Safer ibogaine-based medicine for opioid use disorder
Official title: Development of a Safer and More Effective Ibogaine Analog for the Treatment of Opioid Use Disorder
Funded at Gilgamesh Pharma INC · NIH-11513538 · Data updated 2026-11-12
A new synthetic iboga alkaloid candidate, GM-3009, is being developed to treat opioid use disorder with fewer safety risks and better effectiveness.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Gilgamesh Pharma INC NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project start | March 1, 2024 |
| Project end | February 28, 2027 |
| Funding year | 2025 |
| Award (this year) | $1,851,123 |
| NIH project number | 6UG3DA060053-03 |
| Project ID | NIH-11513538 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are adults with opioid use disorder who may participate in early safety studies or, later, in trials evaluating efficacy in OUD.
✕Less likely to help
Individuals without opioid use disorder or those not suitable for first-in-human safety studies may not benefit.
What this research studies
This project aims to turn a safer, lab-made ibogaine-like compound into a real treatment for people struggling with opioid use disorder. Researchers will manufacture GM-3009 under GMP standards, develop a formulation, and complete toxicity tests that are required before humans can be tested. If these steps go well, the plan is to move into early human trials to test safety in healthy volunteers and gather early signals of benefit in people with OUD. The work will be conducted by Gilgamesh Pharma in New York under the UG3 stage, with potential progression to first-in-human studies.
Why it matters
Potential benefit: If successful, GM-3009 could provide a safer, more effective option for people with opioid use disorder.
How similar studies have gone: This program builds on ibogaine research but uses a novel, safer synthetic compound with preclinical evidence suggesting improved safety and efficacy.
Where this research is happening
-
Gilgamesh Pharma INC
New York, United States Active
Researchers
- Principal investigator: Marek, Gerard Joseph — Gilgamesh Pharma INC
- Study coordinator: Marek, Gerard Joseph
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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.