CLINICAL TRIALS PROFILE FOR VITAMIN A PALMITATE

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.

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).
NCT00065455 ↗	Investigating the Effect of Vitamin A Supplementation on Retinitis Pigmentosa	Completed	National Eye Institute (NEI)	Phase 1	2003-07-17	Retinitis pigmentosa (RP) is a collective term for a group of inherited retinal dystrophies that are a major cause of irreversible blindness. RP of some type occurs in approximately 1 out of 3500 persons in the United States(1). Gene mutations are responsible for the majority of RP. To date, mutations have been identified in 30 different genes linked to RP(2). The visual prognosis of RP is poor, since the gradual but relentless visual field loss leads eventually to some degree of blindness(3). Although no effective treatment for RP has been identified, participants supplemented with a daily oral dose of 15,000 IU vitamin A palmitate have shown, on average, a slower rate of deterioration of retinal function when the intervention is continued over several years(4). The purpose of this research is to determine whether administration of high oral doses of vitamin A can acutely improve cone photoreceptor function in RP participants as measured by electroretinography (ERG). In this interventional, non-randomized, prospective, pilot study, 5 participants will receive a daily oral dose of 50,000 IU of vitamin A palmitate for 4 weeks, followed by a maintenance dose of 15,000 IU daily for the subsequent 2 weeks. The primary efficacy outcome is a relative percentage change in ERG response amplitude subsequent to vitamin A supplementation. A secondary efficacy outcome is a relative percentage change in implicit time from pre- to post- vitamin A supplementation, with improvement specified as a shorter response implicit time. Other secondary outcomes will be improvements in visual field (Humphery, 10-2; sum of thresholds). Safety outcomes include visual fields, ETDRS visual acuity, intraocular pressure, serum vitamin A level and liver function tests.
NCT00073320 ↗	Intramuscular Injections of Paliperidone Palmitate in the Arm or Buttock of Subjects With Schizophrenia	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2003-08-01	The purpose of the study is to compare the pharmacokinetic parameters (blood concentrations) of i.m. paliperidone palmitate after administration in 2 different injection sites (deltoid or gluteal).
NCT00074477 ↗	Safety and Efficacy of an Anti-Psychotic in Patients With Schizophrenia	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 2	2003-10-01	The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate injection compared to placebo in the treatment of the symptoms of schizophrenia in adults. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.
NCT00101634 ↗	Efficacy and Safety of a Long Acting Anti-Psychotic Versus Placebo in Patients With Schizophrenia	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2004-12-01	The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate compared to placebo in the treatment of the symptoms of schizophrenia in adults. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.

Clinical Trial Conditions for vitamin a palmitate

Condition Name

Condition Name for vitamin a palmitate
Intervention	Trials
Schizophrenia	50
Type 2 Diabetes	6
Obesity	5
Healthy	4

Condition MeSH

Condition MeSH for vitamin a palmitate
Intervention	Trials
Schizophrenia	53
Diabetes Mellitus, Type 2	10
Diabetes Mellitus	9
Insulin Resistance	7

Clinical Trial Locations for vitamin a palmitate

Trials by Country

Trials by Country for vitamin a palmitate
Location	Trials
United States	264
Canada	17
Korea, Republic of	17
Taiwan	12
Ukraine	12

Trials by US State

Trials by US State for vitamin a palmitate
Location	Trials
California	20
Texas	20
Missouri	16
Illinois	13
Florida	13

Clinical Trial Progress for vitamin a palmitate

Clinical Trial Phase

Clinical Trial Phase for vitamin a palmitate
Clinical Trial Phase	Trials
Phase 4	24
Phase 3	30
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for vitamin a palmitate
Clinical Trial Phase	Trials
Completed	79
Recruiting	10
Unknown status	7

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)	8
Janssen Scientific Affairs, LLC	6

Sponsor Type

Sponsor Type for vitamin a palmitate
Sponsor	Trials
Other	100
Industry	54
NIH	20

Vitamin a palmitate Market Analysis and Financial Projection

Vitamin A Palmitate: Clinical Trials, Market Analysis, and Projections

Introduction

Vitamin A palmitate, a synthetic form of vitamin A, is gaining significant attention in various industries, including healthcare, cosmetics, and food fortification. This article delves into the current state of clinical trials, market analysis, and future projections for vitamin A palmitate.

Clinical Trials and Medical Applications

Bronchopulmonary Dysplasia (BPD) Treatment

Advent Therapeutics has been at the forefront of developing a novel aerosolized vitamin A formulation to prevent Bronchopulmonary Dysplasia (BPD), a serious complication in premature infants. The company has been awarded a $3 million NIH grant to accelerate the development of this non-invasive inhaled therapy. This grant will support preclinical requirements, manufacturing scale-up, and pivotal human clinical trials, aiming for commercialization in 2025[1].

General Health Outcomes

A systematic review of randomized clinical trials evaluated the preventive effects of vitamin A supplements on various health outcomes. The review found that vitamin A did not significantly reduce mortality in individually randomized trials but showed a beneficial effect on mortality in cluster randomized trials, although with very low certainty of evidence. The review highlights the need for more robust trials to support preventive vitamin A programs[3].

Other Medical Applications

Advent Therapeutics is also exploring the potential of inhaled optimized retinol palmitate to mitigate acute lung injury (ALI), address CBRN (chemical, biological, and radio-nuclear) threat agents, and treat pulmonary infections such as those caused by bacteria, influenza, and SARS-CoV-2. These applications represent significant therapeutic opportunities and are expected to be developed in partnership with other companies[1].

Market Analysis

Current Market Size and Growth

The global vitamin A palmitate market was valued at approximately USD 50 billion in 2023 and is projected to reach USD 120.7 billion by 2031, growing at a CAGR of 10.5% from 2024 to 2031. This growth is driven by increasing health consciousness, rising demand for nutritional supplements, and the expanding use of vitamin A palmitate in fortified foods and cosmetics[2][5].

Key Drivers of Market Growth

• Health Consciousness and Preventative Healthcare: Growing awareness of the importance of vitamin A in maintaining overall health and wellness is driving the demand for vitamin A palmitate supplements and fortified foods.
• Vitamin A Deficiency: The prevalence of vitamin A deficiency, particularly in emerging nations, is a significant factor propelling the market.
• Cosmetics Sector: The use of vitamin A palmitate in cosmetics due to its anti-aging and skin health benefits is another key driver of market growth[2][5].

Geographical Market Trends

The Asia Pacific region is expected to have the highest CAGR due to the growing animal feed and food fortification industries, along with increasing disposable incomes and health consciousness. In contrast, mature markets in North America and Europe are expected to grow at a slower but steady rate, driven by the demand for premium vitamin A palmitate for medical and cosmetic uses[5].

Safety and Regulatory Considerations

Potential Risks

A study by U.S. government scientists suggested that retinyl palmitate, a form of vitamin A, may accelerate the development of skin tumors and lesions when exposed to sunlight. This has raised concerns about the safety of vitamin A ingredients in cosmetics, particularly when combined with excessive sun exposure[4].

Regulatory Support

Despite these concerns, regulatory support for nutritional fortification and the development of new supplement formulations continue to drive the market. However, manufacturers must ensure compliance with safety guidelines and regulatory standards to mitigate potential risks[2][5].

Future Projections

Commercialization and Revenue Potential

Advent Therapeutics anticipates the US launch of its initial vitamin A drug product for injection in early 2025, with potential peak annual revenues exceeding $100 million for the prevention of BPD. The company also plans to pursue broader applications for its novel retinol palmitate drug product, which have significant market potential[1].

Market Expansion

The vitamin A palmitate market is expected to continue its robust growth, driven by innovative product formulations, increasing consumer awareness, and the expanding use in various industries. The market's growth will be fueled by the rising demand for fortified foods, nutritional supplements, and cosmetics[2][5].

Key Takeaways

• Clinical Trials: Vitamin A palmitate is being developed for critical medical applications, including the prevention of BPD in premature infants.
• Market Growth: The global vitamin A palmitate market is projected to grow significantly, driven by health consciousness, vitamin A deficiency, and expanding use in cosmetics.
• Safety Considerations: While there are potential risks associated with vitamin A ingredients in cosmetics, regulatory support and compliance with safety guidelines are crucial.
• Future Projections: The market is expected to expand, with significant revenue potential from both medical and cosmetic applications.

FAQs

Q: What is the current status of clinical trials for vitamin A palmitate in treating BPD?

A: Advent Therapeutics has been awarded a $3 million NIH grant to accelerate the development of an aerosolized vitamin A formulation for preventing BPD, with plans for commercialization in 2025[1].

Q: How does vitamin A palmitate impact mortality rates according to clinical trials?

A: A systematic review found that vitamin A did not significantly reduce mortality in individually randomized trials but showed a beneficial effect in cluster randomized trials, although with very low certainty of evidence[3].

Q: What are the key drivers of the vitamin A palmitate market growth?

A: The market growth is driven by increasing health consciousness, rising demand for nutritional supplements, and the expanding use in fortified foods and cosmetics[2][5].

Q: Are there any safety concerns associated with vitamin A palmitate?

A: Yes, there are concerns about the potential for retinyl palmitate to accelerate skin tumor development when exposed to sunlight, but regulatory support and compliance with safety guidelines are in place[4].

Q: What are the future revenue projections for vitamin A palmitate products?

A: Advent Therapeutics anticipates peak annual revenues exceeding $100 million for the prevention of BPD, with broader applications expected to have significant market potential[1].

Sources

1. Advent Therapeutics Awarded $3 Million NIH Grant for Novel Neonatal Lung Therapy. Biospace.
2. Vitamin A Palmitate Market Size and Projections. Market Research Intellect.
3. A systematic review of randomised clinical trials with meta-analysis. PubMed.
4. The problem with vitamin A. EWG's Guide to Sunscreens.
5. Vitamin A Palmitate Market Size, Share, Industry & Forecast 2030. Verified Market Reports.