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PF614

Phase 3

Postoperative Pain, Acute | Small molecule | Pain |Ensysce Biosciences, Inc.|Last Updated: Jan 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment320
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06602271PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)PHASE3 RECRUITING 320Dec 9, 2025Nov 1, 2026Jan 22, 20263 United States
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Study Endpoints
Primary Endpoints
Pain NRS-R area under the curve through 48 hours (AUC4-48)
4-48 hours

Pain at rest

Secondary Endpoints
Pain NRS-A area under the curve through 48 hours (AUC4-48)
4-48 hours
Pain NRS-R and NRS-A
4-96 hours
Time to first use of rescue opioid medication
0-96 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF614 25 mgEXPERIMENTALOral administration every 12 hours
PF614 37.5 mgEXPERIMENTALOral administration every 12 hours
PF614 50 mgEXPERIMENTALOral administration every 12 hours
PlaceboPLACEBO_COMPARATOROral administration every 12 hours
Interventions
NameTypeDescription
PF614 capsuleDRUGExperimental oxycodone prodrug
PlaceboDRUGInactive medication
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Participant must provide written informed consent prior to the initiation of any protocol specific procedures. 2. Male or female participant, between 18 and 75 years of age, inclusive, at the time of Screening. 3. Participant must be scheduled to undergo a full abdominoplasty...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06602271primaryCompletionDate: changed
LOWMay 24, 2026NCT06602271studyFirstPostDate: changed