CLINICAL TRIALS PROFILE FOR HIPPURAN I 131

All Clinical Trials for HIPPURAN I 131

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00881439 ↗	Safety and Efficacy Study of Add On Aliskiren in Patients With Heart Failure and Renal Impairment	Terminated	University Medical Center Groningen	Phase 2	2009-04-01	The main purpose of this study is to examine the effect of add-on therapy with the direct renin inhibitor Aliskiren in comparison to placebo on renal blood flow in patients with heart failure and reduced renal function. - Primary outcome measure: change in renal blood flow at 6 months - Secondary outcome measures: changes in renal function, N-terminal pro Brain natriuretic peptide, left ventricular function, blood pressure and neurohormones
NCT01584921 ↗	Renal Effects of Erythropoietin in Humans	Completed	Rigshospitalet, Denmark	Phase 1	2012-03-01	Erythropoietin (EPO) is a glycoprotein produced mainly in the kidney. After its release to the bloodstream EPO binds to its receptor predominantly located within the bone marrow where erythropoiesis is stimulated. Recently, we have shown that recombinant human EPO (rHuEPO) down-regulates circulating levels of renin and aldosterone. Concomitant clearance studies revealed a decrease in proximal tubular reabsorption of sodium and water and a fall in glomerular filtration rate (GFR). These results for the first time demonstrate a link between EPO and renal function: By inhibiting proximal tubular reabsorption, which in turn results in rapid declines in GFR and renin/aldosterone levels, EPO may directly reduce the major oxygen consuming factor in the kidney. The expected result will be an increase of the oxygen tension in the environment of renal EPO producing cells, in this way initiating an appropriate signal for down-regulation of endogenous EPO synthesis when circulating levels of EPO are high. The aim of this project is to test this hypothesis by investigating the renal effects of rHuEPO in humans. In a double-blinded manner healthy subjects will be tested with placebo, or low-dose rHuEPO for two weeks, or high-dose rHuEPO for three days. Accurate sodium balance studies will be conducted together with renal clearance studies for measurements of renal plasma flow (131I-Hippuran clearance with renal venous sampling), GFR (51Cr-EDTA clearance) and the segmentel tubular handling of sodium and water (lithium clearance). EPO is the sole haematopoietic growth factor that is mainly produced in the kidneys and the project will provide new information about basic physiological issues regarding the association between renal function and the regulation of EPO synthesis.
NCT01584921 ↗	Renal Effects of Erythropoietin in Humans	Completed	University of Copenhagen	Phase 1	2012-03-01	Erythropoietin (EPO) is a glycoprotein produced mainly in the kidney. After its release to the bloodstream EPO binds to its receptor predominantly located within the bone marrow where erythropoiesis is stimulated. Recently, we have shown that recombinant human EPO (rHuEPO) down-regulates circulating levels of renin and aldosterone. Concomitant clearance studies revealed a decrease in proximal tubular reabsorption of sodium and water and a fall in glomerular filtration rate (GFR). These results for the first time demonstrate a link between EPO and renal function: By inhibiting proximal tubular reabsorption, which in turn results in rapid declines in GFR and renin/aldosterone levels, EPO may directly reduce the major oxygen consuming factor in the kidney. The expected result will be an increase of the oxygen tension in the environment of renal EPO producing cells, in this way initiating an appropriate signal for down-regulation of endogenous EPO synthesis when circulating levels of EPO are high. The aim of this project is to test this hypothesis by investigating the renal effects of rHuEPO in humans. In a double-blinded manner healthy subjects will be tested with placebo, or low-dose rHuEPO for two weeks, or high-dose rHuEPO for three days. Accurate sodium balance studies will be conducted together with renal clearance studies for measurements of renal plasma flow (131I-Hippuran clearance with renal venous sampling), GFR (51Cr-EDTA clearance) and the segmentel tubular handling of sodium and water (lithium clearance). EPO is the sole haematopoietic growth factor that is mainly produced in the kidneys and the project will provide new information about basic physiological issues regarding the association between renal function and the regulation of EPO synthesis.
NCT06259422 ↗	Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate	NOT_YET_RECRUITING	University Medical Center Groningen	NA	2024-06-01	This study is a single centre intervention study to compare two methods of determining the measured glomerular filtration rate (mGFR). Subjects who receive radioactively labeled iothalamate (125I) and hippuran (131I) within the framework of routine clinical care, will be co-administered iohexol. The primary trial endpoint is the mGFR when administered 125I-iothalamate and 131I-hippuran versus iohexol. By determining the mGFR using both iohexol and iothalamate in the same patients, a direct comparison of the two methods can be made in terms of their accuracy and precision. This makes it possible to determine the potential use of the non-radioactive measurement method as an alternative to the radioactive method and thus lower the overall radioactive burden for patients and personnel.

Clinical Trial Conditions for HIPPURAN I 131

Condition Name

Condition Name for HIPPURAN I 131
Intervention	Trials
Kidney Failure	1
Kidney Function Issue	1
Renal Effects	1
Chronic Kidney Diseases	1

Condition MeSH

Condition MeSH for HIPPURAN I 131
Intervention	Trials
Renal Insufficiency, Chronic	1
Disease	1
Renal Insufficiency	1
Heart Failure	1

Clinical Trial Locations for HIPPURAN I 131

Trials by Country

Trials by Country for HIPPURAN I 131
Location	Trials
Netherlands	2
Denmark	1

Clinical Trial Progress for HIPPURAN I 131

Clinical Trial Phase

Clinical Trial Phase for HIPPURAN I 131
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	1
NA	1

Clinical Trial Status

Clinical Trial Status for HIPPURAN I 131
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	1
Terminated	1
Completed	1

Clinical Trial Sponsors for HIPPURAN I 131

Sponsor Name

Sponsor Name for HIPPURAN I 131
Sponsor	Trials
University Medical Center Groningen	2
Rigshospitalet, Denmark	1
University of Copenhagen	1

Sponsor Type

Sponsor Type for HIPPURAN I 131
Sponsor	Trials
Other	4

Last updated: April 24, 2026

HIPPURAN I 131 (Hippuran with I-131): Clinical Trial Update, Market Analysis, and Projection

What is HIPPURAN I 131 and what is the current clinical evidence base?

HIPPURAN I 131 is a radiopharmaceutical: sodium hippurate labeled with iodine-131. It is used for renal functional imaging and assessment of urinary tract physiology (kidney perfusion, renal clearance, and related diagnostic workflows). Its clinical evidence base is largely historical and anchored in radiopharmaceutical practice rather than contemporary randomized efficacy trials typical of newer small molecules and biologics.

Clinical trial update (current cycle) No definitive, up-to-date public signal was produced for a specific “new” pivotal late-stage trial cycle for HIPPURAN I 131 in the current reporting period because public trial registries generally index by generic/brand variations and labeling and the drug’s development history is not dominated by frequent new interventional studies in the modern era.

What is observable in the public record

• Regulatory status and labeling for I-131 hippurate products is primarily evidence of use in established nuclear medicine indications rather than continued expansion via new late-stage trials.
• Interventional trial activity for iodine-hippurate products is limited relative to newer imaging agents and therapy-focused radiopharmaceuticals, with most updates appearing as usage updates, dosimetry/quality or institutional practice.

Market-relevant implication For business planning, the clinical “update” for HIPPURAN I 131 is less about new efficacy endpoints and more about:

• supply continuity for radionuclides and manufacturing,
• reimbursement and access in nuclear medicine,
• and replacement pressure from alternative renal tracers used in gamma camera workflows.

What does the market look like for renal nuclear imaging radiopharmaceuticals (and where does HIPPURAN I 131 fit)?

HIPPURAN I 131 sits in the category of diagnostic radiopharmaceuticals for renal imaging. Demand is driven by:

• chronic kidney disease (CKD) staging and follow-up workflows,
• obstructive uropathy evaluation and differential renal function workups,
• urology and nephrology diagnostic pathways,
• and institutional imaging capacity (gamma camera availability, radionuclide supply programs).

Where HIPPURAN I 131 fits in clinical practice Hospitals use renal tracers to quantify:

• split renal function,
• renal clearance curves,
• and functional contribution of each kidney.

Competitive set (functional substitutes) Market substitution pressure typically comes from:

• other renal imaging agents with different half-life logistics and workflow profiles,
• alternative nuclear medicine tracers used for similar functional assessments,
• and protocol-based tracer selection driven by availability, cost, and local experience.

Pricing mechanics Radiopharmaceutical pricing is not purely market-share dependent. It is shaped by:

• radionuclide availability,
• manufacturing lot economics and regulatory release timing,
• and payer reimbursement structures for nuclear imaging procedures (the tracer is part of a procedure bundle in many systems).

How big is the addressable market and how is it projected?

A reliable, quantified market model requires assumptions about:

• the number of renal imaging procedures per geography,
• tracer utilization rates,
• and the specific market share of I-131 hippurate within renal imaging tracers.

That level of quantified mapping is not available in the provided information. Under the operating constraint, no complete and accurate market sizing model can be produced.

What can be projected from structural drivers Even without quantified sizing, the directional forecast for HIPPURAN I 131 depends on identifiable drivers:

Demand drivers

• rising CKD prevalence and ongoing diagnostic monitoring volumes,
• aging populations and higher urologic evaluation rates,
• continued use of renal functional imaging in nephrology and urology.

Constraints and headwinds

• radionuclide logistics (iodine-131 supply chain volatility),
• site and protocol preferences shifting to other renal tracers,
• competitive replacement where imaging performance or operational convenience favors alternatives,
• regulatory and manufacturing continuity risks common to older radiopharmaceutical platforms.

Resulting business projection (qualitative direction)

• Base case: stable-to-moderate erosion in relative share if institutions continue shifting toward alternative renal agents.
• Upside case: stable demand if replacement pressure is offset by institutional entrenchment and supply reliability.
• Downside case: faster relative decline if reimbursement tightens and tracer selection shifts to lower-operational-friction alternatives.

What is the clinical trial pipeline status and regulatory path likely to look like?

For a mature radiopharmaceutical like HIPPURAN I 131, the practical regulatory path typically emphasizes:

• manufacturing changes control (GMP compliance, radionuclide sourcing, formulation and quality),
• dosimetry and labeling alignment with current practice standards,
• and post-authorization updates rather than novel pivotal clinical trials.

A “pipeline” framing for this product is therefore usually dominated by:

• supply and quality improvements,
• and periodic regulatory maintenance rather than incremental therapeutic innovation.

What should investors and R&D leaders track next?

For HIPPURAN I 131, the highest information-yield monitoring items are:

1. Supply chain continuity

   • radionuclide availability and production capacity for iodine-131,
   • manufacturing batch release schedules and any drug substance sourcing constraints.

2. Labeling and regulatory maintenance

   • changes in indication language, administration specifics, dosimetry statements,
   • updates reflecting current nuclear medicine practice requirements.

3. Utilization trends at nuclear medicine sites

   • tracer selection protocol updates,
   • guideline-driven shifts in renal imaging workflows.

4. Payer and coding pressure

   • reimbursement policy changes for renal nuclear imaging procedures,
   • any bundling or reimbursement compression that affects tracer choice economics.

---

Key Takeaways

• HIPPURAN I 131 (iodine-131 hippurate) is a mature diagnostic renal nuclear medicine radiopharmaceutical whose clinical evidence base is largely historical and practice-driven rather than powered by recent late-stage interventional trials.
• The “clinical trial update” for this product is likely to be dominated by label maintenance, quality, and supply continuity rather than new pivotal efficacy studies.
• Market performance is driven by renal imaging procedure volume, institutional tracer selection, and iodine-131 supply reliability, with substitution pressure from other renal tracers.
• A quantified market size and numeric projection cannot be produced from the provided information; directional forecasting hinges on the structural drivers above.

---

FAQs

1. What indication does HIPPURAN I 131 support?
   Renal functional imaging used to assess kidney function and related urinary tract physiology in nuclear medicine workflows.

2. Is HIPPURAN I 131 undergoing new pivotal clinical trials?
   Publicly visible evidence for a new pivotal late-stage interventional cycle is not established in the provided information; activity for mature radiopharmaceuticals is typically post-authorization and practice-focused.

3. What determines patient and hospital demand for HIPPURAN I 131?
   CKD and urology diagnostic volumes, gamma camera workflow utilization, tracer selection protocols, and radionuclide supply reliability.

4. What are the main substitutes that can pressure HIPPURAN I 131 share?
   Other renal imaging radiopharmaceuticals used for similar functional assessments, selected based on performance and operational convenience.

5. What are the most important risks to track?
   I-131 supply chain continuity, manufacturing and batch release stability, reimbursement and coding changes for renal nuclear imaging procedures, and institutional protocol shifts.

---

References (APA)

[1] U.S. National Library of Medicine. (n.d.). HIPPURAN I 131 (iodine I 131 sodium hippurate). ClinicalTrials.gov. https://clinicaltrials.gov/
[2] Drugs.com. (n.d.). HIPPURAN I-131 information. https://www.drugs.com/
[3] FDA. (n.d.). Drugs@FDA: I-131 hippurate products (relevant labeling and submissions). https://www.accessdata.fda.gov/scripts/cder/daf/
[4] European Medicines Agency. (n.d.). EPAR search for iodine-131 sodium hippurate/HIPPURAN. https://www.ema.europa.eu/
[5] World Nuclear Association. (n.d.). Radioisotopes: iodine-131 supply and use context. https://www.world-nuclear.org/