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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. logo

Ensysce Biosciences, Inc.

NASDAQ:ENSCHealthcare
-3.88%$0.4210
AH$0.4200-0.24%vs close
Mkt Cap$8.19M
Float15.08M
O/S19.46M
Vol
$ Vol
RVOL
Inst Own4.6%
SI2.0%
Earnings
Dilution
Phase Distribution
9 lead-sponsored trials·2 active·7 completed
Phase 17
Phase 21
Phase 31
Status Overview
Recruiting2
Completed7

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Status
Phase
  • Phase 3
    Recruiting

    PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)

    PF614 capsule, Placebo

    Postoperative Pain, Acute

    Enrollment
    320
    Start
    Dec 2025
    Primary Completion
    Aug 2026est.
    Completion
    Nov 2026est.
    NCT06602271
  • Phase 2
    Completed

    Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201)

    PF614, Placebo

    Acute Pain

    Enrollment
    16
    Start
    Oct 2023
    Primary Completion
    Nov 2023
    Completion
    Nov 2023
    NCT06629402
  • Phase 1
    Completed

    Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)

    PF614, Oxycodone extended-release

    Healthy

    Enrollment
    64
    Start
    Nov 2016
    Primary Completion
    Jan 2018
    Completion
    Jan 2018
    NCT02454712
  • Phase 1
    Completed

    Oral Nafamostat in Healthy Volunteers (NAF-101)

    Nafamostat Mesilate, Placebo

    Pharmacokinetics

    Enrollment
    17
    Start
    Sep 2020
    Primary Completion
    Nov 2020
    Completion
    May 2021
    NCT04406415
  • Phase 1
    Completed

    Evaluation of Oral PF614 Relative to OxyContin (PF614-102)

    PF614, Naltrexone Hydrochloride

    Healthy Volunteers

    Enrollment
    84
    Start
    Sep 2021
    Primary Completion
    Mar 2022
    Completion
    Mar 2022
    NCT05043766
  • Phase 1
    Completed

    Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101)

    PF614 solution, Naltrexone Hydrochloride

    Pharmacokinetics

    Enrollment
    111
    Start
    Dec 2021
    Primary Completion
    Apr 2023
    Completion
    Apr 2023
    NCT05090280
  • Phase 1
    Completed

    A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103)

    PF614, Oxycodone

    Recreational Drug Use

    Enrollment
    27
    Start
    Jun 2022
    Primary Completion
    Aug 2022
    Completion
    Aug 2022
    NCT05567354
  • Phase 1
    Completed

    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

    Enrollment
    32
    Start
    Oct 2022
    Primary Completion
    Dec 2022
    Completion
    Dec 2022
    NCT05571345
  • Phase 1
    Recruiting

    Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)

    PF614 capsule, Nafamostat Mesylate

    Pharmacokinetics, Healthy Volunteer

    Enrollment
    54
    Start
    Nov 2024
    Primary Completion
    Dec 2026est.
    Completion
    Apr 2027est.
    NCT06500793