Quotient Sciences has begun a Phase 1 clinical study evaluating an oral drug formulation designed using artificial intelligence, marking a significant milestone in the application of AI to pharmaceutical development.

The study, which has received approval from the UK’s Medicines and Healthcare products Regulatory Agency, is being conducted at the company’s Nottingham facility and will assess the safety and pharmacokinetics of the formulation in healthy volunteers.

According to Quotient Sciences, the programme represents the first reported clinical evaluation of an AI-designed drug formulation. The study is intended to assess not only the drug product itself but also the potential role of AI in supporting formulation development decisions earlier in the drug development process.

While artificial intelligence has become increasingly common in target discovery, molecule design and clinical trial optimisation, its use in formulation development has received less attention. Drug formulation remains a critical stage of development, influencing how medicines are absorbed, distributed and delivered within the body.

The company said the formulation was developed using an AI-driven approach designed to explore and optimise multiple formulation options more rapidly than conventional methods.

The programme utilised machine learning technology developed by Intrepid Labs to support formulation design and optimisation. Quotient Sciences said the system enabled rapid analysis of formulation variables and informed decisions intended to improve expected clinical performance.

Andy Lewis, chief scientific officer at Quotient Sciences, said: “This program marks a significant advancement in harnessing the power of advanced machine learning alongside deep scientific expertise to streamline drug development.”

Lewis said the approach, combined with the company’s Translational Pharmaceutics platform, enables earlier decision-making during development and may help improve confidence in clinical progression strategies.

The launch of the study reflects growing interest across the pharmaceutical industry in applying AI beyond drug discovery and into development activities traditionally driven by laboratory experimentation and empirical testing.

Supporters of AI-enabled formulation development argue that machine learning systems can help identify promising formulations more efficiently by analysing complex relationships between ingredients, manufacturing parameters and expected clinical performance.

However, the ultimate test of such approaches remains clinical validation. The Phase 1 study will provide an opportunity to evaluate whether AI-guided formulation design can translate into successful performance in human subjects.

Quotient Sciences said the study forms part of a broader strategy to integrate AI technologies across formulation development and clinical operations. The company expects to provide further updates as the programme progresses and additional data become available.

If successful, the study could offer early evidence that AI can play a more direct role in the development of drug products, potentially shortening development timelines and improving decision-making during pharmaceutical development.