CLINICAL TRIALS PROFILE FOR THIAMINE HYDROCHLORIDE

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.

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

Condition MeSH

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

Clinical Trial Locations for thiamine hydrochloride

Trials by Country

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

Trials by US State

Trials by US State for thiamine hydrochloride
Location	Trials
Massachusetts	12
New York	6
California	4
Arizona	3
Ohio	3

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

Clinical Trial Status

Clinical Trial Status for thiamine hydrochloride
Clinical Trial Phase	Trials
Completed	44
Recruiting	21
Unknown status	9

Clinical Trial Sponsors for thiamine hydrochloride

Sponsor Name

Sponsor Name for thiamine hydrochloride
Sponsor	Trials
Beth Israel Deaconess Medical Center	9
National Heart, Lung, and Blood Institute (NHLBI)	2
Universitas Sumatera Utara	2

Sponsor Type

Sponsor Type for thiamine hydrochloride
Sponsor	Trials
Other	156
NIH	9
U.S. Fed	4

Thiamine hydrochloride Market Analysis and Financial Projection

Last updated: April 27, 2026

Thiamine Hydrochloride: Clinical-Development Update, Market View, and Forward Projection

What is “Thiamine Hydrochloride” in the market?

Thiamine hydrochloride (vitamin B1, salt form) is a widely used, off-patent essential nutrient and drug ingredient used in:

• Deficiency treatment (beriberi, Wernicke-Korsakoff prevention/treatment risk contexts)
• Nutritional supplementation in multiple dosage forms (oral tablets/capsules; injectable formulations)

For investment and R&D planning, the key constraint is structural: thiamine hydrochloride is a core vitamin active ingredient that is broadly generically available and typically not the subject of enforceable, ingredient-level patent estates. Commercial differentiation usually comes from formulation, manufacturing process, packaging, dosing regimen, combination products, and regional regulatory file ownership rather than novel molecular IP.

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Is there an active, identifiable clinical development pipeline for thiamine hydrochloride?

No single, drug-specific clinical “pipeline” can be responsibly summarized here without trial identifiers and registries. For a widely used, off-patent vitamin salt, the clinical footprint tends to be dominated by:

• Indication-specific academic trials
• Combination regimen studies
• Bioequivalence and formulation evaluations
• Safety/PK studies for product lots or administration routes

Because the request is for a clinical trials update with a market analysis and projection, a complete answer requires verifiable trial registry records (NCT/EudraCT, study status, dosing arms, endpoints) and current market/price-volume data tied to regions and product categories. This dataset is not present in the prompt.

Result: A complete and accurate clinical update cannot be produced under the constraints.

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Market Analysis

Where does revenue come from for thiamine hydrochloride?

Revenue is usually pulled from three buckets:

1. Therapeutic supply for deficiency and related clinical use
2. Institutional and hospital purchasing for parenteral repletion
3. Over-the-counter and supplement channels (oral forms)

In practice, demand is driven by:

• Prevalence of nutritional deficiency risk in target populations
• Hospital protocol adoption for thiamine repletion (especially in at-risk settings)
• Generic penetration and competitive pricing
• Regulatory and quality compliance (GMP, sterile manufacturing, stability)

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Competitive landscape: what matters most?

For thiamine hydrochloride, competition typically concentrates on:

• Pricing and supply reliability for injectables and oral generics
• Shelf life, stability, and bioavailability consistency across formulations
• Regulatory ANDA/EMA national authorization histories per product line
• Sterile manufacturing capability for injection presentations

Given the absence of ingredient-level exclusivity, most value capture is product- and channel-specific rather than patent estate-specific.

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Market Projection

What drives near- to mid-term demand growth?

A defensible projection would normally quantify CAGR by region and product form (oral vs injectable) and isolate category headwinds:

• Generic price erosion
• Substitution across vitamin combinations
• Procurement cycles and tender-based pricing for hospital products
• Regulatory labeling changes that shift use patterns

The prompt does not include market baseline numbers (sales by region/form, unit volumes, or historical CAGR), so a numerical projection cannot be produced without inventing data.

Result: A complete and accurate market projection cannot be produced under the constraints.

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Key Takeaways

• Thiamine hydrochloride is a widely used vitamin salt with broad generics availability, so market differentiation typically comes from formulation and product execution, not enforceable molecular IP.
• A clinical trials update requires registry-specific evidence (trial IDs, status, endpoints, dates) and cannot be completed from the prompt alone.
• A quantified market analysis and projection requires baseline sales/volume and region/product-form data; those inputs are not provided.

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FAQs

1) Is thiamine hydrochloride patent-protected for the active ingredient?

Thiamine hydrochloride is generally treated as an off-patent active ingredient in commercial markets; enforceable exclusivity, where it exists, usually sits in product-specific formulation, process, or regulatory exclusivities, not the underlying vitamin salt itself.

2) Does clinical activity still exist for thiamine hydrochloride?

Yes, but it is commonly distributed across indication-specific studies, combination regimens, and product evaluations, which are often not captured as a single coherent “pipeline” without registry-level trial mapping.

3) What product forms dominate commercial demand?

Demand typically splits between oral supplementation and parenteral (injectable) repletion, with hospital/institutional purchasing often dominating higher-value segments.

4) What most affects pricing for thiamine hydrochloride?

Generic competition, tender-based hospital procurement, and manufacturing cost structure for oral vs sterile injectable supply.

5) Where does differentiation typically occur?

In formulation stability, bioavailability consistency, sterile manufacturing capability for injections, and combination products that align with clinical practice.

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References (APA)

[1] No sources cited.