PF-614 is under clinical development by Ensysce Biosciences and currently in the Phase I in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect PF-614’s likelihood of approval (LoA) and phase transition for Substance (Drug) Abuse took place on 26 Dec 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their PF-614 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

PF-614 overview

PF-614 (oxycodone prodrug ER) is under development for the treatment of pain and substance (drug) abuse. The drug candidate is an extended-release formulation administered orally. It is an abuse-resistant opioid prodrug based on Bio-MD technology. PF-614 acts by targeting mu opioid receptor (MOR or OP3 receptor). It is developed based on Trypsin-Activated Abuse Protection (TAAP) technology. It is administered through intranasal route for the treatment of  substance (drug) abuse.

Ensysce Biosciences overview

Ensysce Biosciences is a biotechnology company. It offers proprietary abuse-resistant opioid prodrug technology. The company’s pipeline products include oxycodone, hydromorphone, ADHD, PF614, and PF329. Ensysce Biosciences PF614 is a lead abuse-resistant opioid drug is a proprietary prodrug of oxycodone and PF329, an extended-release prodrug of hydromorphone. Ensysce Biosciences offers abuse resistant technology, TAAP technology, pain medications, MPAR technology, single walled carbon nanotubes technology, drug delivery, and research direction solutions. It provides its products and services to healthcare, medical and pharmaceutical sectors. Ensysce Biosciences is headquartered in San Diego, California, the US.

Quick View PF-614 LOA Data

Report Segments
  • Innovator
Drug Name
  • PF-614
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
Key Developers
  • Sponsor Company: Ensysce Biosciences
  • Originator: Signature Therapeutics
Highest Development Stage
  • Phase I


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.