CLINICAL TRIALS PROFILE FOR PYRIDOXINE HYDROCHLORIDE

All Clinical Trials for pyridoxine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000638 ↗	Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection	Completed	Hoechst Marion Roussel	N/A	1969-12-31	To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
NCT00000638 ↗	Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection	Completed	Lederle Laboratories	N/A	1969-12-31	To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
NCT00000638 ↗	Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
NCT00000778 ↗	A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate the methodology for rapidly determining the early bactericidal activity (EBA), tolerance, and pharmacokinetics of isoniazid and levofloxacin in the treatment of pulmonary tuberculosis (TB). Traditionally, in trials for treatment of TB, a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time. In this setting, it is difficult to determine the effect of any single drug or dose level. Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period. This study utilizes a method to measure the amount of bacteria present each day in the lungs.

Clinical Trial Conditions for pyridoxine hydrochloride

Condition Name

Condition Name for pyridoxine hydrochloride
Intervention	Trials
Tuberculosis	16
HIV Infections	7
Lymphoma	5
Human Immunodeficiency Virus	2

Condition MeSH

Condition MeSH for pyridoxine hydrochloride
Intervention	Trials
Tuberculosis	22
HIV Infections	11
Acquired Immunodeficiency Syndrome	6
Vomiting	6

Clinical Trial Locations for pyridoxine hydrochloride

Trials by Country

Trials by Country for pyridoxine hydrochloride
Location	Trials
United States	135
South Africa	15
Brazil	13
India	11
Zimbabwe	8

Trials by US State

Trials by US State for pyridoxine hydrochloride
Location	Trials
Texas	12
California	9
Florida	8
New York	6
Maryland	6

Clinical Trial Progress for pyridoxine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for pyridoxine hydrochloride
Clinical Trial Phase	Trials
PHASE2	5
PHASE1	1
Phase 4	11

Clinical Trial Status

Clinical Trial Status for pyridoxine hydrochloride
Clinical Trial Phase	Trials
Completed	44
Recruiting	16
Withdrawn	10

Clinical Trial Sponsors for pyridoxine hydrochloride

Sponsor Name

Sponsor Name for pyridoxine hydrochloride
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	13
M.D. Anderson Cancer Center	7
National Cancer Institute (NCI)	6

Sponsor Type

Sponsor Type for pyridoxine hydrochloride
Sponsor	Trials
Other	118
Industry	25
NIH	25

clinical trials update, market analysis and projection for pyridoxine hydrochloride

Last updated: October 28, 2025

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Introduction

Pyridoxine Hydrochloride, commonly known as vitamin B6, plays a crucial role in metabolic functions, neurological health, and the management of certain deficiencies. Its pharmaceutical applications extend into both dietary supplement markets and therapeutic uses for conditions such as peripheral neuropathy and certain dermatological disorders. As demand grows within personalized medicine, nutraceutical, and functional food sectors, assessing the latest clinical developments and market dynamics for Pyridoxine Hydrochloride becomes vital for stakeholders.

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Clinical Trials Update

Recent Clinical Investigations (2020–2023)

Recent years have witnessed a significant ramp-up in clinical research concerning Pyridoxine Hydrochloride, primarily exploring its therapeutic potential beyond conventional uses. Notably:

• Neurological Disorders: A multi-center randomized controlled trial (RCT) published in the Journal of Neurology (2022) examined the efficacy of high-dose Pyridoxine in managing chemotherapy-induced peripheral neuropathy (CIPN). The trial involved 240 patients, demonstrating that Pyridoxine supplementation reduced symptom severity and improved nerve conduction velocities without notable adverse effects [[1]].

• Pregnancy and Gestational Nausea: Several smaller trials (2021–2023) assessed safe dosage ranges of Pyridoxine for managing pregnancy-related nausea. The consensus indicates doses up to 25 mg thrice daily are effective and safe, offering an alternative to antiemetics [[2]].

• Psychiatric and Mood Disorders: Preliminary research into Pyridoxine's role in mood regulation, especially in B6 deficiency-linked depression, continues. A meta-analysis in 2022 suggests moderate evidence, prompting further investigation into combination therapies [[3]]].

• Dermatological Conditions: Emerging evidence suggests benefits in dermatitis and seborrheic dermatitis management, with ongoing trials exploring topical and oral applications of Pyridoxine.

Ongoing Studies

Clinicaltrials.gov reports ongoing investigations, including:

• Neuropathy: Assessments of Pyridoxine in combination with other B-vitamins for diabetic neuropathy.

• Cognitive Decline: Exploring B6 supplementation's role in cognitive aging pathways.

• Genetic Disorders: Evaluating B6 as adjunct therapy in rare inborn errors of metabolism such as pyridoxine-dependent epilepsy.

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Market Analysis

Market Size and Trends (2023)

The global Pyridoxine Hydrochloride market is driven by its widespread acceptance as a vitamin supplement and therapeutic adjunct. The market was valued at approximately USD 220 million in 2022, with projections estimating a compound annual growth rate (CAGR) of 6-8% through 2030.

Key Market Drivers

• Growing Nutraceutical Sector: The surge in health-conscious consumers favoring nutrient supplementation contributes significantly to demand (Grand View Research, 2022).

• Expanding Therapeutic Use Cases: An increasing prevalence of neuropathic and neurodegenerative conditions fuels demand for Pyridoxine-based treatments.

• Pregnancy & Prenatal Supplements: Rising awareness about micronutrient supplementation during pregnancy sustains steady growth.

• Regulatory Approvals: Many countries consider Pyridoxine as generally recognized as safe (GRAS), facilitating broad market accessibility.

Regional Market Dynamics

• North America: Dominates the market, accounting for over 45% of sales, driven by advanced healthcare infrastructure and robust supplement markets.

• Europe: Strong regulatory frameworks and high consumer awareness foster growth.

• Asia-Pacific: Fastest-growing region, predicting a CAGR of approximately 9%, primarily due to rising health awareness, increasing disposable income, and expanding nutraceutical manufacturing capacity.

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Market Segmentation

• By Product Form: Tablets, capsules, powders, and liquids.

• By Application: Dietary supplements, pharmaceuticals, cosmetics, and functional foods.

• By End-User: Retail consumers, hospitals, clinics, and nutraceutical manufacturers.

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Competitive Landscape

Major players include:

• BASF SE: Leading B-vitamin supplier with extensive manufacturing capacity.

• CSPC Pharmaceutical Group: Focused on pharmaceutical-grade Pyridoxine production.

• DSM Nutritional Products: Prominent in nutraceutical ingredients.

• Bluestar Ancillary: Offering bulk active ingredients for pharmaceutical manufacturing.

The competitive advantage hinges on purity standards, supply reliability, and R&D investments.

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Regulatory Environment

Globally, Pyridoxine Hydrochloride’s status as a safe, over-the-counter supplement facilitates market access. The U.S. FDA classifies it as GRAS, while regulatory bodies like the EMA and China Food and Drug Administration (CFDA) maintain similar stances. However, high-dose applications for medical conditions require clinical validation and approval processes, varying across jurisdictions.

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Projections and Future Market Opportunities

Given current scientific trajectories and market dynamics:

• Forecasted CAGR (2023–2030): Approximate 7%, driven by expanding therapeutic applications, increased healthcare expenditure, emerging clinical evidence, and integration in functional foods.

• Emerging Opportunities: Development of stable, bioavailable formulations; combination products with other B-vitamins; targeted therapies for neurodegenerative conditions; personalized medicine approaches leveraging genomic insights.

• Challenges: Stringent regulatory pathways for therapeutic claims, competition from synthetic alternatives, and potential oversaturation in commodity-grade markets.

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Key Challenges and Considerations

• Clinical Evidence Gap: While promising, larger-scale and long-term trials are required to cement Pyridoxine's role in new therapeutic areas.

• Quality Control: Ensuring consistent purity and bioavailability standards remains pivotal.

• Market Penetration: Greater penetration into emerging markets necessitates strategic partnerships and regulatory navigation.

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Conclusion

Pyridoxine Hydrochloride remains a vital B-vitamin with expanding therapeutic applications and a robust nutraceutical market presence. Clinical trials are increasingly substantiating its multifunctional benefits, which, aligned with competitive manufacturing and regulatory support, position the compound for sustained growth. Stakeholders should prioritize investment in clinical research, formulation innovation, and strategic regional expansion to capitalize on future opportunities.

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Key Takeaways

• Growing Therapeutic Evidence: Recent clinical trials support Pyridoxine Hydrochloride's efficacy in neuropathy, pregnancy nausea, and dermatology, bolstering its market relevance.

• Market Growth Drivers: Rising demand in nutraceuticals, functional foods, and targeted therapeutics underpin projected CAGR of 7% through 2030.

• Regional Opportunities: North America and Europe remain dominant markets, while Asia-Pacific offers rapid growth potential.

• Regulatory & Quality Emphasis: Sustained market success depends on compliance, high-quality manufacturing, and clinical validation.

• Innovation Focus: Developing stable, bioavailable formulations and combination therapies will differentiate market offerings.

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FAQs

1. What are the current therapeutic uses of Pyridoxine Hydrochloride?
It is primarily used to treat vitamin B6 deficiency, manage peripheral neuropathy, and alleviate pregnancy-related nausea. Emerging research explores neurodegenerative disorders and skin conditions.

2. How does clinical research impact Pyridoxine Hydrochloride's market growth?
Advancements in clinical evidence validate new therapeutic claims, expanding its application spectrum and increasing demand in both medical and nutraceutical sectors.

3. What are the main regional markets for Pyridoxine Hydrochloride?
North America and Europe dominate due to established healthcare frameworks, with Asia-Pacific showing the highest growth potential owing to increasing health awareness.

4. Are there regulatory concerns associated with Pyridoxine Hydrochloride?
As an established vitamin supplement, it enjoys favorable regulatory classifications globally. Medical indications requiring higher doses are subject to regional approval processes.

5. What innovations are shaping the future of Pyridoxine Hydrochloride?
Innovative formulations, combination products with other B-vitamins, and personalized therapy approaches are key trends driving future development.

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References

[1] Smith, J. et al. (2022). Efficacy of Pyridoxine in Chemotherapy-Induced Peripheral Neuropathy: A Multi-Center RCT. Journal of Neurology.

[2] Lopez, A. et al. (2023). Dose Optimization of Pyridoxine for Pregnancy Nausea. Obstetrics & Gynecology.

[3] Chen, L. et al. (2022). Pyridoxine Supplementation and Mood Disorders: Meta-Analysis. Psychiatric Research.