Voltaren

(Diclofenac sodium)

ApprovedSmall molecule

Diclofenac sodium is used to reduce pain, swelling, and inflammation from conditions like arthritis, menstrual cramps, and injuries. It works by blocking pain signals and reducing inflammation in the body.[2] Voltaren is currently approved and in use across 13 indications[4].[1]

Voltaren is one of 218 small molecule programs targeting Osteoarthritis, Hand. It is currently in Approved.

Indications

Total Trials

Active Trials

217

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Osteoarthritis, HandActive, not recruiting

Rheumatoid ArthritisUnknown

HemorrhageUnknown

Duodenal UlcerUnknown

Back PainActive, not recruiting

HemorrhoidActive, not recruiting

Renal ColicActive, not recruiting

DermatitisActive, not recruiting

Cholecystitis, ChronicCompleted

Breast CancerActive, not recruiting

Osteoarthritis, HandPreclinical

Active, not recruiting

Rheumatoid ArthritisPreclinical

Unknown

HemorrhagePreclinical

Unknown

Duodenal UlcerPreclinical

Unknown

Back PainPreclinical

Active, not recruiting

HemorrhoidPreclinical

Active, not recruiting

Renal ColicPreclinical

Active, not recruiting

DermatitisPreclinical

Active, not recruiting

Cholecystitis, ChronicPreclinical

Completed

Breast CancerApproved

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Voltaren

Novartis

Approved

1 2

Adenocard

Astellas

Preclinical

2 3

Lexiscan

Astellas

Preclinical

1 4

Voltaren

Novartis

Preclinical

1 5

Zolymbus

AbbVie

Preclinical

1 6

Blenoxane

Bristol-Myers Squibb

Preclinical

1 7

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 8

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 9

Duragesic-100

CCephalon

Preclinical

2 10

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

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

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Dermatitis

NCT06905561

Clinical

Trials by Indication[1]

Diclofenac14 trials

Counterpain PXM Versus Diclofenac Versus Piroxicam

Completed·TTaisho Pharmaceutical Indonesia·Phase 3·NCT07475663·180 enrolled

Comparison of Diclofenac Systemic Exposure From Two Different Products (AMZ001 and Diclofenac Diethylammonium 1.16% Gel) in Healthy Participants After Repeated Topical Administrations for 7 Days.

Completed·AAmzell·Phase 1·NCT06729073·34 enrolled

Oral Diclofenac Sodium Versus Oral Hyoscine Butyl Bromide During Intrauterine Device Insertion

Completed·—·Phase 4·NCT02714231·100 enrolled

Show 11 more trials

Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium

Completed·JJavelin Pharmaceuticals·Phase 1·NCT00474136·36 enrolled

To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets

Completed· Novartis logo

Novartis·Phase 1·NCT00913224·38 enrolled

Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants

Completed·AAmzell·Phase 1·NCT05968482·74 enrolled

Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate

Completed·BBrown, Theodore R., M.D., MPH·Phase 4·NCT01454791·40 enrolled

Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium

Completed·JJavelin Pharmaceuticals·Phase 1·NCT00509743·89 enrolled

Evaluation of Bioavailability of Diclofenac Dermal Products

Completed·UUniversity of Maryland, Baltimore·Phase 1·NCT03145259·12 enrolled

Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

Unknown status·—·N/A·NCT04331210·1,024 enrolled

Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)

Completed·CCerimon Pharmaceuticals·Phase 3·NCT00931866·407 enrolled

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

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT03074162·48 enrolled

Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium

Completed· GSK logo

GSK·Phase 1·NCT02201238·18 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

Osteoarthritis4 trials

Moxibustion in Osteoarthritis of the Knee

Completed·—·Phase 3·NCT02769572·144 enrolled

Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis

Completed· Novartis logo

Novartis·Phase 3·NCT00426621·420 enrolled

Effectiveness and Safety of Sphaeralcea Angustifolia Standardized Extract as a Topical Treatment of Knee Osteoarthritis

Unknown status·CCoordinación de Investigación en Salud, Mexico·Phase 2·NCT04511195·100 enrolled

Show 1 more trial

Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis

Unknown status·GGuang'anmen Hospital of China Academy of Chinese Medical Sciences·N/A·NCT04402047·108 enrolled

Sprain4 trials

Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion

Completed·CCerimon Pharmaceuticals·Phase 3·NCT00869063·214 enrolled

Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain

Completed·CCerimon Pharmaceuticals·Phase 3·NCT00869180·219 enrolled

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain

Completed· Novartis logo

Novartis·Phase 3·NCT01272934·205 enrolled

Show 1 more trial

Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

Terminated·CCerimon Pharmaceuticals·Phase 2/3·NCT00640705·170 enrolled

Actinic Keratosis3 trials

Therapeutic Equivalence of Diclofenac Sodium Gel 3% vs Solaraze ® in the Treatment of Actinic Keratosis

Completed·EEncube Ethicals Pvt. Ltd.·Phase 3·NCT03826550·655 enrolled

A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis

Completed·AActavis Inc.·Phase 3·NCT01962987·476 enrolled

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

Completed· Teva logo

Teva·Phase 3·NCT02611804·492 enrolled

Post Operative Pain2 trials

Gabapentin and Diclofenac Sodium Comparison for Post-Operative Pain Relief

Completed·MMuhammad Aamir Latif·N/A·NCT07267182·240 enrolled

Effect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp.

Unknown status·—·Phase 1·NCT05582421·30 enrolled

38 more indications

Interaction2 trials

Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac

Completed·GGrünenthal GmbH·Phase 1·NCT03766984·36 enrolled

Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers

Completed·ZZambon SpA·Phase 1·NCT02495831·24 enrolled

Fibroma1 trial

Use of Topical Liquid Diclofenac Following Laser Microporation of Cutaneous Neurofibromas in Patients With NF1

Completed·FFundação Educacional Serra dos Órgãos·Phase 2·NCT03090971·7 enrolled

Hemorrhoid1 trial

Various Strategies to Reduce Acute Post Hemorrhoidectomy Pain: A Comparative Study

Completed·ZZagazig University·N/A·NCT06307106·150 enrolled

Post-surgical Pain1 trial

Effect of Local Use of Non-steroidal Anti-inflammatory Agent (Diclofenac Sodium) With and Without Hyaluronidase on Post-surgical Pain and Swelling

Not yet recruiting·MMariam Hesham Mahmoud Abdelfattah Eissa·N/A·NCT07101016·44 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

Pain Management1 trial

Pain Management After Free Gingival Graft Surgery

Completed·IIstanbul Aydın University··NCT06675734·30 enrolled

Tics1 trial

Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel

Completed·MMallinckrodt·Phase 1·NCT01202799·30 enrolled

Low back pain1 trial

To Evaluate the Superiority of Fixed Combination (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to Voltaren® (Diclofenac Sodium 50mg) in the Treatment of Acute Postural Low Back Pain.

Unknown status·AAche Laboratorios Farmaceuticos S.A.·Phase 3·NCT02985671·110 enrolled

Analgesic Efficacy1 trial

Analgesic Efficacy of Arnica Montana in Comparison With Diclofenac Sodium Following a Periodontal Surgical Procedure

Completed·TTatyasaheb Kore Dental College·N/A·NCT03520595·60 enrolled

Post-endodontic Pain1 trial

Effect of DCS on Post-Endodontic Pain

Completed·MMustafa Kemal University·N/A·NCT06632015·90 enrolled

Acetaminophen1 trial

Comparison Between Rectal Suppository Acetaminophen and Diclofenac Sodium as Analgesia for Postpartum Perineal Tear

Completed·—·Phase 2·NCT03041779·909 enrolled

Arthritis1 trial

The Clinical Study on Treating Acute Gouty Arthritis Using Both Internal and External Therapy of Tonifying Spleen and Descending Turbid

Unknown status·—·Phase 2·NCT02545777·120 enrolled

Renal Colic1 trial

Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic

Not yet recruiting·SSuez Canal University·N/A·NCT06342648·570 enrolled

Postoperative Pain Management1 trial

Effect of Genetic Polymorphisms on Response to Preoperative NSAIDs in Endodontic Postoperative Pain Management

Recruiting·—·N/A·NCT06937853·200 enrolled

Breast Cancer1 trial

Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia

Completed·OOsijek University Hospital·Phase 4·NCT05829707·120 enrolled

Skin1 trial

A Safety Study to Investigate the Skin Sensitization Potential of MFC51123

Completed· GSK logo

GSK·Phase 1·NCT02192203·227 enrolled

Bursitis1 trial

Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

Completed·CCerimon Pharmaceuticals·Phase 2/3·NCT00640939·308 enrolled

Analgesia1 trial

The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy

Unknown status·TTaha Uçar·Phase 4·NCT03831321·144 enrolled

Renal insufficiency1 trial

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

Completed·JJavelin Pharmaceuticals·Phase 1·NCT00805090·37 enrolled

Dermatitis1 trial

Topical Diclofenac for Prevention of Radiation-induced Dermatitis

Recruiting·—·N/A·NCT06905561·156 enrolled

Hand Surgery1 trial

Effects of Systemic or Adjunct Tramadol Addition to Lidocaine Used for IVRA in Patients Undergoing Hand Surgery

Completed·—·Phase 3·NCT02658721·60 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries

Completed· Novartis logo

Novartis·Phase 3·NCT01272947·204 enrolled

Lidocaine Infusion1 trial

Lidocaine Infusion in Hystroscopy

Completed·—·Phase 2·NCT03825016·44 enrolled

Preoperative1 trial

Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block.

Completed·FFarjad Zafar·Phase 4·NCT05488925·120 enrolled

Dental Pain1 trial

Injectable Diclofenac for the Prevention of Post-operative Dental Pain

Completed·IIBSA Institut Biochimique SA·Phase 2·NCT01706588·75 enrolled

Intracanal Medicament1 trial

The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament

Recruiting·—·Phase 2/3·NCT06207253·48 enrolled

Otitis Externa1 trial

Topical Voltaren in Otitis Externa

Terminated·SSieff Medical Center·Phase 2·NCT00523120·20 enrolled

Back pain1 trial

The Incidence of Thoracic Disc Herniation in Patients Presenting With Chronic Upper Back Pain

Completed·KKocaeli University··NCT05313997·194 enrolled

Third Molar Surgery1 trial

Comparison of the Use of Dexamethasone and Diclofenac Sodium in Immediate Post-Operative Care in Third Molar Surgery

Unknown status·—·N/A·NCT02698306·30 enrolled

Function1 trial

Penile Fracture: A Comparison of Erectile Function After Immediate Repair Versus Delayed Repair

Completed·MMinistry of Health, Jamaica·N/A·NCT03449940·46 enrolled

Dysmenorrhea1 trial

A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea

Completed·PPamukkale University·Phase 4·NCT02253446·400 enrolled

Acupuncture1 trial

Evaluating Acupuncture Relationship With the Catecholaminergic Pathway

Completed·—·N/A·NCT02876432·30 enrolled

Effectiveness1 trial

Comparative Evaluation of the Effectiveness of Diclofenac Sodium Versus Vitamin D on Myofascial Pain

Completed·YYuzuncu Yil University·Phase 4·NCT06111573·40 enrolled

Sciatica1 trial

COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA

Completed·PPakistan Institute of Medical Sciences·Phase 3·NCT05626140·120 enrolled

Clinical Trial1 trial

Clinical Trial Comparing Intravenous and Oral Diclofenac and Pharmacokinetics

Unknown status·HHamad Medical Corporation·Phase 4·NCT03472339·300 enrolled

Caesarean Section1 trial

Intrathecal Levobupivacaine With Opioids for Caesarean Section

Completed·—·Phase 3·NCT01858090·93 enrolled

Local Anesthesia1 trial

Efficacy of Preprocedural Diclofenac in Males Undergoing Double J Stent Removal Under Local Anesthesia

Completed·—·Phase 2·NCT02598102·150 enrolled

Cholecystitis, Chronic1 trial

Comparative Study Between the Efficacy of Pre- Operative Oral Gabapentin Versus Diclofenac Sodium in Post-operative Analgesia in Adult Undergoing Laparoscopic Cholecystectomy

Completed·SSohag University·Preclinical·NCT07131527·60 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 — 66 trial records for Diclofenac sodium. 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 sodium compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Diclofenac sodium. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022396). U.S. Food & Drug Administration.
[6]
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

Voltaren

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Diclofenac14 trials

Osteoarthritis4 trials

Sprain4 trials

Actinic Keratosis3 trials

Post Operative Pain2 trials

Interaction2 trials

Fibroma1 trial

Hemorrhoid1 trial

Post-surgical Pain1 trial

Platelet Function1 trial

Pain Management1 trial

Tics1 trial

Low back pain1 trial

Analgesic Efficacy1 trial

Post-endodontic Pain1 trial

Acetaminophen1 trial

Arthritis1 trial

Renal Colic1 trial

Postoperative Pain Management1 trial

Breast Cancer1 trial

Skin1 trial

Bursitis1 trial

Analgesia1 trial

Renal insufficiency1 trial

Dermatitis1 trial

Hand Surgery1 trial

Efficacy and Safety1 trial

Lidocaine Infusion1 trial

Preoperative1 trial

Dental Pain1 trial

Intracanal Medicament1 trial

Otitis Externa1 trial

Back pain1 trial

Third Molar Surgery1 trial

Function1 trial

Dysmenorrhea1 trial

Acupuncture1 trial

Effectiveness1 trial

Sciatica1 trial

Clinical Trial1 trial

Caesarean Section1 trial

Local Anesthesia1 trial

Cholecystitis, Chronic1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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