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ZILRETTA

Phase 3

Glenohumeral Osteoarthritis | Small molecule | Musculoskeletal |Pacira BioSciences, Inc.|Last Updated: May 29, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

ZILRETTA · 1 trial · 1 indication

Phase 3 1
NCT06269705ZILRETTA in Subjects With Shoulder OsteoarthritisGlenohumeral Osteoarthritis
ACTIVE NOT_RECRUITING150 Analytics
PHASE3ACTIVE NOT_RECRUITING
ZILRETTA in Subjects With Shoulder Osteoarthritis
Glenohumeral Osteoarthritis
NCT06269705150
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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 to 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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Frequently asked questions about ZILRETTA

What is ZILRETTA used for?

ZILRETTA is an investigational small molecule being developed for glenohumeral osteoarthritis, which is osteoarthritis of the shoulder. It is currently in Phase 3 clinical development and has not been approved by the FDA.

Who makes ZILRETTA?

ZILRETTA is being developed by Pacira BioSciences, Inc., a company traded on the Nasdaq under the ticker PCRX.

What phase is ZILRETTA in?

ZILRETTA is in Phase 3 clinical development for glenohumeral osteoarthritis. It is an investigational drug and has not received FDA approval.

What clinical trials is ZILRETTA in?

ZILRETTA is being studied in a Phase 3 clinical trial with the identifier NCT06269705, titled "ZILRETTA in Subjects With Shoulder Osteoarthritis." The trial is active but not recruiting, with an enrollment of 150 participants in the United States.

Is ZILRETTA the same as any other drug?

ZILRETTA is the proprietary name for the drug being developed by Pacira BioSciences. No alternative names have been reported for this asset.