Developing a new treatment to help people quit smoking

IND-enabling Studies in Support of First in Human Safety Studies of a Novel Anti-Nicotine Human Monoclonal Antibody

NIH-funded research Antidote Therapeutics, INC. · NIH-11079646

This study is testing a new treatment called ATI-1013 to help people who are addicted to nicotine quit smoking, especially those with serious health issues, by reducing their nicotine exposure in a different way than current methods.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionAntidote Therapeutics, INC. NIH-funded
Lab location1 site (Sykesville, United States)
Project IDNIH-11079646 on NIH RePORTER

What this research studies

This research focuses on creating a novel human monoclonal antibody, ATI-1013, designed to help individuals addicted to nicotine quit smoking. The approach involves reducing nicotine exposure without affecting nicotinic receptors, which is different from current smoking cessation methods. The study aims to advance ATI-1013 from pre-clinical development to an Investigational New Drug (IND) application, paving the way for a first-in-human clinical trial. The target population includes smokers with serious health conditions related to smoking who urgently need to quit.

Who could benefit from this research

Good fit: Ideal candidates for this research are smokers with smoking-related diseases who are motivated to quit.

Not a fit: Patients who do not smoke or are not currently seeking to quit smoking may not benefit from this research.

Why it matters

Potential benefit: If successful, this research could provide a more effective treatment option for individuals struggling with nicotine addiction.

How similar studies have performed: While there have been advancements in smoking cessation treatments, this specific approach using a nicotine-specific monoclonal antibody is novel and has not been tested in humans before.

Where this research is happening

Sykesville, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions addictive disorder
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.