Botanix is a medical dermatology company using a novel active and proven drug delivery technology to develop prescription treatments for serious skin diseases. Click on a section below for more information.


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Introduction to Botanix Pharmaceuticals with Matt Callahan, Executive Director and Founder

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Q: Botanix Pharmaceuticals is studying cannabidiol for skin disease – is it a “medicinal cannabis company” or a “pharmaceutical company”?

A: Botanix is a pharmaceutical company. We are utilizing a synthetic form of cannabidiol which is not extracted from the cannabis plant and is a pure, pharmaceutical grade chemical that forms the basis of our drug product for clinical studies. In the same way as the active ingredient in the popular drug aspirin was originally sourced from the bark of the Willow tree, we wouldn’t think of using a natural extract of bark today, when we can synthetically manufacture the drug as a pure and commercial scale chemical. In the same way, we don’t refer to Bayer (the manufacturer of aspirin) as a “Willow tree company”.

Q: Is the difference between naturally extracted cannabidiol and synthetic cannabidiol that important?

A: Unlike cannabidiol sourced from natural extracts commonly used by ‘medicinal cannabis’ companies, synthetic cannabidiol which is manufactured to U.S. Food and Drug Administration (FDA) standards is 100% pure and similar to other drug substance that forms the basis of an approved drug product. Synthetic cannabidiol does not vary in strength or composition due to growing conditions, the genetics of the source plant, or the extraction and purification process that must be used to separate natural cannabidiol from the hundreds of other chemicals found in the cannabis plant.

As a result, synthetic cannabidiol provides an attractive alternative to existing cannabidiol therapies as it permits higher quality, more consistent manufacturing, greater scalability and more straightforward regulatory approval prospects over naturally extracted cannabidiol.

The company believes that using its proprietary source of synthetic cannabidiol substantially increases the likelihood that Botanix products can satisfy the stringent FDA requirements for purity and consistency, and avoid the risks associated with natural extract based products.

For more information on the additional hurdles that companies developing cannabidiol products from natural sources face, the FDA’s Guidance for Industry on Botanical Drug Products provides more details here.

Q: Why does Botanix Pharmaceuticals call itself a “medical dermatology” company not a “cosmetics” or “skin company”?

A: Botanix’s products will be topical treatments for serious skin diseases like acne, psoriasis and atopic dermatitis that will only be available with a prescription from a dermatologist or other medical specialists. We are following a prescription drug development process mandated by the FDA, which means that placebo controlled studies are required to demonstrate exactly what synthetic cannabidiol does and does not do – we are not relying on a general assertion that the multiple chemicals found in the cannabis plant have some “holistic” effect.

Cosmetic or skin companies which develop over-the-counter (OTC) products do not need to follow the FDA or equivalent regulatory processes, but in doing so, they are highly restricted in what they can do with their products in the market as a result. For instance, they cannot make any claims that their products treat a disease, they cannot be prescribed by dermatologists and specialists, they will not be reimbursed by insurance companies and they will face a competitive price point which is much lower than prescription products.

Botanix is focused on the multi-billion opportunity within the acne market where there have been no new medicines approved by the FDA to treat acne for more than 10 years. That’s why we are going to the regulatory process of developing BTX1503 and our pipeline products to be able to address these markets and unmet patient needs.