Apr 22, 2026

DMX-1001 (oral noribogaine) is a novel neuroplastogen therapeutic that combines neuroplasticity and polypharmacology for the treatment of AUD

AUD affects more than 29 million Americans and is a leading cause of preventable death; about 60 percent of patients treated for AUD relapse to hazardous drinking within six months

Successful completion of the planned alcohol interaction trial will support Phase 2 clinical start in 2027

MIAMI, FL – April 22, 2026 – DemeRx, Inc., a clinical-stage biopharmaceutical company dedicated to transforming addiction therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for DMX-1001 (oral noribogaine), a novel neuroplastogen therapeutic for the treatment of alcohol use disorder (AUD).

The company recently completed a multiple ascending dose (MAD) clinical trial of DMX-1001 in healthy volunteers. Results from the MAD study demonstrated safety, tolerability, and pharmacokinetics that support advancing DMX-1001 to Phase 2 clinical trials in people with AUD. DemeRx anticipates initiating the Phase 2 clinical trial of DMX-1001 in AUD in 2027.

“We are grateful to the FDA for their timely review of our IND application for DMX-1001 for the treatment of AUD. The ‘safe to proceed’ authorization marks an important milestone both for patients with AUD and the growth of our company,” said Deborah Mash, Ph.D., CEO and founder of DemeRx. “There is tremendous need for innovative, disease-modifying approaches to treat alcohol and other substance use disorders and we’re excited about the potential of DMX-1001 to address this serious unmet need. I am grateful for the hard work of our team at DemeRx getting us to this next stage of clinical development for DMX-1001, so that we can bring a much-needed treatment option to people struggling with addiction to alcohol or other drugs rapidly.”

DMX-1001 represents a novel therapeutic approach that uniquely combines neuroplasticity and polypharmacology mechanisms of action. Noribogaine is a long-acting metabolite of ibogaine. Noribogaine remains in the body for a much longer duration than ibogaine, driving long-term neuroplastic changes that help repair neural circuits damaged by chronic substance abuse.

DMX-1001 is a “pipeline in a drug” that has rapid antidepressant and anti-anxiety effects. Alcohol use disorder is often associated with mental health disorders, including depression and anxiety which increase the risk of relapse for people in early recovery.

Alcohol use disorder affects more than 29 million people in the United States and is a leading cause of preventable death. Alarmingly, fewer than five percent of those suffering from AUD receive medication, and approximately 60 percent of treated patients relapse to hazardous drinking within six months.

Source: DemeRx, Inc.