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Last Updated: January 9, 2025

CLINICAL TRIALS PROFILE FOR ARGININE HYDROCHLORIDE


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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 TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
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.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 1 of 1 entries

All Clinical Trials for arginine hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for arginine hydrochloride

Condition Name

1311109002468101214HypertensionAsthmaHealthySickle Cell Disease[disabled in preview]
Condition Name for arginine hydrochloride
Intervention Trials
Hypertension 13
Asthma 11
Healthy 10
Sickle Cell Disease 9
[disabled in preview] 0
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Condition MeSH

222116110-2024681012141618202224HypertensionDiabetes MellitusAnemia, Sickle CellAsthma[disabled in preview]
Condition MeSH for arginine hydrochloride
Intervention Trials
Hypertension 22
Diabetes Mellitus 21
Anemia, Sickle Cell 16
Asthma 11
[disabled in preview] 0
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Clinical Trial Locations for arginine hydrochloride

Trials by Country

+
Trials by Country for arginine hydrochloride
Location Trials
United States 353
China 36
Italy 32
United Kingdom 29
Germany 19
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Trials by US State

+
Trials by US State for arginine hydrochloride
Location Trials
Texas 37
California 33
New York 27
Massachusetts 24
Maryland 19
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Clinical Trial Progress for arginine hydrochloride

Clinical Trial Phase

17.7%16.3%5.1%60.9%0020406080100120140160180Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for arginine hydrochloride
Clinical Trial Phase Trials
Phase 4 52
Phase 3 48
Phase 2/Phase 3 15
[disabled in preview] 179
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Clinical Trial Status

54.0%15.5%10.8%19.7%0406080100120140160180200CompletedRecruitingUnknown status[disabled in preview]
Clinical Trial Status for arginine hydrochloride
Clinical Trial Phase Trials
Completed 195
Recruiting 56
Unknown status 39
[disabled in preview] 71
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Clinical Trial Sponsors for arginine hydrochloride

Sponsor Name

trials02468101214161820222426National Heart, Lung, and Blood Institute (NHLBI)Polaris GroupNational Cancer Institute (NCI)[disabled in preview]
Sponsor Name for arginine hydrochloride
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 18
Polaris Group 12
National Cancer Institute (NCI) 10
[disabled in preview] 25
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Sponsor Type

73.8%15.5%9.0%0050100150200250300350400450500OtherIndustryNIH[disabled in preview]
Sponsor Type for arginine hydrochloride
Sponsor Trials
Other 499
Industry 105
NIH 61
[disabled in preview] 11
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Arginine hydrochloride Market Analysis and Financial Projection

Arginine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Arginine hydrochloride is a crucial compound in medical treatments, particularly for enhancing metabolic processes, stimulating growth hormone production, and assisting in the diagnosis of growth hormone deficiencies. This article delves into the current state of clinical trials, market analysis, and future projections for arginine hydrochloride.

Clinical Uses and Applications

Arginine hydrochloride is primarily used in hospitals and clinical settings for various therapeutic and diagnostic purposes. It is administered intravenously to stimulate growth hormone production, making it essential for growth hormone stimulation tests and nutritional support in both children and adults[1][4].

Diagnostic Tests

The compound is used in tests to measure pituitary reserve of human growth hormone. For instance, Pfizer's R-Gene 10 (arginine HCl) is administered via intravenous infusion to assess growth hormone levels[4].

Therapeutic Indications

Arginine hydrochloride is beneficial in treating conditions related to hormonal and metabolic disorders. It supports metabolic processes and can be part of nutritional support regimens.

Clinical Trials Overview

Clinical trials involving arginine hydrochloride are part of broader medical research aimed at improving patient care and understanding the pharmacokinetics and safety of the compound.

Phase I Trials

Phase I trials are critical for determining the optimal dosage and safety profile of arginine hydrochloride in human subjects. These trials are essential for transitioning from preclinical to clinical testing, ensuring that the treatment is safe and effective for human use[3].

Safety and Efficacy

Clinical studies have shown that arginine hydrochloride is generally safe when administered correctly. However, there is a need for continued vigilance due to potential side effects, especially in older adults and pregnant women. For example, reproduction studies in animals have not shown evidence of impaired fertility or harm to the fetus, but human data is limited[4].

Market Analysis

Market Size and Growth

The market for arginine hydrochloride is expanding due to several key factors. The global L-arginine market, which includes arginine hydrochloride, was valued at USD 28.32 billion in 2023 and is projected to grow to USD 53.3 billion by 2032, with a CAGR of 7.3% during the forecast period[5].

Market Drivers

  • Increasing Prevalence of Hormonal and Metabolic Disorders: The rising incidence of these disorders drives the demand for arginine hydrochloride in medical treatments.
  • Advancements in Medical Technologies: Improved diagnostic and therapeutic protocols enhance the use of arginine hydrochloride.
  • Growing Healthcare Spending: Increased investment in healthcare infrastructure and research fuels the market growth[1][5].

Market Restraints

  • Stringent Regulatory Standards: Compliance with FDA regulations and other international standards can be challenging.
  • Potential Side Effects: Adverse reactions, particularly in certain patient groups, can limit market expansion.
  • Price Competition: The market faces pricing volatility, which can impact profitability and market share[1][5].

Market Segmentation

By Product Type

The market is segmented into pharmaceutical grade and research grade arginine hydrochloride. Pharmaceutical grade is predominantly used in clinical settings, while research grade is used in scientific studies[1].

By Application Areas

The primary application areas include pharmaceuticals and research & development. The pharmaceutical segment is driven by the need for diagnostic and therapeutic uses, while the research segment focuses on exploring new applications and formulations[1].

By End Users

Hospitals and clinical settings are the main end users, with a growing demand from fitness and nutrition segments due to the increasing popularity of L-arginine supplements[5].

By Geography

The market is dominated by North America and Europe, with significant growth anticipated in the Asia-Pacific region due to a large population and increasing healthcare needs[5].

Market Opportunities

Personalized Medicine

The emergence of personalized medicine offers opportunities for innovative applications of arginine hydrochloride, tailored to individual patient needs[1].

Strategic Collaborations

Collaborations between healthcare institutions and manufacturers can optimize the usage and development of new formulations of arginine hydrochloride[1].

Growing Demand in Cosmetics and Personal Care

The increasing use of L-arginine in cosmetics and personal care products, due to its benefits in improving skin health and boosting the immune system, presents a new market opportunity[5].

Market Challenges

Economic Impacts

Economic volatility and pricing fluctuations can impact the market growth and profitability of arginine hydrochloride manufacturers[1].

Regulatory Compliance

Ensuring compliance with stringent regulatory standards is a continuous challenge for manufacturers, affecting market expansion and product development[1].

Key Players

Major players in the global arginine market include Ajinomoto Co., Inc., Kyowa Hakko Bio Co., Ltd., CJ CheilJedang Corporation, Evonik Industries AG, and Sichuan Tongsheng Amino Acid Co., Ltd. These companies are driving innovation and market growth through strategic investments and product development[2][5].

Future Projections

Market Growth

The arginine hydrochloride market is expected to continue its growth trajectory, driven by increasing healthcare spending, advancements in medical technologies, and the rising prevalence of hormonal and metabolic disorders[1][5].

Emerging Trends

The market will see a surge in demand from the fitness and nutrition segments, as well as from the cosmetics and personal care industry. Innovations in product formulations and strategic collaborations will be key drivers of market growth[5].

Key Takeaways

  • Growing Demand: The market for arginine hydrochloride is driven by increasing healthcare needs and advancements in medical technologies.
  • Clinical Significance: Arginine hydrochloride plays a vital role in diagnostic and therapeutic protocols, particularly in growth hormone stimulation tests.
  • Market Expansion: The market is expected to grow significantly, with opportunities in personalized medicine, strategic collaborations, and expanding end-use segments.
  • Challenges: Stringent regulatory standards, potential side effects, and economic impacts are key challenges that need to be addressed.

FAQs

What are the primary uses of arginine hydrochloride in clinical settings?

Arginine hydrochloride is primarily used in clinical settings for growth hormone stimulation tests and as part of nutritional support regimens.

Which regions are expected to dominate the arginine hydrochloride market?

North America and Europe currently dominate the market, with significant growth anticipated in the Asia-Pacific region.

What are the key drivers of the arginine hydrochloride market?

Key drivers include the rising prevalence of hormonal and metabolic disorders, advancements in medical technologies, and growing healthcare spending.

Who are the major players in the global arginine market?

Major players include Ajinomoto Co., Inc., Kyowa Hakko Bio Co., Ltd., CJ CheilJedang Corporation, Evonik Industries AG, and Sichuan Tongsheng Amino Acid Co., Ltd.

What are the potential challenges facing the arginine hydrochloride market?

Challenges include stringent regulatory standards, potential side effects, and economic impacts such as pricing volatility.

Sources

  1. 360iResearch: Arginine Hydrochloride for Injection Market Size 2025-2030.
  2. ChemAnalyst: Arginine Market Size, Growth, Analysis & Forecast, 2032.
  3. BioSpace: U.S. Clinical Trials Market Size Industry Analysis Report, 2033.
  4. Pfizer Medical Information: R-GENE® 10 (arginine HCl).
  5. SkyQuest: L-Arginine Market Trends, Size, Share & Forecast | 2032.

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