Last Updated: May 11, 2026

CLINICAL TRIALS PROFILE FOR VITAMIN A PALMITATE


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505(b)(2) Clinical Trials for VITAMIN A PALMITATE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT01451918 ↗ Regulation of Intestinal and Hepatic Lipoprotein Secretion by Resveratrol Completed Canadian Institutes of Health Research (CIHR) Phase 2 2011-10-01 Resveratrol, an ingredient of red wine and available in Canada in highly purified form as an over-the-counter health supplement, has been shown to have a number of health benefits. Data from in vitro and animal studies suggest that it has beneficial effects on insulin sensitivity and lipid lowering. The investigators are not aware, however, of any mechanistic studies that have examined the effect of highly purified resveratrol in vivo on lipoprotein metabolism in humans. Given the potential therapeutic benefit of resveratrol in correcting the metabolic abnormalities of insulin resistant individuals the investigators plan to examine the effects of resveratrol on intestinal and hepatic lipoprotein production in humans.
OTC NCT01451918 ↗ Regulation of Intestinal and Hepatic Lipoprotein Secretion by Resveratrol Completed University Health Network, Toronto Phase 2 2011-10-01 Resveratrol, an ingredient of red wine and available in Canada in highly purified form as an over-the-counter health supplement, has been shown to have a number of health benefits. Data from in vitro and animal studies suggest that it has beneficial effects on insulin sensitivity and lipid lowering. The investigators are not aware, however, of any mechanistic studies that have examined the effect of highly purified resveratrol in vivo on lipoprotein metabolism in humans. Given the potential therapeutic benefit of resveratrol in correcting the metabolic abnormalities of insulin resistant individuals the investigators plan to examine the effects of resveratrol on intestinal and hepatic lipoprotein production in humans.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for VITAMIN A PALMITATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000116 ↗ Randomized Trial for Retinitis Pigmentosa Completed National Eye Institute (NEI) Phase 3 1996-05-01 The purpose of this trial is to determine whether a nutritional supplement in addition to vitamin A will slow the course of retinitis pigmentosa.
NCT00001972 ↗ PET Scan of Brain Metabolism in Relation to Age and Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) 1994-09-01 The main source of energy for the brain comes from a combination of oxygen and glucose (sugar). For brain cells to function normally they must receive a constant supply of these nutrients. As areas of the brain become more active blood flow into and out of these areas increase. In addition to oxygen and glucose, the brain uses chemical compounds known as phospholipids. These phospholipids make up the covering of nerve cells that assist in the transfer of information from cell to cell. Without phospholipids brain cell activity may become abnormal and cause problems in the nervous system. Certain diseases like Alzheimer's disease and brain tumors can affect blood flow to the brain and change the way the brain metabolizes phospholipids. In addition to diseases, changes in the brain occur with normal healthy aging. This study is designed to use PET scan to measure changes in blood flow and changes in phospholipid metabolism. Using this technique, researchers can improve their understanding of how certain diseases change the shape and function of the brain.
NCT00063596 ↗ Vitamin A Supplementation in Preterm Infants Unknown status Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) N/A 2000-01-01 Extremely low birth weight infants have decreased blood levels of Vitamin A. This Vitamin A deficiency may increase the risk of infections and chronic lung disease in these infants. This study will examine the effects of Vitamin A supplementation in premature babies born weighing less than 1500 grams (3.3 lbs).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for VITAMIN A PALMITATE

Condition Name

Condition Name for VITAMIN A PALMITATE
Intervention Trials
Schizophrenia 52
Type 2 Diabetes 7
Obesity 5
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Condition MeSH

Condition MeSH for VITAMIN A PALMITATE
Intervention Trials
Schizophrenia 55
Diabetes Mellitus, Type 2 11
Diabetes Mellitus 9
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Clinical Trial Locations for VITAMIN A PALMITATE

Trials by Country

Trials by Country for VITAMIN A PALMITATE
Location Trials
United States 265
Canada 18
Korea, Republic of 17
China 17
Ukraine 12
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Trials by US State

Trials by US State for VITAMIN A PALMITATE
Location Trials
Texas 21
California 20
Missouri 16
Florida 13
New York 13
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Clinical Trial Progress for VITAMIN A PALMITATE

Clinical Trial Phase

Clinical Trial Phase for VITAMIN A PALMITATE
Clinical Trial Phase Trials
PHASE4 1
Phase 4 24
Phase 3 30
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Clinical Trial Status

Clinical Trial Status for VITAMIN A PALMITATE
Clinical Trial Phase Trials
Completed 80
RECRUITING 14
Unknown status 7
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Clinical Trial Sponsors for VITAMIN A PALMITATE

Sponsor Name

Sponsor Name for VITAMIN A PALMITATE
Sponsor Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 11
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 9
Beijing Tiantan Hospital 6
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Sponsor Type

Sponsor Type for VITAMIN A PALMITATE
Sponsor Trials
Other 112
Industry 55
NIH 21
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VITAMIN A PALMITATE Market Analysis and Financial Projection

Last updated: April 30, 2026

Vitamin A Palmitate: Clinical Trials Update, Market Analysis, and Projection

Vitamin A palmitate is an oral and topical vitamin A source used in dietary supplements and dermatology/cosmetic formulations. It is a mature, off-patent ingredient in most jurisdictions, and clinical development is largely driven by formulation-line extensions, pediatric/nutrition studies, and topical delivery performance rather than novel molecular IP.

What clinical evidence base exists for vitamin A palmitate?

Clinical activity for vitamin A palmitate tends to fall into three buckets: (1) nutrition efficacy and bioavailability, (2) pediatric dosing and safety, and (3) topical or transdermal delivery performance when formulated into cosmetics, emollients, or therapeutic dermatology products. The ingredient is commonly studied as vitamin A in various ester forms rather than as a standalone “drug” with a single, exclusive brand pipeline.

Observed trial patterns (ingredient-level development, not a single “drug pipeline”)

  • Bioavailability and conversion studies compare esterified vitamin A (including palmitate) vs other vitamin A forms (retinol, retinyl acetate) in humans using pharmacokinetic endpoints (Cmax, Tmax, AUC) and sometimes liver storage markers.
  • Nutrition trials enroll infants or children in supplementation programs, focusing on retinol status, anemia markers, growth outcomes, and safety/tolerability.
  • Topical studies test skin tolerability, irritation potential, and retention or local concentration proxies, typically under cosmetic and consumer health frameworks.

Why trial updates are hard to map to “vitamin A palmitate” as a single drug

Vitamin A palmitate does not behave like a typical proprietary small molecule in clinical registries. It is used widely as:

  • a nutrient ingredient in supplements,
  • a vitamin form within combination products, and
  • a formulation component in skin products. Those contexts lead to trials registered under broader vitamin A or product-specific names, which dilutes ingredient-only traceability.

Net: no single, current, ingredient-unique “late-stage” development thread dominates the public clinical record.

What is the market size and demand structure for vitamin A palmitate?

Vitamin A palmitate is consumed primarily through:

  1. Dietary supplements and fortified foods (oral intake; most volume),
  2. Pharmaceutical and medical nutrition preparations (pediatric and malnutrition-related formulations),
  3. Cosmetics and skin-care formulations (topical uses, typically low-dose, performance-driven).

Key demand drivers

  • Micronutrient deficiency burden: vitamin A deficiency remains a public-health issue in multiple regions, sustaining steady demand for vitamin A salts/esters in fortification and supplementation programs.
  • Growth of supplements: global expansion in personal nutrition and preventive health increases ongoing demand for retinol/retinyl esters in multivitamins.
  • Skin-care formulation growth: retinoid-adjacent ingredient systems (vitamin A esters in emollients) support recurring consumption, though the market is fragmented and label-driven.

Pricing and economics

Vitamin A palmitate is generally priced as a commodity vitamin ingredient. Business economics for suppliers depend more on:

  • purity grade and specification,
  • regulatory compliance (food-grade/pharma-grade),
  • supply continuity and toll manufacturing capacity, than on clinical differentiation.

How to model volume and value projection for 2025 to 2030

A defensible projection for “vitamin A palmitate” must be built on ingredient consumption within supplements, fortification, and topical formulations, with value linked to vitamin A mix, pricing, and grade mix (food vs pharma).

Because vitamin A palmitate is not a patent-protected molecular franchise, market growth typically tracks:

  • macro growth in supplements and fortified nutrition,
  • population and program funding (vitamin A interventions),
  • ingredient substitution cycles (retinyl acetate vs palmitate),
  • regulatory limits for vitamin A forms in consumer products.

Projection approach (industry-typical)

  1. Start from vitamin A demand across supplements/fortification and topical.
  2. Apply a palmitate share within retinyl ester use (palmitate vs acetate and other forms).
  3. Apply grade premium for higher purity and pharma/medical nutrition compliance.
  4. Layer in formulation substitution based on stability, solubility, and cost.

Market projection (directional)

  • Base case: steady low-to-mid single-digit CAGR globally through 2030, driven by supplement and fortification demand, with periodic volatility from commodity input costs and regulatory shifts on vitamin A labeling.
  • Upside case: faster growth where public health vitamin A programs expand and where cosmetic formulators increase use of esterified vitamin A systems.
  • Downside case: slower growth if regulations tighten allowable vitamin A levels in consumer products or if retinyl acetate displaces palmitate on cost or stability grounds.

Net projection: vitamin A palmitate is expected to remain a stable, recurring micronutrient ingredient market with limited product-specific upside tied to innovation.

Are there patent or exclusivity issues that affect the “drug” market?

For vitamin A palmitate, the main market structure is not exclusivity around the molecule. Commercial differentiation typically comes from:

  • formulation IP (process, stabilization systems, delivery vehicles),
  • manufacturing know-how and regulatory dossiers,
  • brand-specific product positioning.

What does a clinically actionable view look like for R&D decisions?

For R&D or investment screens, “vitamin A palmitate” should be treated as an ingredient platform rather than a single-drug clinical bet. Clinical value creation is usually driven by:

  • bioavailability proof in intended populations (pediatric, malnutrition-risk, or specific delivery formats),
  • stability and tolerability package for topical use,
  • dose-sparing or improved absorption claims with endpoint design.

In practice, companies compete via regulatory readiness and formulation performance, not via discovery-stage clinical endpoints.


Clinical Trials Update: What’s current and investable?

What kinds of ongoing studies typically move the field?

Ongoing studies, when publicly visible, usually include:

  • supplementation studies evaluating serum retinol status after dosing regimens that contain esterified vitamin A,
  • pediatric or pregnancy nutrition studies that track retinol response and safety,
  • topical tolerability and clinical performance in cosmetic/derm settings using esterified vitamin A components.

What endpoints matter for ingredient-level submissions

For oral supplements/fortification and medical nutrition:

  • serum retinol response (change from baseline),
  • vitamin A status metrics and sometimes functional biomarkers,
  • safety via adverse events and liver-related parameters where relevant.

For topical/cosmetic:

  • tolerability/irritation scoring,
  • retention and penetration proxies or local tissue concentration measures.

Net: investability is typically in study design that de-risks regulatory claims and improves formulation performance, not in late-stage drug-style efficacy trials.


Market Analysis: Competitive landscape and where margins exist

Who competes for vitamin A palmitate supply?

Competition centers on:

  • ingredient suppliers with global manufacturing footprints,
  • toll manufacturers with compliant quality systems,
  • ingredient distributors with grade specialization (food vs pharma/medical nutrition).

Margin opportunities typically come from:

  • higher-grade purity,
  • reliability of supply,
  • long-term supply agreements with supplement and pharma nutrition formulators.

Where value concentrates

  • Food and supplement formulation: large volumes; margins depend on commodity pricing and contract terms.
  • Medical nutrition/pharma: smaller volumes than supplements but higher compliance requirements; better for certified suppliers.
  • Topical/cosmetic: moderate volumes; value depends on stability and formulation compatibility with emulsions and skin delivery systems.

Key Takeaways

  • Vitamin A palmitate is a mature micronutrient ingredient with clinical evidence dominated by nutrition and formulation performance rather than a proprietary drug pipeline.
  • Public clinical updates are typically ingredient-context or formulation-context studies (oral supplementation bioavailability and pediatric nutrition; topical tolerability/retention proxies).
  • Market growth through 2030 is expected to be steady and primarily driven by supplement, fortification, and skin-care demand, with value influenced by commodity pricing and grade mix rather than patent-protected innovation.
  • For R&D or investment, the most actionable path is formulation-led clinical differentiation and regulatory claim substantiation (bioavailability, safety, stability), not late-stage drug development.

FAQs

  1. Is vitamin A palmitate currently protected by major patents that drive market exclusivity?
    No. Vitamin A palmitate is largely treated as an off-patent ingredient; commercial differentiation usually comes from formulation and manufacturing quality, not molecular IP.

  2. What clinical endpoints are most relevant for vitamin A palmitate submissions?
    Serum retinol response and safety endpoints for oral use; tolerability/irritation and retention-related proxies for topical formulations.

  3. Which end markets consume the most vitamin A palmitate?
    Dietary supplements and fortified foods, then medical nutrition and select topical/cosmetic applications.

  4. What most impacts price and procurement strategy?
    Commodity vitamin input costs, purity/grade requirements, and contract supply terms.

  5. How should projections be modeled given the ingredient nature of vitamin A palmitate?
    Use vitamin A demand growth, adjust by palmitate share in retinyl ester use, and layer grade mix and regulatory constraints rather than projecting a single-drug lifecycle curve.


References (APA)

[1] World Health Organization. (2011). Vitamin A supplementation in children: Guidelines for program managers. WHO.
[2] Institute of Medicine (US) Panel on Micronutrients. (2001). Dietary reference intakes for vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc. National Academies Press.
[3] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov/

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