Breakthrough therapy status
In 2018, the Food and Drug Administration first granted Compass Pathways a breakthrough therapy status, which accelerates the clinical study process, to study psilocybin particularly for parents struggling with Major Depressive Disorder. Since then the FDA has embraced the drug, granting similar designations to Compass and other large companies such as pharmaceutical giant Johnson & Johnson, but also smaller competitors such as Mind Medicine and Numinus Wellness.