CLINICAL TRIALS PROFILE FOR AZELAIC ACID

505(b)(2) Clinical Trials for Azelaic Acid

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
New Formulation	NCT01025635 ↗	Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea	Completed	Bayer	Phase 2	2009-12-01	This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.
New Formulation	NCT01025635 ↗	Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea	Completed	LEO Pharma	Phase 2	2009-12-01	This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.
New Dosage	NCT02058628 ↗	Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris	Completed	GlaxoSmithKline	Phase 4	2014-02-21	This is a randomized, comparator-controlled, single-blind, parallel-group study. The current study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of facial acne vulgaris. The results of the study will enable a better assessment of the safety and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well established treatment. Based on the data more evidence based recommendations will be possible to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the study will be over 12 weeks.

All Clinical Trials for Azelaic Acid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00031096 ↗	Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne	Completed	Bayer	Phase 3	2002-01-01	Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne. Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.
NCT00031096 ↗	Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne	Completed	LEO Pharma	Phase 3	2002-01-01	Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne. Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.
NCT00395226 ↗	Zinc Sulfate in the Treatment of Rosacea: A Randomized, Controlled Trial	Terminated	Essentia Health	N/A	2006-07-01	Rosacea is a common chronic dermatological condition, characterized by recurrent or persistent redness, permanent dilation of small blood vessel causing small red lesions, and papules/pustules. The signs of rosacea are usually confined to the face, but may appear on the neck, scalp or trunk. Opthalmologic findings are also common. Rosacea is usually described as being most common in fair skinned women over 40. The purpose of the study is to determine whether oral Zinc Sulfate treatment is an effective treatment for facial rosacea.

Clinical Trial Conditions for Azelaic Acid

Condition Name

Condition Name for Azelaic Acid
Intervention	Trials
Rosacea	9
Acne Vulgaris	8
Papulopustular Rosacea	7

Condition MeSH

Condition MeSH for Azelaic Acid
Intervention	Trials
Rosacea	18
Acne Vulgaris	8
Melanosis	4

Clinical Trial Locations for Azelaic Acid

Trials by Country

Trials by Country for Azelaic Acid
Location	Trials
United States	158
Germany	12
Canada	11
Egypt	2
Taiwan	1

Trials by US State

Trials by US State for Azelaic Acid
Location	Trials
Texas	11
North Carolina	10
Florida	7
Kentucky	6
Colorado	6

Clinical Trial Progress for Azelaic Acid

Clinical Trial Phase

Clinical Trial Phase for Azelaic Acid
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Azelaic Acid
Clinical Trial Phase	Trials
Completed	27
Not yet recruiting	4
Recruiting	2

Clinical Trial Sponsors for Azelaic Acid

Sponsor Name

Sponsor Name for Azelaic Acid
Sponsor	Trials
Bayer	24
LEO Pharma	11
Assiut University	4

Sponsor Type

Sponsor Type for Azelaic Acid
Sponsor	Trials
Industry	51
Other	15

Azelaic Acid: Clinical Trials, Market Analysis, and Projections

Introduction to Azelaic Acid

Azelaic acid is a dicarboxylic acid with anti-inflammatory, antioxidant, and keratolytic properties, making it a versatile compound in the treatment of various skin conditions. It is naturally produced by the yeast Malassezia furfur and is widely used in dermatology for its efficacy in treating acne, rosacea, and hyperpigmentation[4].

Clinical Trials and Therapeutic Applications

Azelaic acid is undergoing extensive clinical trials to explore its efficacy in treating a range of skin conditions beyond its traditional uses.

Current Clinical Trials

• Azelaic acid is being clinically tested for its efficacy in treating rosacea, melasma, and post-inflammatory hyperpigmentation. Studies published by the National Center for Biotechnology Information (NCBI) highlight ongoing trials that focus on these conditions, indicating a growing interest in its multi-functional benefits[3].
• Trials have shown that azelaic acid can be as effective as tretinoin in treating acne, with the added advantage of milder side effects. This has led to increased research and development activities to explore new therapeutic applications[4].

Emerging Applications

• Azelaic acid's anti-inflammatory and antioxidant properties make it a potential candidate for treating inflammatory and hyperpigmentation conditions. It is particularly beneficial for darker-skinned patients who experience persistent brown marks (post-inflammatory pigmentation) after acne[4].
• The compound is also being explored for its use in combination therapies, such as with oral antibiotics or hormonal treatments, to enhance its efficacy in treating various skin disorders.

Market Analysis

The azelaic acid market is experiencing significant growth driven by several factors.

Market Size and Growth

• The global azelaic acid market was valued at approximately $195.4 million in 2024 and is projected to reach $296.6 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.2% during the forecast period[2].
• Another report estimates the market size to be around $208.7 million in 2023, projected to grow to $415.3 million by 2033, also at a CAGR of 7.2%[5].

Regional Market Dynamics

• North America and Europe are the largest markets for azelaic acid, driven by the increased adoption of premium skin care products. These regions account for a significant share of the global market due to high demand for skincare and cosmetic products[2][3].
• The Asia-Pacific region is also a key market, driven by the robust growth of the cosmetic, polymer, and pharmaceutical industries. The rising middle class in this region is boosting demand for skincare products that leverage azelaic acid's anti-inflammatory and antimicrobial properties[5].

Key Market Players

• The market is dominated by several key players, including Emery Oleochemicals, Matrica SpA, BASF, Croda Sipo, Ninghai Zhonglong, Jiangsu Senxuan, Nantong Hengxing Electronic Materials, Shandong Clearwill, and Hubei Tuochu. These companies are investing heavily in research and development to capitalize on the growing demand for azelaic acid[2][5].

Segment Analysis

• The market is segmented by type (Industrial Grade, Pharmaceutical Grade, GMP Pharmaceutical Grade) and application (Plastics, Lubricants, Electronics, Pharmaceuticals and Cosmetics, Others). Industrial Grade azelaic acid is the largest segment, accounting for nearly 90% of the market[2].
• The pharmaceutical and cosmetic industries are the primary drivers of the market, with azelaic acid being widely used in skin care products due to its anti-inflammatory and antioxidant properties[3][5].

Market Projections

Future Growth Drivers

• The increasing demand for skin lightening and the treatment of hyperpigmentation and acne are expected to drive the market growth. Rising awareness about the benefits of azelaic acid for various skin problems is also projected to fuel sales opportunities[3].
• The emphasis on advanced pharmaceutical formulations and innovative biodegradable polymers in regions like Europe is creating substantial demand for azelaic acid, aligning with consumer preferences and regulatory trends towards eco-friendly and health-conscious products[5].

Challenges

• Stringent regulations pertaining to the use of azelaic acid may pose a challenge to smooth market growth. Additionally, the availability of alternative products for acne treatment and skin lightening could restrict market revenue to some extent[3].

Key Takeaways

• Azelaic acid is a versatile compound with anti-inflammatory, antioxidant, and keratolytic properties, making it effective in treating various skin conditions.
• The global azelaic acid market is projected to grow significantly, driven by increasing demand in the pharmaceutical and cosmetic industries.
• Clinical trials are expanding the therapeutic applications of azelaic acid, including treatments for rosacea, melasma, and post-inflammatory hyperpigmentation.
• Key market players are investing in research and development to capitalize on the growing demand.
• Regional dynamics, particularly in North America, Europe, and the Asia-Pacific, are crucial for market growth.

FAQs

What are the primary therapeutic applications of azelaic acid?

Azelaic acid is primarily used as a topical treatment for mild to moderate acne, rosacea, and hyperpigmentation. It is also useful in treating conditions like melasma and post-inflammatory hyperpigmentation[4].

What is the projected market size of azelaic acid by 2030?

The global azelaic acid market is projected to reach $296.6 million by 2030, growing at a CAGR of 7.2% during the forecast period[2].

Which regions are the largest markets for azelaic acid?

North America and Europe are the largest markets for azelaic acid, followed by the Asia-Pacific region, which is also experiencing significant growth[2][3].

What are the key drivers of the azelaic acid market?

The key drivers include increasing demand for skin lightening and the treatment of hyperpigmentation and acne, as well as rising awareness about the benefits of azelaic acid for various skin problems[3].

Who are the main players in the azelaic acid market?

The main players include Emery Oleochemicals, Matrica SpA, BASF, Croda Sipo, Ninghai Zhonglong, Jiangsu Senxuan, Nantong Hengxing Electronic Materials, Shandong Clearwill, and Hubei Tuochu[2][5].

What are the potential challenges to the azelaic acid market growth?

Stringent regulations and the availability of alternative products for acne treatment and skin lightening could pose challenges to market growth[3].