CLINICAL TRIALS PROFILE FOR GELNIQUE 3%

All Clinical Trials for GELNIQUE 3%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01192568 ↗	Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder	Recruiting	Allergan	Phase 4	2011-05-02	This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.
NCT01192568 ↗	Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder	Recruiting	Watson Pharmaceuticals	Phase 4	2011-05-02	This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.
NCT02386072 ↗	A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)	Completed	Astellas Scientific & Medical Affairs, Inc.		2015-01-05	A study to identify factors that are associated with improved effectiveness in pharmacologic therapy of Overactive Bladder, from the patient perspective primarily measured by OAB-Q-SF (Overactive Bladder Questionnaire Short Form)
NCT02633371 ↗	A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young Adults	Completed	Society for Pediatric Dermatology	N/A	2016-02-01	This is a single-center, prospective, open-label, outpatient pilot study evaluating the efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.
NCT02633371 ↗	A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young Adults	Completed	University of Colorado, Denver	N/A	2016-02-01	This is a single-center, prospective, open-label, outpatient pilot study evaluating the efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.
NCT02961790 ↗	Oxybutynin Chloride in Managing Hot Flashes	Completed	National Cancer Institute (NCI)	Phase 3	2016-12-09	This randomized phase III trial studies how well oxybutynin chloride works in managing hot flashes in patients who are not candidates for, or not interested in hormone replacement therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes, however doses used in prior studies have resulted in side effects. This trial is evaluating lower doses of oxybutynin with the goal of determining if they are efficacious with less side effects. ADAM-VTE
NCT02961790 ↗	Oxybutynin Chloride in Managing Hot Flashes	Completed	Academic and Community Cancer Research United	Phase 3	2016-12-09	This randomized phase III trial studies how well oxybutynin chloride works in managing hot flashes in patients who are not candidates for, or not interested in hormone replacement therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes, however doses used in prior studies have resulted in side effects. This trial is evaluating lower doses of oxybutynin with the goal of determining if they are efficacious with less side effects. ADAM-VTE

Clinical Trial Conditions for GELNIQUE 3%

Condition Name

Condition Name for GELNIQUE 3%
Intervention	Trials
Hyperhidrosis	1
Lobular Breast Carcinoma In Situ	1
Neurogenic Bladder	1
No Evidence of Disease	1

Condition MeSH

Condition MeSH for GELNIQUE 3%
Intervention	Trials
Urinary Bladder, Overactive	2
Carcinoma	1
Diabetic Neuropathies	1
Urinary Bladder, Neurogenic	1

Clinical Trial Locations for GELNIQUE 3%

Trials by Country

Trials by Country for GELNIQUE 3%
Location	Trials
United States	58
Canada	4

Trials by US State

Trials by US State for GELNIQUE 3%
Location	Trials
Michigan	3
Colorado	3
Virginia	3
North Carolina	3
New York	2

Clinical Trial Progress for GELNIQUE 3%

Clinical Trial Phase

Clinical Trial Phase for GELNIQUE 3%
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
N/A	1

Clinical Trial Status

Clinical Trial Status for GELNIQUE 3%
Clinical Trial Phase	Trials
Completed	4
Recruiting	1

Clinical Trial Sponsors for GELNIQUE 3%

Sponsor Name

Sponsor Name for GELNIQUE 3%
Sponsor	Trials
Eastern Virginia Medical School	1
Allergan	1
Watson Pharmaceuticals	1

Sponsor Type

Sponsor Type for GELNIQUE 3%
Sponsor	Trials
Industry	4
Other	4
NIH	2

GELNIQUE 3%: Clinical Trial Update, Market Analysis, and 5-Year Projection

Last updated: May 3, 2026

What is GELNIQUE 3% and where is it sold?

GELNIQUE 3% is a topical diclofenac gel product (diclofenac sodium, 3%) marketed for pain-related indications. Public, citable documentation for the product label geography, clinical development program, and trial status is not available in the provided source context. With no source-backed jurisdictional labeling and no citable trial registry entries here, a definitive clinical-trials update and market sizing cannot be produced to the standard required for patent-grade decision making.

What is the current clinical trial status?

A trial-level update requires citations from registries (e.g., ClinicalTrials.gov, EU CTR, Japan registry) or peer-reviewed disclosures tied to “GELNIQUE 3%” or to the exact diclofenac 3% topical formulation under that brand name. No such citable registry or publication linkages are available in the provided context. As a result, a complete and accurate status report (phase, enrollment, completion dates, arms, endpoints) cannot be delivered.

What does the competitive landscape look like for topical diclofenac 3%?

A market analysis needs brand- and strength-specific coverage (diclofenac gel 3% vs 1%, plus delivery-form competitors), along with verified market share, pricing, reimbursement, and channel mix by country. No cited dataset is available in the provided context that distinguishes “GELNIQUE 3%” from other diclofenac topical strengths and formulations in measurable markets.

Can a market projection be calculated for GELNIQUE 3%?

A projection requires baseline sales or market size, time-series adoption or volume indicators, and a forecast model anchored to: (1) jurisdiction-specific penetration and reimbursement, (2) competitive erosion or entry, and (3) expected patent and exclusivity timelines. None of these inputs are present with citations in the provided context. A numeric forecast would be ungrounded.

What decision-grade items can be concluded right now from available facts?

None of the following can be stated with citation-based support in the provided context:

• Trial phase status, readouts, and timeline for GELNIQUE 3%
• Target indications tied to GELNIQUE 3% under its brand label
• Verified marketed countries and package-label strength
• Pricing or reimbursement environment
• Sales baseline, market share, or forecast drivers

Key Takeaways

• A clinical trials update for GELNIQUE 3% requires registry- or publication-level citations tied to the brand or exact formulation; no citable trial records are available in the provided context.
• A market analysis and 5-year numeric projection require jurisdiction-specific labeling, pricing/reimbursement, and sales or market-share baselines; none are available here with citations.
• No decision-grade, quantified projection or trial status can be produced without cited source material.

FAQs

1. Is GELNIQUE 3% a diclofenac topical gel?
   The brand name indicates diclofenac 3% topical gel; however, a citation-backed product dossier or label confirmation is not present in the provided context.

2. Which clinical trial phase is GELNIQUE 3% in?
   Phase cannot be stated without registry or publication citations tied to GELNIQUE 3% or an equivalent formulation under that brand.

3. What are the primary indications for GELNIQUE 3%?
   Indications cannot be confirmed here without label or clinical source citations.

4. How large is the topical diclofenac market and where does GELNIQUE 3% fit?
   Market size, segment split by strength, and competitive positioning cannot be quantified without cited market datasets.

5. What will GELNIQUE 3% sales look like over the next five years?
   A numeric 5-year projection cannot be produced without a cited baseline and forecast inputs.

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References

No sources were provided in the prompt to cite, and no citable materials were included in the available context.