CLINICAL TRIALS PROFILE FOR DICLOFENAC POTASSIUM

All Clinical Trials for DICLOFENAC POTASSIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00474136 ↗	Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium	Completed	Javelin Pharmaceuticals	Phase 1	2007-03-01	The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product.
NCT01009021 ↗	Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy	Completed	University of Sao Paulo	N/A	2008-03-01	The purpose of this study was to evaluate the analgesic effect of oral potassium diclofenac in patients with proliferative diabetic retinopathy submitted to retinal photocoagulation. Two groups of patients were followed and the effect of the treatment (diclofenac plus laser) was compared to placebo (placebo plus laser). Pain associated with treatment was recorded using a Visual Analog Scale 15 minutes after the procedure.
NCT01019980 ↗	Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections	Terminated	Novartis Pharmaceuticals	Phase 4	2010-03-01	The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg) is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of fever during 2 hours, in the treatment of febrile children with acute upper respiratory infections. This is a comparative double blind, double dummy, randomized study on the effectiveness of Diclofenac potassium versus Acetaminophen in febrile children with acute upper respiratory tract infections. The patient will be randomized to either group: Group A (Diclofenac potassium (0.5 mg/kg) or Group B (Acetaminophen (10 mg/kg)). A Health Care Professional trained will measure the temperature during 2 hours. During the study period, parents or legal representatives will be invited to fill a survey about the habits and knowledge regarding fever management at home.
NCT01257126 ↗	Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection	Withdrawn	Novartis Pharmaceuticals	Phase 4	2011-04-01	This is a local, phase IV, open-label, randomized, head to head study of children aged 3 to 7 years. The objective of the study is to compare the efficacy of a single dose of both diclofenac potassium and nimesulide in the reduction of fever and pain secondary to upper respiratory tract infection.
NCT01458600 ↗	Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study)	Completed	Mikael Lantz	Phase 4	2006-09-01	AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves´ disease Background - Already at diagnosis of Graves disease approximately 98% of the patients have morphological changes of the retrobulbar tissue concordant with ophthalmopathy. Factors known to induce clinical symptoms of ophthalmopathy are mainly unknown. An interesting observation is that a patient with stable and inactive Graves´ disease developed ophthalmopathy when treated with a glitazone due to diabetes type 2. Glitazones have been shown to increase differentiation of orbital preadipocytes to mature adipocytes. Glitazones are PPAR-gamma agonists and recently diclofenac have been shown to interact with PPAR-gamma in physiological concentrations. Other non-steroidal antiinflammatory drugs, NSAID, like indomethacin lack this effect. In addition, diclofenac inhibit synthesis of prostaglandins which also may be of importance because the natural ligand to PPAR-gamma is prostaglandin J. Inflammation and adipogenesis are hallmarks of the pathological process in Graves ophthalmopathy and NSAID like diclofenac may affect both. There is only one earlier study demonstrating effects of NSAID (indomethacin) in 7 patients with effects on soft tissue symptoms, eye muscle symptoms and eye protrusion. Aim - to investigate if diclofenac can prevent ophthalmopathy and/or progress of ophthalmopathy. Specific aims: 1. To study the frequency of clinical ophthalmopathy in Graves´ disease after 12 months treatment with or without diclofenac. 2. To study the frequency of progress of clinical signs and symptoms in ophthalmopathy after 12 months treatment with or without diclofenac. 3. To study the frequency of optic neuropathy in clinical ophthalmopathy after 12 months treatment with or without diclofenac. Study plan and randomisation - 150 patients with newly diagnosed Graves´disease without ophthalmopathy will be treated with anti-thyroid drugs and L-thyroxin (block and replace) according to clinical routine for 18 months. These patients will be randomized to diclofenac 50 mg twice daily or not for 12 months.
NCT01666197 ↗	Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain	Completed	Novartis	Phase 4	2012-08-01	The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
NCT01762306 ↗	Efficacy of Diclofenac on Pain During Endometrial Sampling	Unknown status	Mahidol University	N/A	2012-11-01	Abnormal uterine bleeding is common in Thai women. Traditionally, because of a larger number of patients, the diagnosis of its cause is performed via fractional curettage under local anesthesia such as paracervical nerve block or intravenous meperidine. Pain is one of a common adverse effect of this procedure and this topic should be concerned by a responsible doctor. NSAIDs, Diclofenac Potassium in this study, is known as a drug which is effective for pain control and is as effective as coxib in acute pain management. Because of its cost, easy accessible and easy administration, Diclofenac Potassium was selected to be used in this study. Its onset of action is about 1 hour and only one dose of this drug do not cause any serious side effects. The hypothesis of this study is that "Diclofenac Potassium has an additional effectiveness for acute pain control in patients undergoing fractional curettage under paracervical nerve block due to abnormal uterine bleeding" Double blind randomised controlled trial was performed in this study with 45 patients included in each group.

Clinical Trial Conditions for DICLOFENAC POTASSIUM

Condition Name

Condition Name for DICLOFENAC POTASSIUM
Intervention	Trials
Pain	4
Symptomatic Irreversible Pulpitis	3
Healthy	2
Pulpitis - Irreversible	2

Condition MeSH

Condition MeSH for DICLOFENAC POTASSIUM
Intervention	Trials
Pulpitis	5
Pain, Postoperative	4
Migraine Disorders	3
Acute Pain	2

Clinical Trial Locations for DICLOFENAC POTASSIUM

Trials by Country

Trials by Country for DICLOFENAC POTASSIUM
Location	Trials
United States	16
Egypt	12
China	2
Germany	2
Sweden	1

Trials by US State

Trials by US State for DICLOFENAC POTASSIUM
Location	Trials
California	3
Alabama	2
Florida	2
Texas	2
Maryland	1

Clinical Trial Progress for DICLOFENAC POTASSIUM

Clinical Trial Phase

Clinical Trial Phase for DICLOFENAC POTASSIUM
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for DICLOFENAC POTASSIUM
Clinical Trial Phase	Trials
Completed	19
Recruiting	6
Not yet recruiting	6

Clinical Trial Sponsors for DICLOFENAC POTASSIUM

Sponsor Name

Sponsor Name for DICLOFENAC POTASSIUM
Sponsor	Trials
Cairo University	10
Depomed	4
Novartis Pharmaceuticals	3

Sponsor Type

Sponsor Type for DICLOFENAC POTASSIUM
Sponsor	Trials
Other	29
Industry	18
NETWORK	1

Diclofenac Potassium Clinical Trials Update, Market Analysis and Launch Projections (2026)

Last updated: July 26, 2026

Executive summary

• Diclofenac potassium (oral immediate-release NSAID) remains a mature, post-generic-entry market in the US and most major jurisdictions, with ongoing clinical activity concentrated in (i) formulation speed-onset and dose-regimen optimization, (ii) combination or comparative effectiveness studies, and (iii) real-world safety and utilization research rather than breakthrough mechanisms.
• Market growth is driven by substitution among existing NSAID alternatives, formulation-level differentiation, and venue mix (OTC vs prescription where applicable). Volume is unlikely to expand meaningfully without a new regulatory/label inflection or differentiated product durability.
• Near-term “projection” for incremental shares is mostly a function of product-specific competitive positioning (speed of pain relief, tolerability marketing, payer contracting) and litigation/regulatory posture (Orange Book and patent estates are generally constraining only for brand or authorized generics with active exclusivities).
• Clinical trial pipeline risk is moderate: most new entries aim at differentiation within the same therapeutic class, so pricing power stays limited.

What is diclofenac potassium and what is its clinical role vs diclofenac sodium?

Diclofenac potassium is an NSAID used for pain and inflammation, typically targeting musculoskeletal pain and other labeled pain indications depending on the country and product label. Clinically, the “potassium salt” formulation is used to support faster onset characteristics relative to some diclofenac forms, though the degree of advantage is product- and study-dependent.

Key clinical positioning

• Same core pharmacology as other diclofenac salts: COX inhibition with class risks (GI, cardiovascular, renal).
• Formulation differentiation is the main competitive lever: faster dissolution and earlier analgesic onset claims are common in diclofenac potassium brand/product narratives.
• In practice, clinicians choose among NSAID salts and formulations based on tolerability history, comedications, and payer access rather than mechanism.

How does diclofenac potassium compare with diclofenac sodium (oral) on onset and tolerability?

• Onset: diclofenac potassium formulations are engineered for faster dissolution. Comparative trials often test time-to-pain relief or responder rates at early timepoints.
• Tolerability: class effects dominate. Any tolerability advantage typically comes from dosing strategy (lowest effective dose, shortest duration) and regimen design, not from the salt itself.

Where is diclofenac potassium used across indications?

Typical labeled use (varies by market):

• Acute pain states (including musculoskeletal conditions)
• Inflammatory pain states
• Post-surgical pain in certain jurisdictions depending on product approval

What clinical trials are active or recently reported for diclofenac potassium?

Diclofenac potassium clinical research in the last several cycles is dominated by comparative and formulation-performance studies, plus safety monitoring and supportive real-world evidence.

Clinical trial update themes

1. Time-to-onset and analgesic efficacy comparisons
   Studies often compare early pain relief endpoints versus other NSAIDs or other diclofenac formulations.
2. Dose regimen optimization and tolerability characterization
   Trials test different dosing schedules, adherence conditions, and patient subgroups.
3. Combination or adjunct studies
   Where conducted, combinations are designed for pain control optimization or adherence improvements.
4. Safety and cardiovascular/GI risk monitoring
   Post-marketing pharmacovigilance and observational studies remain common for the NSAID class.

What endpoints do diclofenac potassium trials emphasize?

• Primary endpoints: pain intensity reduction scores, proportion of responders, and early timepoint improvement.
• Secondary endpoints: time to meaningful pain relief, rescue medication use, functional improvement, and safety outcomes (GI symptoms, BP changes, renal markers where measured).

How to interpret “pipeline” for a mature NSAID?

• Many studies do not change the therapeutic standard of care.
• Clinical differentiation is most likely to come from formulation properties and regulatory label positioning rather than new target biology.

Which sponsors and geographies dominate diclofenac potassium research?

For mature NSAIDs, trial activity clusters in markets with active generic competition and multiple branded/formulation line extensions. The typical pattern is:

• Multi-country comparative studies in Europe and other OECD markets
• Pharmacokinetic and formulation bridging studies where regulatory pathways require them
• Observational studies led by academic or health-system partners

What does this mean for R&D investment?

• High probability of incremental rather than disruptive clinical outcomes.
• Differentiation typically requires credible evidence of faster onset, reduced early rescue use, or improved tolerability in prespecified subgroups.

What is the regulatory status of diclofenac potassium in the US and major EU markets?

Diclofenac potassium is widely approved and marketed in multiple jurisdictions. In the US, most diclofenac products have an established Orange Book presence, but the practical regulatory barrier for new entrants is less about “novel approval” and more about:

• Bioequivalence and formulation comparability
• Patent and exclusivity status for specific listed products
• Labeling, dosing, and manufacturing control that meet FDA requirements

What is the Orange Book status of diclofenac potassium?

For mature NSAIDs, Orange Book listings typically include:

• Composition-of-matter or formulation patents (expired for many products)
• Use or method patents (often expired or litigated)
• Listed patents tied to specific brand products and strength/formulation combinations

Impact on new generic entry

• The remaining risk is product-specific: some listings may still be active for certain strengths, dosage forms, or salt/formulation combinations, even when the active ingredient is broadly available.

How do FDA pathways typically apply?

• New generics: Abbreviated New Drug Application (ANDA) via bioequivalence and sameness.
• Reformulations: switch to additional NDA/505(b)(2) only when label changes or formulation innovation requires it.
• Bridging: in-vitro dissolution and comparative PK are critical for immediate-release salts.

When does diclofenac potassium lose exclusivity and how does it affect generic launch timing?

For a mature molecule, “exclusivity” is generally product-specific rather than active-ingredient specific. The key timeline drivers are:

• Patent expiration of the last listed patent for a given dosage form/strength
• Any pediatric exclusivity, patent term adjustment, and orphan-like exclusions (rare for this class)
• 180-day generic exclusivity granted after a successful first Paragraph IV (if applicable for that product)

Practical launch reality

• Most market supply is already generic. Incremental entries are commonly constrained by packaging, label claims, and contracting rather than strict statutory barriers once major brand patents expire.
• The most meaningful timing effect occurs when a specific brand product’s remaining listed patents block or delay ANDA approvals and launches.

What patents protect diclofenac potassium and how strong is the remaining estate?

The patent estate for diclofenac potassium is generally mature. Strength varies by:

• Whether patents cover a specific formulation or method of use still on the books
• Whether litigation produced settlements that extend practical barriers
• Whether specific strengths or dosage forms have separate protective coverage

Patent estate composition (typical for mature NSAIDs)

• Composition and formulation patents: often expired or near-expired for many legacy products
• Methods of use: may linger longer if they cover specific dosing regimens or clinical uses
• Manufacturing process patents: generally harder to enforce for generics unless tied to specific controls

Litigation-driven exclusivity

• For this class, patent litigation frequently settles into “carve-outs” on strength/dosage form timing rather than long-running injunctions.
• Where settlements exist, they determine “effective exclusivity,” the date a generic can launch even after formal expirations.

What generic entry risks exist for diclofenac potassium products?

Generic entry risks in NSAIDs are usually:

• Orange Book list conflicts for a specific branded product line and strength
• Labeling risk: proving sameness for the claimed clinical performance statements tied to formulation differentiation
• Formulation or bioequivalence risk: immediate-release dissolution and salt stability can affect PK bridging

How do Paragraph IV challenges typically play out?

• If any listed patents remain active for a specific product, first-filer ANDAs can challenge patents and earn potential exclusivity.
• In mature segments, settlements can shift entry dates for certain strengths, leaving other strengths or dosage forms available earlier.

How large is the diclofenac potassium market and what revenue drivers matter?

Market structure

• Highly competitive genericized market in most developed countries.
• Brand differentiation tends to be formulation-speed narrative and channel contracting.

Revenue drivers

1. Strength of pharmacy and institutional contracts
2. Presence in formularies
3. OTC vs prescription mix (country-specific)
4. Discounting and volume commitments
5. Product switching among NSAIDs

What does this imply for market growth?

• Market value growth is generally slower than unit growth where generics dominate.
• Incremental value capture comes from switching into specific formats that can justify slightly higher wholesale pricing or preferred formulary positions.

Market projection for diclofenac potassium (2026-2030): base, bull, bear scenarios

Because diclofenac potassium is broadly available and mature, projections are scenario-based around share shifts and price erosion rather than demand expansion.

Scenario framework (directional)

• Bear case: accelerated price erosion, weaker formulary position for differentiated brands, intensified generic competition in key strengths.
• Base case: steady volume with continued margin compression; modest share shifts driven by channel contracting and lifecycle management.
• Bull case: differentiated formulation sustains preferred positioning and captures additional volume via faster-onset label positioning and payer support; fewer disruptive entries in key countries.

Quantitative projection (structure)

A robust numeric forecast requires product-level and country-level data inputs (sales, shipments, pricing, formulary share), which are not provided here. Without those inputs, any point estimate would be non-actionable for investment-grade decisions.

Which companies are competing in diclofenac potassium and what is the competitive landscape?

Competition spans:

• Multiple generic manufacturers across Europe and other geographies
• Brand-origin companies that maintain formulations with distinct strengths, blister/packaging differentiation, or promotional positioning
• Authorized generics depending on territory

Competitive differentiation levers

• Time-to-onset evidence in the label narrative
• Bioequivalence and stability performance
• Manufacturing reliability and supply continuity
• Contracting discipline with payers and pharmacy chains

What does this mean for R&D and licensing strategy?

For diclofenac potassium, the highest-probability opportunities are:

• Formulation optimization that can be supported by credible early pain relief data
• Lifecycle extensions that target remaining label claims and improve patient adherence
• IP strategy focusing on what can be credibly defended: formulation-specific patents and method-of-use claims that remain active

Key Takeaways

• Diclofenac potassium is a mature NSAID market; most “clinical trial updates” focus on formulation performance, early analgesic endpoints, and safety surveillance rather than new mechanism breakthroughs.
• Market dynamics are dominated by generic competition, contracting, and product-level differentiation. Growth comes from share shifts and channel mix more than from demand expansion.
• Patent and exclusivity timing is product-specific and typically has limited impact on the overall molecule once major brand patents expire, though strength/dosage form carve-outs can still matter.
• Launch risk for generics is driven by Orange Book listings and bioequivalence/formulation bridging rather than by novel regulatory hurdles.

FAQs

1. Do diclofenac potassium trials show faster pain relief than diclofenac sodium in acute musculoskeletal pain?
2. What Orange Book patents and exclusivities block ANDA approval for specific diclofenac potassium strengths?
3. How do Paragraph IV settlements typically affect when diclofenac potassium generics launch?
4. What FDA requirements govern bioequivalence for immediate-release diclofenac potassium tablets?
5. Which patient safety endpoints matter most in diclofenac potassium post-marketing studies (GI, CV, renal)?

References

1. FDA. Drug Approval Reports and Orange Book (accessed for relevant product listings and exclusivity/patent status).
2. ClinicalTrials.gov. Diclofenac potassium search results for ongoing and recently completed interventional and observational studies.
3. European Medicines Agency (EMA). Product information and EPARs for diclofenac-containing medicines (where applicable).