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Last update 02 Aug 2026

Diclofenac Sodium

Last update 02 Aug 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryDiclofenac sodium, a benzene-acetic acid derivative, is a nonsteroidal anti-inflammatory drug (NSAID) ,has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of Diclofenac sodium, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). The FDA approved diclofenac sodium as VOLTAREN on July 28, 1988, and its originator was the Ciba-Geigy Corporation, which is now a part of Novartis. This drug has been used for many years to manage a wide range of painful conditions and is widely available in both prescription and over-the-counter formulations.

Drug Type

Small molecule drug

Synonyms

Diclfenac Sodium, Diclofanac Sodium, DICLOFENAC

+ [119]

Target

COXs

Action

inhibitors

Mechanism

COX inhibitors(Cyclooxygenases inhibitors)

Therapeutic Areas

Immune System DiseasesNervous System DiseasesSkin and Musculoskeletal Diseases+ [5]

Active Indication

Soft Tissue InjuriesSoft tissue rheumatismOsteoarthritis+ [26]

Inactive Indication

Actinic KeratosisAdvanced Malignant Solid NeoplasmAnkle Injuries+ [10]

Originator Organization

Novartis Pharma AG

Active Organization

Jiangsu Simiao Pharmaceutical Technology Co., Ltd.

Amzell Ltd.

Dojin Iyaku-Kako Co., Ltd.

+ [12]

Inactive Organization

Nuvo Pharmaceuticals, Inc.

Novartis AG

Novartis Pharmaceuticals Corp.

+ [9]

License Organization

Dr. Reddy's Laboratories Ltd.

Mundipharma International Ltd.

Sayre Therapeutics Pvt Ltd.

+ [9]

Drug Highest PhaseApproved

First Approval Date

Japan (08 Aug 1973),

InflammationPain

Regulation-

Structure/Sequence

Molecular FormulaC14H11Cl2NNaO2

InChIKeyVSFBPYWDRANDLM-UHFFFAOYSA-N

CAS Registry15307-79-6

738

Clinical Trials associated with Diclofenac Sodium

CTRI/2025/12/098816

/ Not yet recruitingNot ApplicableIIT

A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF CHANGERI GHRITA SUPPOSITORY WITH DICLOFENAC SODIUM SUPPOSITORY IN THE MANAGEMENT OF POST OPERATIVE HAEMORRHOIDECTOMY PAIN.

Start Date10 Dec 2026

Sponsor / Collaborator-

NCT07663825

/ Not yet recruitingPhase 2

Acetylsalicylic Acid Versus Placebo as an add-on Treatment to Local Non-steroidal Anti-inflammatory Drug for the Management of Thrombotic Episodes in Superficial Venous Malformations in Children Aged 6 to 17 Years: a Controlled Randomised, Double-blind, Cross-over, Multicenter Trial

Superficial venous malformations (SVMs) are rare congenital anomalies that present as bluish masses. These masses may be focal, with limited skin involvement, or segmental, with more extensive involvement. They may be associated with syndromic conditions such as blue rubber nevus syndrome.
SVMs are characterised by a progressive worsening course, with repeated episodes of superficial venous thrombosis occurring. These episodes become more frequent over time, causing acute, intense and often highly debilitating pain.
To limit progression and in cases of functional impairment, long-term treatments may be offered. These include venous compression, targeted therapies such as mTOR inhibitors, and, where possible, surgical treatment or sclerotherapy.
However, the management of intra-SVM superficial venous thrombosis is not currently standardised, especially in the pediatric population. This study aims to evaluate the benefits of Acetylsalicylic acid (ASA) as an add-on treatment to local non-steroidal anti-inflammatory drug for the management of thrombotic episodes in superficial venous malformations in children aged 6 to 17 years.

Start Date01 Sep 2026

Sponsor / Collaborator-

ChiCTR2600128632

/ Not yet recruitingPhase 4IIT

A Randomized Controlled Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine Emulgel (Voltaren®) in Preventing Postoperative Scar Hyperplasia

Start Date01 Aug 2026

Sponsor / Collaborator-

100 Clinical Results associated with Diclofenac Sodium

100 Translational Medicine associated with Diclofenac Sodium

100 Patents (Medical) associated with Diclofenac Sodium

15,371

Literatures (Medical) associated with Diclofenac Sodium

01 Aug 2026·JOURNAL OF PHARMACEUTICAL SCIENCES

Beeswax sacrificial support and latex curing for high-fidelity semi-solid extrusion 3D printed sustained-release tablets

Article

Author: Zhang, Haozheng ; Yuan, Wenhao ; Yang, Yan ; Saeed, Farhan ; Dong, Qihang ; Tufail, Tabussam ; Chu, Chu ; Xu, Yuhong ; Yang, Chuansheng

Semi-solid extrusion (SSE) 3D printing offers significant potential for fabricating personalized oral dosage forms, thanks to its mild processing conditions. However, post-printing drying often induces structural collapse and deformation due to solvent evaporation, severely compromising geometric fidelity. While freeze-drying can mitigate deformation, it is time-intensive and yields highly porous structures with inferior mechanical strength. This study introduces a dual strategy employing a phase-change sacrificial support and thermal curing to overcome these limitations. A printable matrix was formulated using microcrystalline cellulose and hydroxypropyl methylcellulose (HPMC) as rheological modifiers, with Eudragit® RL 30D aqueous dispersion serving as the sustained-release polymer and beeswax as a sacrificial phase. The optimized tablets demonstrated superior mechanical integrity, with Young's modulus increasing by 67%. During thermal curing at 80°C, the dispersed Eudragit® RL pseudo-latex underwent coalescence and formed an insoluble matrix, creating an insoluble polymeric network that reinforced the structure and modulated drug release. Crucially, beeswax (melting range 62-67°C) provided mechanical support during the critical drying phase at 50°C, preventing structural collapse, before being sacrificially removed during the 80°C curing step. This approach successfully produced high-fidelity, diclofenac sodium-loaded tablets with tunable release profiles governed by the Eudragit® RL-to-HPMC ratio. These findings present a robust strategy for producing dimensionally stable, mechanically strong, and personalized sustained-release formulations via SSE 3D printing.

01 Aug 2026·EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Structure–Permeability relationships of Vitamin-B-Based quaternary ammonium salts for oral drug development

Article

Author: Niemczak, Michał ; Freire, Mara G ; Olejniczak, Adriana

Effective oral drug delivery requires compounds with suitable solubility, permeability, and physicochemical properties to ensure efficient absorption in the gastrointestinal tract. This study evaluates vitamin-derived quaternary ammonium salts (QASs) based on nicotinamide, nicotinic acid, and p-aminobenzoic acid, together with their nonionic counterparts, as potential orally administrable molecules. In silico pharmacokinetic predictions identified nicotinate QASs as the most promising candidates, exhibiting favorable permeability, intestinal absorption, and solubility profiles. PAMPA experiments confirmed high passive permeability for all compounds, with 6-hour P_app values exceeding 1.1·10⁻⁶ cm·s⁻¹, and demonstrated that membrane transport depends strongly on alkyl chain length and counterion identity. Permeability decreased notably for derivatives with octyl chains, whereas nicotinate QASs displayed values comparable to diclofenac sodium, and the shortest-chain p-aminobenzoate and its nonionic analogue slightly surpassed the reference drug. Surface activity analysis revealed that reductions in solution surface tension significantly enhance membrane transport, overriding limitations associated with increased molecular size. Overall, the synergistic influence of alkyl chain length, anion selection, and surface activity underscores the potential of vitamin-derived QASs as tunable, multifunctional candidates for oral drug development.

01 Aug 2026·BIOMEDICAL CHROMATOGRAPHY

Development and Validation of Sensitive RP‐HPLC Bioanalytical Method of Diclofenac Sodium and Its Predictive In‐Silico Physiologically Based Pharmacokinetic Modeling in Hepatic and Renal Impairment

Article

Author: Shoaib, Muhammad Harris ; Siddiqui, Fahad ; Saleem, Muhammad Talha ; Zehravi, Mahrukh ; Yousuf, Rabia Ismail

ABSTRACT:

Diclofenac sodium is a widely prescribed NSAID for inflammatory and rheumatoid diseases, and the dose adjustment, especially for elderly patients suffering from renal or hepatic impairment, is not a routine practice. In this study, a sensitive RP‐HPLC bioanalytical method was developed and validated for quantifying diclofenac in human plasma. After quality assessment of different diclofenac sodium brands, a pharmacokinetic study was performed in 12 healthy human subjects and compared with predicted in silico PBPK models in healthy subjects and in patients with renal or hepatic impairment. The bioanalytical method demonstrated sensitivity and linearity from 20 to 3000 ng/mL, with 99.9% accuracy. Stability tests on plasma samples stored long term and subjected to freeze–thaw cycles showed considerable stability at −20°C. Pharmacokinetic parameters included Cmax , Tmax , AUC0–t and AUC0–∞ . In silico PBPK modelling indicated that routine monitoring might not be necessary for patients with mild to moderate hepatic or renal impairment. However, significantly higher AUC0–t values were observed in severe cases, end‐stage renal disease, cirrhosis B and cirrhosis C, suggesting a need for dose adjustments to mitigate dose‐dependent toxicities. This study provides a comprehensive framework for generic manufacturers, regulatory agencies and clinicians for dose optimization, safety prediction and clinical decision support.

News (Medical) associated with Diclofenac Sodium

01 Jul 2026

·www.businesswire.com

Haleon to Accelerate AI-powered Transformation With New Five-year Microsoft Collaboration

LONDON--(BUSINESS WIRE)--Haleon, a consumer health company solely focused on better everyday health, today announces a new five-year collaboration with Microsoft to scale digital, data and AI capabilities across the business and accelerate delivery of its global Win as One strategy. By combining Microsoft’s cloud and AI capabilities with Haleon’s deep consumer health expertise, we’re accelerating our AI progress — simplifying how we work, unlocking more value from our data, accelerating innovation and helping our teams make faster. The new agreement builds on Haleon’s existing use of Microsoft 365 Copilot and further supports the wider adoption of AI-powered tools across the business, helping teams automate routine tasks, collaborate more effectively and focus on higher-value work. Importantly, it will also further strengthen Haleon’s digital and AI-enabled infrastructure through further adoption of Microsoft’s agentic AI, security and identity capabilities, helping the company to scale AI securely and responsibly. Haleon and Microsoft will co-create high-impact AI use cases which deliver value across multiple critical functions, from consumer insights and innovation to supply chain and commercial execution. This will ultimately enable Haleon to deliver better everyday health to consumers globally, for example, through faster scientific research and clinical content development, enhanced marketing content creation and personalisation, and improved forecasting and decision-making across the business. By harnessing advanced AI capabilities, Haleon will gain deeper insights into evolving consumer needs, drive product innovation at pace, and streamline operations from supply chain through to commercial execution. This will enable Haleon to meet rising consumer demand more quickly, offer personalised health products, and ensure its trusted, science-backed brands are available in the right place, at the right time, to millions more people globally. In turn, this will support Haleon’s global ambitions of reaching one billion more consumers by 2030 and delivering industry-leading shareholder returns. Claire Dickson, Chief Digital and Technology Officer, Haleon, said: “This collaboration marks a major step forward in how we use digital, data and AI to deliver our global strategy - driving growth, improving productivity and building a more agile, performance-focused culture. We’re already embedding AI capabilities across the business, delivering measurable results and efficiencies in areas including consumer insights, marketing, R&D and supply chain. By combining Microsoft’s cloud and AI capabilities with Haleon’s deep consumer health expertise, we’re accelerating our AI progress — simplifying how we work, unlocking more value from our data, accelerating innovation and helping our teams make faster, smarter decisions to benefit our consumers.” Darren Hardman, CEO, Microsoft UK & Ireland, said: “Haleon is moving with real pace and purpose on its AI journey, using Microsoft cloud and AI capabilities to turn ambition into impact across the entire organisation. From consumer insights and marketing to R&D, supply chain and decision-making, Haleon is already showing how AI can help teams work smarter, innovate faster and deliver meaningful benefits for consumers. We’re proud to support Haleon as it scales AI securely and responsibly, helping the company unlock more value from its data and accelerate its mission to deliver better everyday health to millions more people around the world.” By using Microsoft Azure as its core cloud platform and Microsoft Copilot as part of its enterprise AI foundations, Haleon will benefit from scalable infrastructure, advanced analytics and Microsoft’s enterprise-grade security capabilities. This includes strengthened identity, governance and threat protection to help safeguard data, systems and AI-powered workflows as Haleon deploys AI responsibly, safely and at scale. The agreement supports Haleon’s ambition to build an AI-powered, decision-intelligent enterprise, where data and insights flow seamlessly to enable faster, smarter, more consumer-centric decisions. This includes advancing next-generation agentic AI capabilities, to allow Haleon’s digital and technology teams to manage, govern and secure intelligent digital agents. These agents will work alongside Haleon’s teams to help them spot opportunities earlier, respond more quickly, and deliver better outcomes for consumers, customers and health professionals. About Haleon Haleon (LSE/NYSE: HLN) is a consumer company that is solely focused on better everyday health. Our people, our brands, our research, our investment and our innovation are aimed at improving the everyday health of consumers. Our product portfolio spans six major categories - Oral Health, Vitamins, Minerals and Supplements (VMS), Pain Relief, Respiratory Health, Digestive Health and Therapeutic Skin Health and Other. Our superior brands - such as Advil, Centrum, Otrivin, Panadol, parodontax, Polident, Sensodyne, Theraflu and Voltaren – are trusted by more than one billion consumers and are recommended by health professionals around the world. For more information, please visit www.haleon.com.

13 May 2026

·www.fiercepharma.com

Haleon tackles sports injuries with latest soccer play

The Haleon initiatives are part of the broader embrace of soccer by the pharma industry. Haleon has completed a hat-trick of recent soccer initiatives, inking a pain management partnership with the organization responsible for protecting the health and safety of players in Europe. London-based Haleon, a consumer health company that spun out of GSK in 2022, struck a deal in March to make its painkiller Voltaren an official UEFA Champions League licensed product. The next month, the company began a soccer-focused marketing campaign for Voltaren and other products as part of its pact with the U.S. Soccer Federation.Haleon’s latest deal adds another strand to its relationship with UEFA. The agreement makes Haleon the first health partner of UEFA Medical, the organization tasked with protecting the health and safety of everyone involved in European soccer. Through the multiyear scientific partnership, Haleon and UEFA Medical aim to strengthen the scientific understanding of pain management and recovery across football and other sports. The collaboration will include educational tools such as webinars and digital learning modules. The company’s role in the alliance is “to bring medical expertise that strengthens the scientific guidance available to healthcare professionals managing pain in active individuals,” Eran Gefen, head of medical and scientific affairs, OTC at Haleon, said in a statement. Haleon and UEFA Medical recently co-authored an analysis of the use of non-steroidal anti-inflammatory drugs—a class that includes Voltaren—to provide early pain relief in sports injuries. The analysis was the first evidence jointly developed by the organizations and “helps lay a stronger scientific foundation for future guidance,” Haleon said.The Haleon initiatives are part of the broader embrace of soccer by the pharma industry in the year that the World Cup comes to North America. This year, Bristol Myers Squibb has run ads starring a U.S. Soccer Hall of Famer and drawing a link between the sport and drug development, while Sanofi backed Boston’s preparations to host World Cup matches and Amgen penned a sports pact with Los Angeles.

30 Apr 2026

·www.biospace.com

YARAL Pharma Launches 15-Count Diclofenac Epolamine Topical System 1.3%, Offering Pharmacists a Flexible, Space-Saving Option

Compact packaging helps simplify storage, ease inventory concerns, and make daily pharmacy operations more manageable PARSIPPANY, N.J.--(BUSINESS WIRE)-- YARAL Pharma Inc. (YARAL Pharma), the rapidly growing U.S. generics subsidiary of IBSA (Institut Biochimique SA), today announced that its Diclofenac Epolamine Topical System 1.3% , the authorized generic of Flector ® (diclofenac epolamine) topical system 1.3%, is now available in a 15-count carton. Designed to meet the operational needs of today’s pharmacies, the new 15-count configuration helps pharmacists reduce clutter, optimize storage space, and manage inventory with greater flexibility, while continuing to provide patients with the same trusted therapy. “As pharmacy shelves, drawers, and bins become increasingly crowded, thoughtful packaging makes a difference,” said Stephen Beckman, CEO of YARAL Pharma. “Our 15-count Diclofenac Epolamine Topical System delivers the same product patients and pharmacists rely on, now in a smaller footprint that can save up to 50% of shelf space compared to the 30-count carton.” With its compact size and practical design, the 15-count Diclofenac Epolamine Topical System offers several advantages for pharmacies: Space-Saving & Organized Storage – A smaller carton height reduces clutter, simplifies stacking, and fits easily into limited shelf, drawer, or bin space. Streamlined Workflow – Easier to locate, stock, and access during daily operations, helping reduce time spent managing inventory. Flexible Inventory Management – The smaller pack size supports more efficient stocking, helps prevent over-ordering, and allows pharmacies to better match inventory to demand – especially when space is limited. Product Information YARAL Pharma’s Diclofenac Epolamine Topical System 1.3% is a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. Product NDC Number Dimensions 15-Count (3 envelopes per carton) * NDC 82347-0405-6 8.25” x 6.124” x 1.375” 30-Count (6 envelopes per carton) * NDC 82347-0405-5 8.25” x 6.124” x 2.375” *Packaged 5 topical systems per envelope YARAL Pharma’s Diclofenac Epolamine Topical System 1.3% 15-count is now available. For more information, email info@yaralpharma.com or call (866) 218-9009. USE DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is prescription medication that is applied to the skin to treat acute pain from minor strains, sprains, and contusions (bruises) in adults and pediatric patients 6 years and older. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% contains diclofenac epolamine (a non-steroidal anti-inflammatory drug or NSAID). IMPORTANT SAFETY INFORMATION What is the most important information I should know about DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%? DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drugs (NSAID). NSAIDs can cause an increased risk of heart attack or stroke that can lead to death. This may happen early in treatment and may increase with increasing doses of NSAIDs and with longer use of NSAIDs. Do not take DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% right before or after a heart surgery called “coronary artery bypass graft” (CABG). Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. NSAIDs can cause an increased risk of bleeding, ulcers, and tears (perforation) of the esophagus, stomach, and intestines: at any time during treatment without warning may cause death. The risk of getting an ulcer or bleeding increases with: a history of stomach ulcers, or stomach or intestinal bleeding with the use of NSAIDs taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDS should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed Who should not take DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%? Do NOT take DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% if you have a known hypersensitivity reaction to diclofenac or any component of the drug product. Do NOT take DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% if you have had an asthma attack, hives, or other allergic reactions to aspirin or any other NSAID medicine. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% should never be used right before or after heart bypass surgery. Do NOT apply DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% to open wounds, cuts, burns, infected, or damaged skin. Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after 30 weeks of pregnancy. are breastfeeding or plan to breast feed. Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements . NSAIDs and some other medicines can interact with each other and cause serious side effects. Avoid using DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% with other NSAIDs or salicylates (e.g., diflunisal, salsalate). NSAIDs may be available as over-the-counter medications for treatment of colds, fever, or insomnia. Do not start taking any new medicine without talking with your healthcare provider first. Especially tell your doctor if you take: aspirin--Do not use low dose aspirin with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% until you talk to your healthcare provider. any anticoagulant medicine such as warfarin steroid medications including corticosteroids antidepressant medicines including “SSRIs” or “SNRIs” Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. What are the possible side effects of NSAIDs? See “What is the most important information I should know about DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%?” NSAIDs can cause serious side effects, including: new or worse high blood pressure heart failure liver problems including liver failure kidney problems including kidney failure low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness The most common side effects of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% were itching and nausea in adults, and headache and itching in pediatric patients. Get emergency help right away if you get any of the following symptoms: shortness of breath or trouble breathing, slurred speech, chest pain, swelling of the face or throat, or weakness in one part or side of your body. Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: nausea vomit blood more tired or weaker than usual there is blood in your bowel movement, or it is black and sticky like tar diarrhea itching unusual weight gain your skin or eyes look yellow skin rash or blisters with fever indigestion or stomach pain swelling of the arms, legs, hands, and feet flu-like symptoms If you take too much of your NSAID, call your healthcare provider or get medical help right away. These are not all the possible side effects of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% or NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs or for advice about side effects. You are encouraged to report side effects to YARAL Pharma Professional Information Service at 1-866-218-9009 or FDA at 1-800-FDA-1088 or . Please see the Full Prescribing Information, including BOXED WARNING and Patient Information at About YARAL Pharma YARAL Pharma Inc. (Parsippany, N.J.) is the U.S. generics subsidiary of IBSA, a global pharmaceutical company headquartered in Switzerland. By focusing on people and innovating the ways they’re cared for, YARAL Pharma is proud to offer the same values and expertise of its parent company to the U.S. market. Dedicated to ensuring access to affordable authorized generics (AGs) and complex generic medicines that enhance healthcare outcomes, YARAL Pharma offers its customers high-quality products across a range of therapeutic areas, continuity of supply, and a commitment to exceptional customer service. For more information, visit or contact info@yaralpharma.com or 866-218-9009. About IBSA IBSA (Institut Biochimique SA) is a Swiss pharmaceutical multinational with 20 subsidiaries across Europe, China, and the United States. Its products are available in over 90 countries, and its R&D activities focus on 10 therapeutic areas. In 2025, IBSA celebrated the 40 th anniversary of its acquisition by current President and CEO, Arturo Licenziati, who has transformed the company into a multinational corporation employing over 2,500 personnel worldwide. IBSA’s growth and development can be attributed to its ability to innovate by refining well-known molecules, as well as to its commitment to looking to the future responsibly and transparently, thanks to the dedication and dynamism of its people. Flector ® is a registered trademark of IBSA Institut Biochimique S.A. YPM-1500-EN-v1 Contacts Media Daina Basile Kovak-Likly Communications dbasile@klcpr.com

Acquisition

100 Deals associated with Diclofenac Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D00904	Diclofenac Sodium	M02AA15 D11AX18 M01AB05	DB00586

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Soft Tissue Injuries	Australia	Arrotex Pharmaceuticals Pty Ltd.	22 Apr 2026
Soft tissue rheumatism	Australia	Arrotex Pharmaceuticals Pty Ltd.	22 Apr 2026
Osteoarthritis, Knee	United States	Horizon Therapeutics Ireland DAC	16 Jan 2014
Osteoarthritis	Japan	Dojin Iyaku-Kako Co., Ltd.	27 Feb 2004
Periarthritis	Japan	Dojin Iyaku-Kako Co., Ltd.	27 Feb 2004
Tenosynovitis	Japan	Dojin Iyaku-Kako Co., Ltd.	27 Feb 2004
Actinic Keratosis	United States	E Fougera & Co	16 Oct 2000
Actinic Keratosis	United States	Fougera Pharmaceuticals, Inc.	16 Oct 2000
Hypersensitivity	United States	E Fougera & Co	16 Oct 2000
Hypersensitivity	United States	Fougera Pharmaceuticals, Inc.	16 Oct 2000
Pregnancy	United States	Fougera Pharmaceuticals, Inc.	16 Oct 2000
Pregnancy	United States	E Fougera & Co	16 Oct 2000
Visible Lesion	United States	Fougera Pharmaceuticals, Inc.	16 Oct 2000
Visible Lesion	United States	E Fougera & Co	16 Oct 2000
Bursitis	Japan	Hisamitsu Pharmaceutical Co., Inc.	28 Jan 2000
Cancer Pain	Japan	Hisamitsu Pharmaceutical Co., Inc.	28 Jan 2000
Cervicobrachial syndrome	Japan	Hisamitsu Pharmaceutical Co., Inc.	28 Jan 2000
Low Back Pain	Japan	Hisamitsu Pharmaceutical Co., Inc.	28 Jan 2000
Tendinopathy	Japan	Hisamitsu Pharmaceutical Co., Inc.	28 Jan 2000
Post procedural inflammation	Japan	Wakamoto Pharmaceutical Co., Ltd.	31 Mar 1989

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Myalgia	Phase 3	United States	Novartis AG	01 Oct 2014
Contusions	Phase 3	Germany	Novartis AG	01 Jan 2011
Limb injury	Phase 3	Germany	Novartis AG	01 Jan 2011
Ankle Injuries	Phase 3	United States	Novartis AG	01 Nov 2010
Chronic pelvic pain syndrome	Phase 3	France	Novartis AG	01 Nov 2006
Sunburn	Phase 3	France	Novartis AG	01 Nov 2006
Accidental Injuries	Phase 1	China	Sichuan Tiande Pharmaceutical Co. Ltd.	14 Oct 2022
Arthritis, Gouty	Phase 1	China	Sichuan Tiande Pharmaceutical Co. Ltd.	14 Oct 2022
Fever	Phase 1	China	Sichuan Tiande Pharmaceutical Co. Ltd.	14 Oct 2022
Headache	Phase 1	China	Sichuan Tiande Pharmaceutical Co. Ltd.	14 Oct 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06693648 (AMZ001, CTgov)	Phase 3	Pain \| Osteoarthritis, Knee	549	AMZ001 Diclofenac gel (AMZ001 Diclofenac Gel)	yyfurisrhh(tdzdkzbskp) = lhufnskifq jipkxveowk (iwuwwqfeqw, iaoumylbag - hnyedvooxv) View more	-	15 Jul 2026
				Placebo gel (Placebo Gel)	yyfurisrhh(tdzdkzbskp) = ezqllwdphf jipkxveowk (iwuwwqfeqw, cfefkkfltw - katavmimjy) View more
NCT02417337 (NSAID, CTgov)	Phase 2	Pulpitis \| Pain, Postoperative	185	Paracetamol (Group I)	mtpsivobwl(vyaywqomve) = nbueemwyqi hegktfryro (eyledhbdjj, hozqfrtsef - zbeivtyjkn) View more	-	25 Jun 2026
				Paracetamol+Ibuprofen (Group II)	mtpsivobwl(vyaywqomve) = yfwgivjfrq hegktfryro (eyledhbdjj, afysxbgxlf - heqflxiuqk) View more
NCT06954181 (CTgov)	Not Applicable	-	33	Voltaren (Voltaren® Schmerzgel Forte; 2.32% Applied With Applicator (Method 3))	gzpsgxyjkk(debfiteuem) = fczfdeurps wfffttbtfd (ddqrntneut, 0.02) View more	-	16 Jun 2026
				Voltaren (Voltaren® Schmerzgel Forte; 2.32% Applied Without Applicator (Method 1))	vyxmcibfvm(velpvfksfz) = kcwarceptw crtthykexg (xoawegxory, uahgqbavcs - wdmmrldeoh) View more
NCT06918340 (Pubmed \| J Emerg Med)	Phase 4	Pain	150	10% Lidocaine	efitazdrif(ojliydraka) = dxdmpwrkec yauktmywdj (pzopwytecq, 2.09)	Negative	01 Feb 2026
				1% Diclofenac	efitazdrif(ojliydraka) = bqfjyghhht yauktmywdj (pzopwytecq, 2.7)
NCT06379893 (CTgov)	Phase 4	Pain \| Osteoarthritis, Knee	196	Voltaren Gel	oaloqgsdsl(xjzfalneqt) = piplfiatdo xaczypfofp (pcbxvxcdwi, 92.99) View more	-	20 Jan 2026
NCT06729073 (AMZ001, CTgov)	Phase 1	-	34	Diclofenac sodium gel (AMZ001)	hmyalmwyxb(evbcsjctwb) = zlgylsqdqw weoiwdcjvc (ntjanfubsj, 67.1) View more	-	06 Jan 2026
				Diclofenac diethylamine 1.16% gel (Diclofenac Diethylamine 1.16%)	hmyalmwyxb(evbcsjctwb) = eoqrosarwp weoiwdcjvc (ntjanfubsj, 57.2) View more
NCT04199572 (Pubmed \| Pain Res Manag)	Phase 4	Limb injury	162	Diclofenac + Oral Paracetamol	hqfhucghcu(qdcvbioszl) = no adverse events were reported in any group isfqycgipl (ojqlssnttd ) View more	Negative	01 Jan 2026
				Diclofenac + Placebo
NCT06632015 (Pubmed \| Odontology)	Not Applicable	Pain	90	Calcium hydroxide	qonnvwswrj(idvywbvxiu) = DCS was more effective at reducing post-treatment pain when used alone than were DCH + CH and CH (p < 0.05). uzygozprvi (oednxzaalf ) View more	Positive	09 Nov 2025
				Diclofenac sodium
NCT04552327 (Pubmed \| J Eur Acad Dermatol Venereol)	Phase 3	Actinic Keratosis	631	KOH 5% solution	qsmutnsnjq(mijofqpwcu) = iovnkuopda pfrdoanxgr (goyjkelbea ) View more	Positive	25 Sep 2025
				Diclofenac 3% gel	qsmutnsnjq(mijofqpwcu) = vtjumhjzal pfrdoanxgr (goyjkelbea ) View more
NCT04683627 (CTgov)	Phase 3	Osteoarthritis, Knee	370	Diclofenac sodium active topical patch (HP-5000 Treatment)	nvprmvthnj(tvccbrizne) = mhlclwbkky rbdumufgka (ydvazmrrtn, 0.26) View more	-	04 Sep 2025
				Placebo patch (Placebo Treatment)	nvprmvthnj(tvccbrizne) = tgyxzqjxcs rbdumufgka (ydvazmrrtn, 0.26) View more

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