About ABV-1504 for Clinical Depression (MDD)
Product Overview
The World Health Organization has reported that more than 300 million people worldwide suffer from major depressive disorder (MDD).
While the market for MDD treatment is very competitive, our solution has strong potential to disrupt the market. We have completed Phase II studies of our plant-based drug and found no adverse side effects. Our studies were conducted by Stanford University and five major medical centers in Taiwan.
ABVC is developing a suite of botanical-based assets to combat rising addiction. We are exploring how to complete Phase III studies for an eventual launch to the market.
INDICATED USE
- Major Depressive Disorder
MECHANISM OF ACTION
- Norepinephrine Transporter (NET) Inhibitor
DEVELOPMENT PARTNERS
- Stanford University (US)
- Taipei Veterans General Hospital (Taiwan)
DEVELOPMENT STATUS
- 2023: Phase II Trial Part II Finished
- Initiating End of Phase II (EOP2) meeting with FDA
PATENT STATUS
- Patents Granted in the United States, the United Kingdom, Japan, Germany, France, Italy, China, and Taiwan
TOXICOLOGY
- Genotoxicity: negative
- NOAEL in rats and dogs: 3,000mg/kg/day
CLINICAL TRIAL
- Completed Phase II Clinical Study Report (CSR) in 2019
SAFETY
- Demonstrated its safety
- No Serious After Events (SAE)s from the completed Phase I and Phase II clinical studies
Innovative Botanical Asset for MDD
MDD Development Timeline
DISCLAIMER: Clinical trials may be in early stages. There is no guarantee that any specific outcome will be achieved. Investments may be speculative, illiquid and there is a risk of loss. Past performance is not indicative of future results.