CLINICAL TRIALS PROFILE FOR TROMETHAMINE

505(b)(2) Clinical Trials for TROMETHAMINE

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
New Dosage	NCT00266786 ↗	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Egalet Ltd	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
New Dosage	NCT00266786 ↗	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Luitpold Pharmaceuticals	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.

All Clinical Trials for TROMETHAMINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001698 ↗	Randomized, Double Blind, Placebo-Controlled, Phase IIB Trial of Ketorolac Mouth Rinse Evaluating the Effect of Cyclooxygenase Inhibition on Oropharyngeal Leukoplakia: Collaborative Study of the NCI, NIDCD and the NIDCR	Completed	National Cancer Institute (NCI)	Phase 2	1998-06-01	In Phase II trials, treatment with ketorolac tromethamine oral rinse has been shown to block periodontal disease progression even in the absence of standard clinical intervention such as scaling and root planing which is routinely done to reduce the periodontal pathogen load that is driving the local destructive host inflammatory response. Resolution of periodontal disease has a favorable effect on normalizing the cellular and biochemical indices of inflammation as reflected by histological changes as well as the levels of prostaglandin E2 (PGE2) and interleukin I beta (IL-1beta). In this trial, we will prospectively evaluate if eliminating the inflammatory process (via inhibition of PGE2 biosynthesis) in the oral cavity has a favorable impact on reversing oropharyngeal leukoplakia. To test this hypothesis, up to 57 prospectively identified individuals with objective findings of oropharyngeal leukoplakia will be randomized to receive either a mouth rinse containing ketorolac or placebo. Ketorolac is a 7-fold selective inhibitor of cyclooxygenase-2 (Cox-2), which has been designed for local delivery to maximize the drug exposure to critical oral target tissues while minimizing gastric and systemic exposure to the drug. All responses will be determined at the three month completion of trial using the response criteria developed at MD Anderson Cancer Center. The drug will be given for three months and then all the patients will be followed for one additional month off all oral treatment to observe for late side effects. Based on the analysis of oral exam and photographically documented change in the pretreatment area of leukoplakia, the response of all patients will be determined. The evaluation of the outcome will include a measurable secondary endpoint consisting of an assessment of histological change as determined by serial punch biopsies of the oral cavity. In addition, a panel of carcinogenesis and inflammatory markers will be serially measured at baseline, at one month follow up or at study conclusion. In the residual tissue, other bioassays will be evaluated to determine their suitability as intermediate endpoint markers. The purpose of this study is a preliminary evaluation of the effectiveness of ketorolac as a potential chemoprevention agent for oropharyngeal cancer. If ketorolac administration in this preliminary Phase IIB trial is associated with reversal of leukoplakia, then a definitive Phase III chemoprevention trial with a cancer reduction endpoint (most likely in a cooperative group-type setting) may be the next validation step.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	Massachusetts General Hospital	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00266786 ↗	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Egalet Ltd	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.

Clinical Trial Conditions for TROMETHAMINE

Condition Name

Condition Name for TROMETHAMINE
Intervention	Trials
Postoperative Pain	7
Pain	6
Cataract	4
Healthy Volunteers	4

Condition MeSH

Condition MeSH for TROMETHAMINE
Intervention	Trials
Pain, Postoperative	16
Cataract	9
Macular Edema	6
Acute Pain	4

Clinical Trial Locations for TROMETHAMINE

Trials by Country

Trials by Country for TROMETHAMINE
Location	Trials
United States	80
China	16
Brazil	7
United Kingdom	5
Iran, Islamic Republic of	4

Trials by US State

Trials by US State for TROMETHAMINE
Location	Trials
California	9
Pennsylvania	7
North Carolina	5
Florida	5
New York	5

Clinical Trial Progress for TROMETHAMINE

Clinical Trial Phase

Clinical Trial Phase for TROMETHAMINE
Clinical Trial Phase	Trials
PHASE1	4
Phase 4	20
Phase 3	14

Clinical Trial Status

Clinical Trial Status for TROMETHAMINE
Clinical Trial Phase	Trials
Completed	63
Unknown status	7
RECRUITING	5

Clinical Trial Sponsors for TROMETHAMINE

Sponsor Name

Sponsor Name for TROMETHAMINE
Sponsor	Trials
Egalet Ltd	11
Luitpold Pharmaceuticals	9
Mateon Therapeutics	4

Sponsor Type

Sponsor Type for TROMETHAMINE
Sponsor	Trials
Other	61
Industry	43
NIH	5

Last updated: July 27, 2026

Tromethamine Clinical Trials Update, Market Analysis, and 2025–2035 Projections

Tromethamine (commonly marketed as “trometamol”) is an established, off-patent, multipurpose small-molecule excipient and alkalinizing agent used across injectables, renal/acid-base management, and buffering indications. The drug’s clinical development footprint is sparse versus branded therapeutics, while market performance tracks hospital and specialty-manufacturing demand, supply reliability, and regulatory/quality events more than patent-driven competition.

Because “Tromethamine” is a widely used ingredient rather than a single branded, IP-locked product, market and trial updates are best interpreted at the product/market-fragment level (by formulation, route, and indication) rather than as one unified clinical pipeline.

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What is tromethamine used for clinically and how is it dosed in major indications?

Tromethamine is used primarily as a buffering/alkalinizing agent, including for metabolic acidosis and to modulate urine pH in certain clinical contexts. In practice, dosing varies by formulation, patient setting, and therapeutic protocol (e.g., ICU acid-base management).

Core clinical contexts

• Metabolic acidosis and acid-base correction (hospital use)
• Buffering and alkalinization where protocol-driven urine or systemic pH adjustment is indicated
• Use as a component in injectable drug products, where tromethamine functions as part of the formulation system

Key formulation and route

• Injectable solutions (hospital and specialty pharmacy supply chain)
• Orally delivered forms exist in some jurisdictions but are less dominant for “tromethamine” as a therapeutic search target than injectables

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What clinical trials exist for tromethamine and what is the latest update?

A current, consolidated “clinical trials update” for tromethamine depends on identifying specific trial records by formulation, indication, and sponsor. Without an article-level source set, a complete, accurate update cannot be compiled.

Because tromethamine is often used as a formulation buffer/excipient and because many studies are protocol-level or combination-level rather than a dedicated “tromethamine drug product” program, a reliable “latest trials” summary requires a registry pull by specific query logic (clinicaltrials.gov EU CTR WHO ICTRP) and by product synonym sets (tromethamine, trometamol, tris(hydroxymethyl)aminomethane, etc.). That sourcing is not present here.

No complete and accurate trial update can be produced under these constraints.

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What is the current market size for tromethamine and what drives demand?

A “market size” answer requires numeric topline values (global and/or regional) and the underlying market-definition scope (API-only, finished injectable, excipient share, or therapeutic segment). No validated market data table or source set is available in the prompt context.

Demand drivers that typically matter

• ICU and hospital protocols for acid-base management
• Supply continuity for injectable buffers and compounded hospital regimens
• Specialty manufacturing constraints and quality events impacting availability
• Pricing pressure typical of off-patent ingredients
• Substitution between equivalent buffering systems (protocol and formulary dependent)

No numeric market size, CAGR, or segmentation table can be stated accurately.

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How should investors and planners project tromethamine revenue through 2030 and 2035?

A projection model needs inputs that are not provided: baseline sales, product mix, regional volume trends, price trend assumptions, and likely supply constraints. In the absence of cited baselines, any numerical projection would not meet the “hard data and actionable insights” standard required.

Projection framework (what typically determines trajectory)

• Volume: hospital utilization and protocol adherence trends
• Price: competitive intensity among generic/API suppliers
• Mix: injectable strength, packaging, and specialty channel share
• Regulatory/QMS: manufacturing disruptions that cause short-term spikes then reversion
• Substitution risk: alternative buffers, compounded substitutions, and formulary dynamics

No defensible 2025–2035 numerical projection can be produced without data.

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When does tromethamine lose exclusivity and is it patent protected?

For tromethamine as a chemical entity, exclusivity is generally not a differentiator for commercial entry. The ingredient is widely used and available through multiple manufacturers globally.

However, exclusivity and patent protection can still exist at the level of:

• Specific finished-dose product compositions
• Specific patents on particular formulations and methods of use tied to regulatory submissions
• Specific manufacturing processes and impurity-control specifications

A complete “what patents protect tromethamine” mapping cannot be produced here without a defined product (brand/ANDA/BLA/NDA) and without Orange Book-style listing inputs.

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What is the Orange Book status of tromethamine products?

The FDA Orange Book lists approved drug products by application and patent codes, but the status is application-specific. “Tromethamine” alone does not uniquely identify a single NDA/ANDA product listing.

Without the exact FDA application identifiers and NDC-level product mapping, a correct Orange Book status summary cannot be compiled.

No complete and accurate Orange Book determination can be provided.

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What generic entry risks exist for tromethamine and how fast can competitors scale?

For widely used off-patent ingredients:

• Commercial risk is usually supply and quality rather than IP
• Entry barriers depend on cGMP capacity, impurity profiles, stability data, and regulatory acceptance for specific dosage strengths

A quantified “generic entry risk” requires competitor mapping, regulatory review history, and any relevant import/manufacturing limitations. Those inputs are not present.

No risk rating or time-to-launch estimate can be stated with accuracy.

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How does tromethamine compare with alternative alkalinizing agents and buffers?

Comparative analysis requires consistent endpoints:

• Equivalence in buffering capacity
• Clinical protocol acceptance and outcomes in metabolic acidosis management
• Safety profiles tied to formulation (not just active ingredient)
• Cost and availability

Without a sourcing set for each alternative (e.g., sodium bicarbonate and other alkalinizing options) and without indication-level comparators, a rigorous “how it compares” section cannot be completed.

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Which companies supply tromethamine and what does the competitive landscape look like?

A market-structure answer requires a manufacturer list with capacity/footprint, finished-dose product coverage, or API market share. None is provided.

No actionable competitor table (companies, sites, regulatory status, product portfolios) can be generated accurately.

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What patent litigation affects tromethamine?

Patent litigation requires identification of specific litigated patents, case captions, courts, and docket outcomes. None is provided.

No litigation impact assessment can be compiled.

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What does FDA regulatory status look like for tromethamine by route and product type?

Regulatory status is tied to applications (NDA/ANDA) and dosage forms. “Tromethamine” is also used as an excipient in other drug products, complicating attribution.

Without application-level inputs, no accurate regulatory status table (approvals, supplements, approvals by route, approvals by strength) can be written.

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Key Takeaways

• Tromethamine is an established alkalinizing/buffering agent used mainly in hospital settings and injectable formulations.
• A complete clinical trials update cannot be produced here without trial-registry source extraction by indication and formulation.
• Market sizing and 2025–2035 numerical projections require baseline sales and market-definition inputs that are not present.
• IP and exclusivity are generally not the primary commercial constraint for tromethamine, but product-specific formulation/manufacturing patents can exist; application-level Orange Book mapping is required for any definitive exclusivity claim.

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FAQs

1) Is tromethamine the same as trometamol?
Yes, “trometamol” is the common name for tromethamine (tris(hydroxymethyl)aminomethane).

2) What therapeutic class does tromethamine fall under?
It is used as an alkalinizing/buffering agent for acid-base management contexts.

3) Is tromethamine still under patent protection?
Exclusivity is typically not driven by the chemical entity in the way it is for branded drugs, but formulation- and product-specific protections can exist.

4) Does tromethamine have FDA approvals as an active ingredient?
Regulatory status is application- and dosage-form specific; tromethamine also appears as an excipient in other products.

5) What is the main business risk in tromethamine supply?
Quality-system compliance, manufacturing capacity, and continuity of injectable supply are usually more important than IP barriers.

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References

No sources were provided in the prompt, and no registry, FDA, or market data sources were cited.