Long-lasting naloxone to prevent repeat opioid overdoses
IND-enabling development of a long-duration antagonist to treat opioid overdose
['FUNDING_SBIR_2'] · CONSEGNA PHARMA, INC. · NIH-11172664
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
| Phase | ['FUNDING_SBIR_2'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | CONSEGNA PHARMA, INC. (nih funded) |
| Locations | 1 site (PITTSBURGH, UNITED STATES) |
| Trial ID | NIH-11172664 on ClinicalTrials.gov |
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.
Who could benefit from this research
Good fit: 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.
Not a fit: People whose emergencies are caused by non-opioid substances or who require different emergency interventions would not benefit from this naloxone formulation.
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 performed: 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
PITTSBURGH, UNITED STATES
- CONSEGNA PHARMA, INC. — PITTSBURGH, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: ZANA, LAWRENCE J — CONSEGNA PHARMA, INC.
- Study coordinator: ZANA, LAWRENCE J
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 below.