Ensysce Biosciences, Inc. (ENSC)
Ensysce Biosciences, Inc. is a clinical-stage pharmaceutical firm dedicated to developing novel prescription drugs for the treatment of severe pain in the United States, with a specific focus on preventing opioid addiction, misuse, abuse, and overdose. The company leverages two primary technological frameworks: the Trypsin Activated Abuse Protection (TAAP) platform, which creates opioid prodrugs designed to resist abuse, and the Multi-Pill Abuse Resistance (MPAR) platform, engineered to offer protection against overdose through its advanced opioid prodrug technology. Ensysce's pipeline features several key candidates, including PF614, an oxycodone prodrug developed using the TAAP platform, currently undergoing Phase II clinical trials for both acute and chronic pain management. Another product, PF614-MPAR, is a combination of PF614 and nafamostat, in Phase I clinical development to provide overdose protection against excessive oral consumption. Furthermore, the company is exploring an oral and inhaled formulation of nafamostat for potential use against coronaviral infections and other pulmonary diseases, such as cystic fibrosis. The company's development efforts also include PF329, an extended-release hydromorphone prodrug similar to PF614. In the area of ADHD treatment, Ensysce is advancing PF8001 and PF8026, which are extended-release and immediate-release amphetamine prodrugs, respectively, aimed at deterring medication abuse. Additionally, PF26810, an extended-release methadone prodrug, is in development for opioid use disorder. Ensysce Biosciences, Inc. operates from its headquarters in La Jolla, California.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Ensysce Biosciences, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Recruiting
PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)
PF614 capsule, Placebo
Postoperative Pain, Acute
NCT06602271Enrollment320StartDec 2025Primary CompletionAug 2026est.CompletionNov 2026est. - Phase 2Completed
Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201)
PF614, Placebo
Acute Pain
NCT06629402Enrollment16StartOct 2023Primary CompletionNov 2023CompletionNov 2023 - Phase 1Completed
Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)
PF614, Oxycodone extended-release
Healthy
NCT02454712Enrollment64StartNov 2016Primary CompletionJan 2018CompletionJan 2018 - Phase 1Completed
Oral Nafamostat in Healthy Volunteers (NAF-101)
Nafamostat Mesilate, Placebo
Pharmacokinetics
NCT04406415Enrollment17StartSep 2020Primary CompletionNov 2020CompletionMay 2021 - Phase 1Completed
Evaluation of Oral PF614 Relative to OxyContin (PF614-102)
PF614, Naltrexone Hydrochloride
Healthy Volunteers
NCT05043766Enrollment84StartSep 2021Primary CompletionMar 2022CompletionMar 2022 - Phase 1Completed
Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101)
PF614 solution, Naltrexone Hydrochloride
Pharmacokinetics
NCT05090280Enrollment111StartDec 2021Primary CompletionApr 2023CompletionApr 2023 - Phase 1Completed
A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103)
PF614, Oxycodone
Recreational Drug Use
NCT05567354Enrollment27StartJun 2022Primary CompletionAug 2022CompletionAug 2022 - Phase 1Completed
A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-104)
PF614, Oxycodone Hydrochloride 40 mg
Recreational Drug Use
NCT05571345Enrollment32StartOct 2022Primary CompletionDec 2022CompletionDec 2022 - Phase 1Recruiting
Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
PF614 capsule, Nafamostat Mesylate
Pharmacokinetics, Healthy Volunteer
NCT06500793Enrollment54StartNov 2024Primary CompletionDec 2026est.CompletionApr 2027est.
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Recruiting | PF614 capsule, Placebo | NCT06602271 |
| Phase 2 | Completed | PF614, Placebo | NCT06629402 |
| Phase 1 | Completed | PF614, Oxycodone extended-release | NCT02454712 |
| Phase 1 | Completed | Nafamostat Mesilate, Placebo | NCT04406415 |
| Phase 1 | Completed | PF614, Naltrexone Hydrochloride | NCT05043766 |
| Phase 1 | Completed | PF614 solution, Naltrexone Hydrochloride | NCT05090280 |
| Phase 1 | Completed | PF614, Oxycodone | NCT05567354 |
| Phase 1 | Completed | PF614, Oxycodone Hydrochloride 40 mg | NCT05571345 |
| Phase 1 | Recruiting | PF614 capsule, Nafamostat Mesylate | NCT06500793 |