Ensysce’s PF614 Steps Forward in Phase 3 Post-Surgery Pain Trial: What Investors Should Watch

Ensysce Biosciences, Inc. (ENSC) announced an update on their ongoing clinical study.

Study Overview: Ensysce Biosciences, Inc. (ENSC) is running a Phase 3 study titled “A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain After Abdominoplasty.” The goal is to see how well PF614, a new form of oral pain medicine, controls short-term post-surgery pain compared with placebo, and to assess safety. This is a key step toward potential approval of PF614 as a new option for managing acute pain after surgery.

Intervention/Treatment: The trial is testing PF614 capsules, an extended-release oral pain drug designed as a prodrug of oxycodone, in doses of 25 mg, 37.5 mg, and 50 mg. These are compared to a placebo capsule. The intent is to provide steady pain relief after surgery while aiming for a safer, more controlled profile than standard opioids.

Study Design: The study is interventional and randomized, meaning participants are assigned by chance to PF614 or placebo. It uses a parallel design, so each patient receives only one treatment throughout the study. It is quadruple-blinded: patients, care providers, investigators, and outcome assessors do not know who receives PF614 or placebo. The main purpose is treatment, focusing on pain reduction and safety in people with moderate to severe pain after abdominoplasty.

Study Timeline: The trial was first submitted on September 16, 2024, signaling the formal start of regulatory tracking and site activation. The study is currently listed as “recruiting,” showing that patient enrollment is in progress and primary completion is still ahead. The most recent update was submitted on January 4, 2026, indicating that the protocol and status have been recently reviewed and kept current, which matters for investors watching trial momentum and execution.

Market Implications: For Ensysce, positive Phase 3 data from PF614-301 could support a key value driver: the potential approval of PF614 in acute post-surgical pain, a large, competitive market dominated by generic opioids and a few newer abuse-deterrent products. Clear evidence of effective pain relief with a differentiated safety or misuse profile could boost ENSC’s valuation, improve access to partnership deals, and support future capital raises. Conversely, weak efficacy or safety concerns could pressure the stock. Investors should also weigh the broader opioid and pain-management landscape, where regulators and payers scrutinize new opioids closely. The fresh update in January 2026 confirms that the study is active and progressing, which may support sentiment among existing shareholders while leaving near-term performance tied to upcoming data milestones.

The PF614 Phase 3 study remains ongoing and recently updated, with further details available on the ClinicalTrials.gov portal under NCT06602271.

To learn more about ENSC’s potential, visit the Ensysce Biosciences, Inc. drug pipeline page.