloids like harmine and harmaline.
For a psychedelic experience to occur, a person must ingest them.
DMT has incredibly low oral bioavailability, with enzymes in the gut breaking it down before it crosses the blood-brain barrier. When consuming the plant extracts in tandem, the alkaloids in the ayahuasca vine block the enzymes in the gut. This allows the DMT from the leaves of the chacruna shrub to digest fully.
“It’s fascinating that Indigenous peoples in the Amazon figured out that if you have this other extract along with the DMT-containing extract, it prevents the breakdown of the DMT. That’s what allows ayahuasca to have an effect,” says Lightburn.
Working with samples of both species, the leaves of each plant turn into a powder, thus beginning the extraction process.
Filament has produced several sample batches of their iteration of ayahuasca so far. It is also working to develop a standardized dose, so ayahuasca can be studied in a formal research setting, too.
“We’re not trying to replace or even replicate the ceremony or tradition,” he says. “What we are trying to do is take the product and give it some standardization. Because with any product, if you don’t make the same thing over and over, then you can’t get insights from clinical trials.”
Filament Health in 2026: Where the Natural vs. Synthetic Psilocybin Debate Stands
When this article was first published, Filament Health was a relatively unknown Canadian biotech pursuing an unusual thesis: that natural, plant-derived psilocybin was worth developing as a pharmaceutical product rather than simply synthesizing the molecule from scratch. In 2026, the natural vs. synthetic debate has become one of the defining arguments in the emerging psychedelic medicine industry — and Filament remains the most prominent advocate for the natural side of that argument. The competitive landscape has shifted: Compass Pathways (synthetic COMP360) has the most advanced regulatory position in the psilocybin space, with a rolling New Drug Application expected in Q4 2026 following two positive Phase 3 trials. Usona Institute, also pursuing synthetic psilocybin, has its own Phase 3 enrolled. Filament’s PEX010 — a standardized natural psilocybin extract derived from Psilocybe mushrooms — is earlier in the pipeline, but Filament argues that the natural vs. synthetic choice is not just a regulatory pathway question: it may be a clinical efficacy question.
The entourage effect hypothesis. Filament’s central scientific argument is that natural psilocybin mushrooms contain a constellation of compounds beyond psilocybin itself — including baeocystin, norbaeocystin, and aeruginascin — that may modulate or enhance the therapeutic effects of the psilocybin experience. This “entourage effect” hypothesis draws an analogy to cannabis, where CBD, minor cannabinoids, and terpenes are now understood to interact with THC in clinically meaningful ways. For psilocybin, the entourage hypothesis is biologically plausible: baeocystin has structural similarities to psilocybin and may have mild psychoactive properties; aeruginascin has been proposed to shift the affective tone of the experience toward more positive valence. However, as of 2026, the entourage hypothesis remains clinically unproven. No published randomized controlled trial has compared natural psilocybin extract to synthetic psilocybin head-to-head with clinical outcomes as endpoints. Filament’s commercial differentiation depends partly on this hypothesis holding up — which makes their upcoming clinical data critical to watch.
Standardizing ayahuasca: the technical challenge. Filament’s ayahuasca standardization program represents an even more ambitious technical challenge than natural psilocybin. Ayahuasca is not a single compound — it is a brew typically made from two distinct plants: Psychotria viridis (the source of N,N-DMT) and Banisteriopsis caapi (the source of monoamine oxidase inhibitors, primarily harmine, harmaline, and tetrahydroharmine). The MAO inhibitors are what make the DMT orally active — without them, digestive enzymes would break down the DMT before it could cross the blood-brain barrier. Standardizing this two-plant pharmacological interaction to pharmaceutical-grade consistency involves controlling for variability in both plant matrices simultaneously, which is a technically demanding process. No ayahuasca-based pharmaceutical product has been approved anywhere in the world. Filament’s approach would be, if successful, a genuine pharmaceutical first.
The FDA precedent and Filament’s regulatory path. Filament’s natural psilocybin NDA pathway is more established than it might seem. The FDA approved Epidiolex in 2018 — a plant-derived, highly purified cannabidiol (CBD) product — establishing a precedent for botanical drug approvals where the active compound is extracted and standardized from plant material. Filament’s PEX010 is designed to follow the same logic: a defined, standardized natural extract with consistent psilocybin content and characterized minor compounds. The challenge is that the FDA’s botanical drug guidance requires extensive characterization of the full chemical matrix — not just the primary active compound — which is why natural product NDAs typically take longer and cost more than synthetic drug NDAs. Filament is publicly traded (TSX Venture: FH; OTC: FLHLF), which means its pipeline progress and financial runway are public information. Investors and observers tracking the natural psilocybin thesis have a transparent data source in Filament’s quarterly filings.
Frequently Asked Questions
What is natural psilocybin and how is it different from synthetic?
Psilocybin is a chemical compound that can either be synthesized in a laboratory from precursor chemicals (synthetic psilocybin) or extracted and purified from Psilocybe mushrooms that produce it naturally (natural psilocybin). The psilocybin molecule itself is identical in both cases — synthetic and natural psilocybin are chemically indistinguishable. The difference lies in what else is present: natural psilocybin extracts, even when highly purified, may contain trace amounts of related compounds — baeocystin, norbaeocystin, aeruginascin — that are absent in pure synthetic psilocybin. Companies like Compass Pathways and Usona Institute are developing synthetic psilocybin (COMP360 and PSIL-201, respectively), which offers easier pharmaceutical-grade consistency and a more straightforward regulatory path. Filament Health is developing PEX010, a standardized natural psilocybin extract, on the hypothesis that the full mushroom chemistry may be clinically superior. The natural approach faces a higher regulatory burden — standardizing a complex botanical matrix — but may offer commercial differentiation if the entourage hypothesis proves out in clinical trials.
What is the entourage effect in psychedelic mushrooms?
The “entourage effect” in psychedelic mushrooms refers to the hypothesis that compounds present in Psilocybe mushrooms beyond psilocybin itself — particularly baeocystin, norbaeocystin, and aeruginascin — may interact with or modulate the psilocybin experience in clinically meaningful ways. The concept borrows from cannabis pharmacology, where the interplay between THC, CBD, minor cannabinoids, and terpenes has been shown to meaningfully affect outcomes. For mushrooms, the hypothesis is biologically plausible: baeocystin is structurally similar to psilocybin and may have mild psychoactivity; aeruginascin has been proposed to influence the affective quality of experiences. However, as of 2026, this remains a hypothesis — no published randomized controlled trial has tested natural vs. synthetic psilocybin head-to-head with clinical outcome measures. The entourage effect is not proven; it is an educated hypothesis with biological plausibility and significant commercial implications if supported by future clinical data.
Is there an FDA-approved ayahuasca drug?
No — there is no FDA-approved ayahuasca drug anywhere in the world as of 2026. Ayahuasca is a pharmacologically complex brew combining DMT (from Psychotria viridis) with monoamine oxidase inhibitors (from Banisteriopsis caapi) that make the DMT orally active. Standardizing this two-plant combination to pharmaceutical-grade consistency is technically demanding: both plant matrices must be characterized and controlled for variability simultaneously, and the pharmacological interaction between the DMT and the MAOIs adds another layer of complexity. Filament Health is the most prominent company attempting to develop a standardized ayahuasca pharmaceutical product. The legal ayahuasca landscape is limited: the União do Vegetal (UDV) and Santo Daime churches have U.S. Supreme Court-protected rights to use ayahuasca in religious ceremonies, but this is a narrow religious exemption, not a general legal framework. Some retreat centers operate in Peru, Brazil, and other countries where ayahuasca is legal or decriminalized.
Which psilocybin drug is closest to FDA approval?
As of mid-2026, Compass Pathways’ COMP360 (synthetic psilocybin) is the closest to FDA approval. Compass has completed two positive Phase 3 trials in treatment-resistant depression and is pursuing a rolling New Drug Application expected in Q4 2026. The rolling NDA process allows Compass to submit sections of the application as they are completed rather than waiting to submit everything at once — a mechanism typically available to companies with Breakthrough Therapy Designation, which Compass holds. Usona Institute’s PSIL-201 is in Phase 3 for major depressive disorder (non-treatment-resistant), enrolled as of 2025–2026, but is earlier in the process than Compass. Filament Health’s PEX010 is earlier still, as are other natural psilocybin programs. The MDMA (PTSD) pathway through Lykos Therapeutics experienced a significant setback with the 2024 FDA rejection, and a redesigned Phase 3 is underway — approval, if it comes, is likely 2027–2028. For the psychedelic medicine field broadly, Compass COMP360 approval (expected 2027 if the NDA proceeds on timeline) would be a landmark moment.
