Optimi Health is a Canadian-based drug manufacturer and formulator licensed by Health Canada to produce and supply psychedelic substances such as 3,4-Methylenedioxymethamphetamine DMA and natural GMP-grade psilocybin, as well as functional mushrooms that focus on the health and wellness markets.
DRUG PROGRAMS TARGET:
SUBSTANCE FOCUS: Psilocybin, MDMA.
FACILITIES:
2 x 10,000 sq ft production and research facilities with an on-site analytical laboratory in Princeton, British Columbia.
NEWS & PARTNERSHIPS:
2021
The company entered into a non-exclusive agreement with Vitasave for product distribution via Vitasave’s 2 retail locations and online platform in Canada.
The company became 1 of TheraPsil’s first Core Spore Supporters through a generous donation and ongoing advocacy to the TheraPsil Coalition in support of their continued national initiatives aimed at increasing patient access to psilocybin. TheraPsil is a non-profit coalition of healthcare professionals, patients, and advocates dedicated to obtaining legal access to psilocybin-assisted psychotherapy for Canadians in medical need.
The company launched sales of functional mushroom capsules plus a vegan protein + mushroom formulation.
The company entered into a lab services agreement with Numinus Wellness to further R&D projects in psilocybin-producing mushrooms, psychedelic compounds and related product formulations through access to services encompassing laboratories, equipment, and expert talent within Numinus’ licensed facilities and with all the resulting IP being owned by Optimi.
2022
The company finalized a supply agreement with Bloom Psychedelic Therapy and Research Centre, a Calgary-based provider of mental health services, including psychedelic-assisted therapies employing ketamine treatments. Optimi will supply Bloom with sufficient biomass of natural psilocybin to begin conducting its previously announced clinical trial in partnership with the IMPACT Clinical Trial Accelerator Program housed within Alberta’s Life Sciences Innovation Hub at the University of Calgary.
Health Canada approved the company to manufacture MDMA, DMT, Mescaline, Ketamine, LSD, Phencyclidine, GHB, Harmaline, Harmalol, Salvia Divinorum, Salvinorin A and 2C-B.
The company finalized 3 Canadian retail and e-commerce distribution agreements for its Optimi Life nutraceutical mushroom products. The agreements with Well.ca, Vitasave, and Healthy Planet come within 6 months of the Company’s February launch of Optimi Life.
The company entered into an agreement with Avida Global to supply Avida with an extensive catalog of Optimi Life functional mushroom supplement formulations. Avida will function as the exclusive distributor for Optimi’s line of functional mushroom products in the United Kingdom, the European Union, Switzerland, India, Japan, Indonesia, Thailand, and Israel. The supplements will be available for distribution to clients and partners worldwide via Avida Labs, Avida’s white-labelling and manufacturing business. The terms of the agreement further stipulate the potential for the sale of psilocybin mushrooms via the same distribution networks in response to the still-evolving demands of international markets.
The company announced that it has entered into an exploratory supply agreement with ATMA Journey Centers. The Company has finalized an agreement which will supply psilocybin products to ATMA for future therapist initiatives and supply requirements. Optimi Health is looking forward to opportunities presented by this partnership with ATMA to advance the knowledge base of trained psychedelic therapists by providing learning experiences and real-world data derived from the direct administration of a natural psilocybin product. Further, the Company views this and other early-phase trials and supply agreements as an opportunity to refine approaches and improve efficiencies around the commercial distribution and clinical applications of psilocybin in anticipation of more robust demand as clinical research improves regulatory outcomes for psychedelic medicine.
The company entered into a supply agreement with SABI Mind, a Calgary-based clinic group providing psychedelic-assisted therapies. The Company has signed an agreement which will provide SABI Mind’s trained clinical staff with supplies of GMP-psilocybin and MDMA.
The company signed 2 supply agreements in less than a week. The 1st involves supplying Halucenex Life Sciences with whole, dried mushroom fruiting bodies corresponding to the first batch of psilocybe cubensis mushrooms cultivated at its Princeton, British Columbia location. The supplied mushrooms will serve the purpose of developing a psychedelic-assisted psychotherapeutic model for conditions such as anxiety and post-traumatic stress disorder with a safe and consistent supply of GMP psilocybin. The 2nd agreement is for supplying Filament Health for 1 year from Optimi’s facility at Princeton and will be utilized for potential drug development, testing and analysis by Filament’s research team, with the possibility of placing orders on a case-by-case basis.
The company signed a supply agreement with Filament to supply Filament with whole, dried mushroom fruiting bodies for potential drug development and analysis by Filament’s research team. Under the agreement, both companies have agreed to a one-year term which would allow Filament to place orders for whole, dried fruiting body mushrooms on a case-by-case basis.
The company entered into a supply agreement with Halucenex Life Sciences which pertains to the entirety of the company’s first harvested batch of psilocybe cubensis mushrooms at its Princeton, British Columbia facility which will be supplied to Halucenex in the form of whole, dried mushroom fruiting bodies.
The company acquired a diverse catalog of psilocybin and functional mushroom strains intended for cultivation in its 20,000 square foot, EU-GMP compliant facility in Princeton, British Columbia. The Company’s acquisition includes 24 psychedelic and nine functional strains, giving it one of the largest genetic banks in the sector. Formulated psychedelic strains will be made available to licensed researchers, Canada’s Special Access Program, as well as being utilized for on-site research in Optimi’s recently expanded analytical laboratory, while the functional strains will be optimized for the Company’s growing whole body, natural supplement brand, Optimi Life.
The company was added to the list of approved suppliers under the Special Access Program by Health Canada.
The company launched an e-commerce platform for sales of its line of functional mushroom supplements to Canadian consumers.
2023
The company entered into a strategic supply agreement with Sunshine Earth Labs with both of the parties sharing a commitment to ensuring a secure, global supply of GMP quality-controlled substances for medicinal and research purposes. “The supply agreement outlines Optimi’s commitment to manufacturing and supplying Sunshine Labs with Full Spectrum Active Pharmaceutical Ingredient (API) and encapsulated psilocybin product, and encapsulated MDMA from Optimi’s 10,000 sq ft, state-of-the-art facility in Princeton, British Columbia. The purchase quantity under this agreement will be determined on a case-by-case basis to meet the evolving needs of the market.” Both companies are committed to the highest standard of GMP drug production required by Health Canada under the CSDA and Part C, Division 2 of the Food and Drug Regulations.
The company announced the expansion of its sales network in Canada;
For the increase of sales and distribution of its Optimi Life line of functional mushroom formulations, the company chose M2 Brand Management as its exclusive retail broker throughout Canada.
The company announced an agreement for the distribution of its Optimi Life line of functional mushroom formulations with Purity Life Health Products, the largest distributor of natural, healthy living products across both natural and conventional retailers in Canada.
The company partnered with OeP, a Seattle-based consulting service devoted to Amazon optimization, to assist both in its store development and on-going product, promotion and inventory management, for its new Canadian Amazon store online.
The company announced the availability of its Optimi Life formulations at 6 Holt Renfrew retail locations across Canada as well as listed in Holt Renfrew’s online store.
The company was selected to manufacture and supply MDMA for a practitioner experiential clinical trial, sponsored by Numinus Wellness.
The company entered the Australian medical MDMA and psilocybin market through a distribution agreement with Mind Medicine to provide said substances through the Authorized Prescriber’s Scheme of the country’s Therapeutic Goods Administration. The agreement gives Mind Medicine the option to arrange the supply of additional doses as they determine market demand. Signed purchase orders with Mind Medicine to ensure that patients with treatment resistant PTSD have access to medical grade GMP-MDMA through Optimi’s MDMA formulation, OPTI-MHCL and patients with treatment resistant depression have access to GMP encapsulated psilocybin as part of therapy through their authorized treating psychiatrists.
The company announced a 1.2 million CAD GMP-psilocybin supply agreement with a private entity for clinical research and development. To fulfill its obligations, Optimi is cultivating dried GMP psilocybin-containing biomass and extract into a refined substance, which will be distributed to the Client’s international research sites.
The company was awarded its Natural Health Product Site Licence allowing for the manufacturing, packaging, and labelling of Natural Health Products at the company’s Princeton, British Columbia facility. The license also gives the company the ability to encapsulate products on site.
2024
The company announced it received a Certificate of Analysis from an independent, third-party laboratory testing that confirms its formulated MDMA meets GMP-specifications.
The company was awarded a Drug Establishment Licence from Health Canada for the manufacturing and sale of its MDMA and psilocybin capsules, enabling the company to supply MDMA and psilocybin capsules to patients with PTSD and TRD under Australia’s Authorized Prescriber Scheme and to regulated jurisdictions globally. Following this, the company completed its first international shipment to Israel of its in-house manufactured MDMA API to the Institute for Psychedelic Research at Tel Aviv University to support the institute’s research investigating the effects of MDMA on animal models of alcohol addiction.
The company announced an innovative research and development partnership with Kwantlen Polytechnic University Applied Genomics Centre, entitled: “Genetic Identification of Psilocybin Containing Mushroom” and will utilize KPU AGC’s state-of-the-art genomics technology to unravel makeup of Optimi’s psilocybin-containing mushrooms. The company seeks to enhance its DNA characterization abilities, enabling precise species and strain-level identification of mushroom genetics for potential use in clinical trials and authorized medicinal activities. The AGC will first extract DNA from 20 mushrooms of the Psilocybe and Panaeolus species cultivated from Optimi’s genetics laboratory, using the cetyltrimethylammonium bromide method. Extracted DNA from the 20 selected samples will undergo ITS sequencing to create a genotyping protocol for species identification. They will develop a novel method for strain-level identification, making this the first study that will provide single nucleotide polymorphism data for Psilocybe and Panaeolus strains.
The company announced the signing of an international natural psilocybin supply agreement with Mātai Medical Research Institute on behalf of the Tū Wairua Project in New Zealand. Optimi will provide Mātai with a quantity of its validated GMP Full Spectrum Natural Psilocybin extract. Further, the agreement includes tracked stability of the extract, ensuring the highest standards of GMP quality and compliance.
The company was granted an amendment to its Health Canada Controlled Drugs and Substances Licence allowing for the following increases: MDMA from 2 KG to 20 KG, MDA from 1 KG to 2 KG and 2C-B from 400 grams to 4 KG.
The company was a presenting sponsor for the 4th Annual Psychedelic Therapeutics and Drug Development Conference in Boston May 23rd-24th.
The company received a Certificate of Analysis (COA) for its 40mg and 60mg MDMA GMP capsules.
The company signed a letter of intent with ATMA Journey Centers to support a Phase II clinical trial using psilocybin for Major Depressive Disorder. Optimi will become the exclusive supplier of GMP-grade natural psilocybin for the trial and potential shared revenue from future commercial sales.
The company received an import permit allowing it to export GMP-grade MDMA and psilocybin capsules to Australia through its partner, Mind Medicine Australia. The medicines will be supplied to authorized psychiatrists under Australia’s Authorised Prescriber Scheme, where MDMA is approved for PTSD and psilocybin for treatment-resistant depression.
The company received a Drug Establishment Licence from Health Canada allowing it to manufacture and sell GMP-certified MDMA and psilocybin capsules.
The company signed a binding agreement with Psyence Biomedical making Optimi the exclusive supplier of natural GMP-grade psilocybin for Psyence’s Phase IIb clinical trial, future Phase III studies, and potential commercialization in palliative care. In addition to supplying the drug, Optimi will provide regulatory and manufacturing support.
2025
The company completed its second shipment of GMP-certified MDMA capsules to Australia and increased its 2025 production forecast to supply enough MDMA for more than 5,000 patients worldwide.
The company completed its largest-ever production batch of MDMA capsules, enough to treat over 1,000 patients. The company also validated a one-year shelf life for its capsules and launched a two-year stability program.
The company received a US FDA Establishment Identifier, officially registering its manufacturing facility with the FDA. This regulatory milestone positions the company to supply GMP-grade MDMA and psilocybin to authorized US entities and prepares it for future opportunities if psychedelic medicines receive broader FDA approval.
The company completed its largest MDMA export to Australia, delivering 1,000 capsules for PTSD treatment under the country’s Authorised Prescriber Scheme.
The company launched its natural psilocybin capsules in Australia for the treatment of treatment-resistant depression, shipping its first commercial batch of 1,000 capsules.
The company announced that its psilocybin capsules were selected for inclusion in Medibank’s insurance-backed psychotherapy program for treatment-resistant depression.
The company was selected to supply MDMA capsules for a Ministry of Health-approved clinical trial in Israel led by MAPS Israel and sponsored by Sheba Medical Center.
2026
The company completed its first MDMA export to Australia in 2026, delivering 1,000 capsules for PTSD treatment under the Authorised Prescriber Scheme.
The company completed its 2nd shipment of its natural 5mg psilocybin capsules to Australia for treatment-resistant depression.
The company announced that the first Australian patients had been treated with its psilocybin capsules outside clinical trials under the Authorised Prescriber Scheme.
The company launched an ibogaine development initiative, expanding its GMP psychedelic manufacturing platform beyond MDMA and psilocybin.
The company announced the production of its highest-purity natural psilocybin extract to date, reaching approximately 6% psilocybin content.
The company completed a new GMP production run of its 5mg psilocybin capsules, the same formulation currently prescribed for treatment-resistant depression in Australia. Additional product from the batch will support planned clinical trials in the US and Europe.
The company expanded its psychedelic pipeline by securing natural ibogaine supply and beginning development of pharmaceutical-grade ibogaine capsules. The company plans to develop standardized 50mg and 100mg products for future research and regulated markets, targeting areas such as opioid addiction, PTSD and traumatic brain injury.
The company completed its first export of natural psilocybin to the United Kingdom for a planned Phase 2 clinical trial. The shipment included both psilocybin biomass and finished 5mg capsules.
The company launched standardized 1mg and 2mg psilocybin capsules for clinical research organizations studying microdosing.
The company completed its 3rd commercial shipment of 5mg psilocybin capsules to Australia for treatment-resistant depression patients.