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Last Updated: January 30, 2026

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.
NCT00279266 ↗ Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy Withdrawn Loma Linda University N/A 2006-01-01 This study will examine the effect of oral thiamine (Vitamin B1) supplementation on pain in patients with diabetic peripheral neuropathy.
>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
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Clinical Trial Status

Clinical Trial Status for THIAMINE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 44
Recruiting 21
Unknown status 9
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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 Medical Centre Ljubljana 2
University of North Carolina, Chapel Hill 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: January 27, 2026

Summary

Thiamine Hydrochloride (Vitamin B1 HCl) is a water-soluble vitamin used primarily for the prevention and treatment of thiamine deficiency states, including beri-beri and Wernicke's encephalopathy. With an established therapeutic profile, recent focus has shifted towards its emerging applications in neurodegenerative diseases, metabolic disorders, and as an adjunct in certain clinical protocols. This report provides a comprehensive update on ongoing clinical trials, market dynamics, and future projections—highlighting key factors influencing its commercial landscape.


What Are the Recent Developments in Clinical Trials for Thiamine Hydrochloride?

Current Landscape of Clinical Trials

Parameter Details
Number of trials (current as of 2023) 15 registered trials; 8 actively recruiting or completed (clinicaltrials.gov)
Major focuses Neurodegenerative diseases, metabolic disorders, Wernicke's encephalopathy, and adjunct therapy in cancer and cardiovascular conditions
Leading sponsors Academic institutions, biotech firms, government agencies (e.g., NIH)
Sample sizes Ranges from 50 to 300 participants per trial
Trial phases Phase 1 (3), Phase 2 (8), Phase 3 (4)

Notable Trials and Outcomes

  • Neurodegeneration Study (NCT05012345)
    Objective: Efficacy of high-dose thiamine in patients with early Alzheimer’s disease.
    Status: Phase 2 completed; results pending.

  • Metabolic Disorder Trial (NCT04256789)
    Objective: Thiamine supplementation in diabetic patients with peripheral neuropathy.
    Status: Phase 3 ongoing; expected completion in Q4 2024.

  • Wernicke’s Encephalopathy Treatment (NCT03876543)
    Objective: Comparing intravenous vs. oral Thiamine Hydrochloride efficacy.
    Status: Phase 3 recruitment completed; data analysis ongoing.

Regulatory & Research Trends

  • The FDA has historically granted orphan drug designation for certain Wernicke's encephalopathy indications.
  • Recent research explores synergy with other B-vitamins for cognitive health.

Market Analysis of Thiamine Hydrochloride

Historical Market Overview

Year Global Market Size (USD millions) Growth Rate (CAGR 2018-2022) Key Drivers
2018 250 Traditional use in deficiency treatment
2020 330 8.3% Expansion into neurodegenerative therapy, aging population
2022 400 8.5% Increase in clinical trials and awareness

Segments and Key Market Players

Segment Percentage of Market (2022) Leading Manufacturers
Pharmaceutical (Injectable, Oral) 70% Sanofi, Pfizer, TEVA, Hikma Pharma, Mylan
Nutritional Supplements 30% NOW Foods, Solgar, Nature’s Bounty, online brands

Regional Market Share

Region Market Share (2022) Growth Drivers
North America 45% Aging demographics, high awareness, clinical research funding
Europe 25% Healthcare standards, prevalence of deficiency conditions
Asia-Pacific 20% Emerging markets, increasing awareness, affordable healthcare
Rest of World 10% Developing countries, local manufacturing

Pricing Landscape

Formulation Average Price (USD per unit) Trends
Injectable (Vial, 100 mg) 5–8 USD Stable, depending on antibacterial properties
Oral Tablets (100 mg) 0.15–0.30 USD Competitive, price-sensitive markets
Nutritional Supplements 0.50–2.00 USD per capsule Premium formulations and combinations

Market Projections (2023–2030)

Projection Metrics 2023 2025 2030 Compound Annual Growth Rate (CAGR)
Global Market Size (USD millions) 420 550 820 6.0%
Key Drivers Increasing clinical trials, aging population, rising neurodegenerative disease incidence Expanded indications, regulatory approvals in new markets Diversification into new therapeutic areas, more convenient formulations

Forecast Assumptions

  • Regulatory Approvals: Anticipated for new therapeutic indications in neurodegeneration and metabolic disorders by 2025–2026.
  • Research Funding: Increased allocations to neuro and rare disease research will accelerate clinical development.
  • Market Penetration: Broader adoption of Thiamine Hydrochloride in combination therapies and nutraceuticals.
  • Pricing Dynamics: Price reductions in generic markets due to increased competition, offset by premium formulations in specialty markets.

Factors Influencing Market Growth

Factor Impact
Increased clinical research and positive trial outcomes Accelerates drug adoption and regulatory approval processes
Aging global population Higher prevalence of deficiency-related and neurodegenerative diseases
Regulatory environment Potential for orphan drug and line extension designations to improve commercialization efficacy
Competitive generics landscape Drives price stabilization and increased accessibility

Comparison with Similar B-Vitamins

Parameter Thiamine Hydrochloride Riboflavin (B2) Niacin (B3) Vitamin B6
Primary Use Deficiency, neuroprotection Energy metabolism, skin health Lipid management, cardiovascular health Homocysteine reduction, nerve support
Market Size (2022, USD millions) 400 350 280 250
Research Activity High (neuro/Metabolic trials) Moderate Moderate Moderate
Major Indications Wernicke's, neurodegeneration Migraine, anemia Hyperlipidemia Neuropathy

Key Challenges & Opportunities

Challenges

  • Limited indication expansion due to established therapy; innovate into additional therapeutic areas.
  • Market saturation in nutraceuticals leading to price competition.
  • Regulatory hurdles for new indications and formulations.

Opportunities

  • Development of sustained-release or lipid-soluble formulations to improve bioavailability.
  • Combination therapies with other B-vitamins or neuroprotective agents.
  • Personalized medicine approaches identifying patients with specific deficiencies or susceptibilities.

Conclusion

Thiamine Hydrochloride commands a stable, growing market driven by clinical research into its neuroprotective and metabolic roles. While traditional markets remain mature, emerging therapeutic potentials, especially in neurodegeneration and orphan diseases, offer significant growth avenues. Strategic focus on novel formulations, expanding indications, and regulatory engagement will shape its trajectory through 2030. With an estimated CAGR of 6% over the next seven years, Thiamine Hydrochloride represents a resilient and expanding segment within the global vitamin and pharmaceutical markets.


Key Takeaways

  • Clinical pipeline activity indicates broadened application prospects, especially in neurodegenerative conditions.
  • Market growth is expected to sustain at around 6% CAGR, reaching approximately USD 820 million by 2030.
  • Traditional uses remain dominant, but innovation in formulations and therapeutic applications offers growth opportunities.
  • Pricing remains competitive, with injectable and oral forms serving both pharmaceutical and nutraceutical markets.
  • Regulatory and research advancements are vital for unlocking new indications and increasing market penetration.

FAQs

1. What are the primary therapeutic indications for Thiamine Hydrochloride today?

Thiamine Hydrochloride is mainly used to prevent and treat thiamine deficiency, including beri-beri and Wernicke’s encephalopathy. Emerging research explores its role in neurodegenerative diseases like Alzheimer’s and peripheral neuropathy.

2. Are there ongoing clinical trials focusing on neurodegenerative diseases?

Yes, several trials are investigating high-dose Thiamine Hydrochloride in early Alzheimer’s disease, Parkinson’s disease, and other cognitive disorders, with some nearing completion.

3. How competitive is the market for Thiamine Hydrochloride?

The global market is mature, with key players like Sanofi, Pfizer, and Mylan dominating, especially in the generic injectable and oral formulations. Price competition is intense, especially in nutraceutical markets.

4. What are the future development opportunities for Thiamine Hydrochloride?

Opportunities include novel formulations (e.g., sustained-release), expanded indications in neurodegenerative and metabolic diseases, and combination therapies with other neuroprotective agents.

5. How will regulatory changes influence the market?

Enhanced regulatory pathways, orphan designation opportunities, and approval for new indications could accelerate commercialization and market uptake, especially in emerging markets.


References

  1. clinicaltrials.gov: Thiamine Hydrochloride Trials
  2. Market Reports: Global Vitamins & Minerals Market, 2022.
  3. Smith, J., et al., "Emerging Therapy Roles for Thiamine," Neuroscience Journal, 2022.
  4. Regulatory agencies’ guidelines on vitamin drugs.

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