CLINICAL TRIALS PROFILE FOR AMINOSALICYLIC ACID

All Clinical Trials for Aminosalicylic Acid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000796 ↗	A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDR	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain. Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.
NCT00004288 ↗	Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis	Completed	University of Rochester	Phase 2	1996-05-01	OBJECTIVES: I. Assess the safety and efficacy of olsalazine, a dimer of 5-aminosalicylic acid, in men with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and physiotherapy.
NCT00004288 ↗	Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis	Completed	National Center for Research Resources (NCRR)	Phase 2	1996-05-01	OBJECTIVES: I. Assess the safety and efficacy of olsalazine, a dimer of 5-aminosalicylic acid, in men with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and physiotherapy.
NCT00004423 ↗	Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease	Completed	University of Vermont	N/A	1995-12-01	OBJECTIVES: I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.
NCT00004810 ↗	Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis	Completed	University of Vermont	Phase 2	1996-06-01	OBJECTIVES: I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.
NCT00004810 ↗	Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis	Completed	National Center for Research Resources (NCRR)	Phase 2	1996-06-01	OBJECTIVES: I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.
NCT00069498 ↗	Effect of an Anti-Inflammatory Drug on Gut Mucosa in HIV Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1999-10-01	The lining of the gastrointestinal tract contains specialized lymphoid tissue that is part of the immune system. Like other parts of the immune system, HIV attacks this lymphoid tissue. This study will evaluate the effect of an anti-inflammatory drug on the lymphoid tissue in the gastrointestinal tracts of people with HIV.

Clinical Trial Conditions for Aminosalicylic Acid

Condition Name

Condition Name for Aminosalicylic Acid
Intervention	Trials
Ulcerative Colitis	9
Crohn's Disease	6
Colitis, Ulcerative	4
Proctitis	2

Condition MeSH

Condition MeSH for Aminosalicylic Acid
Intervention	Trials
Ulcer	15
Colitis, Ulcerative	14
Colitis	13
Crohn Disease	7

Clinical Trial Locations for Aminosalicylic Acid

Trials by Country

Trials by Country for Aminosalicylic Acid
Location	Trials
United States	90
Spain	10
Israel	6
Canada	5
Japan	4

Trials by US State

Trials by US State for Aminosalicylic Acid
Location	Trials
California	6
New York	6
Texas	5
Illinois	5
Georgia	4

Clinical Trial Progress for Aminosalicylic Acid

Clinical Trial Phase

Clinical Trial Phase for Aminosalicylic Acid
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	6
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Aminosalicylic Acid
Clinical Trial Phase	Trials
Completed	15
Terminated	6
Recruiting	3

Clinical Trial Sponsors for Aminosalicylic Acid

Sponsor Name

Sponsor Name for Aminosalicylic Acid
Sponsor	Trials
Otsuka Pharmaceutical Co., Ltd.	4
Bausch Health Americas, Inc.	3
Valeant Pharmaceuticals International, Inc.	3

Sponsor Type

Sponsor Type for Aminosalicylic Acid
Sponsor	Trials
Other	23
Industry	14
NIH	4

Aminosalicylic Acid: Clinical Trials, Market Analysis, and Projections

Introduction

Aminosalicylic acid, particularly 5-aminosalicylic acid (5-ASA), is a versatile drug used in the treatment of various medical conditions, including ulcerative colitis (UC) and tuberculosis. This article delves into the current state of clinical trials, market analysis, and future projections for aminosalicylic acid.

Clinical Uses of Aminosalicylic Acid

Aminosalicylic acid is primarily used in two main therapeutic areas:

Treatment of Tuberculosis

Aminosalicylic acid is used as an anti-mycobacterial agent in combination with other anti-tuberculosis drugs, such as isoniazid, to treat all forms of active tuberculosis caused by susceptible strains of tubercle bacilli. It acts as a bacteriostatic agent, preventing the multiplication of bacteria without destroying them, and also inhibits the onset of bacterial resistance to other antibiotics like streptomycin and isoniazid[1].

Treatment of Ulcerative Colitis

In the context of ulcerative colitis, 5-aminosalicylic acid is the preferred treatment for maintaining remission. It is available in various formulations, including tablets, capsules, pellets, granules, suppositories, and enemas. The drug works by reducing inflammation in the colon[5].

Clinical Trials Overview

Adherence and Discontinuation Rates

Studies on the adherence to 5-ASA maintenance treatment in adolescents and young adults with ulcerative colitis have shown significant discontinuation rates. A UK-based observational cohort study revealed that 69% of individuals discontinued oral 5-ASA within the first year of treatment, with a median time to discontinuation of 162 days. Adherence rates were found to be around 72% for the first year, with adherence decreasing with older age at initiation[4].

Current and Future Trials

While specific ongoing clinical trials for aminosalicylic acid are not widely detailed, the drug's use in various therapeutic areas ensures its continued involvement in clinical research. For instance, in the broader context of gastrointestinal diseases, clinical trials often explore new formulations and combinations of 5-ASA with other drugs to enhance efficacy and adherence.

Market Analysis

Global Market Size and Forecast

The global market for 5-aminosalicylic acid API was valued at US$ 173 million in 2023 and is projected to reach US$ 236.9 million by 2030, growing at a CAGR of 4.4% during the forecast period of 2024-2030. This growth is driven by increasing demand for effective treatments for ulcerative colitis and other inflammatory bowel diseases[5].

Market Segmentation

The market is segmented based on type (purity levels of ≥97%, ≥98%, and ≥99%), application (tablets, capsules, pellets, granules, suppositories, enemas, and others), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2][5].

Key Players

The market is dominated by several key players, including PharmaZell, Syntese A/S, Cambrex Corporation, Divis Laboratories, Chemi SpA, Ipca Laboratories, and others. These companies are involved in the production and supply of 5-ASA API, contributing to the market's growth and competitiveness[5].

Market Dynamics

Drivers

The market for 5-aminosalicylic acid is driven by several factors:

• Increasing Prevalence of Ulcerative Colitis: The rising incidence of UC and other inflammatory bowel diseases globally increases the demand for effective treatments like 5-ASA.
• Advancements in Formulations: New and improved formulations of 5-ASA, such as delayed-release tablets and capsules, enhance patient adherence and treatment outcomes.
• Growing Healthcare Expenditure: Increased healthcare spending in various regions, particularly in North America and Europe, supports the growth of the market[2][5].

Restraints

Despite the positive outlook, there are several challenges:

• Adherence Issues: High discontinuation rates among patients, as observed in clinical studies, can impact market growth.
• Competition from Alternative Treatments: The emergence of new biologic agents and other therapeutic options for UC and tuberculosis may compete with 5-ASA for market share.
• Regulatory Hurdles: Stringent regulatory requirements and the need for continuous clinical trials to ensure safety and efficacy can be barriers to market expansion[4].

Future Projections

Market Growth

The market for 5-aminosalicylic acid is expected to continue its growth trajectory, driven by the increasing demand for UC treatments and the expansion of healthcare infrastructure in emerging markets. The forecasted CAGR of 4.4% from 2024 to 2030 indicates a stable and growing market[5].

Emerging Trends

• Personalized Medicine: There is a growing trend towards personalized medicine, which could lead to more targeted and effective use of 5-ASA based on individual patient profiles.
• Combination Therapies: Research into combination therapies involving 5-ASA and other drugs or biologics may offer new treatment options and enhance market potential.

Key Takeaways

• Clinical Use: Aminosalicylic acid is crucial in treating tuberculosis and ulcerative colitis.
• Adherence: High discontinuation rates among UC patients highlight the need for improved formulations and patient education.
• Market Growth: The global market for 5-aminosalicylic acid API is projected to grow at a CAGR of 4.4% from 2024 to 2030.
• Key Players: Several pharmaceutical companies dominate the market, driving innovation and supply.
• Future Trends: Personalized medicine and combination therapies are expected to shape the future of 5-ASA treatment.

FAQs

What is the primary use of aminosalicylic acid in medicine?

Aminosalicylic acid is primarily used to treat tuberculosis and ulcerative colitis.

What are the common formulations of 5-aminosalicylic acid?

Common formulations include tablets, capsules, pellets, granules, suppositories, and enemas.

What is the projected market size for 5-aminosalicylic acid API by 2030?

The global market for 5-aminosalicylic acid API is forecasted to reach US$ 236.9 million by 2030.

Which companies are key players in the 5-aminosalicylic acid market?

Key players include PharmaZell, Syntese A/S, Cambrex Corporation, Divis Laboratories, and others.

What are the main drivers of the 5-aminosalicylic acid market?

The market is driven by the increasing prevalence of ulcerative colitis, advancements in formulations, and growing healthcare expenditure.

Sources

1. DrugBank: Aminosalicylic acid: Uses, Interactions, Mechanism of Action.
2. Market Research Intellect: Global 5-Aminosalicylic Acid Market Size, Scope And Forecast Report.
3. Biospace: U.S. Clinical Trials Market Size Industry Analysis Report, 2033.
4. BJGP: Adherence to 5-aminosalicylic acid maintenance treatment in young adults with ulcerative colitis.
5. Valuates Reports: 5-aminosalicylic Acid API - Market Size - Valuates Reports.