Model-Informed Development Accelerates Transformative Treatment for Sleeping Sickness

Human African Trypanosomiasis (sleeping sickness), a parasitic disease endemic to sub-Saharan Africa that progresses to coma and death if untreated, saw case counts fall from more than 25,000 in 2000 to fewer than 600 in 2024, but existing Stage 2 treatments required complex administration and invasive procedures. Acoziborole, developed by DNDi and Sanofi with Gates Foundation support, offered potential as a single-dose oral cure for both disease stages. Certara scientists used physiologically-based pharmacokinetic (PBPK) modeling via its Simcyp Simulator to minimize the number of clinical pharmacology studies needed to characterize the drug's long half-life and assess drug-drug interaction and age-related metabolism risks. Acoziborole received a positive scientific opinion from the EMA through an accelerated assessment pathway, positioning it for WHO prequalification and broader rollout across endemic regions, with pediatric formulation development continuing.

The customer is anonymised in Certara’s own case study — not withheld by us.

Certara is a biosimulation software company (Simcyp, Phoenix) whose PK/PD and QSP models predict drug behavior in the body; the FDA itself licenses Certara's software to review sponsor submissions.

This sits in the Build stage of the AI use-case lifecycle: Named examples from the foundation-model labs and platforms pharma teams use to actually construct, train and generate the model or application.