Data updated: May 26, 2026
ZILRETTA (triamcinolone acetonide)
Trial Activity: Stable 1 active trials
Musculoskeletal
Approved 2017-10-06
Zilretta helps patients with osteoarthritis pain in the knee through an extended-release formulation of a synthetic corticosteroid. It is administered as an injection directly into the joint to help manage localized discomfort. Because the safety and effectiveness of multiple doses have not been established, it is currently used as a single-administration option for knee pain management.
Source: FDA Label • PACIRA PHARMS INC
How ZILRETTA Works
This medication works by binding to and activating glucocorticoid receptors, which triggers the production of anti-inflammatory proteins called lipocortins. This process blocks the release of arachidonic acid and prevents the body from synthesizing inflammatory substances like prostaglandins and leukotrienes. By inhibiting these inflammatory pathways, the drug helps reduce pain within the joint.
Development Insights
Pacira Pharmaceuticals, Inc conducting 2 trials (40%)
8 indications explored (Moderate)
→ osteoarthritis of hip (1 trials)
→ glenohumeral osteoarthritis (1 trials)
→ tibial meniscus injuries (1 trials)
2
Indications
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Prescription
- First Approved
- 2017-10-06
- Patent Cliff
- 2031
- Routes
- INTRA-ARTICULAR
- Dosage Forms
- FOR SUSPENSION, EXTENDED RELEASE
ZILRETTA Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2017 to 2024 · 1 indication expansions
What ZILRETTA Treats
1 indicationsZILRETTA is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoarthritis
Source: FDA Label
ZILRETTA Competitive Set
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MoA expansion candidates
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Indication competitors
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Drugs Similar to ZILRETTA
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Clinical Trial Registry
62 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04207931 CCCA | IRB00043796 | Ph 4 | recruiting | Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study |
| NCT07453238 CALISTA-AA | AA-RCT-2026-01 | Ph 4 | not yet recruiting | Comparison of Topical Calcipotriol and Intralesional Steroids in Alopecia Areata |
| NCT05436535 LEADS | DAIT ADRN-12 | Ph 4 | completed | Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis |
| NCT04002362 results posted | IRB00111087 R01NR018666 | Ph 2 | completed | Symptom Clusters in Children With Exacerbation-prone Asthma |
| NCT06401317 CASITOA | CASITOA | Ph 2 | recruiting | Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA) |
| NCT06977568 | 006-C-202 | Ph 2 | terminated | A Study to Evaluate an Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Immediate Release in Subjects With Osteoarthritis of the Hip |
| NCT05190770 results posted | 21-091 | Ph 2 | completed | A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer |
| NCT05535738 | STUDY00000321 | Ph 2, Ph 3 | active not recruiting | Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation |
| NCT06269705 | 006-C-301 | Ph 3 | recruiting | ZILRETTA in Subjects With Shoulder Osteoarthritis |
| NCT07189572 | UHCT250873 | Ph 3 | not yet recruiting | Intranasal Corticosteroid Spray for Preventing Otitis Media With Effusion After Radiotherapy in Nasopharyngeal Carcinoma |
| NCT07141446 | GDCH/IEC/I-2024(04) | Ph 1, Ph 2 | completed | Evaluation of Efficacy of Neem (Azadirachta Indica) Versus Triamcinolone Acetonide in the Treatment of Oral Lichen Planus. |
| NCT07114016 | FDASU-REC0787 | Ph 4 | completed | Efficacy of Topical Glucosamine Versus Corticosteroid in Oral Lichen Planus |
| NCT04469075 | 19-342 | Ph 2 | active not recruiting | Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields |
| NCT07100145 | FDASU-Rec IM012414 | Ph 4 | not yet recruiting | Efficacy of Coconut Gel Compared to Corticosteroid Gel in the Management of Oral Lichen Planus |
| NCT07014280 | BevaVSsteroid:keloids | Ph 4 | active not recruiting | Bevacizumab Versus Triamcinolone Acetonide for the Treatment of Keloids. |
| NCT04731233 results posted | IRB202000689-A OCR40106 | Ph 4 | terminated | Efficacy of PRGF Supplementation After TMJ Arthrocentesis in Patients With TMJ Osteoarthritis |
| NCT06814288 | DV-202501.01 | Ph 2 | active not recruiting | The Effectiveness of Intralesional Botulinum Toxin A and Triamcinolone Acetonide Injections in Keloid Treatment |
| NCT06810752 | 24-092 | Ph 1, Ph 2 | enrolling by invitation | Thyme Honey for Management of Oral Lichen Planus |
| NCT05806021 | 21.411 | Ph 4 | recruiting | The Efficacy of Intra-articular Triamcinolone Acetonide 5mg vs. 10 mg vs. 40 mg in Patients With Knee Osteoarthritis |
| NCT05512962 CAPE results posted | OXUCT-103 - CAPE 2022-001533-37 | Ph 2 | completed | Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema |
| NCT05158699 EPICAT | NL72427.068.19 2019-004890-21 | Ph 3 | terminated | Effectiveness of Periocular Drug Injection in CATaract Surgery |
| NCT06524323 | 2024-0042 | Ph 3 | not yet recruiting | A Randomized, Double-blinded, Self-controlled Clinical Study of Intralesional Injection of 5-fluorouracil Plus Triamcinolone for the Treatment of Refractory Nodular Prurigo |
| NCT03166761 results posted | SCHNEIBJ03152017153735 | Ph 4 | terminated | Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection |
| NCT04075136 | IRB00058375 | Ph 4 | withdrawn | Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy |
| NCT03636373 results posted | Pro2018000562 | Ph 4 | terminated | Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout |
| NCT04331002 SLAM results posted | 53136 | Ph 2 | terminated | Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury |
| NCT05413330 | UDMS-Opthal-01-2022 | Ph 2, Ph 3 | completed | Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes. |
| NCT05492851 | 2022H0168 | Ph 4 | terminated | Trial Comparing Three Single Dose Injections for Knee Osteoarthritis |
| NCT03293368 | PRP-olp | Ph 2 | completed | Efficacy of Intralesional Injection of Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus |
| NCT03382925 results posted | 106288 | Ph 4 | terminated | Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness? |
| NCT05429450 TOMATO | MD-139-2020 | Ph 2 | completed | Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections |
| NCT03627741 | 17-008766 | Ph 1 | completed | A Pilot Study of Intralesional Injection of Triamcinolone Acetonide for Desmoid Tumors |
| NCT03895840 results posted | STUDY00142926 | Ph 4 | completed | The Effect of Intra-articular Bilateral Knee Injections of Zilretta on Performance Measures in Adults With Knee OA |
| NCT03248856 | 1456/2017 2017-002377-19 | Ph 1 | completed | Triamcinolone Levels in Cochlear Perilymph |
| NCT02873026 ASCOT | CHAD1031 | Ph 3 | completed | Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study |
| NCT04976673 | kb256/2020 | Ph 2 | completed | Comparison of Clinical Efficiency of Photodynamic Therapy and Topical Corticosteroid in Treatment of Oral Lichen Planus |
| NCT01572350 ALBA | ALBA09 | Ph 3 | completed | Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Laser Versus Laser Alone for the Treatment of Diffuse Non-tractional Diabetic Macular Edema |
| NCT02877485 results posted | IRB-36535 | Ph 4 | completed | The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation |
| NCT02025023 CTS | STUDY00003748 | Ph 3 | recruiting | Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study |
| NCT02221453 | PersDMEcytokineTA | Ph 2 | completed | Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide |
| NCT02120261 USAMPS results posted | HSC-MS-14-0072 | Ph 4 | terminated | Using Saline for Myofascial Pain Syndromes (USAMPS) |
| NCT03319784 | STUDY00008014 | Ph 4 | withdrawn | Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients |
| NCT02598869 | 00011584 | Ph 4 | withdrawn | Posterior Subtenon Versus Intravitreal Injection of Triamcinolone Acetonide for Treatment of Uveitic Cystoid Macular Edema |
| NCT02294656 | ML27905 | Ph 1 | completed | Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide |
| NCT03535233 | AA22 | Ph 4 | completed | Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata |
| NCT03120923 | HE551338 | Ph 4 | completed | Combined Corticosteroid With Low Volume Compared to High Volume in Impingement Syndrome |
| NCT01230424 results posted | NIH NIAMS R01-AR057802 Tufts MC IRB Protocol # 9417 | Ph 4 | completed | Effect of Steroid Injections in a Knee With Osteoarthritis |
| NCT01362608 results posted | CACZ885H2358 2010-024172-26 | Ph 3 | terminated | Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective |
| NCT01978301 | 117287 | Ph 1 | terminated | Study to Evaluate Fractional Collagen Synthesis Within Keloid Scars and Identify Biomarkers of Keloid Scars |
| NCT01774474 PREMED | NL42463.068.12 | Ph 3 | completed | PRevention of Macular EDema After Cataract Surgery |
Showing 50 of 62 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZILRETTA FDA Label Details
Indications & Usage
FDA Label (PDF)ZILRETTA is indicated for the treatment of Osteoarthritis.
View full patent landscape →
2 OB patents · 1 families ·
58 international docs across 24 countries
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Deep insights for ZILRETTA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 2 active patents
Trial Analysis
- • 5 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment