Drugs / PF614
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials · 2 met primary | ||||||
| Phase 1 | NCT06500793 | Nov 2024 → Dec 2026 expected | — | Ensysce Biosciences | Recruiting | No outcome recorded |
| Phase 1 | NCT05571345 | Oct → Dec 2022 | — | Ensysce Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT05567354 | Jun → Aug 2022 | — | Ensysce Biosciences | Completed | Met primary |
| Phase 1 | NCT05090280 | Dec 2021 → Apr 2023 | — | Ensysce Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT05043766 | Sep 2021 → Mar 2022 | — | Ensysce Biosciences | Completed | Met primary |
| Phase 1 | NCT02454712 | Nov 2016 → Jan 2018 | — | Ensysce Biosciences | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06629402 | Oct → Nov 2023 | — | Ensysce Biosciences | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06602271 | Dec 2025 → Aug 2026 overdue | — | Ensysce Biosciences | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-03-03 | Ensysce Biosciences | Results Ensysce Biosciences Announces First Peer-Reviewed Clinical Publication Demonstrating Oral Overdose Protection with MPAR(R) Technology ensysce.com ↗
Data presented in the publication demonstrate that PF614-MPAR achieved appropriate opioid plasma levels under normal dosing conditions, while preventing large increases in opioid delivery when supratherapeutic doses were administered. |
| 2025-04-15 | Ensysce Biosciences | Results Ensysce Biosciences Announces Positive Data from Opioid Overdose Protection Study ensysce.com ↗
Part 1 of this second study of PF614-MPAR overdose protection confirmed that a 100 mg dosage of PF614-MPAR delivers oxycodone to treat severe pain and provides overdose protection when a greater-than-prescribed dose is consumed. |
| 2025-02-05 | Ensysce Biosciences | Results Ensysce Biosciences Reports Continued Positive Progress in Groundbreaking Trial on PF614-MPAR, Comments on Current Landscape for Pain Treatment ensysce.com ↗
In the current study of PF614-MPAR-102, data showed that a 100 mg dosage form of PF614-MPAR provides overdose protection when a greater-than-prescribed dose is consumed at one time. |
| 2025-01-22 | Ensysce Biosciences | Results Ensysce Biosciences Announces Positive Interim Data for Breakthrough Therapy PF614-MPAR ensysce.com ↗
The PF614-MPAR-102 study showed that a 100 mg dosage form of PF614-MPAR provides overdose protection when a greater-than-prescribed dose is consumed at one time. |
| 2024-02-15 | Ensysce Biosciences | Results Ensysce Biosciences Announces Publication of Clinical Bioequivalence Manuscript ensysce.com ↗
The results from the two-part PF614‑102 study are very significant as we believe they demonstrate a clear dose relationship between PF614 and oxycodone, which is the foundation for the FDA submission. |
| 2024-01-25 | Ensysce Biosciences | Results Ensysce Biosciences to Present Groundbreaking Oral Overdose Protection for Opioids at the 5th Annual NIH HEAL Meeting ensysce.com ↗
The trial being presented was undertaken to optimize the PF614-MPAR combination drug product and successfully met its overdose protection endpoints. |
| 2024-01-23 | Ensysce Biosciences | Regulatory Ensysce Biosciences Announces FDA Breakthrough Therapy Designation Granted for PF614-MPAR ensysce.com ↗
today announced receipt of notice from the U.S Food and Drug Administration (FDA) that it has granted Breakthrough Therapy Designation (BTD) for PF614-MPAR. |
| 2023-12-14 | Ensysce Biosciences | Results Ensysce Biosciences Announces Key Efficacy Data for Lead Analgesic ensysce.com ↗
This study met its primary goal and successfully demonstrated the efficacy for PF614 using a well-established, validated experimental pain model in healthy subjects. |
| 2023-05-09 | Ensysce Biosciences | Results Ensysce Biosciences Announces Successful Completion of Ground-Breaking Study on Overdose Protection ensysce.com ↗
The final Part B of the study examined dose escalation of PF614-MPAR from 25 to 200 mg (1 to 8 dose units) and showed that PF614-MPAR successfully reduced opioid delivery when three or more doses are consumed simultaneously. |
| 2023-04-03 | Ensysce Biosciences | Results Ensysce Biosciences Announces Positive Results from Oral Human Abuse Potential Trial for PF614 ensysce.com ↗
The study met all key endpoints and showed PF614 had significantly lower scores of "Drug Liking" than the oxycodone comparator at both the low and mid doses studied. |
| 2022-12-19 | Ensysce Biosciences | Results Ensysce Biosciences Announces Data from PF614-MPAR-101-Part A Successfully Demonstrating Opioid Overdose Protection ensysce.com ↗
Data from the trial was able to show that in healthy subjects we could deliver oxycodone similarly with PF614 and PF614-MPAR, which was the goal of the study. |
| 2022-10-31 | Ensysce Biosciences | Results Ensysce Biosciences Announces Positive Topline Results of Clinical Study Evaluating Human Abuse Potential of Intranasal Administration of PF614, a TAAP Abuse-Deterrent Oxycodone Extended-Release Product ensysce.com ↗
In the study, PF614 powder produced significantly lower peak "drug liking" (Emax) when compared with intranasal crushed IR oxycodone (p = 0.0133) using the full modified completer population in a 3-period crossover of PF614 vs. crushed oxycodone and placebo. |
| 2022-07-27 | Ensysce Biosciences | Results Ensysce Biosciences Announces Positive Bioequivalence (BE) Study Data of Novel "TAAP" Opioid PF614 and Provides Timing of Corporate Update Call ensysce.com ↗
Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, announced today the data from the Part B, Bioequivalence (BE) arm of the PF614-102 study examining the Company's novel Trypsin-Activated Abuse-Protected ( TAAP ) Opioid, PF614. |
| 2022-05-05 | Ensysce Biosciences | Results Ensysce Biosciences Announces New Clinical Results from Trials PF614-102 and PF614-MPAR-101 ensysce.com ↗
The results of the study show the longer-lasting half-life of PF614 versus OxyContin as seen in the prior Phase 1 single-ascending dose study of PF614 oral solution versus OxyContin. |
| 2022-01-04 | Ensysce Biosciences | Results Ensysce Biosciences Achieves Successful Completion of Part A of Multiple-Ascending Dose (MAD)/Bioequivalents (BE) Trial for its Next Generation Opioid, PF614 ensysce.com ↗
PK data confirmed similar dose-proportionate increases in plasma oxycodone following PF614 and OxyContin and there were no unexpected adverse events in either the PF614 or OxyContin dose groups. |
| 2021-04-29 | Ensysce Biosciences | Regulatory Ensysce Biosciences Receives Investigational New Drug Allowance for its Unique PF614-MPAR™ Opioid with Overdose Protection ensysce.com ↗
Ensysce has received U.S. Food and Drug Administration (“FDA”) allowance for an Investigational New Drug (IND) application for PF614-MPAR™ |
| 2018-09-17 | Ensysce Biosciences | Results Ensysce Biosciences Receives Multi-Year NIDA Grant to Study and Deliver Opioid Overdose Protection ensysce.com ↗
The trial results in 60 subjects randomized to receive PF614 or OxyContin™, showed over 90% efficient release of oxycodone from PF614 and an improved safety profile over OxyContin™. |
| 2018-01-29 | Ensysce Biosciences | Regulatory Ensysce Biosciences Inc. Receives Fast Track Designation for PF614, BIO-MD™ Abuse Deterrent Extended Release Oxycodone Prodrug ensysce.com ↗
Ensysce Biosciences is pleased to announce that the FDA has granted Fast Track designation for the development of PF614 for management of moderate to severe chronic pain when a continuous, around-the-clock analgesic is needed for an extended period of time. |
| 2017-09-25 | Ensysce Biosciences | Results Ensysce Biosciences Inc. to Present at 11th Annual Pain and Migraine Therapeutic Summit in San Diego, CA on September 27, 2017 ensysce.com ↗
She will be discussing the recently completed clinical trial which demonstrated the safety and efficient oral activation of BIO-MD TM oxycodone prodrug, PF614. |
| 2017-04-03 | Ensysce Biosciences | Results Ensysce Biosciences Inc. Publishes Manuscript Describing the in Vitro Abuse Deterrence of Oxycodone Prodrug, PF614 ensysce.com ↗
This prodrug approach reduces the intravenous and nasal abuse potential of PF614, through requiring a two-step activation process following oral administration. |
All press releases naming this drug 44 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PF614 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05090280 ↗ |
| Route | Oral | “Subjects will receive PF614 (n=6) or OxyContin as comparator (n=2) orally in the fasted state.” NCT02454712 ↗ |