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
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2008
Completed
7
77.8%
Recruiting
2
22.2%
No approval data available
- Ensysce Biosciences completed the acquisition of Cy Biopharma, adding clinical-stage candidate CY200 for Complex Regional Pain Syndrome (CRPS) to its pipeline. - The transaction includes up to $77 million in financing through a cash contribution, private placement, and milestone-based tranche led by Ally Bridge Group. - CY200 has received FDA Orphan Drug Designation, and funding is expected to support the program through Phase 2 proof-of-concept data and into registrational planning. - Former Cy Biopharma shareholders are expected to own approximately 74.94% of the combined company following shareholder approval, significantly reshaping Ensysce's ownership structure.
- A new pipeline report identifies over 40 companies and 50 drug candidates in development for postoperative pain, spanning Phase III through preclinical stages. - PF614, an oxycodone-based prodrug from Ensysce Biosciences that remains inactive until digestion, is the most advanced candidate currently in Phase III trials. - ATX101, a sodium ion channel blocker with a biopolymer from Allay Therapeutics, targets extended relief after knee arthroplasty and is in Phase II development. - Novel candidates including LC-400 and GB-6002 aim to deliver multi-day pain relief from a single administration, addressing key limitations of current opioid-based therapies.
- Ensysce Biosciences has enrolled the first patient in a pivotal Phase 3 clinical trial for PF614, its lead opioid candidate designed to provide pain relief while limiting abuse potential. - PF614 utilizes proprietary TAAP technology that renders oxycodone inactive until it reaches the small intestine, representing a fundamental rethinking of opioid delivery with built-in safety mechanisms. - The company has received FDA Breakthrough Therapy designation for PF614-MPAR, which combines abuse protection with overdose prevention technology that switches off opioid release when more than prescribed doses are taken. - Ensysce is expanding beyond pain management into opioid use disorder treatment with PF9001, a potential safer methadone alternative that recently secured U.S. patent protection.
- Ensysce Biosciences received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering its MPAR (Multi-Pill Abuse Resistance) technology, extending protection through 2042. - The MPAR technology, which earned FDA Breakthrough Therapy Designation in January 2025, demonstrated effective pain relief when taken as prescribed while preventing excessive opioid delivery during overdose attempts in clinical testing. - The company is expanding MPAR technology beyond opioids to include amphetamines and methadone for developing safer treatments for pain, ADHD, and opioid use disorder. - Ensysce combines MPAR overdose protection with its TAAP abuse-deterrent platform to create a dual safety approach for pain medications, with ongoing clinical trials supported by National Institute on Drug Abuse funding.
- Ensysce Biosciences initiated enrollment for its pivotal PF614-301 Phase 3 trial in December 2025, evaluating the abuse-resistant oxycodone analgesic for post-surgical pain management. - The FDA provided positive feedback on Ensysce's commercial manufacturing strategy for PF614, agreeing with proposed regulatory starting materials and specifications to enable commercial-scale production. - The company secured up to $20 million in funding through November 2025 and extended MPAR® patent protection through 2042, strengthening its intellectual property portfolio. - PF614-MPAR continues advancing under FDA Breakthrough Therapy designation with over $25 million in NIDA grant funding supporting overdose protection technology development.
- Ensysce Biosciences received a U.S. patent for PF9001, a methadone prodrug designed to treat opioid use disorder with reduced cardiotoxicity and overdose risks. - The company's stock soared over 91% following the announcement, trading at $3.58 on unusually high volume of 70 million shares compared to an average of 75 thousand. - PF9001 leverages Ensysce's proprietary TAAP™ and MPAR technologies to create a safer alternative to traditional methadone therapy, addressing longstanding concerns about cardiac side effects and respiratory depression.
- 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. - The company is preparing for a pivotal Phase 3 study of PF614, with plans to submit a New Drug Application in 2026, while simultaneously advancing clinical studies for its overdose-protected pain medicine PF614-MPAR. - Ensysce is also developing PF9001, a novel treatment for opioid use disorder featuring both abuse deterrence and overdose protection mechanisms, with IND-enabling studies planned for the coming year.
- 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. - The innovative treatment leverages Ensysce's proprietary TAAP and MPAR technologies to create a safer alternative to traditional methadone, potentially offering once-daily dosing with more predictable effects. - The development was supported by the National Institute on Drug Abuse and addresses significant limitations of current OUD treatments, including cardiac side effects and respiratory depression risks.
- Ensysce Biosciences has developed chemically modified oxycodone that remains inactive unless taken orally, significantly reducing abuse potential while maintaining pain relief efficacy. - The innovative technology includes built-in overdose protection mechanisms that prevent drug release when excessive doses are taken, addressing a critical safety concern in pain management. - The FDA has granted both Fast Track and Breakthrough Therapy designations to Ensysce's modified oxycodone, recognizing the urgent medical need for safer opioid alternatives.
- Ensysce Biosciences reports significant progress in its clinical programs for PF614 and PF614-MPAR, designed for safer pain relief with reduced abuse potential. - PF614, an extended-release oxycodone, is set to begin Phase 3 trials in Q2 2025, evaluating its efficacy in post-abdominoplasty pain management. - PF614-MPAR received FDA Breakthrough Therapy designation and is undergoing Phase 1b trials to verify overdose protection and effective oxycodone delivery. - Ensysce's Opioid Use Disorder (OUD) program advances with PF9001 as the lead candidate, showing promise for safer treatment with fewer cardiovascular side effects.
