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Last Updated: January 20, 2025

Investigational Drug Information for L-Citrulline


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What is the development status for investigational drug L-Citrulline?

L-Citrulline is an investigational drug.

There have been 34 clinical trials for L-Citrulline. The most recent clinical trial was a Phase 3 trial, which was initiated on October 20th 2021.

The most common disease conditions in clinical trials are Anemia, Sickle Cell, Hypertension, and Lung Injury. The leading clinical trial sponsors are Asklepion Pharmaceuticals, LLC, National Institutes of Health (NIH), and Vanderbilt University.

There are three hundred and eighty-one US patents protecting this investigational drug and zero international patents.

Recent Clinical Trials for L-Citrulline
TitleSponsorPhase
Study to Improve Deployment Related Asthma by Using L-Citrulline SupplementationNational Jewish HealthPhase 2
Study to Improve Deployment Related Asthma by Using L-Citrulline SupplementationUnited States Department of DefensePhase 2
Study to Improve Deployment Related Asthma by Using L-Citrulline SupplementationUniversity of Colorado, DenverPhase 2

See all L-Citrulline clinical trials

Clinical Trial Summary for L-Citrulline

Top disease conditions for L-Citrulline
trials01122334455667Anemia, Sickle CellHypertensionLung InjuryAcute Lung Injury[disabled in preview]
Top clinical trial sponsors for L-Citrulline
trials01122334455667Asklepion Pharmaceuticals, LLCNational Institutes of Health (NIH)Vanderbilt University[disabled in preview]

See all L-Citrulline clinical trials

US Patents for L-Citrulline

DrugnamePatent NumberPatent TitlePatent AssigneeEstimated Expiration
L-Citrulline ⤷  Subscribe Monomethylvaline compounds having phenylalanine side-chain modification at the C-terminus Seattle Genetics, Inc. (Bothell, WA) ⤷  Subscribe
L-Citrulline ⤷  Subscribe Methods of expressing products in mammalian cells INTREXON CEU, INC. (Blacksburg, VA) ⤷  Subscribe
L-Citrulline ⤷  Subscribe Method of diagnosing and treating cancer using B-catenin splice variants The United States of America, as represented by the Secretary, Department of Health & Human Services (Washington, DC) ⤷  Subscribe
L-Citrulline ⤷  Subscribe Seaweed-derived cosmetic compositions Skinergistics Clinical Skin Solutions Inc. (Vancouver, CA) ⤷  Subscribe
>Drugname>Patent Number>Patent Title>Patent Assignee>Estimated Expiration
Showing 1 to 4 of 4 entries

International Patents for L-Citrulline

DrugnameCountryDocument NumberEstimated ExpirationRelated US Patent
L-Citrulline Australia AU2007345497 2027-01-29 ⤷  Subscribe
L-Citrulline Canada CA2676865 2027-01-29 ⤷  Subscribe
L-Citrulline European Patent Office EP2114986 2027-01-29 ⤷  Subscribe
L-Citrulline Spain ES2425575 2027-01-29 ⤷  Subscribe
>Drugname>Country>Document Number>Estimated Expiration>Related US Patent
Showing 1 to 4 of 4 entries

Development Update and Market Projection for L-Citrulline

Introduction to L-Citrulline

L-Citrulline is a non-essential amino acid that plays a crucial role in various physiological processes, including the urea cycle and the production of L-arginine. Its versatility and health benefits have made it a significant component in multiple industries, including pharmaceuticals, food and beverages, and dietary supplements.

Physical and Chemical Characterization

L-Citrulline is well-characterized and stable under ordinary storage conditions, whether in solid or liquid oral dosage forms. It is soluble in water and can be produced through fermentation of L-arginine using specific microorganisms like Arthrobacter paraffineus and Bacillus subtilis, or through chemical synthesis, although the latter method is less efficient and more environmentally unfriendly[1].

Historical Use in Compounding

L-Citrulline has been used historically in compounding for the treatment of urea cycle disorders (UCDs). It is a standard of care for conditions such as NAGS deficiency, CPS1 deficiency, OTCD, and HHH syndrome. L-Citrulline serves as a precursor to L-arginine, helping maintain normal protein turnover and promoting anabolism and growth in children[1].

Current Applications

Pharmaceutical Use

L-Citrulline is nominated for inclusion on the list of bulk drug substances for use in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Its efficacy in treating UCDs is well-documented, although no clinical trials specifically on L-Citrulline for these conditions have been conducted[1].

Dietary Supplements and Sports Nutrition

L-Citrulline is widely used in dietary supplements, energy drinks, and sports nutrition products due to its benefits in enhancing exercise performance, reducing muscle soreness, and improving recovery. It is particularly popular among athletes and fitness enthusiasts seeking performance-enhancing supplements[2][3].

Food and Beverages

The inclusion of L-Citrulline in food and beverages is on the rise, driven by consumer demand for functional foods that offer additional health benefits. It is used in various products to enhance physical performance, support cardiovascular health, and aid in recovery from physical exertion[3].

Market Projection

Global Market Size and Growth

The global L-Citrulline market was valued at approximately USD 1.11 billion in 2023 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.98% from 2024 to 2030, reaching nearly USD 1.66 billion by 2030[2].

Regional Analysis

  • North America: This region emerged as a prominent market in 2023, driven by increasing demand for dietary supplements, sports nutrition products, and energy drinks. The United States leads the charge, with a significant consumption rate that rose by approximately 8-10% compared to 2022[2].
  • Europe: The European market is expected to experience substantial growth, driven by ongoing product innovations catering to the increasing consumer demand for health and wellness solutions[3].
  • Asia Pacific: This region is expected to witness a CAGR of 6.0% from 2024 to 2030, with China and India being significant contributors due to their large populations and expanding middle class. Southeast Asia also presents untapped potential for the L-Citrulline market[3].

Key Drivers of Market Growth

  • Growing Consumer Demand for Functional Foods and Drinks: Consumers are increasingly seeking products that provide extra health benefits beyond basic nutrition, driving the inclusion of L-Citrulline in various food and drink items[5].
  • Global Nutraceutical Sector Expansion: The nutraceutical sector, which includes functional foods, beverages, and dietary supplements, is growing, and L-Citrulline is a key component in many of these products[5].
  • Research and Development Activities: Continuous efforts to investigate L-Citrulline’s medicinal potential for various medical ailments support market expansion and could reveal novel uses[5].
  • Increasing Disposable Income: Rising disposable income in emerging nations allows consumers to spend more on wellness and health products, including L-Citrulline-containing dietary supplements[5].

Key Players

The market is dominated by key players such as Kyowa Hakko Bio Co., Ltd., Nutrition Labs, NOW Foods, and Bulk Supplements, among others. These companies have ramped up their operations to meet the growing demand for high-quality L-Citrulline formulations[2].

Health Benefits and Safety

L-Citrulline has several health benefits, including enhancing exercise performance, reducing muscle soreness, and improving recovery. It also positively influences the mTOR pathway and can improve nitrogen balance in humans. Unlike arginine and ornithine, high doses of L-Citrulline are generally well-tolerated and do not cause gastrointestinal distress[4].

Future Outlook

The future of the L-Citrulline market looks promising, driven by its versatility and the growing demand for health and wellness products. As research continues to uncover new potential uses for L-Citrulline, the market is expected to expand further, catering to a broader range of applications across different industries.

Key Takeaways

  • L-Citrulline is a well-characterized, stable amino acid used in various applications.
  • It is a standard of care for certain urea cycle disorders.
  • The global market is expected to grow at a CAGR of 5.98% from 2024 to 2030.
  • North America, particularly the United States, is a leading market for L-Citrulline.
  • Growing consumer demand for functional foods and beverages, along with expanding nutraceutical and research activities, drive market growth.
  • Key players are investing in high-quality formulations to meet increasing demand.

FAQs

What is the current market size of the global L-Citrulline market?

The global L-Citrulline market was valued at approximately USD 1.11 billion in 2023[2].

What is the expected growth rate of the global L-Citrulline market?

The global L-Citrulline market is expected to grow at a CAGR of 5.98% from 2024 to 2030[2].

Which region holds the largest share in the global L-Citrulline market?

North America, particularly the United States, holds the largest share in the global L-Citrulline market[2].

What are the primary applications of L-Citrulline?

L-Citrulline is used in pharmaceuticals, dietary supplements, sports nutrition products, energy drinks, and various food and beverage items[2][3].

Is L-Citrulline safe for long-term supplementation?

Research to date suggests that L-Citrulline is well-tolerated in most individuals, although the safety of long-term supplementation with high doses warrants further investigation[4].

Sources

  1. FDA Presentations for the November 20-21, 2017 Meeting of the Pharmacy Compounding Advisory Committee - FDA.report
  2. L Citrulline Market: Global Industry Analysis and Forecast - Maximize Market Research
  3. L-Citrulline Market Size, Share And Growth Report, 2030 - Grand View Research
  4. Citrulline benefits, dosage, and side effects - Examine.com
  5. L Citrulline Market Size, Share, Trends, Growth, Scope & Forecast - Verified Market Research

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