Aladote® is a “first-in-class” drug candidate, the first of its kind with the potential to reduce liver damage caused by paracetamol poisoning. A Proof of Principle study, Phases I/IIa, has been successfully completed. A pivotal phase II/III study is planned to be initiated mid-2020.
In relevant preclinical studies, Aladote® has also demonstrated significant efficacy in the time window when N-acetylcysteine (NAC) treatment is no longer effective (> 8 hours).
Paracetamol is one of the most widely used drugs in the world for the relief of pain and fever, but also one of the most common drugs taken in overdoses, both intentional and accidental. Intentional paracetamol overdose is one of the most popular methods of attempted suicide. When excessive amounts of paracetamol are broken down in the liver, the toxic metabolite NAPQI is formed and can lead to acute liver failure. The current treatment for paracetamol poisoning (NAC) is most effective when given within eight hours of the overdose. However, for patients arriving at the hospital after that time window, there is no effective treatment option at present.