Data updated: May 26, 2026
ZORVOLEX (diclofenac)
Trial Activity: Mature 4 active trials
Pain
Approved 2013-10-18
Development Insights
Pfizer conducting 4 trials (7%)
61 indications explored (Broad Platform)
→ pain (8 trials)
→ osteoarthritis (7 trials)
→ healthy (2 trials)
2
Indications
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2013-10-18
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ZORVOLEX Approval History
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
20 FDA actions from 2013 to 2024
Jan 2015 SUPPL
Mfg
Aug 2014 SUPPL
Mfg
Apr 2014 SUPPL
Mfg
What ZORVOLEX Treats
2 FDA approvalsOriginally approved for its first indication in 2013 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
50 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06373978 | 24-307 | Ph 4 | recruiting | NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow |
| NCT03595150 | Post-ERCP-01 | Ph 2, Ph 3 | not yet recruiting | Diclofenac for Prevention of Post-ERC Pancreatitis |
| NCT06918340 | 2024-KAEK-64 | Ph 4 | active not recruiting | Evaluation of Analgesic Efficacy of Lidocaine and Diclofenac Spray in Radial Artery Blood Gas Sampling by Visual Analogue Scale and Perfusion Index |
| NCT03781544 OPIOVASC | OPIOVASC | Ph 4 | recruiting | Effects of Opioids and NSAIDs on Sympathetic Nervous System and Vascular Function |
| NCT03949673 results posted | R475-OA-1816 2018-001618-13 | Ph 2 | terminated | Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip |
| NCT02689024 DEPTHip | NL54580.018.15 2015-003650-40 | Ph 4 | terminated | Delirium in Elderly Patients With Trauma of the Hip |
| NCT03493490 | NDOL-001-2016 | Ph 4 | completed | Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative Pain After Elective Knee Surgery |
| NCT03199924 | COL-NEPHR | Ph 2 | completed | Treatment of Renal Colic in the Emergency Departement (ED). |
| NCT03861611 results posted | 2019-10026 | Ph 4 | completed | A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain. |
| NCT00777127 LEIDA | X-03016-3271 2007-004884-24 | Ph 4 | completed | Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses |
| NCT01453179 LEIDA 2 | X-03016-3284 2010-022054-16 | Ph 4 | completed | Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2) |
| NCT03605914 results posted | HSC-MS-18-0242 | Ph 4 | completed | Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty |
| NCT01067430 | IISP 35166 | Ph 4 | withdrawn | Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA) |
| NCT04819828 | CI-HRAEB-2008-009 | Ph 4 | completed | Tamsulosin as Adjunctive Therapy After Extracorporeal Shock Wave Lithotripsy for Renal Stones |
| NCT00864097 results posted | A4091017 2009-009318-41, P3 6 MO OA HIP/KNEE DICLOFENAC | Ph 3 | terminated | Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip |
| NCT02666846 results posted | FM52 | Ph 1 | completed | Assess the Efficacy and Safety in Volunteers of DCF100, TIB200 and SPR300 vs. Placebo and Control(s) in a UV Pain Model |
| NCT01596647 | CTKI258A2119 2011-001489-16 | Ph 1 | completed | Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors |
| NCT03039426 | RJBUPI | Ph 4 | completed | Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine |
| NCT03473665 results posted | AAAR3505 | Ph 4 | terminated | Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis |
| NCT03178539 | 17100114 | Ph 2, Ph 3 | completed | Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management |
| NCT03910088 PDPH | CairoU11112017 | Ph 4 | completed | Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean |
| NCT02700815 results posted | 1358.1 2015-000404-25 | Ph 3 | completed | Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain |
| NCT03072485 | IRB-37203 | Ph 1 | completed | Phase 1 Study of the Effects of Combining Topical FDA-approved Drugs on Age-related Pathways on the Skin of Healthy Volunteers |
| NCT01413854 | eudraCT number 2010-021024-10 | Ph 1, Ph 2 | withdrawn | Diclofenac add-on to Treatment as Usual for Suicidal Patients |
| NCT03745599 | Near East Uni | Ph 4 | completed | Evaluation of the Effects of Different Analgesics on Pericoronitis Pain and Quality of Life |
| NCT02361619 D-cocktail | T162/2014 2014-003628-38 | Ph 1 | completed | Dabigatran in an Interaction Probe Drug Cocktail |
| NCT03221946 | PMVIDS&RC/IEC/OMR/PR 0051-15 | Ph 4 | completed | A Comparative Evaluation of Diclofenac Sodium Transdermal Patch, Oral Diclofenac Sodium With Intramuscular Injections of Diclofenac Sodium in Patients Suffering From Oral Pain |
| NCT01190722 | 201001HV | Ph 4 | withdrawn | A Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain |
| NCT01590342 AINEP-1 | 2012-000247-27 | Ph 2, Ph 3 | terminated | Diclofenac for Submassive PE |
| NCT02445599 | DEOEC RKEB/IKEB 4044-2013 | Ph 4 | completed | Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain |
| NCT02714842 | FM1501 | Ph 1 | completed | Delayed Release Diclofenac Sodium Formulation vs Voltaren® |
| NCT02779530 | U1111-1131-8461 | Ph 4 | completed | CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs |
| NCT02286453 | MTU-EC-ES-6-152/56 TCTR20140816001 | Ph 2 | completed | Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac |
| NCT02547896 | 30880914.1.0000.5417 | Ph 4 | completed | Effectiveness of Diclofenac and Its Association to Codeine After Lower Third Molar Extraction. |
| NCT01039545 | 254/09 | Ph 4 | terminated | Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting. |
| NCT02417337 | University of Khartoum | Ph 2 | completed | Efficacy of Different Drugs to Control Post Root Canal Treatment Pain |
| NCT02187614 | IRB Number: 14-00059 Hamad Medical Corporation-MRC | Ph 4 | completed | Efficacy Study of Different Analgesic Options in Kidney Stone Pain Management |
| NCT01358045 | MEC 10-2-088 | Ph 2 | completed | Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma |
| NCT00766402 | CR015322 TRAMAPPAI4034 | Ph 4 | terminated | An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs) |
| NCT01229774 | Eto-Dic-01 | Ph 3 | completed | Use of Etoricoxib Compared to Diclofenac in the Perioperative Treatment of Patients After Total Hip Arthroplasty |
| NCT01461369 results posted | DIC3-08-05 | Ph 3 | completed | Study of Diclofenac Capsules to Treat Osteoarthritis Pain |
| NCT01510912 results posted | DIC3-08-06 | Ph 3 | completed | Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain |
| NCT01876615 | YH4808-109 | Ph 1 | completed | Pharmacokinetic Drug Interaction Between YH4808 and Diclofenac |
| NCT01812928 DUF | 122010SUR | Ph 2 | completed | Diclofenac Suppository to Control Pain During Flexible Cystoscopy |
| NCT00792376 | 00045-2008 1-47-12225-05-1 | Ph 4 | completed | "NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes" |
| NCT01907984 | 5481-1/2013/EKU DEOEC RKEB/IKEB:3769-2012 | Ph 4 | completed | Diclofenac Administered Before Skull Operations Reduces the Severity of Headache After the Intervention |
| NCT01860833 NSKO | LGOG1 | Ph 4 | completed | NSAID Treatment in Knee Osteoarthritis |
| NCT01481610 | PEMEX-805415-00-2 | Ph 2 | terminated | Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia |
| NCT01456611 | DCL-269 | Ph 3 | completed | Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1% |
| NCT00595543 | 5349 | Ph 4 | completed | Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5% |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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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.
ZORVOLEX FDA Label Details
View full patent landscape →
7 OB patents · 1 families ·
70 international docs across 24 countries
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Deep insights for ZORVOLEX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 28 active patents
Trial Analysis
- • 55 total trials
- • Stage: Mature
Competitive Landscape
- • Competitor tracking
- • 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