Data updated: May 26, 2026
DYLOJECT (diclofenac sodium)
Trial Activity: Declining 1 active trials
Pain
Approved 2014-12-23
Development Insights
Cerimon Pharmaceuticals conducting 3 trials (11%)
31 indications explored (Broad Platform)
→ pain (4 trials)
→ actinic keratosis (3 trials)
→ healthy (3 trials)
1
Indication
--
Phase 3 Trials
11
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2014-12-23
- Patent Cliff
- 2027
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
DYLOJECT Approval History
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2014 to 2016
Jul 2015 SUPPL
Mfg · Manufacturing (CMC)
May 2015 SUPPL
Mfg · Manufacturing (CMC)
What DYLOJECT Treats
1 FDA approvalsOriginally approved for its first indication in 2014 .
- Other (1)
📋
Clinical Trial Registry
26 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07565012 DIPI-PEP | AFID-OPER-PEP-2025-01 IRB Approval Number | Ph 4 | completed | Comparative Evaluation of Diclofenac Sodium and Ibuprofen for Post-Endodontic Pain Management |
| NCT06207253 | 23-039 | Ph 2, Ph 3 | recruiting | The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament |
| NCT06111573 | YYU-10/31.05.2023 | Ph 4 | completed | Comparative Evaluation of the Effectiveness of Diclofenac Sodium Versus Vitamin D on Myofascial Pain |
| NCT05829707 | OsijekUH21 | Ph 4 | completed | Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia |
| NCT05626140 EDCLAS | PIMS-05-002 | Ph 3 | completed | COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA |
| NCT05488925 | BDC/ERB/2021/016 | Ph 4 | completed | Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block. |
| NCT01962987 results posted | 71204901 | Ph 3 | completed | A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis |
| NCT03825016 | AS1855 | Ph 2 | completed | Lidocaine Infusion in Hystroscopy |
| NCT03074162 results posted | 1358.2 | Ph 1 | completed | Comparison of the Bioavailability of Diclofenac in a Combination Product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) With Two Diclofenac Only Products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel, in Healthy Volunteers |
| NCT02598102 | INU/RRC/01/2014-15 | Ph 2 | completed | Efficacy of Preprocedural Diclofenac in Males Undergoing Double J Stent Removal Under Local Anesthesia |
| 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 |
| NCT03090971 | NX101-02-2016 | Ph 2 | completed | Use of Topical Liquid Diclofenac Following Laser Microporation of Cutaneous Neurofibromas in Patients With NF1 |
| NCT02201238 | 202188 RH02175 | Ph 1 | completed | Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium |
| NCT02611804 | SYM 2015-01 | Ph 3 | completed | A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp |
| NCT00523120 | HP 7-264S | Ph 2 | terminated | Topical Voltaren in Otitis Externa |
| NCT02495831 results posted | Z7219J01 | Ph 1 | completed | Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers |
| NCT02658721 | IVRA | Ph 3 | completed | Effects of Systemic or Adjunct Tramadol Addition to Lidocaine Used for IVRA in Patients Undergoing Hand Surgery |
| NCT02253446 | MDhayri2014 | Ph 4 | completed | A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea |
| NCT01706588 DP4 results posted | 12UK/DCsc04 | Ph 2 | completed | Injectable Diclofenac for the Prevention of Post-operative Dental Pain |
| NCT01858090 | KA08/48 | Ph 3 | completed | Intrathecal Levobupivacaine With Opioids for Caesarean Section |
| NCT01272934 results posted | VOSG-P-318 | Ph 3 | completed | Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain |
| NCT01272947 results posted | VOSG-P-319 | Ph 3 | completed | Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries |
| NCT00931866 | DCF-006 | Ph 3 | completed | Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED) |
| NCT00869180 SUPPORT 2 | DCF-004 | Ph 3 | completed | Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain |
| NCT00805090 | DFC-PK-009 | Ph 1 | completed | Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects |
| NCT00640705 | DCF-002 | Ph 2, Ph 3 | terminated | Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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.
DYLOJECT FDA Label Details
View full patent landscape →
1 OB patents · 1 families ·
34 international docs across 12 countries
DYLOJECT Patents & Exclusivity
Latest Patent: Mar 2027
Patents (1 active)
US8946292
Expires Mar 22, 2027
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for DYLOJECT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 1 active patents
Trial Analysis
- • 27 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
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