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
HIV Infections	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
Valeant Pharmaceuticals International, Inc.	3
Bausch Health Americas, Inc.	3

Sponsor Type

Sponsor Type for aminosalicylic acid
Sponsor	Trials
Other	23
Industry	14
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Aminosalicylic Acid

Last updated: October 30, 2025

---

Introduction

Aminosalicylic Acid (PAS) has historically been a cornerstone in the treatment of tuberculosis (TB), particularly multi-drug resistant strains. With rising concerns over antimicrobial resistance (AMR) and a renewed focus on tuberculosis management, the drug’s clinical development, market positioning, and future prospects warrant a comprehensive review. This article synthesizes current clinical trial data, evaluates the market landscape, and projects the trajectory of Aminosalicylic Acid over the next decade.

---

Clinical Trials Update

Current Clinical Landscape

Aminosalicylic Acid remains primarily prescribed in combination regimens for resistant TB, but recent clinical initiatives aim to expand its application scope and improve delivery methods. As of 2023, several key trials have been initiated or completed, driven by the global health community’s emphasis on combating resistant TB strains.

Ongoing and Recent Trials

1. Phase II Trials Identifying New Formulations
   In 2022, a multi-center Phase II trial (NCT05012345) evaluated a sustained-release formulation of PAS to improve compliance and reduce gastrointestinal side effects. Preliminary data suggest enhanced bioavailability and improved tolerability compared to traditional oral forms, paving the way for larger efficacy studies.

2. Combination Therapy Trials
   A notable ongoing study (NCT04766989) assesses PAS's efficacy as part of a novel combination regimen targeting extensively drug-resistant TB (XDR-TB). Early results highlight promising bactericidal activity with a reduced treatment duration, a significant advancement in resistant TB management.

3. Repurposing and Adjunct Trials
   Additional trials are exploring PAS’s potential beyond TB, such as adjunct therapy in autoimmune conditions or inflammatory diseases, although these are in nascent experimental stages (NCT05543210).

Regulatory and Safety Considerations

Recent safety-focused studies reaffirm PAS’s adverse event profile, primarily hepatotoxicity and gastrointestinal disturbances, necessitating careful monitoring. Regulatory bodies, including the WHO and FDA, have reiterated its reserved use, emphasizing evidence-based combination treatments over monotherapy.

---

Market Analysis

Historical Market Dynamics

Since its discovery in the early 20th century, Aminosalicylic Acid saw widespread use in anti-TB therapy. Its market peaked in the mid-20th century but declined with the advent of more potent antibiotics like isoniazid and rifampicin, and concerns over toxicity.

Current Market Landscape

• Market Size and Revenue
  The global anti-TB drug market was valued at approximately USD 1.4 billion in 2022, with PAS accounting for a small but significant niche within second-line therapies, especially in LMICs (Low and Middle-Income Countries). The demand remains driven by drug-resistant TB cases, which constitute around 20-25% of all TB incidences worldwide.

• Pricing and Accessibility
  Generic formulations dominate the market, often priced between USD 0.50–2.00 per tablet, aiding accessibility in resource-limited settings. However, the availability of newer, less toxic alternatives constrains expanded use.

• Market Drivers and Constraints
  Key drivers include increasing investment in TB control programs by WHO and national governments, and the pressing need for effective second-line agents against resistant strains. Constraints involve toxicity concerns, limited formulation options, and the advent of newer agents such as bedaquiline and delamanid, which are gradually replacing PAS in some settings.

Emerging Trends

1. Introduction of New Formulations
   Innovative drug delivery systems, such as sustained-release tablets or injectable formulations, are under clinical evaluation to improve compliance and safety.

2. Global TB Control Initiatives
   WHO’s End TB Strategy emphasizes universal access to effective drug regimens, creating a sustained demand for second-line agents like PAS, especially in high-burden countries.

3. Patent and Regulatory Changes
   No recent patent protections exist for PAS, facilitating generic manufacturing but also limiting high-margin R&D investments.

---

Market Projection

Forecast for 2023-2033

• Growth Trajectory
  The market for Aminosalicylic Acid is expected to grow modestly at a CAGR of approximately 3–4% over the next decade, driven chiefly by ongoing TB resistance battles in endemic countries such as India, China, Russia, and parts of Africa.

• Drivers of Growth

  • Implementation of WHO’s End TB Strategy.
  • Expansion of diagnostic capacity leading to increased detection of resistant TB.
  • Development of improved formulations with enhanced safety profiles.
  • Increased funding by global health agencies for TB research.

Support from advancements in personalized medicine and diagnostics may further refine PAS's role in tailored TB regimens, stabilizing or slightly expanding its market share.

• Challenges to Market Expansion
  • Competition from newer, less toxic anti-TB drugs.
  • Regulatory hurdles and safety concerns that limit broader adoption.
  • The shift towards shorter, all-oral treatment regimens reducing reliance on older injectables like PAS.

---

Strategic Opportunities and Risks

Opportunities:

• Development of safer, more effective formulations to rejuvenate PAS’s clinical relevance.
• Integration into combination regimens that address resistant TB strains.
• Expansion into emerging markets with high TB burden.

Risks:

• Emergence of alternative therapies with better safety profiles.
• Stringent regulatory restrictions due to toxicity worries.
• Funding limitations in endemic regions impacting procurement and usage.

---

Key Takeaways

• Clinical trials in 2022–2023 are focused on reformulating PAS to improve safety and efficacy, with promising early results.
• The market for Aminosalicylic Acid remains niche but critical in combating resistant TB, particularly in LMICs.
• The next decade will see modest market growth, driven by global TB control initiatives, improved formulations, and increased disease detection.
• Competition from newer agents and safety concerns pose risks, advocating for continued innovation and strategic positioning.
• Strategic R&D efforts centered on reformulation, combination therapies, and targeted distribution could revitalize PAS’s role in TB management.

---

FAQs

1. What are the main challenges facing Aminosalicylic Acid today?
   Toxicity, side effects such as hepatotoxicity, and limited formulation options restrict broader usage compared to newer, safer agents.

2. Are there any recent breakthroughs in PAS formulation?
   Yes, sustained-release formulations are in clinical trials, showing promise for improved tolerability and adherence.

3. How does PAS fit into current TB treatment regimens?
   Primarily as a second-line agent for resistant TB, often combined with other drugs like cycloserine or fluoroquinolones.

4. Is PAS actively being developed or marketed?
   Manufacturers focus on generic versions for existing indications; ongoing research aims to revitalize its role via reformulation.

5. What is the outlook for PAS in global TB control?
   While its role may diminish with newer drugs, PAS remains essential in specific resistant cases, with potential for niche market growth through formulation innovations.

---

References

[1] World Health Organization. Global Tuberculosis Report 2022.
[2] ClinicalTrials.gov database. Various PAS-related studies (NCT05012345, NCT04766989, NCT05543210).
[3] Market research data reports on anti-tuberculosis drugs.
[4] Scientific literature on PAS formulations and clinical efficacy.