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Last Updated: January 17, 2025

Investigational Drug Information for L-Leucovorin


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

L-Leucovorin is an investigational drug.

There have been 25 clinical trials for L-Leucovorin. The most recent clinical trial was a Phase 3 trial, which was initiated on February 1st 2003.

The most common disease conditions in clinical trials are Colorectal Neoplasms, Autistic Disorder, and Adenocarcinoma. The leading clinical trial sponsors are Gruppo Oncologico del Nord-Ovest, Pfizer, and Hokkaido Gastrointestinal Cancer Study Group.

Recent Clinical Trials for L-Leucovorin
TitleSponsorPhase
Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer PatientsFoundation MedicinePhase 2
Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer PatientsServierPhase 2
Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer PatientsGruppo Oncologico del Nord-OvestPhase 2

See all L-Leucovorin clinical trials

Clinical Trial Summary for L-Leucovorin

Top disease conditions for L-Leucovorin
Top clinical trial sponsors for L-Leucovorin

See all L-Leucovorin clinical trials

Development Update and Market Projection for L-Leucovorin

Introduction to L-Leucovorin

L-Leucovorin, also known as (6S)-leucovorin or 5-formyltetrahydrofolate, is a crucial drug in the treatment of various cancers and blood cell disorders. It is widely used in combination with chemotherapy, particularly with 5-fluorouracil (5FU), to enhance the efficacy of cancer treatments.

Clinical Applications of L-Leucovorin

Cancer Treatment

L-Leucovorin is primarily used in the treatment of colorectal, breast, lung, and ovarian cancers. It works by enhancing the antitumor activity of 5FU by increasing and prolonging the inhibition of thymidylate synthase (TS), a key enzyme in DNA synthesis. This is achieved through the formation of a stable ternary covalent complex with the 5FU metabolite and TS, which retains TS inhibition for several days[4].

Blood Cell Disorders

L-Leucovorin is also used to treat megaloblastic anemia, a condition often caused by folic acid deficiency, and to counteract the toxic effects of certain chemotherapy agents like methotrexate, trimethoprim, and pyrimethamine. It is particularly effective in cases where oral therapy is not feasible[2][3].

Market Dynamics

Growth Drivers

The global L-Leucovorin market is driven by several key factors:

  • Increasing Cancer Cases: The rising prevalence of cancer globally, with approximately 19.3 million new cases recorded in 2020, significantly boosts the demand for L-Leucovorin as an adjunct to chemotherapy[5].
  • Geriatric Population: The growing geriatric population is at a higher risk of developing cancer and other health issues, further driving the demand for L-Leucovorin[3].
  • Advancements in Healthcare: Improvements in healthcare infrastructure, particularly in North America and the Asia-Pacific region, contribute to the market growth. High healthcare expenditure and advanced medical facilities in these regions also play a crucial role[2][3].

Market Segmentation

By Type

L-Leucovorin is available in various forms, including tablets and injections. The injections segment dominates the market due to its rapid action and higher bioavailability[5].

By Distribution Channel

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to hold the largest market share due to the expanding healthcare system and the necessity of prescription-based purchases[2].

By Region

North America is anticipated to hold the largest revenue share by 2037, driven by the presence of major pharmaceutical companies and high healthcare expenditure. The Asia-Pacific region is also expected to exhibit significant growth due to infrastructural improvements and increasing R&D activities[2][3].

Market Projections

Revenue Growth

The global L-Leucovorin calcium market is projected to experience substantial revenue growth. By 2037, the market is estimated to exceed USD 187.87 million, growing at a CAGR of over 16.1% from 2025 to 2037[2].

Regional Outlook

  • North America: Expected to hold the largest market share due to advanced healthcare infrastructure and high healthcare expenditure[2][3].
  • Asia-Pacific: Anticipated to grow at the fastest revenue CAGR, driven by improving healthcare systems and rising cancer and blood cell disorder cases[3].
  • Europe: Growth driven by rising disposable income, increasing incidence of chronic diseases, and an aging population[3].

Competitive Landscape

The L-Leucovorin market is competitive, with prominent players such as Teva Pharmaceutical Industries Ltd., Mylan N.V., and Hikma Pharmaceuticals plc. These companies are involved in manufacturing, marketing, and distributing L-Leucovorin products, as well as engaging in R&D activities to develop more effective therapies. Strategic developments, including mergers and acquisitions, partnerships, and collaborations, are also common in this market[5].

Challenges and Opportunities

Challenges

  • High Cost and Availability of Alternatives: These are significant restraints for revenue growth in the global L-Leucovorin market[3].
  • Supply Chain Issues: Restrictions on the import of raw materials and product recalls due to drug interactions can hinder market growth[2].

Opportunities

  • Potential Applications in Autoimmune Diseases: L-Leucovorin has shown potential in treating autoimmune diseases such as rheumatoid arthritis and Crohn’s disease, which could expand its market[3].
  • Improving Healthcare Infrastructure: Advancements in healthcare systems, especially in developing countries, present opportunities for market expansion[2][3].

Strategic Developments

Companies in the L-Leucovorin market are focusing on research and development to optimize the administration and efficacy of the drug. For instance, the use of the active isomer, L-Leucovorin, has partially replaced the racemic mixture of D- and L-Leucovorin in several treatment schedules for colorectal cancer, enhancing treatment outcomes[4].

Optimal Administration

Studies have highlighted the importance of optimal administration of L-Leucovorin to enhance its antitumor activity. Pre- and simultaneous treatment with L-Leucovorin, along with high-dose 5FU, can significantly improve treatment efficacy[4].

Key Takeaways

  • Growing Demand: The market is driven by increasing cancer cases and the growing geriatric population.
  • Regional Growth: North America and the Asia-Pacific region are expected to be key drivers of market growth.
  • Competitive Landscape: The market is competitive with major players focusing on R&D and strategic partnerships.
  • Challenges and Opportunities: High costs and supply chain issues are challenges, while potential applications in autoimmune diseases and improving healthcare infrastructure present opportunities.

FAQs

What is L-Leucovorin used for?

L-Leucovorin is used in the treatment of various cancers, such as colorectal, breast, lung, and ovarian cancers, and to treat blood cell disorders like megaloblastic anemia.

How does L-Leucovorin enhance cancer treatment?

L-Leucovorin enhances the antitumor activity of 5-fluorouracil (5FU) by increasing and prolonging the inhibition of thymidylate synthase (TS), a key enzyme in DNA synthesis.

What are the major drivers of the L-Leucovorin market?

The major drivers include the rising prevalence of cancer, the growing geriatric population, and advancements in healthcare infrastructure.

Which region is expected to hold the largest market share for L-Leucovorin?

North America is expected to hold the largest market share due to advanced healthcare infrastructure and high healthcare expenditure.

What are the challenges facing the L-Leucovorin market?

High costs, availability of alternatives, and supply chain issues are significant challenges facing the market.

Sources

  1. MDPI: "Folic Acid and Leucovorin Have Potential to Prevent SARS-CoV-2 Infection by Inhibiting the S-Glycoprotein/NRP-1 Complex"[1].
  2. Research Nester: "Leucovorin Calcium Market Size, Growth Forecasts 2037"[2].
  3. Growth Plus Reports: "Leucovorin Calcium Market Forecast 2031 - CAGR of 13.8% | GPR"[3].
  4. Frontiers in Pharmacology: "The role of l-leucovorin uptake and metabolism in the modulation of 5-fluorouracil activity"[4].
  5. OMR Global: "Global Leucovorin Calcium Market Trends 2021"[5].

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