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June 11, 2026
dsm-firmenich has published a clinical study in CNS Drugs on a novel drug delivery technology CBtru®, enabling faster absorption of highly lipophilic molecules, such as cannabidiol (CBD), and more reliable dosing compared to conventional oil-based products.
SGS Nutrasource is pleased to have supported this milestone through the conduct of the study, which stands out not only for its clinical outcomes, but also for the scientific, regulatory, and operations rigor applied from the very beginning.
Zdravka Misic, PhD, Associate Innovation Director Pharma, HNC at dsm-firmenich comments, “dsm‑firmenich partnered with SGS Nutrasource to support a pharmacokinetic clinical trial for our novel oral solid CBD formulation, CBtru®. The trial was delivered efficiently, with solid organization, strong regulatory engagement, and a collaborative, trustful working relationship throughout, to support the successful advancement of the project. It was a pleasure working with SGS Nutrasource and I can highly recommend working with their team.”
View Publication: https://link.springer.com/article/10.1007/s40263-026-01280-1
As a cannabis-derived product classified as a drug, the study was reviewed through one of the most stringent regulatory pathways, Health Canada’s Pharmaceutical Drugs Directorate. Through a robust Clinical Trial Application, approval was secured within just seven days of Acknowledgement of Receipt, without a single Information Request Notice.
This level of regulatory efficiency reflects deep expertise, strong alignment with agency expectations, and a commitment to submission quality from the outset.
As noted by Paula Guerra, PhD, Associate Director of Regulatory Affairs, “The successful authorization and quick turnaround speak to the strength, quality, and completeness of the Clinical Trial Application, as well as strong alignment with Health Canada expectations. This outcome reflects the regulatory expertise and strategic guidance of SGS Nutrasource, demonstrating that even complex, non-traditional products can be efficiently advanced through the Canadian drug regulatory pathway with a robust submission strategy.”
Following regulatory authorization, the clinical program delivered strong results, including:
- A novel powder formulation for a highly lipophilic molecule (CBD)
- Faster absorption compared to an oil-based product, Epidiolex, for both fed and fasted states
- Comparable bioavailability to Epidiolex with improved patient-centric dosing
- Reduced interindividual variability, supporting more consistent outcomes
From study design through execution, the program highlights the importance of integrated scientific and operational expertise.
Adam Kuttenkeuler, PMP, Project Manager, adds, “This trial is a strong example of cross functional execution, from a highly technical study design to seamless delivery. Our team’s ability to translate complex formulation science into a robust pharmacokinetic study underscores a high level of pharmaceutical clinical expertise across our organization.”
Beyond cannabis, this work signals broader potential for advancing delivery technologies for other highly lipophilic compounds while reinforcing the value of well-designed, regulatory-aligned clinical programs.
Read dsm-firmenich’s, “Ask-the-Expert: What does new clinical evidence mean for CBtru® and oral solid drug delivery?” : https://www.dsm-firmenich.com/en/businesses/health-nutrition-care/news/talking-nutrition/ask-the-expert-what-does-new-clinical-evidence-mean-for-cbtru-and-oral-solid-drug-delivery.html
From concept to claim, SGS Nutrasource is proud to support partners in bringing complex, innovative therapies to market with confidence.