NIH-funded research U01 cooperative agreement

PF614-MPAR: an opioid with built-in overdose protection

Official title: PF614-MPAR: clinical development of opioid with oral overdose protection

Funded at Ensysce Biosciences, INC. · NIH-11351036 · Data updated 2026-11-12

A new opioid medicine with built-in protections aims to reduce abuse and overdose while still helping patients with moderate-to-severe pain.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionEnsysce Biosciences, INC.
NIH-funded
Lab location1 site (La Jolla, United States)
Project startSeptember 1, 2024
Project endMay 31, 2027
Funding year2026
Award (this year)$5,279,389
NIH project number5U01DA059791-03
Project IDNIH-11351036 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are adults with moderate-to-severe legitimate pain who require opioid therapy and who are at risk of misuse or overdose.

Less likely to help

Patients not at risk of abuse or overdose may not benefit from the specific protective features of this product.

What this research studies

This grant supports developing PF614-MPAR, an opioid prodrug designed to release pain relief only under specific conditions, with features intended to deter crushing or snorting and to reduce the risk of overdose. The project combines a prodrug (PF614) and a trypsin inhibitor (nafamostat) to block abuse and limit overdose, with the goal of safer pain management. Researchers will study the chemistry, safety markers, and potential performance of this product in preclinical and early development stages to support future clinical testing. The work is led by Ensysce Biosciences and involves collaboration across translational disciplines to bring a safer opioid option closer to patients who need relief from moderate-to-severe pain.

Why it matters

Potential benefit: If successful, this approach could provide effective pain relief with lower risks of abuse and overdose.

How similar studies have gone: Previous abuse-deterrent strategies exist, but this program pursues a novel overdose-protection mechanism integrated into the drug itself.

Where this research is happening

  • Ensysce Biosciences, INC.
    La Jolla, United States
    Active

Researchers

  • Principal investigator: Kirkpatrick, Lynn — Ensysce Biosciences, INC.
  • Study coordinator: Kirkpatrick, Lynn

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.
Last reviewed 2026-11-14 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.