MedPath

Ensysce Biosciences

Ensysce Biosciences logo
🇺🇸United States
Ownership
Public
Established
2008-01-01
Employees
9
Market Cap
$5.4M
Website
http://www.ensysce.com
Introduction

Ensysce Biosciences, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of solutions for severe pain relief while reducing the fear of and the potential for misuse and overdose. The firm's Trypsin Activated Abuse Protection and Multi-Pill Abuse Resistance platforms are in the process of developing a new class of powerful, tamper-proof opioids that prevent both drug abuse and overdoses. The company was founded in April 2003 and is headquartered in La Jolla, CA.

Clinical Trials

9

Active:0
Completed:7

Trial Phases

3 Phases

Phase 1:7
Phase 2:1
Phase 3:1

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (9 trials with phase data)• Click on a phase to view related trials

Phase 1
7 (77.8%)
Phase 2
1 (11.1%)
Phase 3
1 (11.1%)

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

Phase 2
Completed
Conditions
Acute Pain
Interventions
Drug: Placebo
First Posted Date
2024-10-07
Last Posted Date
2024-10-07
Lead Sponsor
Ensysce Biosciences
Target Recruit Count
16
Registration Number
NCT06629402
Locations
🇺🇸

Dr. Vince Clinical Research, Overland Park, Kansas, United States

PF614 Analgesic Activity in Acute Postoperative Pain

Phase 3
Not yet recruiting
Conditions
Postoperative Pain
Postoperative Pain, Acute
Interventions
Drug: PF614 capsule
Drug: Placebo
First Posted Date
2024-09-19
Last Posted Date
2024-10-02
Lead Sponsor
Ensysce Biosciences
Target Recruit Count
300
Registration Number
NCT06602271

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

Phase 1
Recruiting
Conditions
Pharmacokinetics
Interventions
Drug: PF614 capsule
First Posted Date
2024-07-15
Last Posted Date
2025-05-25
Lead Sponsor
Ensysce Biosciences
Target Recruit Count
50
Registration Number
NCT06500793
Locations
🇺🇸

Quotient Sciences, Miami, Florida, United States

A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users

Phase 1
Completed
Conditions
Recreational Drug Use
Interventions
First Posted Date
2022-10-07
Last Posted Date
2023-01-05
Lead Sponsor
Ensysce Biosciences
Target Recruit Count
32
Registration Number
NCT05571345
Locations
🇺🇸

Dr. Vince Clinical Research, Overland Park, Kansas, United States

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

Phase 1
Completed
Conditions
Recreational Drug Use
Interventions
First Posted Date
2022-10-05
Last Posted Date
2022-12-27
Lead Sponsor
Ensysce Biosciences
Target Recruit Count
27
Registration Number
NCT05567354
Locations
🇺🇸

Ohio Clinical Trails, Columbus, Ohio, United States

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News

Ensysce Biosciences Secures Patent for Novel Opioid Use Disorder Treatment PF9001

Ensysce Biosciences received a U.S. patent for PF9001, a methadone prodrug designed to treat opioid use disorder with reduced cardiotoxicity and overdose risks.

Ensysce Biosciences Strengthens Regulatory Team Ahead of Critical Phase 3 Trials and NDA Submission

Ensysce Biosciences has appointed Tracy Hysong, CCRA, as Senior Director of Regulatory Affairs to support multiple clinical trials and upcoming regulatory submissions for its novel pain medications.

Ensysce Biosciences Secures Patent for Novel Methadone-Based Opioid Use Disorder Treatment

Ensysce Biosciences has received a U.S. patent for PF9001, a new methadone prodrug designed to treat opioid use disorder with reduced risks of cardiotoxicity and overdose.

Ensysce Biosciences Pioneers Novel Opioids with Built-in Overdose Prevention Technology

Ensysce Biosciences has developed chemically modified oxycodone that remains inactive unless taken orally, significantly reducing abuse potential while maintaining pain relief efficacy.

Ensysce Biosciences Advances Abuse-Resistant Opioids PF614 and PF614-MPAR Towards Market

Ensysce Biosciences reports significant progress in its clinical programs for PF614 and PF614-MPAR, designed for safer pain relief with reduced abuse potential.

Ensysce Biosciences Secures Supply and Partnership to Advance Abuse-Resistant Pain Relief

Ensysce Biosciences partners with a specialty drug manufacturer for the development and commercial launch of PF614 and PF614-MPAR, aiming for efficient regulatory approval.

Ensysce Biosciences' PF614-MPAR Demonstrates Overdose Protection in Clinical Trial

Ensysce Biosciences' PF614-MPAR shows overdose protection in a Phase 1b clinical trial, reducing oxycodone blood concentration.

Ensysce Biosciences Advances Novel Analgesics PF614 and PF614-MPAR Towards Phase 3 Trials

Ensysce Biosciences is advancing PF614, an extended-release oxycodone, towards Phase 3 trials after positive clinical trial data and FDA discussions.

Ensysce Biosciences Advances Abuse-Deterrent and Overdose-Protection Opioid Programs

Ensysce Biosciences is focused on developing next-generation opioid products with abuse-deterrent and overdose protection features using its TAAP™ and MPAR™ technology platforms.

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