CLINICAL TRIALS PROFILE FOR VITAMIN A SOLUBILIZED

All Clinical Trials for VITAMIN A SOLUBILIZED

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00901498 ↗	Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease	Completed	Bristol-Myers Squibb	Phase 1	2009-05-01	The purpose of this study is to assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study.
NCT00948402 ↗	PED/PEA-15 Protein, PCOS, Obesity, Insulin Sensitivity Indexes, Metformin, Oral Contraceptives	Completed	Federico II University	Phase 3	2006-12-01	Insulin-resistance plays an important role in polycystic ovary syndrome (PCOS) physiopathology. The phosphoprotein enriched in the diabetes (PED/PEA-15), a 15 kDa protein related to insulin sensitivity, is over-expressed in type 2 diabetic patients and in PCOS women, independently of obesity. The effectiveness of oral contraceptives pills (OCP) or metformin (MET) in PCOS management is still uncertain. Aim of this pilot clinical study was to compare the effects of OCPs or MET on the expression of PED/PEA-15 in association with insulin sensitivity in obese PCOS women. Outcome measures: PED/PEA-15, BMI, plasma glucose and insulin, 1/HOMA-IR, homeostasis model assessment of insulin resistance; QUICKI, quantitative insulin sensitivity check index; ISI: whole-body insulin sensitivity index. Study design: twenty obese PCOS women (age: 24.7±18 yr; BMI: 30±2.4 kg/m2) were randomized according to insulin sensitivity to receive 30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month or MET 1250 mg three times daily for 6 months. Results: At baseline, age and BMI were not different in the two groups; PED/PEA-15 protein expression was higher in MET than in OCP group (p=0.011), along with higher 1/HOMA-IR (p=0.004), and lower QUICKI and ISI (p=0.003 and p
NCT01140321 ↗	Efficacy and Safety of Neridronate (Nerixia®)to Treat Osteoporosis in Patients With TM and TI	Completed	Azienda Ospedaliera V. Cervello	Phase 2	2004-01-01	An Italian Multicentric randomized, open-label therapeutic trial evaluating the efficacy and safety of Neridronate in the treatment of Osteoporosis in patients with Thalassemia Major and Severe Thalassemia Intermedia. Efficacy and safety of the drug will be evaluated measuring at every visit this parameters: - haematological: Haemochrome - blood chemistry: creatinine, BUN, AST, ALT, Ca, P, proteins electrophoresis, total proteins. The prevalence of ectopic calcification and pseudoxantoma elasticum (PXE)-like syndrome and their follow-up will be evaluated at the beginning of the study vs 24 months through physical examination, abdominal echography and fundus oculi examination. During the trial other known risks factors for osteoporosis will be recorded, including prevalence and incidence of bone fractures and, if executed, Polimorphisms COLIA1. At the beginning of the study and at months 12 and 24 morphometry DXA will be performed to evaluate of the presence of bone deformities. Furthermore data regarding QOL and symptom pain will be evaluated trough administration of scale SF-36. At 12 months an intratrial analisis will be performed on efficacy and safety parameters in order to introduce possible amendments to the study design and to decide the prosecution of the trial During the trial all adverse events will be recorded
NCT01140321 ↗	Efficacy and Safety of Neridronate (Nerixia®)to Treat Osteoporosis in Patients With TM and TI	Completed	Azienda Ospedaliera Villa Sofia	Phase 2	2004-01-01	An Italian Multicentric randomized, open-label therapeutic trial evaluating the efficacy and safety of Neridronate in the treatment of Osteoporosis in patients with Thalassemia Major and Severe Thalassemia Intermedia. Efficacy and safety of the drug will be evaluated measuring at every visit this parameters: - haematological: Haemochrome - blood chemistry: creatinine, BUN, AST, ALT, Ca, P, proteins electrophoresis, total proteins. The prevalence of ectopic calcification and pseudoxantoma elasticum (PXE)-like syndrome and their follow-up will be evaluated at the beginning of the study vs 24 months through physical examination, abdominal echography and fundus oculi examination. During the trial other known risks factors for osteoporosis will be recorded, including prevalence and incidence of bone fractures and, if executed, Polimorphisms COLIA1. At the beginning of the study and at months 12 and 24 morphometry DXA will be performed to evaluate of the presence of bone deformities. Furthermore data regarding QOL and symptom pain will be evaluated trough administration of scale SF-36. At 12 months an intratrial analisis will be performed on efficacy and safety parameters in order to introduce possible amendments to the study design and to decide the prosecution of the trial During the trial all adverse events will be recorded
NCT01140321 ↗	Efficacy and Safety of Neridronate (Nerixia®)to Treat Osteoporosis in Patients With TM and TI	Completed	Ospedale "Perrino" Brindisi	Phase 2	2004-01-01	An Italian Multicentric randomized, open-label therapeutic trial evaluating the efficacy and safety of Neridronate in the treatment of Osteoporosis in patients with Thalassemia Major and Severe Thalassemia Intermedia. Efficacy and safety of the drug will be evaluated measuring at every visit this parameters: - haematological: Haemochrome - blood chemistry: creatinine, BUN, AST, ALT, Ca, P, proteins electrophoresis, total proteins. The prevalence of ectopic calcification and pseudoxantoma elasticum (PXE)-like syndrome and their follow-up will be evaluated at the beginning of the study vs 24 months through physical examination, abdominal echography and fundus oculi examination. During the trial other known risks factors for osteoporosis will be recorded, including prevalence and incidence of bone fractures and, if executed, Polimorphisms COLIA1. At the beginning of the study and at months 12 and 24 morphometry DXA will be performed to evaluate of the presence of bone deformities. Furthermore data regarding QOL and symptom pain will be evaluated trough administration of scale SF-36. At 12 months an intratrial analisis will be performed on efficacy and safety parameters in order to introduce possible amendments to the study design and to decide the prosecution of the trial During the trial all adverse events will be recorded

Clinical Trial Conditions for VITAMIN A SOLUBILIZED

Condition Name

Condition Name for VITAMIN A SOLUBILIZED
Intervention	Trials
Vaginal Infection	3
Osteoporosis	1
Polycystic Ovarian Syndrome	1
Thalassemia Intermedia	1

Condition MeSH

Condition MeSH for VITAMIN A SOLUBILIZED
Intervention	Trials
Infections	3
Infection	3
Conjunctivitis, Allergic	1
Polycystic Ovary Syndrome	1

Clinical Trial Locations for VITAMIN A SOLUBILIZED

Trials by Country

Trials by Country for VITAMIN A SOLUBILIZED
Location	Trials
United States	73
Italy	1
Netherlands	1

Trials by US State

Trials by US State for VITAMIN A SOLUBILIZED
Location	Trials
New Jersey	4
Ohio	3
North Carolina	3
New York	3
Nevada	3

Clinical Trial Progress for VITAMIN A SOLUBILIZED

Clinical Trial Phase

Clinical Trial Phase for VITAMIN A SOLUBILIZED
Clinical Trial Phase	Trials
Phase 3	5
Phase 2	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for VITAMIN A SOLUBILIZED
Clinical Trial Phase	Trials
Completed	8

Clinical Trial Sponsors for VITAMIN A SOLUBILIZED

Sponsor Name

Sponsor Name for VITAMIN A SOLUBILIZED
Sponsor	Trials
Curatek Pharmaceuticals, LLC	3
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena	1
Reggio Calabria	1

Sponsor Type

Sponsor Type for VITAMIN A SOLUBILIZED
Sponsor	Trials
Other	10
Industry	6

VITAMIN A SOLUBILIZED Market Analysis and Financial Projection

Last updated: February 8, 2026

What is the current status of clinical trials for Vitamin A Solubilized?

There are limited publicly available clinical trial data specifically labeled as "Vitamin A Solubilized." The majority of research focuses on formulations of Vitamin A in topical, oral, or injectable forms rather than proprietary solubilized variants. Key points include:

• Phase and Enrollment: No publicly registered Phase I–III clinical trials explicitly using "Vitamin A Solubilized" as a sole intervention.
• ClinicalTrials.gov Data: Searches yield primarily evaluations of Vitamin A in combination with other compounds, not as a distinct solubilized formulation.
• Published Studies: The scientific literature includes experimental formulations enhancing solubility, often in research settings, but lacks large-scale, pivotal trials demonstrating efficacy or safety of the solubilized form. For example, topical Vitamin A studies rarely specify solubilization techniques.

Implication: Currently, no significant clinical trial data support clinical claims for a unique "Vitamin A Solubilized" product.

How does the market structure and competition look?

The market for Vitamin A supplements and derivatives is segmented into:

• Oral Supplements: Products like retinyl palmitate and retinyl acetate dominate, with an estimated global market size of $1.5 billion in 2022 (source: Grand View Research).
• Topical Dermatology Formulations: Retinoids such as tretinoin and adapalene account for approximately $1 billion annually, with increasing demand driven by anti-aging and acne treatments.
• Injectable Vitamin A (Retinoids for Deficiency): Accounts for a smaller segment, with presence mainly in developed markets.

Notably, companies investing in specialized solubilized formulations include:

• BASF and Dow Chemical: Offer solubilized vitamin A ingredients primarily for industrial and cosmetic applications.
• Research-driven startups: Developing novel delivery systems like nanocarriers or liposomes to improve bioavailability.

Competition Analysis: Patents in this space focus on delivery methods (microemulsions, liposomes) rather than Vitamin A alone, indicating limited proprietary claims on "solubilized" Vitamin A as a standalone ingredient.

What are the projections for this market segment?

Market projections are contingent on formulation advances and regulatory approvals:

• Market Growth: The global Vitamin A market is projected to grow at a CAGR of 5% from 2023 to 2030, reaching approximately $2.2 billion (source: Grand View Research).
• Innovative Formulation Impact: Improvements in solubilization could enhance bioavailability, creating a niche market for specialized delivery systems. This sub-sector could expand at a faster rate, potentially reaching a CAGR of 8-10% over the same period.
• Regulatory Environment: Clearance for new formulations depends on demonstrating bioavailability and safety equivalence, particularly in dietary supplements and pharmaceuticals.

Forecast Scenario: If a formulary breakthrough with proven bioavailability enhancement occurs, market adoption could accelerate, especially in topical and injectable categories. This would favor companies holding foundational solubilization technologies or patents.

How does this compare with other Vitamin A derivatives and formulations?

Aspect	Standard Oral Vitamin A	Topical Retinoids	Solubilized Vitamin A (Projected)
Bioavailability	Well-established	High for targeted skin delivery	Potentially higher with advanced delivery systems
Clinical evidence	Extensive	Substantial, especially for dermatology	Limited currently
Market size (2022)	$1.5 billion	$1 billion	Undefined, niche development pending
Regulatory hurdles	Clear, well-defined pathways	Clear, with safety considerations	Pending, depends on formulation and claims

What are the key regulatory considerations?

• Safety and Efficacy: Demonstrating bioavailability and safety for novel solubilized forms.
• Claims Substantiation: Claims around improved absorption require pharmacokinetic data.
• Classification: Products may be classified as dietary supplements, cosmetics, or pharmaceuticals, each with different regulatory pathways.
• Patents and Intellectual Property: Securing patents for unique formulations can influence market exclusivity.

Key Takeaways

• Clinical trial data for "Vitamin A Solubilized" as a distinct entity remains scant; current research focuses on formulation innovation rather than clinical validation.
• The overall Vitamin A market is sizable and growing; niche delivery technologies, including solubilization, represent potential growth areas.
• Competition centers on proprietary delivery systems rather than on the core ingredient.
• Regulatory pathways hinge on demonstrating enhanced bioavailability and safety, which may slow entry but could create high-value differentiation.

FAQs

1. Are there any large clinical trials for solubilized Vitamin A?
   No, there are no known large-scale clinical trials specifically targeting solubilized Vitamin A as an individual drug.

2. What patent opportunities exist in this space?
   Patent opportunities lie in novel delivery systems (liposomes, nanoemulsions) that improve solubility and bioavailability of Vitamin A.

3. What applications could a solubilized Vitamin A formulation serve?
   Potential applications include enhanced topical treatments for skin conditions, improved oral bioavailability supplements, and injectable therapies for deficiency correction.

4. Which regulatory agencies oversee these formulations?
   The U.S. FDA, EMA, and other regional agencies oversee dietary supplements, cosmetics, and pharmaceuticals, with specific pathways depending on the intended use and claims.

5. What is the outlook for market adoption of solubilized Vitamin A?
   Adoption hinges on clinical validation of benefits, regulatory approval, and patent protection. Delivery technology advancements could accelerate uptake, especially in dermatology and nutraceuticals.

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References

[1] Grand View Research, "Vitamin A Market Size, Share & Trends Analysis Report," 2022.