SGS has announced it has received formal approval from the Belgian Federal Agency for Nuclear Control (FANC) to resume human ADME (Adsorption, Distribution, Metabolism and Excretion) studies using ¹⁴C-radiolabelled investigational products.
SGS
The approval enables SGS to reintroduce ¹⁴C human ADME studies at its clinical pharmacology unit in Antwerp, reinstating a highly specialised capability within its European early-phase clinical research portfolio.
The resumption of human ADME studies builds on SGS’s extensive legacy in radiolabelled clinical research. Formerly, SGS conducted ¹⁴C human ADME studies at its Stuivenberg clinical pharmacology site and through its bioanalysis laboratory in Wavre. Following the transition of clinical activities into the new clinical pharmacology unit in Antwerp, SGS implemented a phased approach to re-establishing specialised capabilities.
With the completion of all regulatory, radiological and operational preparations, the Antwerp unit is now fully qualified to conduct human ¹⁴C ADME studies. FANC approval confirms that the facility meets all required standards for radiation safety, environmental protection and compliant clinical execution.
Human ADME trials in early development
Human ADME studies provide an integrated assessment of how an investigational drug behaves in the human body, characterising how it is absorbed, distributed, metabolised and eliminated. These studies enable the identification and quantification of circulating metabolites, elucidate metabolic pathways, and provide insight into the relative contributions of renal, biliary and faecal routes of excretion.
In early development, human ADME data are critical for guiding dose selection, assessing the need for dedicated drug-drug interaction or organ impairment studies, and informing regulatory strategy. The resulting data supports informed decision-making before progressing to larger patient trials, de-risking later-stage development.
Renewed relevance of human ADME
While investment in biologics has increased over the past decade, small-molecule drug development remains a key focus area across pharma and biotech pipelines. At the same time, the number of European sites equipped to conduct complex human ADME trials has declined due to stringent infrastructure, operational and radiological compliance requirements.
This limited availability, combined with sustained demand for high-quality disposition data, has renewed the strategic importance of human ADME studies. A clear understanding of human metabolic profiles remains essential for regulatory submissions and for mitigating late-stage attrition.
Wim Verreth, pharma, head of business development and support, SGS said: “SGS is delighted to have gained FANC approval, giving us the green light to re-commence ADME trials and, most critically, help meet the rising demand for early-phase clinical studies.
“As one of the few European CROs able to deliver complex, end-to-end human ADME programs, this will be welcome news for pharmaceutical and biotech sponsors in need of high-quality, regulator-accepted disposition data at a critical stage of their drug development journey.”
SGS reintroduces human ADME capabilities
In reinstating human ADME to its portfolio, SGS strengths its ability to support drug development programs with critical early clinical data. This enhanced capability also enables the delivery of modern microtracer studies combined with accelerator mass spectrometry (AMS). This approach enables ADME characterisation using ultra-low levels of radioactivity, significantly reducing risk to healthy volunteers while accelerating go/no go decision making.
SGS’s integrated service offering includes scientific consultancy for study design, clinical conduct, management of radiolabelled materials, radiological and regulatory compliance, and partnerships for isotope labelling and ultra-sensitive bioanalysis. This end-to-end capability gives sponsors a streamlined, compliant, and scientifically robust pathway to obtain essential human ADME data with greater efficiency and reduced operational complexity.