CLINICAL TRIALS PROFILE FOR THIAMINE HYDROCHLORIDE

All Clinical Trials for THIAMINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.

Clinical Trial Conditions for THIAMINE HYDROCHLORIDE

Condition Name

Condition Name for THIAMINE HYDROCHLORIDE
Intervention	Trials
Sepsis	18
Septic Shock	18
Thiamine Deficiency	8
Lactic Acidosis	5

Condition MeSH

Condition MeSH for THIAMINE HYDROCHLORIDE
Intervention	Trials
Shock, Septic	22
Sepsis	16
Shock	15
Toxemia	12

Clinical Trial Locations for THIAMINE HYDROCHLORIDE

Trials by Country

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Trials by Country for THIAMINE HYDROCHLORIDE
Location	Trials
United States	59
Brazil	8
Canada	4
China	3
Egypt	3

Trials by US State

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−

Trials by US State for THIAMINE HYDROCHLORIDE
Location	Trials
Massachusetts	12
New York	6
California	3
Ohio	3
North Carolina	3

Clinical Trial Progress for THIAMINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for THIAMINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	18
Phase 3	15
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for THIAMINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	44
Recruiting	18
Unknown status	9

Clinical Trial Sponsors for THIAMINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for THIAMINE HYDROCHLORIDE
Sponsor	Trials
Beth Israel Deaconess Medical Center	9
University of California, San Francisco	2
University of Aarhus	2

Sponsor Type

Sponsor Type for THIAMINE HYDROCHLORIDE
Sponsor	Trials
Other	152
NIH	8
U.S. Fed	4

Thiamine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Thiamine hydrochloride, a vital form of Vitamin B1, is crucial for energy metabolism and brain function. This article delves into the current clinical trials, market analysis, and future projections for thiamine hydrochloride, highlighting its significance in healthcare and the market landscape.

Clinical Trials: Current Status and Findings

Chronic Fatigue in PBC Patients

A recent clinical trial conducted at Aarhus University Hospital in Denmark investigated the efficacy of high-dose oral thiamine in reducing fatigue in patients with Primary Biliary Cholangitis (PBC). The study, a randomized, double-blinded, placebo-controlled, crossover trial, found that four weeks of high-dose oral thiamine treatment was similar to placebo in reducing fatigue. This suggests that thiamine may not be a significant factor in alleviating fatigue in PBC patients[1].

Diabetic Ketoacidosis (DKA)

The Thiamine as Adjunctive Therapy for Diabetic Ketoacidosis (DKAT) trial is a single-center, double-blind, randomized, placebo-controlled trial aimed at assessing the clinical efficacy of intravenous thiamine in patients with DKA. The trial hypothesizes that intravenous thiamine will lead to faster resolution of acidemia through improvement in aerobic metabolism. Participants are randomized to receive either intravenous thiamine or placebo for 48 hours, with the primary outcome being the change in bicarbonate levels over 24 hours[4].

Market Analysis

Market Size and Growth

The thiamine hydrochloride injection market is projected to grow significantly over the next few years. As of 2024, the market size is estimated at USD 174.17 million and is expected to reach USD 226.81 million by 2029, growing at a Compound Annual Growth Rate (CAGR) of 4.5%[2].

Regional Market Dynamics

North America holds a significant market share, driven by increased awareness of thiamine deficiency disorders and advancements in generic drug approvals. However, the Asia Pacific region is expected to be the fastest-growing market, driven by its increasing usage in pharmaceuticals, animal feed, and food preparation[2][5].

Key Players

Major players in the thiamine hydrochloride injection market include Viatris Inc., Lupin, Fresenius Kabi USA, Sagent Pharmaceuticals, and Hikma Pharmaceuticals. These companies are actively involved in research and development, product launches, and strategic initiatives to maintain their market positions[2][3].

Market Projections

Global Thiamine Market

The global thiamine market, which includes thiamine hydrochloride, is expected to experience robust growth. Valued at USD 170.98 million in 2021, the market is projected to reach USD 549.93 million by 2030, growing at a CAGR of 13.9% from 2022 to 2030. This growth is driven by increasing demand in pharmaceuticals, animal feed, and food preparation, particularly in the Asia Pacific region[5].

Drivers of Growth

Key factors driving the thiamine market include the growing demand for dietary supplements, the development of healthcare industries in regions like India and China, and the rise of medical tourism. Additionally, the expanding use of thiamine in mental health and its role in energy metabolism and cell health are significant drivers[3][5].

Challenges and Opportunities

Supply Chain Issues

Despite the promising market outlook, the thiamine hydrochloride injection market faces challenges such as limited supply of raw materials, which hampers production at optimal levels. This constraint is a significant barrier to market growth[2].

Regulatory Approvals

Recent regulatory approvals, such as the US FDA's permission for Aurobindo Pharma Limited to produce and sell Thiamine HCl Injection, and Hikma Pharmaceuticals' launch of Thiamine Hydrochloride Injection in the US, indicate favorable regulatory environments that support market growth[3].

Competitive Landscape

Strategic Initiatives

Top players in the thiamine market are engaging in various strategic actions, including setting up research programs, lowering prices, and implementing expansion initiatives. These efforts are aimed at gaining a competitive edge and ensuring consumer satisfaction[3][5].

New Entrants

The increasing demand and limited supply create opportunities for new businesses to enter the market. With the assistance of experienced R&D, new companies can develop market-ready products and gain a strategic advantage[3].

Key Takeaways

• Clinical Trials: Ongoing trials like the DKAT trial are exploring the efficacy of thiamine in treating conditions such as DKA, while other trials have shown mixed results in addressing chronic fatigue.
• Market Growth: The thiamine hydrochloride injection market is expected to grow at a CAGR of 4.5% from 2024 to 2029, with the global thiamine market projected to reach USD 549.93 million by 2030.
• Regional Dynamics: North America and the Asia Pacific region are key markets, with the latter expected to be the fastest-growing.
• Challenges and Opportunities: Supply chain issues are a significant challenge, but regulatory approvals and increasing demand present opportunities for growth.

FAQs

What is the current market size of the thiamine hydrochloride injection market?

The thiamine hydrochloride injection market size is expected to reach USD 174.17 million in 2024[2].

Which region is expected to be the fastest-growing market for thiamine hydrochloride injections?

The Asia Pacific region is expected to be the fastest-growing market for thiamine hydrochloride injections[2][5].

What are the primary drivers of the thiamine market growth?

The primary drivers include growing demand for dietary supplements, development of healthcare industries, and the rise of medical tourism, particularly in India and China[3][5].

Who are the major players in the thiamine hydrochloride injection market?

Major players include Viatris Inc., Lupin, Fresenius Kabi USA, Sagent Pharmaceuticals, and Hikma Pharmaceuticals[2][3].

What are the challenges facing the thiamine hydrochloride injection market?

The market faces challenges such as limited supply of raw materials, which hampers production at optimal levels[2].

Sources

1. PLOS ONE: "High-dose oral thiamine versus placebo for chronic fatigue in patients with primary biliary cholangitis: A randomized, double-blinded, placebo-controlled, crossover trial"[1].
2. Mordor Intelligence: "Thiamine Hydrochloride Injection Market Size & Share Analysis"[2].
3. GlobeNewswire: "Thiamine Market is slated to Witness Tremendous Revenue Growth of US$ 715.32 Mn by 2032 - Future Market Insights, Inc."[3].
4. BMJ Open: "Thiamine as adjunctive therapy for diabetic ketoacidosis (DKAT) trial: protocol for a single centre, double-blind, randomised, placebo-controlled, parallel group interventional trial"[4].
5. Grand View Research: "Thiamine Market Size & Share Analysis Report, 2022-2030"[5].