What is the drug thought to do in the body?
Inflammation in the brain and spinal cord is thought to contribute to MND progression. Usnoflast, also known as ZYIL1, is thought to block a protein involved in inflammation, called NLRP3. It is thought that blocking NLRP3 could reduce inflammation in the brain and spinal cord. Usnoflast is being developed by Zydus Lifesciences, a pharmaceutical company based in Ahmedabad, India.
Phase 2b - UNITE-ALS
Current status: Not yet recruiting
Primary objective: To test whether Usnoflast is effective and safe in people with MND.
The phase 2b trial will test two different doses of Usnoflast, to see if the drug has an effect on the ALSFRS-R score and survival. They will also measure vital capacity (the amount of air which can be expelled from the lungs after taking a deep breath), and levels of neurofilament light (a biomarker for motor neurons breaking down). People who take part in the trial will be randomly allocated to receive one of two doses of Usnoflast or a placebo (dummy drug) which will be given as tablets. The trial aims to recruit 240 people and will last 36 weeks. After the trial is completed, all participants will have the opportunity to receive Usnoflast in an open label extension. You can find out more about the trial here.
This trial will be recruiting in the USA.
Previous Clinical Trials
Phase 2a
In the phase 2a trial, Usnoflast was tested for safety and effectiveness in people with MND. The trial lasted 12 weeks. The trial found that Usnoflast was well tolerated over the 12 weeks. It showed some reduction in neurofilament light in the spinal fluid, but this was not reduced enough to be statistically significant. People taking Usnoflast also showed an improvement in ALSFRS-R score, and vital capacity.
Phase 1
In the phase 1 trial, Usnoflast was given to healthy participants aged 18-55, and was found to be safe and well tolerated.
Last updated: 23/07/25