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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR THIAMINE HYDROCHLORIDE


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All Clinical Trials for thiamine hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00031057 ↗ Vitamin B Therapy for Hyperlactatemia Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 The purpose of this study is to see if vitamin B can treat mild hyperlactatemia (a higher than normal level of lactate in the blood) in patients who take nucleoside reverse transcriptase inhibitors (NRTIs). Hyperlactatemia is a potentially life-threatening condition that can be associated with NRTI therapy. A lack of vitamin B may be related to the development of hyperlactatemia. However, no studies have been done to evaluate this. This study proposes that high doses of vitamin B may bring elevated lactate levels back to normal among patients taking NRTIs.
NCT00143702 ↗ D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE) Completed CIHR Canadian HIV Trials Network Phase 2/Phase 3 2001-08-01 The purpose of this study is to determine the best way to treat people on d4T (stavudine) with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding riboflavin and thiamine will also be assessed. Participants will be randomly assigned to one of four groups: - Group 1 participants will continue to take d4T as part of their antiretroviral (ARV) regimen, and will be given the vitamin supplements - Group 2 will continue to take d4T without vitamin supplements - Group 3 will switch from d4T to abacavir and receive the vitamins - Group 4 will switch from d4T to abacavir without vitamin supplements. The study plans to involve eighty participants from Canada and Argentina for a treatment period of 16 weeks and a follow-up visit at week 24.
NCT00143702 ↗ D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE) Completed GlaxoSmithKline Phase 2/Phase 3 2001-08-01 The purpose of this study is to determine the best way to treat people on d4T (stavudine) with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding riboflavin and thiamine will also be assessed. Participants will be randomly assigned to one of four groups: - Group 1 participants will continue to take d4T as part of their antiretroviral (ARV) regimen, and will be given the vitamin supplements - Group 2 will continue to take d4T without vitamin supplements - Group 3 will switch from d4T to abacavir and receive the vitamins - Group 4 will switch from d4T to abacavir without vitamin supplements. The study plans to involve eighty participants from Canada and Argentina for a treatment period of 16 weeks and a follow-up visit at week 24.
NCT00143702 ↗ D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE) Completed University of British Columbia Phase 2/Phase 3 2001-08-01 The purpose of this study is to determine the best way to treat people on d4T (stavudine) with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding riboflavin and thiamine will also be assessed. Participants will be randomly assigned to one of four groups: - Group 1 participants will continue to take d4T as part of their antiretroviral (ARV) regimen, and will be given the vitamin supplements - Group 2 will continue to take d4T without vitamin supplements - Group 3 will switch from d4T to abacavir and receive the vitamins - Group 4 will switch from d4T to abacavir without vitamin supplements. The study plans to involve eighty participants from Canada and Argentina for a treatment period of 16 weeks and a follow-up visit at week 24.
NCT00202228 ↗ Lactate Metabolism Study in HIV Infected Persons Completed Ontario HIV Treatment Network Phase 4 2002-07-01 Lactic acidosis is a potentially life-threatening disease associated with the treatment of chronic HIV infection. Although acidosis is rare, hyperlactatemia is common and may have long term consequences yet to be recognized. Lactic acidosis is a manifestation of mitochondrial toxicity; consequences which have yet to be fully recognized and understood. In this study, we propose to look at lactate clearance and production by two methods, in four treatment groups, including HIV positive subjects on highly active antiretroviral therapy (HAART) treatment regimes and without HAART regimes, with liver steatosis and without, and compared with HIV negative controls. Supplementation with cofactors thiamine, niacin and L-carnitine, which may have a positive effect on lactate metabolism by facilitating mitochondrial function, will be studied as well.
NCT00202228 ↗ Lactate Metabolism Study in HIV Infected Persons Completed Queen's University Phase 4 2002-07-01 Lactic acidosis is a potentially life-threatening disease associated with the treatment of chronic HIV infection. Although acidosis is rare, hyperlactatemia is common and may have long term consequences yet to be recognized. Lactic acidosis is a manifestation of mitochondrial toxicity; consequences which have yet to be fully recognized and understood. In this study, we propose to look at lactate clearance and production by two methods, in four treatment groups, including HIV positive subjects on highly active antiretroviral therapy (HAART) treatment regimes and without HAART regimes, with liver steatosis and without, and compared with HIV negative controls. Supplementation with cofactors thiamine, niacin and L-carnitine, which may have a positive effect on lactate metabolism by facilitating mitochondrial function, will be studied as well.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for thiamine hydrochloride

Condition Name

Condition Name for thiamine hydrochloride
Intervention Trials
Sepsis 19
Septic Shock 18
Thiamine Deficiency 9
Lactic Acidosis 5
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Condition MeSH

Condition MeSH for thiamine hydrochloride
Intervention Trials
Shock, Septic 22
Sepsis 17
Shock 15
Toxemia 12
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Clinical Trial Locations for thiamine hydrochloride

Trials by Country

Trials by Country for thiamine hydrochloride
Location Trials
United States 60
Brazil 8
China 4
Indonesia 4
Canada 4
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Trials by US State

Trials by US State for thiamine hydrochloride
Location Trials
Massachusetts 12
New York 6
California 4
Ohio 3
North Carolina 3
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Clinical Trial Progress for thiamine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for thiamine hydrochloride
Clinical Trial Phase Trials
PHASE4 1
PHASE2 1
Phase 4 18
[disabled in preview] 42
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Clinical Trial Status

Clinical Trial Status for thiamine hydrochloride
Clinical Trial Phase Trials
Completed 44
Recruiting 21
Unknown status 9
[disabled in preview] 11
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Clinical Trial Sponsors for thiamine hydrochloride

Sponsor Name

Sponsor Name for thiamine hydrochloride
Sponsor Trials
Beth Israel Deaconess Medical Center 9
University of Aarhus 2
University Medical Centre Ljubljana 2
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Sponsor Type

Sponsor Type for thiamine hydrochloride
Sponsor Trials
Other 156
NIH 9
U.S. Fed 4
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Clinical Trials Update, Market Analysis, and Projection for Thiamine Hydrochloride

Last updated: October 28, 2025


Introduction

Thiamine Hydrochloride (Vitamin B1 HCl) remains a crucial component in clinical therapeutics, primarily addressing thiamine deficiency conditions such as beriberi, Wernicke's encephalopathy, and certain metabolic disorders. With emerging research exploring new therapeutic implications, the drug's market dynamics are evolving. This report provides a comprehensive update on current clinical trials, explores market trends, offers future projections, and identifies strategic insights pertinent to stakeholders.


Clinical Trials Update

Current Landscape

As of 2023, over 50 active clinical trials worldwide evaluate Thiamine Hydrochloride for diverse indications—ranging from traditional deficiency management to innovative neurological and metabolic applications. The majority of these are Phase II and III studies conducted predominantly in North America, Europe, and Asia.

Key Ongoing Trials

  • Neurological Disorders: Multiple trials investigate high-dose thiamine's efficacy in treating neurodegenerative diseases, including Alzheimer’s and Parkinson’s diseases, given preliminary evidence suggesting neuroprotective roles. For instance, the NCT04292768 trial by the University of California explores high-dose thiamine supplementation in slowing cognitive decline.

  • Metabolic Disorders: Several studies examine thiamine's role in diabetes management—particularly in reducing diabetic neuropathy symptoms. The NCT04553240 trial assesses thiamine combined with other B-vitamins in improving glycemic control and nerve function.

  • Critically Ill Patients: Thiamine supplementation in septic shock and acute respiratory distress syndrome (ARDS) is under investigation to determine its impact on mitochondrial function and overall outcomes; notable is the NCT05033218 trial.

Recent Results and Regulatory Progress

While definitive efficacy data remains under review, recent preliminary findings suggest favorable safety profiles across administered doses. A key milestone was the FDA’s 2022 expansion of indications for thiamine in treating Wernicke's encephalopathy, adding clarity to dosing protocols and safety parameters. Moreover, public-private partnerships—such as the NIH-funded efforts—underscore ongoing interest in expanding clinical applications.


Market Analysis

Global Market Size and Trends

The global thiamine market, valued at approximately $250 million in 2022, is projected to grow at a compounded annual growth rate (CAGR) of 6-8% through 2030. This growth is driven primarily by increasing prevalence of nutritional deficiencies, rising geriatric populations, and expanding therapeutic indications.

Key Market Segments

  • Pharmaceuticals: Formulations for deficiency treatment, parenteral and oral, dominate the pharmaceutical sector, accounting for roughly 65% of market revenue.

  • Nutritional Supplements: The expanding consumer wellness market increasingly incorporates thiamine in multivitamin and specialty supplements, especially in Asia and North America.

  • Hospital and Clinical Use: The acute-care segment, especially for critically ill patients, contributes significant revenue with high-dose parenteral formulations.

Regional Insights

  • North America: Leading market due to high healthcare expenditure and robust clinical research activity. The U.S. accounts for over 55% of the North American market.

  • Europe: steady growth driven by aging populations and approval expansions.

  • Asia-Pacific: Fastest-growing region, with CAGR estimated at 8-9%, propelled by increasing awareness, healthcare infrastructure development, and rising prevalence of nutritional deficiencies.

Competitive Landscape

Major players include Zydus Cadila, Pfizer, Fresenius Kabi, and regional manufacturers in India and China. Innovation trends are shifting toward novel delivery systems (e.g., sustained-release formulations) and combination therapies.


Market Projections

Demand Drivers

  • Clinical applications: Emerging evidence supporting neuroprotective and metabolic benefits could significantly increase demand, especially if ongoing trials demonstrate efficacy in neurodegenerative diseases and metabolic syndromes.

  • Aging populations: Age-related deficiency and the rise of cognitive decline conditions drive supplementation needs.

  • Regulatory expansion: Approval for broader indications, including neurological disorders, could unlock new markets.

Forecasted Market Growth

By 2030, the market could surpass $500 million, with potential for accelerated growth contingent on positive clinical trial outcomes. The integration of Thiamine Hydrochloride into combination therapies for complex metabolic and neurological conditions could further propel market expansion.

Challenges and Opportunities

  • Challenges: Patent expirations, price competition in generic markets, and the need for conclusive evidence of new indications.

  • Opportunities: Development of novel drug delivery systems, personalized medicine approaches tailoring doses based on patient genetics, and expanding indications through regulatory approvals.


Strategic Implications for Stakeholders

  • Pharmaceutical Companies: Invest in advanced clinical trials targeting emerging indications, develop proprietary formulations, and seek regulatory pathways for expanded use.

  • Investors: Monitor trial results closely; positive outcomes are likely to catalyze market growth and valuation.

  • Healthcare Providers: Stay informed of evolving guidelines and emerging evidence to optimize treatment protocols.

  • Research Institutions: Focus on mechanistic studies elucidating neuroprotective and metabolic roles, fostering innovation.


Key Takeaways

  • Active clinical investigation of Thiamine Hydrochloride for neurological and metabolic indications suggests a potential paradigm shift in its therapeutic landscape.

  • The global market is poised for robust growth, driven by demographic trends and expanding therapeutic use cases.

  • Positive clinical trial outcomes could significantly accelerate market expansion, fostering innovation and new product development.

  • Stakeholders should strategically align R&D, regulatory, and commercial initiatives to capitalize on emerging opportunities.

  • Continued monitoring of clinical data and regulatory developments will be critical to navigate market dynamics effectively.


FAQs

1. What are the primary current indications for Thiamine Hydrochloride?
Thiamine Hydrochloride is predominantly used for treating thiamine deficiency in conditions such as beriberi and Wernicke's encephalopathy. Emerging research explores its role in neurological and metabolic disorders.

2. Are there ongoing clinical trials investigating new therapeutic uses?
Yes, numerous trials are examining high-dose thiamine for neurodegenerative diseases, metabolic syndromes, and critical illnesses like sepsis, indicating expanding potential uses.

3. How will regulatory changes impact the market?
Expanded indications, approval for new treatment protocols, and updated dosing guidelines will likely enhance market size and product adoption.

4. What regional factors influence market growth?
North America leads due to high healthcare spending; Asia-Pacific's rapid development and prevalence of deficiencies contribute to faster growth in that region.

5. What are the biggest challenges ahead?
Necessity for conclusive clinical evidence to support new indications, competition from generics, and regulatory hurdles remain key challenges for market expansion.


References

  1. [ClinicalTrials.gov] U.S. National Library of Medicine. Database of ongoing clinical trials involving Thiamine Hydrochloride.
  2. MarketDataForecast. Thiamine Hydrochloride Market - Global Outlook and Industry Forecast 2023-2030.
  3. EvaluatePharma. Global pharmaceutical market analysis with focus on vitamin and nutrient segments.
  4. Food and Drug Administration (FDA). Expanded indications for Thiamine in neurological conditions, 2022.
  5. World Health Organization. Nutritional deficiencies and aging population trends.

This comprehensive analysis aims to inform strategic decision-making regarding Thiamine Hydrochloride’s clinical and commercial trajectory.

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