Phase I study of an AI‑designed oral formulation sets a new standard in drug development
NOTTINGHAM, UK – 28 MAY 2026: Quotient Sciences today announces the successful initiation of a clinical study evaluating a novel drug product developed using artificial intelligence (AI) - a landmark achievement highlighting the growing potential of AI to guide formulation design and accelerate drug development.
The pioneering Phase I clinical study was initiated at Quotient Sciences’ UK facility following approval from the Medicines and Healthcare products Regulatory Agency (MHRA). The study will assess the safety and pharmacokinetics of an oral solid dose formulation in healthy volunteers.
A key objective of the study is to validate the use of AI in drug product development, demonstrating the potential of AI to accelerate formulation design and drive better drug development decisions. Quotient Sciences believes this to be the first reported case of an AI-designed formulation being evaluated in the clinic.
Quotient Sciences’ AI-driven formulation development program - combined with real-time clinical testing - empowers pharmaceutical and biotech partners to make faster, more informed decisions earlier in the development process. This innovative approach enhances clinical predictability and significantly increases the probability of successful outcomes.
Andy Lewis, Chief Scientific Officer at Quotient Sciences, commented:
“This program marks a significant advancement in harnessing the power of advanced machine learning alongside deep scientific expertise to streamline drug development. This approach, coupled with our Translational Pharmaceutics® platform, enables our customers to make earlier, more informed decisions with greater confidence, ultimately increasing the likelihood of clinical success.”
The study leveraged Intrepid Labs’ advanced machine learning algorithm to support formulation design and optimisation. This AI-driven approach enabled rapid exploration of formulation options and more data-informed decision-making, helping to optimise the expected clinical performance of the drug product.
This milestone represents the beginning of Quotient Sciences’ broader strategy focused on integrating AI-enabled approaches across formulation development and clinical workflows. The company expects to share further updates and data over the coming months as it continues to advance and expand its AI-enabled capabilities.