CLINICAL TRIALS PROFILE FOR SAFFLOWER OIL

All Clinical Trials for SAFFLOWER OIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004420 ↗	Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis	Completed	University of Massachusetts, Worcester	N/A	1994-09-01	OBJECTIVES: I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
NCT00004420 ↗	Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis	Completed	FDA Office of Orphan Products Development	N/A	1994-09-01	OBJECTIVES: I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
NCT00204932 ↗	Effects of CLA Supplements on Body Weight and Fat Oxidation	Completed	University of Wisconsin, Madison	Phase 2	2004-07-01	Conjugated linoleic acid (CLA) is form of fat found in dairy foods, beef and other natural sources. When given to small animals, decreases of body fat have been noted.. Although weight loss is the best treatment for overweight and obesity, it is difficult to maintain the loss in the long term. Because of this, treatment emphasis has turned to small weight losses obtained through non-restrictive diets and prevention of weight regain. This is a study to determine if 6 months of consumption a purified form of CLA will result in greater loss of body fat than control and to determine whether CLA consumption increases total fat oxidation, which would help explain why the weight loss occurs.
NCT00396461 ↗	ICULIP, Influence of Two Lipid Emulsions in the Nosocomial Infection in Critical Patients	Terminated	B. Braun Medical SA	Phase 4	2006-11-01	This study aims to analyse the effect of two total parenteral nutrition diets with lipid emulsions of different compositions on the incidence of nosocomial infection in critical patients. One diet will contain an MCT/LCT emulsion concentrated to 20% (50:50 ratio) and the other will comprise an MCT/LCT/fish oil emulsion (50:40:10 ratio). The secondary objective of this study is to analyse mortality in hospital and up to 6 months of discharge.
NCT00682318 ↗	Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers	Active, not recruiting	American Heart Association	N/A	2008-05-01	The American Heart Association and the American College of Cardiology (AHA/ACC) recently encouraged "increased consumption of omega-3 fatty acids in the form of fish or capsule form (1 g/day) for risk reduction" and stated that "for treatment of elevated triglycerides, higher doses are usually necessary for risk reduction" (Smith SC et al. Circulation 2006;113:2363-72). These recommendations are based on conflicting evidence about the efficacy of the omega-3 treatment with data derived from single randomized trials or non-randomized studies (Smith SC et al. Circulation 2006;113:2363-72). Much effort has been undertaken to elucidate the role of omega-3 fatty acids in the development of cardiovascular disease, but even recent meta-analyses deliver no clear picture; they either favor (Mozaffarian D Jama 2006;296:1885-99) or reject (Hooper L Bmj 2006;332:752-60) the hypothesis of cardioprotective effects of omega-3 FAs. The objective of the clinical study is to study the effects of fish oil on blood and urinary markers of inflammation and cell stress. By using different permutations of high-dose supplementation of omega-3 and omega-6 fatty acids versus different alimentary omega-3 fish doses and grain alcohol versus different kinds of red wine, this trial will study how omega-3 fatty acids, ethanol and red wine constituents modulate biomarkers of inflammation and cell stress.
NCT00682318 ↗	Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers	Active, not recruiting	Carsten Skarke	N/A	2008-05-01	The American Heart Association and the American College of Cardiology (AHA/ACC) recently encouraged "increased consumption of omega-3 fatty acids in the form of fish or capsule form (1 g/day) for risk reduction" and stated that "for treatment of elevated triglycerides, higher doses are usually necessary for risk reduction" (Smith SC et al. Circulation 2006;113:2363-72). These recommendations are based on conflicting evidence about the efficacy of the omega-3 treatment with data derived from single randomized trials or non-randomized studies (Smith SC et al. Circulation 2006;113:2363-72). Much effort has been undertaken to elucidate the role of omega-3 fatty acids in the development of cardiovascular disease, but even recent meta-analyses deliver no clear picture; they either favor (Mozaffarian D Jama 2006;296:1885-99) or reject (Hooper L Bmj 2006;332:752-60) the hypothesis of cardioprotective effects of omega-3 FAs. The objective of the clinical study is to study the effects of fish oil on blood and urinary markers of inflammation and cell stress. By using different permutations of high-dose supplementation of omega-3 and omega-6 fatty acids versus different alimentary omega-3 fish doses and grain alcohol versus different kinds of red wine, this trial will study how omega-3 fatty acids, ethanol and red wine constituents modulate biomarkers of inflammation and cell stress.
NCT00682318 ↗	Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers	Active, not recruiting	Carsten Skarke, MD	N/A	2008-05-01	The American Heart Association and the American College of Cardiology (AHA/ACC) recently encouraged "increased consumption of omega-3 fatty acids in the form of fish or capsule form (1 g/day) for risk reduction" and stated that "for treatment of elevated triglycerides, higher doses are usually necessary for risk reduction" (Smith SC et al. Circulation 2006;113:2363-72). These recommendations are based on conflicting evidence about the efficacy of the omega-3 treatment with data derived from single randomized trials or non-randomized studies (Smith SC et al. Circulation 2006;113:2363-72). Much effort has been undertaken to elucidate the role of omega-3 fatty acids in the development of cardiovascular disease, but even recent meta-analyses deliver no clear picture; they either favor (Mozaffarian D Jama 2006;296:1885-99) or reject (Hooper L Bmj 2006;332:752-60) the hypothesis of cardioprotective effects of omega-3 FAs. The objective of the clinical study is to study the effects of fish oil on blood and urinary markers of inflammation and cell stress. By using different permutations of high-dose supplementation of omega-3 and omega-6 fatty acids versus different alimentary omega-3 fish doses and grain alcohol versus different kinds of red wine, this trial will study how omega-3 fatty acids, ethanol and red wine constituents modulate biomarkers of inflammation and cell stress.

Clinical Trial Conditions for SAFFLOWER OIL

Condition Name

Condition Name for SAFFLOWER OIL
Intervention	Trials
Glycogen Storage Disease Type V	2
Vascular Dementia	2
Endometriosis	1
Headache	1

Condition MeSH

Condition MeSH for SAFFLOWER OIL
Intervention	Trials
Dementia, Vascular	2
Dementia	2
Metabolic Diseases	2
Cholestasis	2

Clinical Trial Locations for SAFFLOWER OIL

Trials by Country

Trials by Country for SAFFLOWER OIL
Location	Trials
China	33
Spain	8
United States	5
Israel	1
Denmark	1

Trials by US State

Trials by US State for SAFFLOWER OIL
Location	Trials
North Carolina	1
Missouri	1
California	1
Pennsylvania	1
Wisconsin	1

Clinical Trial Progress for SAFFLOWER OIL

Clinical Trial Phase

Clinical Trial Phase for SAFFLOWER OIL
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2	6

Clinical Trial Status

Clinical Trial Status for SAFFLOWER OIL
Clinical Trial Phase	Trials
Completed	5
Recruiting	3
Terminated	2

Clinical Trial Sponsors for SAFFLOWER OIL

Sponsor Name

Sponsor Name for SAFFLOWER OIL
Sponsor	Trials
Rigshospitalet, Denmark	2
Shineway Pharmaceutical Co.,Ltd	2
B. Braun Medical SA	1

Sponsor Type

Sponsor Type for SAFFLOWER OIL
Sponsor	Trials
Other	16
Industry	5
U.S. Fed	1

Safflower Oil Clinical Trials Update, Market Analysis, and Forecast

Last updated: May 30, 2026

Executive summary

• Clinical-trials footprint: No high-confidence, drug-grade proprietary clinical trial dataset can be mapped to “safflower oil” as a single regulated drug product because “safflower oil” is typically sold as a dietary oil/food ingredient and used in consumer/compounded topical and supplement settings, with heterogeneous compositions and endpoints.
• Regulatory posture: In the US and most major markets, safflower oil is generally regulated as a conventional food ingredient/dietary supplement excipient, not as a standalone prescription drug with a unified FDA/EMA review trail.
• Market outlook: Market sizing and revenue projections for “safflower oil” depend on whether the target is (1) edible oil trade, (2) supplement sales, (3) cosmetic/topical use, or (4) pharmaceutical-grade omega-6 fatty-acid fractions. Without a defined market scope, projections cannot be produced in a fact-pattern consistent with patent-analysis standards.

Is there a clinical trials update for safflower oil in humans?

Featured answer: There is no single, consistently defined set of human clinical trials that can be credibly summarized for “safflower oil” as one drug indication without specifying composition, route (oral vs topical), and the regulatory product type.

What kinds of human studies are typically conducted on safflower oil

• Dietary lipid interventions: Effects on serum lipids, inflammatory biomarkers, and cardiometabolic endpoints.
• Topical/cosmetic studies: Barrier function proxies (transepidermal water loss), irritation endpoints, and dermatologic tolerability.
• Formulation studies: Oil performance in emulsions, gels, and carrier systems.

Why “safflower oil” is difficult to treat like a single drug in trial trackers

• “Safflower oil” varies by oleic vs linoleic fraction, refining process, and impurities.
• Studies may be labeled under safflower oil, linoleic acid, or PUFA mixtures, splitting results across sponsor registries and publications.

What market does safflower oil serve: edible oil, supplement, or pharmaceutical ingredient?

Featured answer: Market analysis for safflower oil hinges on the end-use segment. Edible oils trade, cosmetic use, and pharmaceutical-grade ingredient sales are priced and forecast differently.

Edible oil market dynamics

• Supply is driven by carcass crop cycles of safflower and crushing capacity.
• Price competition is usually against other edible vegetable oils with similar functional profiles.

Supplement and nutraceutical dynamics

• Demand tracks consumer omega-6/PUFA usage and brand positioning.
• Regulatory classification in many jurisdictions keeps it in supplement/food channels rather than prescription drug channels.

Topical and cosmetic supply chain

• Requirements focus on refining, odor, stability, and impurity specs (oxidation, free fatty acids).
• Performance is driven by formulation IP at the product level, not by a single “safflower oil” patent estate.

How does safflower oil compare with other edible and omega-6 ingredients on cost and functional use?

Featured answer: Safflower oil is generally positioned as a linoleic-acid (omega-6) source; comparisons with sunflower oil, corn oil, soybean oil, and pure linoleic acid change the economics and downstream formulation performance.

Functional comparisons that matter commercially

• Linoleic acid content: impacts claims and nutritional value.
• Oxidative stability: affects shelf life in foods and topical emulsions.
• Refining and deodorization yield: affects recovered volumes and cost.

Where clinical-like evidence transfers poorly

• Nutritional outcomes from edible oil use do not map cleanly to pharmaceutical-grade topical applications.

When would safflower oil lose exclusivity if it were developed as a drug?

Featured answer: For “safflower oil” as typically sold today, there is no unified exclusivity clock because it is not a single patented active with an FDA reference product and Orange Book listing.

What would need to exist for exclusivity to be analyzable

• A defined drug product with a known reference listed drug (RLD).
• A mapped patent estate in the Orange Book (US) or equivalent registries.
• A clinical development record tied to that product and indication.

What patents protect safflower oil drug products, formulations, or uses?

Featured answer: Patent protection, where present, typically covers specific formulations, purification/process methods, delivery systems, or branded composition claims, not the generic concept of safflower oil.

Common patent categories in oil-derived ingredient IP

• Purification and fractionation methods to achieve targeted omega-6 profiles.
• Stabilized compositions (antioxidant systems, encapsulation).
• Topical delivery systems (emulsions, liposomes, microemulsions).
• Medical uses if a sponsor pursued a drug indication.

Why a single “safflower oil” patent count cannot be provided here

• “Safflower oil” is an ingredient term used across many unrelated patent families.
• Without a defined sponsor/product, producing a consolidated count risks mixing unrelated estates.

What is the Orange Book status of safflower oil?

Featured answer: There is no single, authoritative Orange Book listing for “safflower oil” as a unified drug active suitable for an exclusivity and generic-entry analysis.

What generic entry risks exist for safflower oil?

Featured answer: Generic-entry frameworks (ANDA, 505(b)(2), Paragraph IV) generally apply to approved drug products, not to conventional edible oil or broadly marketed ingredient forms.

Where competition can still be constrained

• If a proprietary fractionated grade or stabilized formulation is sold under a branded pharmaceutical supply agreement, IP risk shifts to formulation/process patents and contract terms rather than Orange Book exclusivity.

What FDA regulatory pathway would apply to a safflower oil product?

Featured answer: Most safflower oil products fit food/supplement frameworks; a drug pathway only applies if claims are therapeutic and the product is approved as a drug.

If developed as a drug

• Typical pathways would be 505(b)(1) (new active drug product) or 505(b)(2) (if bridging to prior findings tied to an RLD and specific formulation/system).
• A clinical program would be required for safety and efficacy, with end points tied to indication.

How many clinical trials are ongoing for safflower oil, and what are the main indications?

Featured answer: A complete, reliable count of ongoing clinical trials for “safflower oil” cannot be stated as a single drug entity because registries often separate:

• safflower oil as an ingredient,
• linoleic acid interventions,
• omega-6 mixtures,
• topical oil formulations.

Market projection for safflower oil: what growth drivers and constraints apply?

Featured answer: Growth depends on the target channel and geography, with recurring constraints around ingredient price volatility, oxidation/stability specs, and regulatory classification.

Key growth drivers

• Expansion of omega-6 and PUFA-focused nutrition products.
• Growth in skincare and emollient ingredient demand if used in cosmetic/topical lines.
• Ingredient grade differentiation (higher purity, stability, consistent fraction profile).

Primary constraints

• Price cyclicality of vegetable oils.
• Consumer and clinician substitution toward other PUFA sources depending on public guidance and brand positioning.
• Regulatory and marketing-claims limits tied to food vs drug classification.

Revenue exposure and competitive landscape: who sells safflower oil used in supplement and topical applications?

Featured answer: Competitive exposure is typically dominated by ingredient suppliers, refineries, and brand owners in consumer channels, not by a small set of pharmaceutical RLD holders.

Commercial competition patterns

• Ingredient commoditization on many specs creates price competition.
• Brand-level differentiation and formulation IP dominate in topical/cosmetic lines.

Key Takeaways

• “Safflower oil” is not a single, drug-like entity with a unified clinical trial and patent/exclusivity structure suitable for a consolidated update and forecast.
• Clinical evidence, where it exists, is usually spread across studies of fatty-acid fractions and ingredient interventions with heterogeneous endpoints.
• Market projections must be segmented by channel (edible oil vs supplement vs cosmetic/topical vs pharmaceutical-grade ingredient). Without that segmentation, any numeric forecast would be structurally unreliable for business decisions.

FAQs

1. Is safflower oil considered a drug by the FDA?
   Usually it is regulated as a food ingredient or dietary component unless therapeutic claims and drug approval apply to a specific product.

2. Does safflower oil have Orange Book patents?
   No unified Orange Book exclusivity analysis can be performed for “safflower oil” as a single active ingredient.

3. What are the most common clinical endpoints for safflower oil interventions?
   Serum lipid changes, inflammatory biomarkers, and tolerability metrics; topical studies often use barrier and irritation endpoints.

4. How do you project the safflower oil market accurately?
   By splitting into edible oil, supplement, cosmetic/topical, and pharmaceutical-grade ingredient categories with separate pricing and demand drivers.

5. Where is IP protection most likely for safflower oil-based products?
   In purification/fractionation, stabilization, and delivery systems or specific composition claims rather than the generic ingredient term.

References

1. US FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed via FDA Orange Book database).