Long-lasting naloxone to prevent repeat opioid overdoses
Official title: IND-enabling development of a long-duration antagonist to treat opioid overdose
Funded at Consegna Pharma, INC. · NIH-11172664 · Data updated 2026-11-12
A new long-acting naloxone formulation designed to protect people who overdose on fentanyl and other powerful opioids from falling back into overdose.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Consegna Pharma, INC. NIH-funded |
| Lab location | 1 site (Pittsburgh, United States) |
| Project start | September 15, 2023 |
| Project end | February 28, 2027 |
| Funding year | 2025 |
| Award (this year) | $377,843 |
| NIH project number | 5R44DA050386-04 |
| Project ID | NIH-11172664 on NIH RePORTER |
Who could benefit from this research
✓Could help
People at high risk of opioid overdose—especially those exposed to fentanyl or other potent synthetic opioids—would be the intended candidates for eventual trials.
✕Less likely to help
People whose emergencies are caused by non-opioid substances or who require different emergency interventions would not benefit from this naloxone formulation.
What this research studies
If you or a loved one is at risk of opioid overdose, this project is creating a naloxone medicine that works right away and then keeps working for 12–24 hours so the opioid levels can fall safely. The team is developing a formulation called CP216 and performing laboratory and animal studies, plus the safety and manufacturing work needed for FDA permission to begin human trials. This stage (IND-enabling) focuses on proving the drug is safe, stable, and can be produced consistently rather than enrolling patients. If those preclinical steps succeed, the next phase would be clinical testing in people at risk of opioid overdose.
Why it matters
Potential benefit: If successful, this could prevent renarcotization and reduce deaths by providing extended protection after naloxone revival.
How similar studies have gone: Standard naloxone reliably reverses overdoses but wears off quickly, and long-acting antagonist formulations are a newer approach with limited clinical testing to date.
Where this research is happening
-
Consegna Pharma, INC.
Pittsburgh, United States Active
Researchers
- Principal investigator: Zana, Lawrence J — Consegna Pharma, INC.
- Study coordinator: Zana, Lawrence J
Related research
Other NIH-funded projects on the same topics.
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Developing a long-lasting treatment for opioid overdose
This study is working on a new version of naloxone, a lifesaving medication for opioid overdoses, that could help keep people safe for up to 24 hours after an overdose, making it easier to manage these situations outside of hospitals.
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Using long-lasting ketamine to treat substance use disorders without side effects.
This study is testing a new long-lasting injectable form of ketamine to help people with substance use disorders by reducing cravings and supporting recovery, while aiming to make the treatment easier to stick with and more comfortable.
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.