This section highlights FDA-related milestones and regulatory updates for drugs developed by Ensysce Biosciences (ENSC).
Over the past two years, Ensysce Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CY200, PF614-MPAR-102, PF614, and PF614-MPAR. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
CY200 FDA Regulatory Events
CY200 is a drug developed by Ensysce Biosciences for the following indication: for the Treatment of CRPS.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CY200
- Announced Date:
- September 24, 2026
- Indication:
- for the Treatment of CRPS
Announcement
Ensysce Biosciences, Inc. announced the submission of the protocol for a Phase 2a clinical study of CY200, the Company's newest drug candidate from the newly acquired Cy Biopharma Inc.
Read Announcement
PF614-MPAR-102 FDA Regulatory Timeline and Events
PF614-MPAR-102 is a drug developed by Ensysce Biosciences for the following indication: To study the effect of food on the MPAR technology.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PF614-MPAR-102
- Announced Date:
- August 31, 2026
- Indication:
- To study the effect of food on the MPAR technology.
Announcement
Ensysce Biosciences, announced completion of enrollment in the final stage of the PF614-MPAR-102 clinical study.
Read Announcement- Drug:
- PF614-MPAR-102
- Announced Date:
- June 26, 2026
- Indication:
- To study the effect of food on the MPAR technology.
Announcement
Ensysce Biosciences, Inc. announced initiation of the final stage of the PF614-MPAR-102 clinical study.
AI Summary
Ensysce Biosciences announced the start of Part 3, the final stage of its PF614-MPAR-102 clinical study. The study is designed to further test PF614-MPAR, a first-in-class opioid with breakthrough therapy status, to see how well it helps protect against oral overdose while still providing therapeutic pain relief. Early data have shown that the drug keeps plasma levels steady at normal doses and reduces sharp increases in exposure at higher doses. This final stage will examine that protective effect across a wider range of dosing situations. The work is being supported by the National Institute on Drug Abuse. Ensysce also said it hopes to apply its MPAR technology beyond pain treatment to other medicines, including amphetamines and methadone, with the goal of making treatments safer for pain, ADHD, and opioid use disorder.
Read Announcement- Drug:
- PF614-MPAR-102
- Announced Date:
- April 16, 2026
- Indication:
- To study the effect of food on the MPAR technology.
Announcement
Ensysce Biosciences, Inc. announced Investigational Review Board (IRB) approval to initiate Part 3 of the PF614-MPAR-102 clinical study, marking the final stage in this study evaluating its novel MPAR® (Multi-Pill Abuse Resistance) overdose-protection technology.
AI Summary
Ensysce Biosciences announced Institutional Review Board (IRB) approval to begin Part 3 of the PF614‑MPAR‑102 clinical study, the final stage testing its MPAR® (Multi‑Pill Abuse Resistance) overdose‑protection technology. Earlier clinical data show PF614‑MPAR keeps therapeutic opioid levels under normal dosing while significantly reducing spikes in opioid exposure at supratherapeutic doses. Part 3 is designed to further characterize this protective effect across a range of dosing scenarios.
Ensysce’s CEO, Dr. Lynn Kirkpatrick, says MPAR® represents a new class of chemically engineered opioids intended to actively protect patients in cases of dosing error or misuse, moving toward a higher standard of opioid safety. The study continues to build on prior findings with support from the National Institute on Drug Abuse (NIDA).
Ensysce is also exploring MPAR® applications beyond pain, including amphetamines and methadone, with the goal of creating safer treatments for pain, ADHD, and opioid use disorder.
Read Announcement- Drug:
- PF614-MPAR-102
- Announced Date:
- June 24, 2025
- Indication:
- To study the effect of food on the MPAR technology.
Announcement
Ensysce Biosciences, Inc. announced it has fully enrolled Part 2 of the critical three-part PF614-MPAR-102 clinical study to study the effect of food on the MPAR technology.
AI Summary
Ensysce Biosciences announced that it has fully enrolled Part 2 of its three-part PF614-MPAR-102 clinical study, which is designed to evaluate the effect of food on its MPAR technology. This study is a key step in determining how food impacts the performance and safety of its novel opioid formulation. PF614-MPAR leverages proprietary TAAP and MPAR technologies to maintain effective pain relief while including built-in overdose protection if doses exceed the prescribed amount. The clinical study is an important milestone in the company’s efforts to develop safer opioid medications, especially in the context of reducing opioid abuse and overdose risks. This phase of research contributes to Ensysce’s overall mission to introduce innovative, tamper-proof treatments for severe pain, potentially redefining treatment protocols and improving patient safety.
Read Announcement
PF614 FDA Regulatory Timeline and Events
PF614 is a drug developed by Ensysce Biosciences for the following indication: Pain Relief.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PF614
- Announced Date:
- January 28, 2026
- Indication:
- Pain Relief
Announcement
Ensysce Biosciences, nnounced it has enrolled 50% of subjects targeted for interim review in its pivotal Phase 3 clinical trial of PF614, the Company's next-generation opioid candidate engineered to deliver powerful pain relief with built-in abuse protection..
AI Summary
Ensysce Biosciences announced it has enrolled 50% of the subjects targeted for an interim review in its pivotal Phase 3 PF614 trial. Enrollment began in late December 2025 and is moving quickly across three U.S. sites: CenExel JBR (Salt Lake City, Utah), CenExel Atlanta (Decatur, Georgia), and ERG‑HD Research (Houston, Texas). The PF614‑301 study is a multicenter, randomized, double‑blind, placebo‑controlled trial testing twice‑daily PF614 for moderate to severe pain after abdominoplasty. The study is led by Dr. Todd Bertoch, Dr. Jessica McCoun, and Dr. D’Aunno.
PF614 is Ensysce’s next‑generation opioid candidate built with proprietary chemical activation technology that keeps the opioid inactive until swallowed, aiming to limit tampering and dose manipulation while providing extended‑release pain control. The company says the trial will assess both efficacy and safety, with the 50% enrollment milestone marking progress toward an interim readout that could guide the drug’s remaining development steps.
Read Announcement- Drug:
- PF614
- Announced Date:
- December 9, 2025
- Indication:
- Pain Relief
Announcement
Ensysce Biosciences, announced that the first patient has been enrolled in the Company's pivotal Phase 3 clinical trial of PF614, its lead product candidate.
AI Summary
Ensysce Biosciences announced the first patient has been enrolled in its pivotal Phase 3 trial of PF614, its lead product candidate. The PF614-301 study is a multicenter, randomized, double-blind, placebo- and active-controlled trial testing PF614 for moderate to severe pain after abdominoplasty. The trial aims to show strong, consistent post-surgical pain relief with a built-in chemical mechanism designed to lower abuse risk. PF614 uses twice-daily dosing to smooth blood levels and reduce peaks and troughs.
Enrollment began at CenExel JBR in Salt Lake City and CenExel Atlanta, led by Dr. Todd Bertoch and Dr. Jessica McCoun. Ensysce’s CEO called the Phase 3 start a major milestone toward redefining pain care, highlighting PF614’s potential to deliver reliable analgesia with added safeguards. Ensysce develops opioid products that incorporate Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) technologies.Read Announcement
- Drug:
- PF614
- Announced Date:
- November 20, 2025
- Indication:
- Pain Relief
Announcement
Ensysce Biosciences, announced that the Food and Drug Administration (FDA or Agency) provided Written Responses to a meeting request.
Read Announcement- Drug:
- PF614
- Announced Date:
- July 16, 2025
- Indication:
- Pain Relief
Announcement
Ensysce Biosciences, Inc. announced the initiation of its pivotal Phase 3 study of PF614, the Company's lead product candidate.
Read Announcement
PF614-MPAR FDA Regulatory Timeline and Events
PF614-MPAR is a drug developed by Ensysce Biosciences for the following indication: Opioid overdose.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PF614-MPAR
- Announced Date:
- July 31, 2025
- Indication:
- Opioid overdose
Announcement
Ensysce Biosciences, Inc. announced that it received positive feedback and constructive guidance from the U.S. Food and Drug Administration (FDA) on the development of PF614-MPAR, the Company's first-of-its-kind opioid analgesic designed with both abuse deterrence and overdose protection.
AI Summary
On July 23, 2025, Ensysce Biosciences met with the FDA and received positive feedback on its new opioid drug, PF614-MPAR. It has Breakthrough Therapy designation and uses Ensysce’s TAAP and MPAR technologies that keep pain relief strong but trigger overdose protection when needed. The FDA praised its unique overdose protection feature.
The agency agreed that Ensysce could seek special overdose protection labeling, helping doctors and patients understand its safety benefits. They also guided the company on clinical, non-clinical, and manufacturing steps needed for approval.
Additionally, Ensysce learned that PF614-MPAR might use a faster 505(b)(2) regulatory path to reach the market more quickly. This collaborative approach brings the drug one step closer to offering safer pain relief for patients.
Read Announcement- Drug:
- PF614-MPAR
- Announced Date:
- April 15, 2025
- Indication:
- Opioid overdose
Announcement
Ensysce Biosciences, Inc. announced completion of Part 1 of its second clinical trial to evaluate PF614-MPAR for overdose protection.
AI Summary
Ensysce Biosciences announced the completion of Part 1 of its second clinical trial for PF614-MPAR, a formulation designed to treat severe pain while reducing the risk of overdose. In this study, subjects received multiple 100 mg doses of PF614-MPAR, which combines the Company’s TAAP™ and MPAR® technologies. The results showed that when more than the prescribed dosage was taken, the maximum release of oxycodone (Cmax) was lower than with the unprotected version, indicating successful overdose protection. Importantly, the trial reported no unexpected adverse events, supporting both the safety and the overdose protection profile of PF614-MPAR. These promising findings will be shared with the FDA in upcoming meetings as Ensysce moves forward with further parts of the trial. The company is optimistic that these results will help advance PF614-MPAR toward eventual commercialization as a safer opioid treatment option.
Read Announcement- Drug:
- PF614-MPAR
- Announced Date:
- February 5, 2025
- Indication:
- Opioid overdose
Announcement
Ensysce Biosciences, announced continued subject enrollment and successful dosing augmenting the progress of its second clinical trial to evaluate PF614-MPAR for overdose protection.
AI Summary
Ensysce Biosciences has reported significant progress with its second clinical trial evaluating PF614-MPAR for overdose protection. The company announced continued enrollment of subjects and successful dosing, which marks an important step in the trial’s progress. The study, known as PF614-MPAR-102, is evaluating a 100 mg dosage form of the drug to confirm its ability to protect against overdose even when larger doses are taken. Researchers have now enrolled subjects in the highest dosing cohort, equivalent to five times the 100 mg dose unit, and have observed only limited adverse events. This positive progress supports PF614-MPAR’s safety profile and highlights the drug’s potential as a novel opioid treatment. The recent results contribute to the overall momentum in developing safer pain management treatments with built-in overdose protection.
Read Announcement- Drug:
- PF614-MPAR
- Announced Date:
- January 22, 2025
- Indication:
- Opioid overdose
Announcement
Ensysce Biosciences, announced interim data from its second clinical trial to evaluate PF614-MPAR for overdose protection.
AI Summary
Ensysce Biosciences has shared promising interim results from its second clinical trial evaluating PF614-MPAR for overdose protection. The study, PF614-MPAR-102, explored the full dosage range of the formulation, including a 100 mg dose that was designed to reduce the blood concentration of oxycodone when an excessive dose is taken. In the trial, subjects served as their own controls and showed significantly lower maximum blood levels of oxycodone (Cmax) with PF614-MPAR compared to the standard PF614 formulation, highlighting its protective benefits. The study also compared single dosing, where no significant differences were observed, with multiple dosing that demonstrated clear overdose protection. Future phases of the trial will look at potential food effects and the impact of repeat dosing. These encouraging findings support ongoing efforts to develop safer opioid treatments with built-in overdose protection.
Read Announcement- Drug:
- PF614-MPAR
- Announced Date:
- November 26, 2024
- Target Action Date:
- Q1 2025
- Estimated Target Date Range:
- January 1, 2025 - March 31, 2025
- Indication:
- Opioid overdose
Announcement
Ensysce Biosciences Expects Early Interim Data in 1Q 2025
AI Summary
Ensysce Biosciences, a company working on safer pain relief options, has started its PF614-MPAR-102 study. The study is designed to assess the pharmacokinetics and safety of PF614-MPAR, an opioid developed to lower the risk of abuse and overdose. The company aims to complete this three-part trial with the goal of collecting early interim data in the first quarter of 2025. This data will be important for advancing discussions with the FDA about registering the product as an overdose-protected opioid. The drug has received Breakthrough Therapy designation from the FDA, highlighting its potential in addressing the risks tied to prescription opioids. Ensysce is using advanced technology platforms and collaborations to achieve a safer treatment option for severe pain, supporting its focus on reducing accidental and deliberate overdoses.
Read Announcement- Drug:
- PF614-MPAR
- Announced Date:
- November 26, 2024
- Indication:
- Opioid overdose
Announcement
Ensysce Biosciences, Inc. announced that it has treated its first group of subjects in the PF614-MPAR-102 study.
AI Summary
Ensysce Biosciences, Inc. announced that it has begun treating the first group of subjects in its PF614-MPAR-102 study. The trial is aimed at evaluating the safety and effectiveness of PF614-MPAR, a next-generation opioid designed to help reduce the risk of both accidental and intentional overdoses. The study will test PF614-MPAR in various dose ranges and under different conditions, including food effects and multi-ascending doses, to gather a broad set of data. Early interim results are expected in the first quarter of 2025, which could provide key insights into the drug's overdose protection features. Ensysce is partnering with Quotient Sciences and using their Translational Pharmaceutics® platform to support this work, as part of their continued effort to develop safer pain relief alternatives.
Read Announcement
