Voltaren

(Diclofenac)

ApprovedSmall molecule

Diclofenac is used to reduce pain, swelling, and inflammation from conditions like arthritis, menstrual cramps, and minor injuries. It works by reducing pain signals and decreasing inflammation in the body.[2] Voltaren is currently approved and in use across 54 indications[4].[1]

Voltaren is one of 928 small molecule programs targeting Low back pain. It is currently in Approved.

Indications

131

Total Trials

Active Trials

927

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Low Back PainActive, not recruiting

Duodenal UlcerActive, not recruiting

Depressive DisorderApproved

Migraine DisorderActive, not recruiting

ArthritisActive, not recruiting

Cystoid Macular EdemaActive, not recruiting

Basal Cell CarcinomaActive, not recruiting

Rheumatic DiseaseActive, not recruiting

Skin CancerActive, not recruiting

Bone FractureApproved

Low Back PainApproved

Active, not recruiting

Duodenal UlcerApproved

Active, not recruiting

Depressive DisorderApproved

Approved

Migraine DisorderApproved

Active, not recruiting

ArthritisApproved

Active, not recruiting

Cystoid Macular EdemaApproved

Active, not recruiting

Basal Cell CarcinomaPhase 2

Active, not recruiting

Rheumatic DiseaseApproved

Active, not recruiting

Skin CancerPhase 2

Active, not recruiting

Bone FractureApproved

Approved

Showing 10 of 51 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Voltaren

Novartis

Approved

1 2

Tykerb

GSK

Preclinical

80 3

Adriamycin

GGynecologic Oncology Group

Preclinical

87 4

Avastin

BBio-Thera Solutions

Preclinical

153 5

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 6

Prolia

Amgen

Preclinical

14 7

Gemzar

GGynecologic Oncology Group

Preclinical

22 8

MS Contin

Merck & Co.

Preclinical

2 9

Lexiscan

Astellas

Preclinical

1 10

Adenocard

Astellas

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Diclofenac

NCT06053411

Phase 1Recruiting

Diclofenac

NCT06636227

Q4 2026

Phase 1/2Recruiting

Ketorolac

NCT06158620

N/ARecruiting

Indomethacin

NCT07071441

Q4 2028

Phase 2/3Not yet recruiting

Pancreatitis

NCT03595150

Clinical

Trials by Indication[1]

Osteoarthritis15 trials

Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip

Terminated· Regeneron logo

Regeneron·Phase 2·NCT03949673·23 enrolled

Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac

Completed·TThammasat University·Phase 2·NCT02286453·84 enrolled

Fenugreek Wraps in Osteoarthritis of the Knee

Completed·UUniversität Duisburg-Essen·N/A·NCT03528824·81 enrolled

Show 12 more trials

Cabbage Leaf Wraps in Osteoarthritis of the Knee

Completed·UUniversität Duisburg-Essen·N/A·NCT02027792·81 enrolled

Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis

Completed·NNuvo Research GmbH·Phase 3·NCT00108992·750 enrolled

The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis

Completed·—·Phase 4·NCT01383954·52 enrolled

Study to Assess the Efficacy and Safety of Meloxicam vs. Diclofenac SR in Patients With Osteoarthritis of the Knee

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02183129·91 enrolled

Sahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II

Unknown status·MMr NARIN KAKATUM·Phase 2·NCT04591795·80 enrolled

Celecoxib Versus Diclofenac In The Treatment Of Osteoarthritis Of The Hip

Completed· Pfizer logo

Pfizer·Phase 4·NCT00174317·250 enrolled

Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain

Completed·IIroko Pharmaceuticals, LLC·Phase 3·NCT01510912·602 enrolled

Study of Diclofenac Capsules to Treat Osteoarthritis Pain

Completed·IIroko Pharmaceuticals, LLC·Phase 3·NCT01461369·305 enrolled

The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults

Completed·AAtrium Innovations·Phase 2·NCT02088411·150 enrolled

Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip

Terminated· Pfizer logo

Pfizer·Phase 3·NCT00864097·607 enrolled

Comparative Clinical Trial of Lornoxicam to Diclofenac in Patients of Osteoarthritis of Knee Joint.

Completed·GGovernment Medical College, Bhavnagar·N/A·NCT01055470·40 enrolled

NSAID Treatment in Knee Osteoarthritis

Completed·UUniversity of Catanzaro·Phase 4·NCT01860833·90 enrolled

Diclofenac13 trials

Comparison of Diclofenac vs. Nepafenac Ophthalmic Drops: Patient Comfort

Unknown status·WWolfson Medical Center·N/A·NCT02506348·30 enrolled

A Comparative Evaluation of Diclofenac Sodium Transdermal Patch, Oral Diclofenac Sodium With Intramuscular Injections of Diclofenac Sodium in Patients Suffering From Oral Pain

Completed·PPanineeya Mahavidyalaya Institute of Dental Sciences & Research Centre·Phase 4·NCT03221946·90 enrolled

Diclofenac as a KMO Inhibitor

Active, not recruiting·UUniversity of Maryland, Baltimore·Phase 1·NCT06029296·12 enrolled

Show 10 more trials

Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%

Completed·AAnchen Pharmaceuticals, Inc·Phase 3·NCT01456611·749 enrolled

Delayed Release Diclofenac Sodium Formulation vs Voltaren®

Completed·BBDD Pharma Ltd·Phase 1·NCT02714842·36 enrolled

Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief in HSG in a Tertiary Hospital in Kano

Unknown status·—·Phase 4·NCT02918812·140 enrolled

Diclofenac Dose Response Study

Recruiting·UUniversity of Maryland, Baltimore·Phase 1·NCT06636227·24 enrolled

Diclofenac Suppository to Control Pain During Flexible Cystoscopy

Completed·—·Phase 2·NCT01812928·60 enrolled

Comparison Between Diclofenac and Sterile Water Injection for Relief of Labour Associated Bachache

Active, not recruiting·PPakistan Institute of Medical Sciences·N/A·NCT07203651·100 enrolled

Diclofenac add-on to Treatment as Usual for Suicidal Patients

Withdrawn·RRegion Skane·Phase 1/2·NCT01413854

Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin

Terminated·MMayo Clinic·Phase 2/3·NCT00276419·25 enrolled

Diclofenac for Submassive PE

Terminated·MMinistry of Health, Spain·Phase 2/3·NCT01590342·34 enrolled

Contribution of UGT2B17 to the Pharmacokinetics of Diclofenac

Recruiting·WWashington State University·Phase 1·NCT06053411·30 enrolled

Pancreatitis5 trials

Diclofenac for Prevention of Post-ERC Pancreatitis

Not yet recruiting·KKarolinska Institutet·Phase 2/3·NCT03595150·1,000 enrolled

Intramuscular Diclofenac in the Prevention of Post-ERCP Pancreatitis

Completed·YYonsei University·N/A·NCT01717599·343 enrolled

Prevention of Post-ERCP Pancreatitis by Indomethacin Vs Diclofenac

Terminated·—·N/A·NCT05947461·1,204 enrolled

Show 2 more trials

Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Oral N-Acetyl Cysteine Versus Rectal Diclofenac in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Completed·TTanta University·Phase 1/2·NCT06252441·46 enrolled

Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients

Terminated·QQueen's University·Phase 4·NCT00428025·23 enrolled

Sprain4 trials

A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib And Diclofenac In Patients With A Sprained Ankle

Completed· Pfizer logo

Pfizer·Phase 4·NCT00671320·202 enrolled

Topical Treatments for Ankle Sprains

Active, not recruiting·—··NCT06623929·100 enrolled

TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain

Completed·BBiologische Heilmittel Heel GmbH·Phase 3·NCT01066520·449 enrolled

Show 1 more trial

Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident

Terminated·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00894790·8 enrolled

Low back pain4 trials

A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.

Completed·MMontefiore Medical Center·Phase 4·NCT03861611·198 enrolled

Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

Completed·MMontefiore Medical Center·Phase 4·NCT04611529·198 enrolled

Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain

Completed· Pfizer logo

Pfizer·Phase 4·NCT00649610·340 enrolled

Show 1 more trial

Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00640432·244 enrolled

71 more indications

Efficacy and Safety4 trials

Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery

Completed·JJavelin Pharmaceuticals·Phase 3·NCT00448110·331 enrolled

A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac

Completed·HHandok Inc.·Phase 3·NCT04421911·236 enrolled

Assess the Efficacy and Safety in Volunteers of DCF100, TIB200 and SPR300 vs. Placebo and Control(s) in a UV Pain Model

Completed·FFutura Medical Developments Ltd.·Phase 1·NCT02666846·60 enrolled

Show 1 more trial

A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction

Completed· Pfizer logo

Pfizer·Phase 4·NCT00650598·328 enrolled

Hysteroscopy3 trials

Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy:

Unknown status·—·Phase 3·NCT02760888·102 enrolled

Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy

Unknown status·—·Phase 3·NCT02419651·210 enrolled

Tramadol Versus Diclofenac for Prevention of Pain in Operative Outpatient Hysteroscopy

Unknown status·—·Phase 3·NCT02428777·210 enrolled

Renal Colic3 trials

Treatment of Renal Colic in the Emergency Departement (ED).

Completed·UUniversity of Monastir·Phase 2·NCT03199924·600 enrolled

Parecoxib in Renal Colic

Terminated· Pfizer logo

Pfizer·Phase 3·NCT00139646·50 enrolled

Nebulized Salbutamol in Acute Renal Colic

Not yet recruiting·OOman Medical Speciality Board·N/A·NCT06276231·214 enrolled

Rheumatoid Arthritis2 trials

Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis

Approved for marketing·MMallinckrodt··NCT01579890

Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)

Withdrawn·NNorthumbria Healthcare NHS Foundation Trust·Phase 4·NCT01067430

Pain Management2 trials

Efficacy Study of Different Analgesic Options in Kidney Stone Pain Management

Completed·HHamad Medical Corporation·Phase 4·NCT02187614·1,645 enrolled

Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management

Completed·—·Phase 2/3·NCT03178539·100 enrolled

Single Dose2 trials

Relative Bioavailability of Dabigatran and Diclofenac After Dabigatran Etexilate and Diclofenac Single Dose Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02171507·24 enrolled

Efficacy of Single Dose Rectal Diclofenac With Oral Diclofenac for the Relief of Perineal Pain Within 24 Hours After Episiotomy

Completed·FFederal Teaching Hospital Abakaliki·N/A·NCT06220279·146 enrolled

Effectiveness2 trials

Effectiveness and Safety of Breeded Leech for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint

Terminated·—·N/A·NCT03020368·52 enrolled

Effectiveness of Diclofenac and Its Association to Codeine After Lower Third Molar Extraction.

Completed·UUniversity of Sao Paulo·Phase 4·NCT02547896·50 enrolled

Headache2 trials

Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean

Completed·—·Phase 4·NCT03910088·30 enrolled

Diclofenac Administered Before Skull Operations Reduces the Severity of Headache After the Intervention

Completed·UUniversity of Debrecen·Phase 4·NCT01907984·200 enrolled

Pain2 trials

Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease

Recruiting·UUniversity Hospital, Strasbourg, France·Phase 4·NCT06012097·70 enrolled

Efficacy of Pain Control Following Root Canal Treatment Using Paracetamol Alone and in Combination With Three Different Non-Steroidal Anti-Inflammatory Analgesics

Completed·UUniversity of Khartoum·Phase 2·NCT02417337·185 enrolled

Actinic Keratoses2 trials

Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2)

Completed·MMEDA Pharma GmbH & Co. KG·Phase 4·NCT01453179·221 enrolled

Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses

Completed·MMEDA Pharma GmbH & Co. KG·Phase 4·NCT00777127·258 enrolled

Actinic Keratosis2 trials

The Real Life Topical Field Treatment of Actinic Keratosis Study

Completed· LEO Pharma logo

LEO Pharma··NCT02362152·1,168 enrolled

Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head

Completed·UUniversity Hospital Tuebingen·Phase 4·NCT00204542·418 enrolled

Post Operative Pain2 trials

Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative Pain After Elective Knee Surgery

Completed·MMedical University of Vienna·Phase 4·NCT03493490·72 enrolled

Analgesic Equivalence of NSAIDs and a Weak Opioid in Acute Postoperative Pain Following Minimally Invasive Surgery Under Balanced General Anaesthesia: A Pilot Randomised Controlled Trial

Completed·IISSSTE Hospital Regional "Gral. Ignacio Zaragoza"·Preclinical·NCT07500454·30 enrolled

Back pain2 trials

Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department

Completed·SSan Antonio Military Medical Center·N/A·NCT03996564·26 enrolled

Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02700815·746 enrolled

Ankylosing Spondylitis2 trials

Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis

Completed· Pfizer logo

Pfizer·Phase 3·NCT00648141·458 enrolled

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)

Terminated·JJohnson & Johnson Taiwan Ltd·Phase 4·NCT00766402·8 enrolled

Interaction2 trials

Pharmacokinetic Drug Interaction Between YH4808 and Diclofenac

Completed·YYuhan Corporation·Phase 1·NCT01876615·49 enrolled

Dabigatran in an Interaction Probe Drug Cocktail

Completed·TTurku University Hospital·Phase 1·NCT02361619·16 enrolled

Tendinopathy1 trial

"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"

Completed·AArgentine Tennis Association·Phase 4·NCT00792376·56 enrolled

Vascular Function1 trial

Effects of Opioids and NSAIDs on Sympathetic Nervous System and Vascular Function

Recruiting·UUniversity of Zurich·Phase 4·NCT03781544·90 enrolled

Thoracoscopic Surgery1 trial

A Study Investigating Pain Following Single-port or Multi-port Video Assisted Thoracoscopic Surgery

Withdrawn·UUniversity Hospitals Bristol and Weston NHS Foundation Trust·N/A·NCT02556970

Arthritis1 trial

Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

Terminated·—·Phase 4·NCT03473665·9 enrolled

Chest pain1 trial

Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy

Completed·—·Phase 4·NCT00800527·110 enrolled

Pharyngitis1 trial

Efficacy and Safety of Meloxicam Suspension Versus Diclofenac Suspension or Nimesulide Suspension in Patients With a Diagnosis of Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or Laryngitis

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02229747·128 enrolled

Lidocaine Infusion1 trial

Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy

Unknown status·—·N/A·NCT03298646·44 enrolled

Phase 11 trial

Phase 1 Study of the Effects of Combining Topical FDA-approved Drugs on Age-related Pathways on the Skin of Healthy Volunteers

Completed·AAnne Chang·Phase 1·NCT03072485·10 enrolled

Breast Cancer1 trial

Comparative Effectiveness of Acupuncture and Nonsteroidal Anti-inflammatory Drugs for the Management of Aromatase Inhibitor Induced Arthralgia Among Breast Cancer Survivors

Completed·—·N/A·NCT04511832·54 enrolled

Diabetic Retinopathy1 trial

Pharmacological Intervention in Diabetic Retinopathy

Completed·UUniversity of Aarhus·N/A·NCT00619034·87 enrolled

Completed·NNear East University, Turkey·Phase 4·NCT03745599·60 enrolled

Cesarean Delivery1 trial

Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

Completed·DDepartment of Medical Services Ministry of Public Health of Thailand·Phase 4·NCT03039426·120 enrolled

Total Hip Arthroplasty1 trial

Use of Etoricoxib Compared to Diclofenac in the Perioperative Treatment of Patients After Total Hip Arthroplasty

Completed·UUniversity of Regensburg·Phase 3·NCT01229774·100 enrolled

Adjuvant Treatment1 trial

Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study)

Completed·MMikael Lantz·Phase 4·NCT01458600·65 enrolled

Cystoid Macular Edema1 trial

Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%

Completed·BBp Consulting, Inc·Phase 4·NCT00595543·166 enrolled

Celecoxib1 trial

The Standard Care Versus Celecoxib Outcome Trial

Completed·UUniversity of Dundee·Phase 4·NCT00447759·7,297 enrolled

Functional Endoscopic Sinus Surgery1 trial

Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT03605914·100 enrolled

Overweight1 trial

Effect of Reduction of Inflammatory Status on Glucose Metabolism in Overweight Men

Completed·TTNO·N/A·NCT00221052·20 enrolled

Dexamethasone1 trial

Diclofenac vs Dexamethasone in Combined Surgery

Completed·SSheba Medical Center·N/A·NCT00825864·50 enrolled

Indomethacin1 trial

Indomethacin vs Diclofenac for Preventing PEP

Recruiting·—·N/A·NCT07071441·4,050 enrolled

Intravenous1 trial

The Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.

Completed·HHamad Medical Corporation·N/A·NCT01891435·434 enrolled

Platelet Function1 trial

Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers

Completed·JJavelin Pharmaceuticals·Phase 1·NCT00548678·30 enrolled

Dysmenorrhea1 trial

Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea

Completed·—·N/A·NCT03269591·50 enrolled

Caesarean Section1 trial

Rectal Versus Intramuscular Diclofenac for Pain Relief Following Caesarean Section

Completed·AAssumpta Nnenna Nweke·N/A·NCT06845930·60 enrolled

Skin Cancer1 trial

Topical Chemoprevention of Skin Cancer Biomarkers

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT02636569·24 enrolled

Cesarean Section1 trial

Intramuscular Versus Rectal Diclofenac for Pain Relief After Cesarean Section in Women

Completed·—·Phase 4·NCT07379762·60 enrolled

Clinical Trial1 trial

A Clinical Trial to Compare Safety and Effectiveness for Relieving Tenderness of 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel in the Treatment of Strains and Bruises of the Legs.

Completed· Bayer logo

Bayer·Phase 2·NCT05026320·76 enrolled

Inflammation1 trial

Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

Completed· Novartis logo

Novartis·Phase 4·NCT00377806·200 enrolled

Ketorolac1 trial

Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease

Recruiting·UUniversity of Texas Southwestern Medical Center·Phase 1/2·NCT06158620·80 enrolled

Intravitreal Injections1 trial

Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections

Completed·UUniversity Hospital of Patras·N/A·NCT02837770·76 enrolled

Infertility1 trial

Tubal Flushing Using Water Soluble Media for Unexplained Infertility

Unknown status·—·Phase 3·NCT02433418·300 enrolled

Thoracic Paravertebral Block1 trial

Pain Control After Open Radical Nephrectomy: Thoracic Paravertebral Block Versus External Oblique Intercostal Block

Completed·HHacettepe University·N/A·NCT07071012·98 enrolled

Menopausal Women1 trial

Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women

Unknown status·—·Phase 3·NCT02425709·210 enrolled

Treatment1 trial

Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion

Completed·FFrench Cardiology Society·Phase 4·NCT00247052·200 enrolled

Epidural Analgesia1 trial

NSAIDs With Morphine-PCA Compared to Epidural Analgesia in Thoracotomy Pain

Completed·HHelsinki University Central Hospital·N/A·NCT01541137·30 enrolled

Delirium1 trial

Delirium in Elderly Patients With Trauma of the Hip

Terminated·—·Phase 4·NCT02689024·239 enrolled

Microcirculation1 trial

Microcirculation & ASICs

Completed·HHospices Civils de Lyon·N/A·NCT01246180·20 enrolled

Renal Stones1 trial

Tamsulosin as Adjunctive Therapy After Extracorporeal Shock Wave Lithotripsy for Renal Stones

Completed·HHospital Regional de Alta Especialidad del Bajio·Phase 4·NCT04819828·60 enrolled

Kidney Failure1 trial

Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia

Terminated·—·Phase 2·NCT01481610·28 enrolled

Medical Procedure1 trial

Comparative Analysis of Radiotherapeutic and Medical Procedures for the Prophylaxis of Heterotopic Ossifications

Completed·UUniversity of Jena··NCT06251349·512 enrolled

Visual Analogue Scale1 trial

Evaluation of Analgesic Efficacy of Lidocaine and Diclofenac Spray in Radial Artery Blood Gas Sampling by Visual Analogue Scale and Perfusion Index

Active, not recruiting·HHaydarpasa Numune Training and Research Hospital·Phase 4·NCT06918340·150 enrolled

Pilot Study1 trial

Feasibility of n-of-1 Trials - a Pilot Study

Completed·UUniversity of Bristol·Phase 2·NCT00371696·10 enrolled

Hallux valgus1 trial

A Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain

Withdrawn·KKarolinska Institutet·Phase 4·NCT01190722

Satisfaction1 trial

To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine

Completed·HHaEmek Medical Center, Israel·N/A·NCT02440399·200 enrolled

Pain Control1 trial

NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow

Recruiting·TThe Cleveland Clinic·Phase 4·NCT06373978·92 enrolled

Shoulder pain1 trial

Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain

Completed·UUniversity of Debrecen·Phase 4·NCT02445599·3 enrolled

Drug Metabolism1 trial

KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism

Completed·HHelsinki University Central Hospital·N/A·NCT06566794·12 enrolled

Non-steroidal Anti-inflammatory Drugs1 trial

CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs

Completed·EEduardo Barbosa Coelho·Phase 4·NCT02779530·20 enrolled

Local Anesthesia1 trial

Local Anesthesia Versus Combined Local Anesthesia With Single Dose Analgesia on Pain Control During Thoracic Ultrasound Guided Procedures

Unknown status·—·Phase 4·NCT05121233·100 enrolled

Medication1 trial

Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications

Completed·NNorwegian University of Science and Technology·N/A·NCT00476593·218 enrolled

Urinary Tract Infection1 trial

Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting.

Terminated·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT01039545·253 enrolled

Basal Cell Carcinoma1 trial

Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma

Completed·MMaastricht University Medical Center·Phase 2·NCT01358045·128 enrolled

Patients With Advanced Solid Tumors1 trial

Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors

Completed· Novartis logo

Novartis·Phase 1·NCT01596647·39 enrolled

Chronic pain1 trial

Metamizol for the Treatment of Neoplastic Chronic Pain

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02181920·6 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 28, 1988

VOLTAREN

NDA NDA019201

Mar 28, 1991

VOLTAREN

NDA NDA020037

Nov 24, 1993

CATAFLAM

NDA NDA020142

Mar 8, 1996

VOLTAREN-XR

NDA NDA020254

May 4, 1998

DICLOFENAC SODIUM

NDA NDA020809

Oct 16, 2000

SOLARAZE

NDA NDA021005

Oct 17, 2007

VOLTAREN ARTHRITIS PAIN

NDA NDA022122

Jun 16, 2009

ZIPSOR

NDA NDA022202

Jun 17, 2009

CAMBIA

NDA NDA022165

Nov 4, 2009

PENNSAID

NDA NDA020947

Oct 18, 2013

ZORVOLEX

NDA NDA204592

Jan 16, 2014

PENNSAID

NDA NDA204623

Dec 23, 2014

DYLOJECT

NDA NDA022396

Sources

References

[1]
ClinicalTrials.gov — 131 trial records for Diclofenac. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Voltaren drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Diclofenac compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Diclofenac. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022396). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Voltaren. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclooxygenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[6]

Patent Cliff

Mar 22, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8927604Jun 16, 2026

8097651Jun 16, 2026

7759394Jun 16, 2026

9827197Jun 16, 2026

8946292Mar 22, 2027

32 more patents

9168305Oct 17, 2027

9066913Oct 17, 2027

9339551Oct 17, 2027

8871809Oct 17, 2027

9168304Oct 17, 2027

9101591Oct 17, 2027

8563613Oct 17, 2027

9132110Oct 17, 2027

9539335Oct 17, 2027

9339552Oct 17, 2027

9220784Oct 17, 2027

8252838Apr 21, 2028

7884095Feb 24, 2029

8110606Feb 24, 2029

7662858Feb 24, 2029

7939518Feb 24, 2029

8623920Feb 24, 2029

9561200Feb 24, 2029

9415029Jul 10, 2029

9375412Jul 10, 2029

8217078Jul 10, 2029

9370501Jul 10, 2029

8618164Jul 10, 2029

8741956Jul 10, 2029

8679544Apr 23, 2030

9173854Apr 23, 2030

9186328Apr 23, 2030

8999387Apr 23, 2030

9180096Apr 23, 2030

9180095Apr 23, 2030

9017721Apr 23, 2030

8546450Aug 9, 2030

Voltaren

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q4 2028

Trials by Indication[1]

Osteoarthritis15 trials

Diclofenac13 trials

Pancreatitis5 trials

Sprain4 trials

Low back pain4 trials

Efficacy and Safety4 trials

Hysteroscopy3 trials

Renal Colic3 trials

Rheumatoid Arthritis2 trials

Pain Management2 trials

Single Dose2 trials

Effectiveness2 trials

Headache2 trials

Pain2 trials

Actinic Keratoses2 trials

Actinic Keratosis2 trials

Post Operative Pain2 trials

Back pain2 trials

Ankylosing Spondylitis2 trials

Interaction2 trials

Tendinopathy1 trial

Vascular Function1 trial

Thoracoscopic Surgery1 trial

Arthritis1 trial

Chest pain1 trial

Pharyngitis1 trial

Lidocaine Infusion1 trial

Phase 11 trial

Breast Cancer1 trial

Diabetic Retinopathy1 trial

Acute1 trial

Diabetic Macular Edema1 trial

Quality of Life1 trial

Cesarean Delivery1 trial

Total Hip Arthroplasty1 trial

Adjuvant Treatment1 trial

Cystoid Macular Edema1 trial

Celecoxib1 trial

Functional Endoscopic Sinus Surgery1 trial

Overweight1 trial

Dexamethasone1 trial

Indomethacin1 trial

Intravenous1 trial

Platelet Function1 trial

Dysmenorrhea1 trial

Caesarean Section1 trial

Skin Cancer1 trial

Cesarean Section1 trial

Clinical Trial1 trial

Inflammation1 trial

Ketorolac1 trial

Intravitreal Injections1 trial

Infertility1 trial

Thoracic Paravertebral Block1 trial

Menopausal Women1 trial

Treatment1 trial

Epidural Analgesia1 trial

Delirium1 trial

Microcirculation1 trial

Renal Stones1 trial

Kidney Failure1 trial

Medical Procedure1 trial

Visual Analogue Scale1 trial

Pilot Study1 trial

Hallux valgus1 trial

Satisfaction1 trial

Pain Control1 trial

Shoulder pain1 trial

Drug Metabolism1 trial

Non-steroidal Anti-inflammatory Drugs1 trial

Local Anesthesia1 trial

Medication1 trial