We are currently supporting a number of clinical trials and institutions globally with our clinical-grade LaNeo™ MDMA Drug Product.
PharmAla Biotech was formed by a devoted team of biomanufacturing, regulatory and financial professionals, driven by the belief that MDMA shows clinical promise as a treatment for numerous disorders. We believe that the only way to advance the scientific research directly related to the medicinal use of MDMA is to ensure that researchers have a steady and accessible supply of clinical grade Active Pharmaceutical Ingredient (API).
PharmAla also believes that the base MDMA molecule can be improved upon. PharmAla researches and develops Novel Chemical Entities (NCEs) based on the MDXX class of molecules. Our goal is to improve these molecules’ safety properties, to allow their use to treat a diverse range of disorders.
*The efficacy and safety of MDMA-assisted therapy are currently under investigation. MDMA has not yet been approved by Health Canada or any other regulatory body.*
PharmAla works with established, best- in-class laboratories across Canada to develop novel processes for the supply of LaNeo™ MDMA and other MDXX substances.
We hold ourselves to the highest standards of compliance and rigour. Our Research and Development team is engaged in preclinical research on 2 of our novel chemical entities, with the goal of increasing the safety of MDMA and its analogs.
*The efficacy and safety of MDMA-assisted therapy are currently under investigation. MDMA has not yet been approved by Health Canada or any other regulatory body.*
The Psychedelics market in the US is growing with a CAGR of 16% in the forecast period of 2020 to 2027 and is expected to reach US$ 6.9B by 2027 from US$ 2.1B in 2019. MDMA is the first “psychedelic” molecule likely to be granted regulatory approval as a medicine in the US, having already completed two Phase III trials, it is currently under consideration for approval by the FDA.
See our most recent company presentation to learn more about investing in PharmAla Biotech.
Currently, there is a global shortage of MDMA to sustain critical research. While MDMA is an off-patent molecule, the process development and regulatory burden for the manufacturing of a controlled substance have significantly narrowed the number of manufacturers. PharmAla Biotech, in concert with our manufacturing partners, is currently the only supplier of MDMA for human use in Canada manufactured under Good Manufacturing Practice guidelines.
Regulators look at drugs through two lenses: efficacy, and safety. While many companies are working to prove the efficacy of LaNeo™ MDMA in treating various conditions, PharmAla is one of only a small number of companies which is working to improve the molecule’s safety. We selected this approach because PharmAla is a “regulatory-first” organization: we know that there is no pathway to drug approval without trust from regulators.
PharmAla Biotech has developed the first legal commercial value chain in North America for clinical-grade GMP LaNeo™ MDMA products. We are researching novel formulation methods and delivery pathways to ensure that the LaNeo™ MDMA developed by the company can be delivered by researchers and clinicians with the greatest safety, while reducing cost.
Our team consists of passionate professionals who are on the cutting edge of psychedelic research. We work closely with researchers across Canada and the US to develop and advance the research into novel patented compounds based around MDMA, as well as establishing MDMA delivery processes.
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