CLINICAL TRIALS PROFILE FOR UROLOGIC G IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for UROLOGIC G IN PLASTIC CONTAINER

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT06819111 ↗	Role of Medication in Making Urine Less Acidic as Part of Kidney Stone Prevention	NOT_YET_RECRUITING	University of Texas Southwestern Medical Center	PHASE1	2026-01-01	Diet and medications are the cornerstones of kidney stone prevention. Potassium citrate is a commonly prescribed medication to help prevent kidney stones by making urine less acidic. There are different forms of potassium citrate such as over-the-counter tablet or powder, and slow-release tablets that require a prescription. However, it is unknown if one form is better than the others. Therefore, we want to compare different forms of potassium citrate and find out how well they work and whether patients prefer one form over the others. The study period will last approximately 6 weeks for each participant. Patients will be instructed to take one form of potassium citrate for one week at a time followed by a washout period for one week. This process will be completed a total of three times as we seek to study the effects of three forms of potassium citrate. At the end of each trial week patients will be asked to provide urine samples and complete two surveys. Urine will need to be collected for 24 hours, which will then be examined to determine the effects that each form of potassium citrate has on urine. In addition, completed surveys will give us information on how well the medication was tolerated and their satisfaction with the treatment. There is a possibility that patients like one form better than others, and it is also possible that they do not see a difference at all. Throughout the duration of the study patients will be asked to be a directed diet. This will be based on general recommendations by the National Kidney Foundation for the prevention of kidney stones.

All Clinical Trials for UROLOGIC G IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003930 ↗	Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	1999-09-01	RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy and surgery may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer that can be removed by surgery.
NCT00003930 ↗	Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer	Completed	Radiation Therapy Oncology Group	Phase 1/Phase 2	1999-09-01	RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy and surgery may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer that can be removed by surgery.
NCT00132301 ↗	Chemotherapy After Prostatectomy (CAP) For High Risk Prostate Carcinoma	Completed	Sanofi	Phase 3	2006-06-01	VA Cooperative Study #553 is designed to prospectively evaluate the efficacy of early adjuvant chemotherapy using docetaxel and prednisone added to the standard of care for patients who are potentially cured by radical prostatectomy but who are at high risk for relapse. The standard of care is surveillance, with the addition of androgen deprivation at the time of biochemical relapse. This study will assess the effect of adding early chemotherapy to the standard of care on progression free survival in Veterans at high risk for progression after prostatectomy.

Clinical Trial Conditions for UROLOGIC G IN PLASTIC CONTAINER

Condition Name

Condition Name for UROLOGIC G IN PLASTIC CONTAINER
Intervention	Trials
Prostate Cancer	9
Bladder Cancer	6
Pain, Postoperative	6

Condition MeSH

Condition MeSH for UROLOGIC G IN PLASTIC CONTAINER
Intervention	Trials
Pain, Postoperative	14
Urinary Bladder Neoplasms	10
Syndrome	7

Clinical Trial Locations for UROLOGIC G IN PLASTIC CONTAINER

Trials by Country

Trials by Country for UROLOGIC G IN PLASTIC CONTAINER
Location	Trials
United States	218
Japan	25
Canada	21
Korea, Republic of	8
Egypt	6

Trials by US State

Trials by US State for UROLOGIC G IN PLASTIC CONTAINER
Location	Trials
New York	14
California	13
Michigan	11
Illinois	10
Texas	10

Clinical Trial Progress for UROLOGIC G IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for UROLOGIC G IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for UROLOGIC G IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	57
Recruiting	28
Not yet recruiting	17

Clinical Trial Sponsors for UROLOGIC G IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for UROLOGIC G IN PLASTIC CONTAINER
Sponsor	Trials
University of Texas Southwestern Medical Center	5
National Cancer Institute (NCI)	4
Yonsei University	4

Sponsor Type

Sponsor Type for UROLOGIC G IN PLASTIC CONTAINER
Sponsor	Trials
Other	176
Industry	26
NIH	6

Last updated: July 29, 2026

Urologic G In Plastic Container clinical trials update, market analysis, and sales projection

What is “Urologic G in plastic container” and how is it used clinically?

No complete, verifiable drug identity (active ingredient, dosage form, strength, manufacturer, NDA/BLA, or therapeutic indication) is provided for “Urologic G In Plastic Container.” Without that, clinical-trials sourcing, FDA status mapping, and market projection cannot be tied to a specific regulated product.

Which clinical trials are ongoing or completed for Urologic G in plastic container?

A trials update requires a specific product identifier (active ingredient + strength + route, or NDA/BLA number). With no such identifier, trial registries (ClinicalTrials.gov), publications, and sponsor statements cannot be correctly matched.

What is the FDA regulatory status of Urologic G in plastic container (Orange Book, approvals, exclusivity)?

Orange Book status depends on the exact FDA product listing (NDA number and listed patents). No NDA/BLA number or ingredient is supplied, so Orange Book patent listings, exclusivity periods, and regulatory milestones cannot be produced.

What patents protect Urologic G in plastic container and when do they expire?

Patent and exclusivity timelines require an exact FDA reference-listed drug (RLD) identity and associated Orange Book patent numbers. No product identity is provided, so patent estate construction is not possible.

How many Paragraph IV generic candidates could challenge Urologic G in plastic container?

Paragraph IV risk profiling depends on Orange Book listings, ANDA filings, and litigation dockets. None can be mapped without the underlying FDA product entry.

What is the competitive landscape for urologic products in plastic containers?

A competitive set requires the competing agents’ active ingredients and specific market segment (e.g., catheter irrigation solutions, anesthetics, antibiotics, bladder instillations, or GI/urology adjuncts). “Urologic G in plastic container” does not define a uniquely attributable product category.

What does the market look like for Urologic G in plastic container, by geography and segment?

A market forecast must anchor to an identifiable product with measurable unit economics (NDC, pricing, volume, distribution model). No product identity is available to enable credible segmentation and projections.

How strong are clinical and commercial signals for Urologic G in plastic container?

Clinical signals require endpoints and phase-stage information for a specific asset, and commercial signals require sales/market share history tied to that same asset. No asset identity or trial details are provided.

Sales projection: what is the expected revenue trajectory for Urologic G in plastic container?

A revenue projection must rest on actual or reported sales data, uptake curves, pricing baselines, and competitive/entry assumptions. Without product identification, there is no defensible basis for any numeric projection.

What are the key risks to Urologic G in plastic container commercialization (manufacturing, IP, reimbursement, safety)?

Risk factors must be mapped to the specific product’s regulatory history, formulation/manufacturing platform, and IP. With no product identity, there is no reliable way to enumerate risks that correspond to the correct regulated product.

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Key Takeaways

No actionable clinical-trials update, regulatory status, patent/exclusivity timeline, or market forecast can be produced for “Urologic G In Plastic Container” because the drug is not uniquely identifiable from the information provided.