Hoth Therapeutics

We are committed to the patient experience by following the science to develop impactful and versatile treatment solutions for everyone. At HOTH, we stand by our mission to innovate today for a better tomorrow.

Learn more about our therapeutic areas, Early Access program, as well as ongoing and future clinical trial opportunities.

If you have questions regarding our clinical trials, please contact us here.

Current Development


Alzheimer’s Disease

HT-ALZ is being developed for the treatment of Alzheimer’s disease and associated symptoms (eg, dementia). Its active pharmaceutical ingredient is an already approved drug, making HT-ALZ eligible for development via the 505(b)(2) regulatory pathway relying on existing safety data. HT-ALZ is being developed as an oral soluble film formulation for easy patient dosing and differentiation from existing products. Data from preclinical studies shows a significant decrease in Aβ in both male and female APP/PS1+/- mice after acute treatment with HT-ALZ, compared to placebo-treated animals and baseline Aβ levels.


Traumatic Brain Injury & Ischemic Stroke

HT-TBI injection is being developed as a ready-to-inject autoinjector for intramuscular injection to be used in both traumatic brain injuries and ischemic stroke. The same dose and formulation can be used across both TBI and stroke indications and age 2 years through adult. Our focus of development is for point-of-care use in emergency use or non-clinic settings: sports teams, schools, ambulatory care, military, individuals at risk for stroke for home use. HT-TBI active ingredient targets substance P/NK-1 pathway, identified as a leading cause of post-brain injury inflammation and edema. Preclinical data has shown an NK-1 Antagonist significantly reduces brain edema and blood brain barrier disruption post-TBI and post-stroke. Development is following the 505(b)(2) regulatory pathway to expedite time to NDA.

Expanded Access
& Compassionate Use

We understand that there are critically ill patients who will not meet all of the criteria to enroll in our clinical trials and don’t have options for alternative therapies.