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ZILRETTA

Phase 3

Glenohumeral Osteoarthritis | Small molecule | Musculoskeletal |Pacira BioSciences, Inc.|Last Updated: May 29, 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
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Trial Design
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06269705ZILRETTA in Subjects With Shoulder OsteoarthritisPHASE3 ACTIVE NOT_RECRUITING 150Feb 5, 2024Dec 1, 2026May 29, 202632 United States
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Study Endpoints
Primary Endpoints
Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 12 for ZILRETTA relative to placebo
Week 12
Secondary Endpoints
Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 12 for ZILRETTA relative to TCA-IR
Week 12
Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 18 for ZILRETTA relative to TCA-IR
Week 18
Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 2 for ZILRETTA relative to placebo
Week 2
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ZILRETTAEXPERIMENTAL100 subjects will receive 32 mg ZILRETTA
PlaceboPLACEBO_COMPARATOR50 subjects will receive normal saline placebo
Interventions
NameTypeDescription
ZILRETTADRUGIA injection of 32 mg ZILRETTA
PlaceboOTHERIA injection of placebo (normal saline)
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Eligibility Criteria
Age Range50 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria To be included in the trial, participants must fulfill the following criteria: 1. Written informed consent has been obtained prior to initiating any study-specific procedures. 2. Willingness and ability to comply with the study procedures and visit schedules and ability to follo...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 29, 2026NCT06269705Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMMay 29, 2026NCT06269705Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMMay 29, 2026NCT06269705Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT06269705primaryCompletionDate: changed
LOWMay 24, 2026NCT06269705studyFirstPostDate: changed