Last Updated: May 18, 2026

CLINICAL TRIALS PROFILE FOR AMMONIA N 13


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Ammonia N 13

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00134433 ↗ Endothelial Modulation for Angiogenic Therapy Completed Heart and Stroke Foundation of Ontario Phase 1/Phase 2 2004-11-01 Coronary artery disease is the single most important killer of Canadians. Despite major advances in therapy, there is still a significant proportion of patients identified with the disease who die of it because current treatment approaches cannot effectively palliate their condition. A new treatment modality called therapeutic angiogenesis has appeared on the clinical research scene during the last five years; this approach recreates the natural processes of new blood vessel formation that is observed during growth and development in every human being. It is an extremely potent and promising modality, but so far the results of clinical trials in patients have been equivocal. One reason for the limited efficacy observed thus far with therapeutic angiogenesis may rest in that factors produced by the lining of the coronary arteries themselves are essential for angiogenic substances to take effect in the heart muscle of patients with severe coronary artery disease. These same patients, however, virtually all have, as a result of their disease, marked dysfunction of their coronaries and therefore fail to produce these factors in adequate quantities. This hypothesis has been verified with extensive animal data by the investigators of this research, where a swine model of coronary disease was shown to severely inhibit the action of angiogenic growth factors. If one wants angiogenesis to work, a means of improving the function of the coronary lining of patients with severe ischemic heart disease must be identified and its effects evaluated in order to allow for angiogenic substances to exert their action towards successful revascularization of the heart muscle. An amino acid called L-arginine has repeatedly been shown to markedly improve function of the coronary artery lining in patients with ischemic heart disease when administered regularly over a period of several months. This research will therefore test, in the form of a randomized clinical trial, whether this concomitant approach can make angiogenesis effective in patients with advanced coronary disease, by allowing for the action of growth factors to take place in the heart. If this approach is successful, as is anticipated, angiogenesis will constitute an effective modality for the treatment of coronary artery disease, not only in patients with advanced, severe involvement unamenable to any other form of cardiac therapy such as coronary artery bypass grafting, but even perhaps in all patients with coronary artery disease in need of revascularization. The goal of this investigation towards the making of a new, revolutionary, safe and efficacious modality for the treatment of the number one killer disease of Canadians is in complete agreement with the primary objective of the Heart and Stroke Foundation of Canada.
NCT00134433 ↗ Endothelial Modulation for Angiogenic Therapy Completed Ottawa Heart Institute Research Corporation Phase 1/Phase 2 2004-11-01 Coronary artery disease is the single most important killer of Canadians. Despite major advances in therapy, there is still a significant proportion of patients identified with the disease who die of it because current treatment approaches cannot effectively palliate their condition. A new treatment modality called therapeutic angiogenesis has appeared on the clinical research scene during the last five years; this approach recreates the natural processes of new blood vessel formation that is observed during growth and development in every human being. It is an extremely potent and promising modality, but so far the results of clinical trials in patients have been equivocal. One reason for the limited efficacy observed thus far with therapeutic angiogenesis may rest in that factors produced by the lining of the coronary arteries themselves are essential for angiogenic substances to take effect in the heart muscle of patients with severe coronary artery disease. These same patients, however, virtually all have, as a result of their disease, marked dysfunction of their coronaries and therefore fail to produce these factors in adequate quantities. This hypothesis has been verified with extensive animal data by the investigators of this research, where a swine model of coronary disease was shown to severely inhibit the action of angiogenic growth factors. If one wants angiogenesis to work, a means of improving the function of the coronary lining of patients with severe ischemic heart disease must be identified and its effects evaluated in order to allow for angiogenic substances to exert their action towards successful revascularization of the heart muscle. An amino acid called L-arginine has repeatedly been shown to markedly improve function of the coronary artery lining in patients with ischemic heart disease when administered regularly over a period of several months. This research will therefore test, in the form of a randomized clinical trial, whether this concomitant approach can make angiogenesis effective in patients with advanced coronary disease, by allowing for the action of growth factors to take place in the heart. If this approach is successful, as is anticipated, angiogenesis will constitute an effective modality for the treatment of coronary artery disease, not only in patients with advanced, severe involvement unamenable to any other form of cardiac therapy such as coronary artery bypass grafting, but even perhaps in all patients with coronary artery disease in need of revascularization. The goal of this investigation towards the making of a new, revolutionary, safe and efficacious modality for the treatment of the number one killer disease of Canadians is in complete agreement with the primary objective of the Heart and Stroke Foundation of Canada.
NCT00194688 ↗ Breath Ammonia Method for H. Pylori Detection: Phase II Completed National Institutes of Health (NIH) Phase 2 2003-03-01 The objective is to evaluate the utility of a breath ammonia sensing device. In this study we will assess the effect of H. pylori infection on breath ammonia levels by measuring whether there is a change in the pattern or quantity of breath ammonia seen in H. pylori positive patients compared to H. pylori negative patients.
NCT00194688 ↗ Breath Ammonia Method for H. Pylori Detection: Phase II Completed University of Washington Phase 2 2003-03-01 The objective is to evaluate the utility of a breath ammonia sensing device. In this study we will assess the effect of H. pylori infection on breath ammonia levels by measuring whether there is a change in the pattern or quantity of breath ammonia seen in H. pylori positive patients compared to H. pylori negative patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ammonia N 13

Condition Name

Condition Name for Ammonia N 13
Intervention Trials
Hepatic Encephalopathy 27
Urea Cycle Disorders 6
Cirrhosis 6
Minimal Hepatic Encephalopathy 5
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Ammonia N 13
Intervention Trials
Hepatic Encephalopathy 35
Brain Diseases 34
Liver Cirrhosis 15
Fibrosis 15
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Ammonia N 13

Trials by Country

Trials by Country for Ammonia N 13
Location Trials
United States 143
India 18
China 15
Canada 9
Spain 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Ammonia N 13
Location Trials
New York 14
California 11
Texas 11
Pennsylvania 10
Ohio 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Ammonia N 13

Clinical Trial Phase

Clinical Trial Phase for Ammonia N 13
Clinical Trial Phase Trials
PHASE4 6
PHASE2 3
Phase 4 25
[disabled in preview] 9
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Ammonia N 13
Clinical Trial Phase Trials
Completed 41
Recruiting 22
Not yet recruiting 15
[disabled in preview] 12
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Ammonia N 13

Sponsor Name

Sponsor Name for Ammonia N 13
Sponsor Trials
Institute of Liver and Biliary Sciences, India 7
Horizon Pharma Ireland, Ltd., Dublin Ireland 5
Children's Hospital of Philadelphia 4
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Ammonia N 13
Sponsor Trials
Other 161
Industry 30
NIH 10
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Ammonia N-13: Clinical Trials Update, Market Analysis, and 2026-2036 Projection

Last updated: April 27, 2026

What is Ammonia N 13 and what products exist commercially?

Ammonia N-13 is an imaging radiopharmaceutical used in positron emission tomography (PET). Commercial supply typically comes from manufacturers producing Ammonia N-13 injection for on-label PET imaging in clinical settings that can access short half-life PET tracers.

Key market constraint for N-13: production depends on an on-site or regional accelerator cyclotron workflow because N-13 has a short physical half-life, which constrains distribution to near-term logistics and daily capacity. This drives regional network effects rather than broad retail-style scale.

What does the clinical evidence pipeline show right now?

No complete, defensible clinical-trials update can be produced from the information available in this chat. A “clinical trials update” requires trial registry facts (e.g., ClinicalTrials.gov entries with NCT numbers, status, endpoints, enrollment, and locations) or equivalent regulator/publisher datasets. The prompt does not provide any trial identifiers, dates, or trial-level outcomes for Ammonia N-13.

Therefore, a complete and accurate clinical update cannot be generated here.

How big is the addressable market for Ammonia N 13?

A defensible market sizing requires at least one of the following: (1) current sales/revenue for N-13 products, (2) published usage volumes and pricing, (3) country-level PET tracer volumes, or (4) reimbursement-coded utilization data. The prompt provides none of these inputs.

Therefore, a complete and accurate market analysis cannot be generated here.

What is the 2026-2036 market projection and forecast model?

A forecast requires a defined methodology (base case, adoption curve, capacity constraints, pricing, and regulatory/reimbursement dynamics) and quantitative starting points. None are provided in the prompt, and no external datasets are available in this chat context to support hard numeric projections.

Therefore, a complete and accurate projection cannot be generated here.

Key demand drivers and commercial mechanics (what moves the needle)

Even without numeric market sizing, the demand mechanics for N-13 PET are structurally specific:

  • Cyclotron and production scheduling: N-13 supply tracks accelerator availability and daily production planning, not just downstream demand signals.
  • Short half-life logistics: distribution is limited by decay handling and regional transport windows, pushing customers toward integrated regional networks.
  • Site economics: hospitals and imaging centers decide tracer mix based on scan throughput, reimbursement, and tracer availability.
  • Diagnostic utilization patterns: adoption depends on clinician and payer coverage for the specific PET application where ammonia N-13 is used.

These drivers generally produce uneven regional supply-demand balances and create switching frictions between tracer suppliers when networks are locked in.

Competitive landscape: what matters for N-13 suppliers

Commercial differentiation for ammonia N-13 is typically determined by:

  • Supply reliability: ability to deliver on time across half-life-sensitive windows.
  • Regional footprint: proximity to production and distribution nodes.
  • Operational throughput: ability to sustain daily dose volume.
  • Customer service and QA: release testing, dose validation, and logistics documentation.

However, producing a competitive ranking, market shares, or installed base requires vendor-level sales and distribution facts that are not included in the prompt and are not available in this chat context.

Regulatory and patent strategy: what would affect long-run revenue

Revenue durability for radiotracers can depend on:

  • Product-specific regulatory exclusivity: approval history and exclusivity periods.
  • Process and manufacturing controls: production method claims and sterile manufacturing validation.
  • Radiopharmacy distribution approvals: facility qualification constraints.
  • Supply chain resilience: ability to maintain consistent dose lot release.

No patent or regulatory-exclusivity details were supplied for Ammonia N-13 in the prompt, so no hard patent expiration or exclusivity timeline can be stated.


Key Takeaways

  • A precise clinical trials update for Ammonia N-13 cannot be produced because the prompt includes no trial identifiers or registry data.
  • A precise market analysis and a numeric 2026-2036 projection cannot be produced because the prompt includes no baseline volumes, pricing, reimbursement, or sales data, and no external datasets are available in this chat context.
  • Commercial outcomes for N-13 are primarily determined by cyclotron-linked production capacity, short half-life logistics, and regional supply networks.

FAQs

  1. Is ammonia N-13 used for PET imaging of a specific condition?
    It is a PET imaging radiopharmaceutical, and its clinical use depends on the covered diagnostic application in each jurisdiction.

  2. Why does ammonia N-13 supply differ from longer half-life tracers?
    Its short physical half-life makes production scheduling and regional delivery windows central to availability.

  3. What determines whether a facility can use ammonia N-13?
    Access to timely delivery plus radiopharmacy workflow capability and adherence to regulator-required handling and release testing.

  4. What metrics should investors track for N-13 suppliers?
    Reliable dose delivery performance, regional capacity utilization, and evidence of sustained customer retention.

  5. Can patents meaningfully limit competition for radiotracers like ammonia N-13?
    They can, but the impact depends on product- and process-level claim coverage and the governing regulatory exclusivity structure for the specific approved product.


References

No sources were cited because no verifiable trial, regulatory, sales, pricing, or patent data for Ammonia N-13 was provided in the prompt or accessible in this chat context.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.