Published on 15/01/2025      Reading time : 5 minutes

 

Efficacy and safety of acoziborole in patients with human African trypanosomiasis caused by Trypanosoma brucei gambiense: a multicentre, open-label, single-arm, phase 2/3 trial

 

The CHMP of the European Medicines Agency has issued a positive opinion on acoziborole, developed by the Drugs for Neglected Diseases initiative (DNDi) and Sanofi to treat human African trypanosomiasis (HAT), also known as sleeping sickness.

 

This decision is based on a Phase II/III study showing up to 96% success at 18 months, across all disease stages — a major breakthrough for patients.

A true success story for RCTs

RCTs is proud to have contributed to the success of this study, notably through its work in data management and statistical analyses on fexinidazole, in line with our commitment to projects that transform patient care and save lives.

A huge thank-you to the teams at DNDi and Sanofi for this scientific and human achievement.

Learn more:

– Un rêve de médecin, an award‑winning DNDi video recognized by WHO :

– The study published in The Lancet Infectious Diseases : Efficacy and safety of acoziborole in patients with human African trypanosomiasis caused by Trypanosoma brucei gambiense: a multicentre, open-label, single-arm, phase 2/3 trial – The Lancet Infectious Diseases

 

 

 

To explore more inspiring projects led by our teams, feel free to browse all our Success Stories.