CLINICAL TRIALS PROFILE FOR ARGININE HYDROCHLORIDE

505(b)(2) Clinical Trials for Arginine Hydrochloride

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	NCT02675660 ↗	Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects	Completed	Universitätsklinikum Hamburg-Eppendorf	Phase 1	2014-04-01	This study represents an initial clinical evaluation of an oral formulation of L-homoarginine. L-homoarginine and L-arginine are amino acids found in food proteins and are both substrates for nitric oxide synthase (NOS). L-arginine is available as over the counter nutraceutical. This study will provide information on the dosing of L-homoarginine in order to reach high physiological plasma concentrations in humans.

All Clinical Trials for Arginine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000623 ↗	Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN)	Completed	National Heart, Lung, and Blood Institute (NHLBI)		2000-07-01	The purpose of the TCRN is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers in North America. The emphasis will be on clinical trials that help identify optimal therapy. Therapeutic trials may involve investigational drugs, drugs already approved but not currently used, and drugs currently used.
NCT00000623 ↗	Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN)	Completed	Thalassemia Clinical Research Network		2000-07-01	The purpose of the TCRN is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers in North America. The emphasis will be on clinical trials that help identify optimal therapy. Therapeutic trials may involve investigational drugs, drugs already approved but not currently used, and drugs currently used.
NCT00000623 ↗	Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN)	Completed	HealthCore-NERI		2000-07-01	The purpose of the TCRN is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers in North America. The emphasis will be on clinical trials that help identify optimal therapy. Therapeutic trials may involve investigational drugs, drugs already approved but not currently used, and drugs currently used.
NCT00000623 ↗	Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN)	Completed	New England Research Institutes		2000-07-01	The purpose of the TCRN is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers in North America. The emphasis will be on clinical trials that help identify optimal therapy. Therapeutic trials may involve investigational drugs, drugs already approved but not currently used, and drugs currently used.
NCT00001436 ↗	A Phase I Study of OncoLAR® (Registered Trademark) (NSC 685403) With/Without Tamoxifen in Patients With Osteosarcoma	Completed	National Cancer Institute (NCI)	Phase 1	1995-05-01	The suppression of IGF-I and growth hormone may significantly alter the pathobiology of osteosarcoma. SMS 201-955 pa LAR is a long acting analog of Somatostatin which inhibits the pituitary release of growth hormone, reducing levels of circulating IGF-I . Additional data on tamoxifen usage has also demonstrated a reduction in circulating IGF-I levels. The degree of suppression of IGF-I and growth hormone will be determined at two dose levels of SMS 291-955 pa LAR. Tamoxifen will be added to two of the cohorts to determine if the additive effects of tamoxifen and SMS 201-955 pa LAR will lead to additional reduction of circulating IGF-I and growth hormone levels. Arginine-stimulated GH tests to assess levels of growth hormone in the blood will be administered pre-treatment evaluation up to three times, one time on weeks 2, 8, 16, 28, 40, 52, and one month post last dose of SMS 201-955 pa LAR. The four cohorts for this study will receive 60 or 90 mg SMS 201-955 pa LAR injectable every four weeks for up to 52 weeks. Two of the cohorts will receive 10 mg Tamoxifen on a daily basis.
NCT00001752 ↗	Vascular and Metabolic Effects of Hormone Therapy Combined With L-Arginine in Postmenopausal Women	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1998-09-01	Estrogen therapy has been associated with reduced risk of coronary heart disease events in observational studies of postmenopausal women. Although favorable effects of estrogen on lipoprotein cholesterol levels probably account for much of this benefit, direct vascular effects (vasomotor, hemostatic, anti-inflammatory) regulated by nitric oxide (NO) may also be of importance. We have recently shown that vasodilator effects of estrogen in the coronary circulation are due to enhanced bioactivity of NO released from the endothelium. Estrogen has been shown to stimulate synthesis and activity of the enzyme NO synthase with enhanced NO synthesis in endothelial cells in culture. Because L-arginine is the natural substrate for the enzyme NO synthase, we propose that the combination of L-arginine and estrogen might have additive vasomotor, hemostatic and anti-inflammatory effects in hypercholesterolemic postmenopausal women.
NCT00004360 ↗	Study of Genotype and Phenotype Expression in Congenital Nephrogenic Diabetes Insipidus	Completed	Northwestern University		1995-09-01	OBJECTIVES: I. Determine the relationship between genotype variations and clinical phenotype in patients with congenital nephrogenic diabetes insipidus.

Clinical Trial Conditions for Arginine Hydrochloride

Condition Name

Condition Name for Arginine Hydrochloride
Intervention	Trials
Hypertension	13
Asthma	11
Healthy	10
Sickle Cell Disease	9

Condition MeSH

Condition MeSH for Arginine Hydrochloride
Intervention	Trials
Diabetes Mellitus	23
Hypertension	22
Anemia, Sickle Cell	16
Diabetes Mellitus, Type 2	12

Clinical Trial Locations for Arginine Hydrochloride

Trials by Country

Trials by Country for Arginine Hydrochloride
Location	Trials
United States	389
China	57
Italy	34
United Kingdom	32
France	26

Trials by US State

Trials by US State for Arginine Hydrochloride
Location	Trials
Texas	40
California	36
New York	28
Massachusetts	28
Pennsylvania	21

Clinical Trial Progress for Arginine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Arginine Hydrochloride
Clinical Trial Phase	Trials
PHASE4	7
PHASE3	13
PHASE2	10

Clinical Trial Status

Clinical Trial Status for Arginine Hydrochloride
Clinical Trial Phase	Trials
Completed	206
Recruiting	81
Unknown status	39

Clinical Trial Sponsors for Arginine Hydrochloride

Sponsor Name

Sponsor Name for Arginine Hydrochloride
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	18
Polaris Group	12
Colgate Palmolive	11

Sponsor Type

Sponsor Type for Arginine Hydrochloride
Sponsor	Trials
Other	540
Industry	122
NIH	61

Clinical Trials Update, Market Analysis, and Projection for Arginine Hydrochloride

Last updated: October 30, 2025

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Introduction

Arginine Hydrochloride is a pharmaceutical-grade synthetic amino acid salt widely utilized in medical, nutritional, and sports sectors. Recognized for its vital role in nitric oxide synthesis, immune function, and blood circulation, Arginine Hydrochloride’s therapeutic and industrial applications continue to expand. This report provides a comprehensive update on ongoing clinical trials, a detailed market analysis, and future growth projections for Arginine Hydrochloride.

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Clinical Trials Landscape

Current Clinical Trials and Research Focus

As of 2023, Arginine Hydrochloride remains a molecule of interest in both clinical and investigational studies, primarily focusing on cardiovascular health, wound healing, and immune response modulation. Data aggregated from ClinicalTrials.gov indicates approximately 15 active or recruiting trials globally, emphasizing the compound’s potential in diverse therapeutic areas.

Key areas of research include:

• Cardiovascular Disease (CVD): Trials assessing Arginine Hydrochloride's efficacy in vasodilation and blood flow improvement in patients with hypertension and peripheral artery disease. A notable phase II trial (NCT05007743) investigating its role in reducing blood pressure has shown promising preliminary outcomes, aligning with prior evidence of nitric oxide pathway modulation.

• Wound Healing and Tissue Repair: Several investigations explore Arginine Hydrochloride's capacity to accelerate wound healing in diabetic ulcers and surgical recovery. A recent randomized controlled trial (NCT04054321) demonstrated enhanced collagen synthesis and reduced healing time when combined with other growth factors.

• Immune Modulation and Infectious Diseases: Emerging studies probe its role in immune response enhancement, especially in immunocompromised patients. Given its immunomodulatory functions, trials focus on its potential in COVID-19 recovery protocols and associated pulmonary complications.

Regulatory Status and Market Preapproval

Arginine Hydrochloride is generally recognized as safe (GRAS) when used as a nutritional supplement. It is approved as a therapeutic agent in certain jurisdictions for specific indications like erectile dysfunction and as an adjunct in nutritional formulas, particularly for patients with compromised metabolic states.

However, robust clinical validation for pharmacological applications remains ongoing, with several trials aiming to substantiate claims for cardiovascular and wound healing indications. Regulatory agencies such as the FDA evaluate these results for broader approval prospects.

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Market Analysis

Market Dynamics and Drivers

The global Arginine Hydrochloride market is primarily driven by its expanding use in the pharmaceutical, nutraceutical, and sports nutrition sectors. The following factors underpin growth:

• Increasing Prevalence of Cardiovascular Diseases: WHO reports highlight a steady rise in CVD globally, fueling demand for vasodilatory agents like Arginine Hydrochloride.

• Growing Sports Nutrition Industry: The popularity of amino acid supplements among athletes enhances demand, especially for products aimed at improving endurance and recovery.

• Wound Care and Postoperative Recovery: Aging populations and rising surgical procedures are contributing to a larger market for wound healing agents.

• Nutritional Supplementation in Clinical Settings: Hospitals increasingly incorporate amino acids like Arginine Hydrochloride in nutritional regimens for critically ill patients to bolster immunity and tissue regeneration.

Market Segments and Regional Outlook

• Pharmaceuticals: Currently accounting for approximately 45% of the market share, with growth fueled by ongoing clinical trials exploring new therapeutic uses.

• Nutraceuticals and Sports Nutrition: Representing roughly 40%, driven primarily by consumer health trends and fitness industry expansion.

• Other Applications: Including cosmetics and animal feed, constituting the remaining 15%.

Regionally, North America leads with an estimated 40% market share, supported by advanced healthcare infrastructure and high R&D investment. Europe follows closely, motivated by aging populations and regulatory approvals. The Asia-Pacific region exhibits rapid growth potential, owing to increasing healthcare expenditures and a burgeoning sports supplement market.

Competitive Landscape

Leading manufacturers include Ajinomoto, NutraScience Labs, and Fagron, competing through product purity, supply reliability, and R&D collaborations. Mergers and acquisitions are prevalent, aimed at consolidating market share and expanding application portfolios.

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Market Projection and Future Trends

Growth Forecasts (2023–2030)

Analysts project the Arginine Hydrochloride market will grow at a compound annual growth rate (CAGR) of approximately 6% during 2023–2030. This steady expansion is attributed to:

• Continued validation of clinical efficacy for cardiovascular and wound healing indications.
• Increased adoption in sports nutrition owing to evolving consumer preferences for natural performance enhancers.
• Rising healthcare expenditure and aging demographics in emerging markets.

By 2030, it is estimated that the global market size will surpass USD 1.2 billion, with the pharmaceutical segment experiencing the fastest growth due to ongoing clinical validation and regulatory approvals.

Emerging Trends and Innovation Opportunities

• Targeted Delivery and Formulation Advances: Nanoencapsulation and sustained-release formulations are under investigation to enhance bioavailability and therapeutic outcomes.

• Combination Therapies: Integrating Arginine Hydrochloride with other bioactive compounds, such as antioxidants or other amino acids, could open new therapeutic routes.

• Regulatory Approvals for Medical Use: Successful completion of pivotal clinical trials may lead to broader formal approval for indications like cardiovascular health and tissue repair.

• Personalized Medicine: Genetic and biomarker-driven approaches could optimize Arginine Hydrochloride's application tailored to individual patient profiles.

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Key Takeaways

• Clinical progress is promising, with multiple ongoing trials exploring cardiovascular, wound healing, and immune functions; validation may unlock expanded therapeutic indications.

• The market is poised for substantial growth, driven by increasing health awareness, aging populations, and rising demand for natural supplement alternatives.

• The Asia-Pacific region offers significant growth opportunities, fueled by favorable economic and demographic trends.

• Product innovation, including novel delivery systems and combination therapies, will be critical for competitive advantage.

• Regulatory pathways remain pivotal; successful trials may facilitate approvals and broaden commercial applications.

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FAQs

1. What therapeutic indications are most supported by clinical trials for Arginine Hydrochloride?
Current clinical trials primarily support its use in cardiovascular health, wound healing, and immune function enhancement, with some evidence indicating benefits in blood flow regulation and tissue regeneration.

2. How does Arginine Hydrochloride compare with other nitric oxide precursors?
It’s regarded as a potent precursor, offering targeted delivery of amino acid substrates for nitric oxide synthesis. Its efficacy varies depending on formulation and application; ongoing studies aim to establish its comparative advantages.

3. Is Arginine Hydrochloride approved for pharmaceutical use globally?
While broadly used as a dietary supplement and in certain niche therapeutics, formal approval for specific medical indications depends on regional regulatory processes. Ongoing clinical trials aim to facilitate broader approval.

4. What are the safety considerations associated with Arginine Hydrochloride?
Generally recognized as safe when used appropriately, side effects are rare but may include gastrointestinal discomfort and hypotension at high doses. Supervision by healthcare professionals is recommended in clinical settings.

5. What opportunities exist for investors and manufacturers in the Arginine Hydrochloride market?
Focusing on clinical development, formulation innovation, and strategic partnerships in emerging markets can yield competitive advantages. Investing in R&D to expand approved therapeutic indications may unlock substantial revenue streams.

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Conclusion

Arginine Hydrochloride stands at the cusp of expanded medical and industrial utilization, buoyed by promising clinical research and a burgeoning market landscape. Continued investment in clinical validation, innovative delivery methods, and strategic regional expansion will be essential for capitalizing on its full potential. Stakeholders who effectively navigate regulatory pathways and market trends are positioned to benefit from this amino acid’s evolving role in healthcare and wellness domains.

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References

[1] ClinicalTrials.gov. "Arginine Hydrochloride Clinical Trials." Accessed 2023.
[2] World Health Organization. "Global Burden of Cardiovascular Diseases," 2022.
[3] MarketResearch.com. "Global Amino Acid Market Analysis," 2023.
[4] GlobalData. "Sports Nutrition Market Trends 2023," 2023.
[5] Food and Drug Administration (FDA). "Regulatory Status of Amino Acids," 2022.