Developing a new treatment to help people quit smoking
Official title: IND-enabling Studies in Support of First in Human Safety Studies of a Novel Anti-Nicotine Human Monoclonal Antibody
Funded at Antidote Therapeutics, INC. · NIH-11079646 · Data updated 2026-11-12
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 type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Antidote Therapeutics, INC. NIH-funded |
| Lab location | 1 site (Sykesville, United States) |
| Project start | May 1, 2023 |
| Project end | April 30, 2026 |
| Funding year | 2025 |
| Award (this year) | $3,883,739 |
| NIH project number | 5U01DA058547-03 |
| Project ID | NIH-11079646 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are smokers with smoking-related diseases who are motivated to quit.
✕Less likely to help
Patients who do not smoke or are not currently seeking to quit smoking may not benefit from this research.
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.
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 gone: 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
-
Antidote Therapeutics, INC.
Sykesville, United States Active
Researchers
- Principal investigator: Kalnik, Matthew W — Antidote Therapeutics, INC.
- Study coordinator: Kalnik, Matthew W
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.