TheraRadar
Data updated: Nov 8, 2026

ZUEINO (diclofenac sodium) · ADVENTAPHARMA

Approved 2026-09-25

ZUEINO is FDA-approved to treat 1 condition (same as DICLOFENAC SODIUM).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2026-09-25
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

ADVENTAPHARMA
Active Ingredient: DICLOFENAC SODIUM

ZUEINO Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Sep 2026 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What ZUEINO Treats

1 indications

ZUEINO is approved for 1 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Arthritis

Same approved indications as DICLOFENAC SODIUM (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

27 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
NCT07919938 1160/2026 Ph 3 not yet recruiting Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

ZUEINO FDA Label Details

Indications & Usage

FDA Label (PDF)

ZUEINO is FDA-approved to treat 1 condition — same approved indications as DICLOFENAC SODIUM.

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Data Sources

FDA Approval: NDA218379 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.