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Last Updated: March 27, 2025

CLINICAL TRIALS PROFILE FOR NIACIN


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All Clinical Trials for NIACIN

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00000461 ↗ Harvard Atherosclerosis Reversibility Project (HARP) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1986-12-01 To determine by sequential coronary arteriography whether a lipid-lowering diet with and without lipid-lowering drugs could reverse coronary artery disease in normocholesterolemic patients. Also, to test whether fish oil supplements could improve human coronary atherosclerosis. Finally, to determine the effect of combination therapy with lipid-reducing drugs in patients with coronary heart disease and "normal" cholesterol levels. At least three clinical trials were conducted.
NCT00000483 ↗ Coronary Drug Project Mortality Surveillance Completed National Heart, Lung, and Blood Institute (NHLBI) N/A 1981-06-01 To determine whether there were any long term sequelae of the drugs used in the Coronary Drug Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).
NCT00000482 ↗ Coronary Drug Project Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1965-04-01 To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result in significant reduction in total mortality over a five year period. Secondarily, to determine whether the degree to which these drugs changed serum lipids was correlated with any effect on mortality and morbidity rates; to gain further information on the long-term prognosis of myocardial infarction (by studying the control group as intensively as the treatment group); to acquire further experience and knowledge concerning the techniques and methodology of long-term clinical trials; to determine, in a substudy, the effectiveness of aspirin, a platelet inhibitor, in reducing recurrences of myocardial infarction.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for NIACIN

Condition Name

2116120-20246810121416182022DyslipidemiaHypercholesterolemiaAtherosclerosis[disabled in preview]
Condition Name for NIACIN
Intervention Trials
Dyslipidemia 21
Hypercholesterolemia 16
Atherosclerosis 12
[disabled in preview] 0
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Condition MeSH

40232200510152025303540DyslipidemiasHypercholesterolemiaCoronary Artery Disease[disabled in preview]
Condition MeSH for NIACIN
Intervention Trials
Dyslipidemias 40
Hypercholesterolemia 23
Coronary Artery Disease 22
[disabled in preview] 0
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Clinical Trial Locations for NIACIN

Trials by Country

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Trials by Country for NIACIN
Location Trials
United States 227
Canada 31
Switzerland 7
China 5
Germany 5
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Trials by US State

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Trials by US State for NIACIN
Location Trials
California 21
Pennsylvania 18
Maryland 15
Texas 11
Florida 10
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Clinical Trial Progress for NIACIN

Clinical Trial Phase

52.3%42.0%5.7%005101520253035404550Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for NIACIN
Clinical Trial Phase Trials
Phase 4 46
Phase 3 37
Phase 2/Phase 3 5
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Clinical Trial Status

77.1%11.8%11.1%0020406080100120CompletedTerminatedRecruiting[disabled in preview]
Clinical Trial Status for NIACIN
Clinical Trial Phase Trials
Completed 118
Terminated 18
Recruiting 17
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Clinical Trial Sponsors for NIACIN

Sponsor Name

trials051015202530Merck Sharp & Dohme Corp.National Heart, Lung, and Blood Institute (NHLBI)Abbott[disabled in preview]
Sponsor Name for NIACIN
Sponsor Trials
Merck Sharp & Dohme Corp. 29
National Heart, Lung, and Blood Institute (NHLBI) 16
Abbott 11
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Sponsor Type

58.7%29.5%11.7%0020406080100120140160180OtherIndustryNIH[disabled in preview]
Sponsor Type for NIACIN
Sponsor Trials
Other 175
Industry 88
NIH 35
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Niacin: Clinical Trials, Market Analysis, and Projections

Introduction to Niacin

Niacin, also known as vitamin B3 or nicotinic acid, is a vital nutrient essential for skin, nerve, and digestive health, as well as food metabolism and energy production. Despite its well-documented health benefits, recent studies have shed new light on its complex role in cardiovascular health and its market dynamics.

Clinical Trials and Cardiovascular Health

The Niacin Paradox

Historically, niacin was one of the first treatments prescribed to lower LDL or "bad" cholesterol. However, clinical trials have revealed a paradox: despite niacin's cholesterol-lowering effects, it does not significantly reduce the risk of cardiovascular disease and may even increase overall mortality[1][4].

Recent Findings

A Cleveland Clinic-led study has identified a link between high levels of niacin and cardiovascular disease. The research suggests that excess niacin leads to the production of metabolites such as N1-methyl-2-pyridone-5-carboxamide (2PY) and N1-methyle-4-pyridone-3-carboxamide (4PY), which are associated with increased risk of major adverse cardiovascular events (MACE)[1][4].

These findings explain why niacin's clinical benefits have been less than anticipated, despite its ability to lower LDL cholesterol. The study highlights the importance of investigating residual cardiovascular risk and the potential adverse effects of excess niacin.

Market Analysis

Global Market Size and Growth

The global nicotinic acid market is projected to grow significantly over the coming years. By the end of 2025, the market is estimated to be worth USD 362.4 million and is expected to reach USD 601.7 million by 2035, growing at a CAGR of 5.2% during this period[2].

Regional Market Dynamics

  • USA: The USA is a key geography for the growth of the vitamin B3 industry, driven by the increasing incidence of cardiovascular ailments and the trend towards clean-label and organic supplements[2].
  • China: China leads the East Asia niacin and niacinamide market, with small and major biopharmaceutical businesses relying on contract research organizations (CROs) for their R&D operations[3].
  • India: India is an emerging market, accounting for a significant share in the global niacin and niacinamide market. The country is expected to witness lucrative growth opportunities due to the rapid development of chemical studies and rising healthcare costs[3].
  • Asia Pacific: The vitamin B3 market in the Asia Pacific region is driven by rapid urbanization, increasing disposable incomes, and rising awareness of health and wellness trends[5].

Market Segments

Dietary Supplements and Fortified Foods

The increasing popularity of niacin in dietary supplements and fortified foods is a significant driver of market growth. Health-conscious consumers are driving demand for niacin as a way to maintain proper cholesterol balance and overall health[2].

Skincare and Cosmetic Products

Niacinamide, a form of niacin, is gaining traction in the skincare and cosmetic industry due to its benefits in brightening the skin, reducing acne, and hydrating. This has led to a robust growth in the demand for niacinamide, particularly in liquid form, which is preferred for its convenience and bioavailability[2][3].

Pharmaceutical Sector

The pharmaceutical sector is also a major contributor to the growth of the niacin market. Niacin is used to treat various health conditions, including cardiovascular-related problems, cognitive function, and energy production. The increasing acceptance of niacin as a preferred therapy for skin rejuvenation and vitamin deficiency is driving market growth[2][3].

Projections and Future Outlook

Growth Rate

The global niacin and niacinamide market is expected to grow at a CAGR of 5.2% from 2022 to 2032, reaching a projected market value of USD 2.05 billion by 2032[3].

Emerging Trends

  • Clean and Natural Products: The increased acceptance of clean and natural products is driving the demand for nicotinic acid, as consumers seek out products that align with their health and wellness goals[2].
  • Research and Development: Major players are focusing on research and development to improve the bioavailability and effectiveness of their products, particularly in the liquid segment, which is gaining traction due to its convenience and bioavailability[2].
  • Skincare and Cosmetics: The use of niacinamide in skincare products is expected to continue growing, driven by its benefits in skin rejuvenation and the increasing influence of social media and influencer marketing[3].

Key Players

Companies such as Lonza Group, BASF SE, and DSM are key players in the niacin market. These companies are enhancing their production capabilities, launching new formulations, and focusing on research and development to meet the growing demand for niacin and niacinamide[2][3].

Key Takeaways

  • Clinical Paradox: Despite lowering LDL cholesterol, high levels of niacin are associated with increased cardiovascular risk due to the production of harmful metabolites.
  • Market Growth: The global nicotinic acid market is projected to grow at a CAGR of 5.2% from 2025 to 2035.
  • Regional Dynamics: The USA, China, and India are significant markets driven by health-conscious consumers and the pharmaceutical sector.
  • Emerging Trends: Clean and natural products, research and development, and skincare applications are driving market growth.

FAQs

What is the current status of niacin in clinical trials for cardiovascular health?

Niacin is no longer considered a go-to treatment for lowering cholesterol due to its association with increased cardiovascular risk and higher mortality rates despite its cholesterol-lowering effects.

How is the global nicotinic acid market expected to grow?

The global nicotinic acid market is projected to grow from USD 362.4 million in 2025 to USD 601.7 million by 2035, at a CAGR of 5.2%.

What are the main drivers of the niacin market?

The main drivers include the increasing demand for dietary supplements and fortified foods, the growing use in skincare and cosmetic products, and the pharmaceutical sector's interest in niacin for various health conditions.

Which regions are key markets for niacin?

The USA, China, and India are significant markets for niacin, driven by different factors such as health awareness, pharmaceutical research, and skincare trends.

What is the role of niacinamide in skincare?

Niacinamide is a preferred ingredient in skincare due to its benefits in brightening the skin, reducing acne, and hydrating, making it a key component in various skincare products.

Sources

  1. Cleveland Clinic-Led Study Discovers Link between High Levels of Niacin – a Common B Vitamin – and Heart Disease. Cleveland Clinic Newsroom.
  2. Nicotinic Acid Market Sales, Share, Trend & Analysis Report 2032. Future Market Insights.
  3. Niacin and Niacinamide Market Size, Share, Outlook & Trend - 2032. Future Market Insights.
  4. Link Discovered Between Excess Niacin and Cardiovascular Disease. Cleveland Clinic Consult QD.
  5. Vitamin B3 Market Size, Share, Trends Analysis Report, 2030. Grand View Research.

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