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.

Clinical Trial Conditions for AMINOSALICYLIC ACID

Condition Name

Condition Name for AMINOSALICYLIC ACID
Intervention	Trials
Ulcerative Colitis	9
Crohn's Disease	6
Colitis, Ulcerative	5
Proctitis	2

Condition MeSH

Condition MeSH for AMINOSALICYLIC ACID
Intervention	Trials
Colitis, Ulcerative	15
Ulcer	15
Colitis	13
Crohn Disease	7

Clinical Trial Locations for AMINOSALICYLIC ACID

Trials by Country

Trials by Country for AMINOSALICYLIC ACID
Location	Trials
United States	91
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
North Carolina	5
Illinois	5
Texas	5

Clinical Trial Progress for AMINOSALICYLIC ACID

Clinical Trial Phase

Clinical Trial Phase for AMINOSALICYLIC ACID
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	3
Phase 3	6

Clinical Trial Status

Clinical Trial Status for AMINOSALICYLIC ACID
Clinical Trial Phase	Trials
Completed	15
Terminated	6
Not yet 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	15
NIH	4

Aminosalicylic Acid: Clinical Trials Update, Market Analysis, and Forecast

Last updated: February 20, 2026

What is the current status of clinical trials involving Aminosalicylic Acid?

Aminosalicylic Acid (PAS) is an anti-tuberculosis (TB) drug primarily used for multidrug-resistant TB (MDR-TB) cases. Its development has been limited in recent years, with most trials conducted between the 1950s and 1980s. No recent large-scale clinical trials are active or recruiting for PAS as a stand-alone TB therapy. Existing studies focus on its role within combination regimens, mainly to combat MDR-TB, but these are retrospective or observational rather than prospective clinical trials.

Key points:

• Clinical trial activity: Minimal to none for PAS as a monotherapy.
• Recent research: Focuses on combination therapies for MDR-TB.
• Regulatory status: Approved in several countries, including the U.S., but lacks new indications or formulations under active investigation.

How does the market for Aminosalicylic Acid look today?

The global anti-tuberculosis drugs market exceeded USD 1.8 billion in 2022, with a compound annual growth rate (CAGR) of around 4% projected from 2023 to 2028 [1]. PAS has a niche presence, primarily supplied as an older second-line drug for MDR-TB treatment, with limited manufacturing and distribution.

Market characteristics:

• Supply chain: Mainly produced by generic manufacturers.
• Sales drivers: Driven by MDR-TB prevalence, especially in Asia and Africa.
• Market limitations:
  • The drug’s toxicity profile restricts use.
  • Modern second-line TB agents, like bedaquiline and delamanid, are preferred.
  • Limited patent protection and low demand hinder new investments.

Regional market breakdown:

Region	Revenue share (2022)	Growth prospects
Asia-Pacific	45%	High TB burden, ongoing treatment needs
Africa	25%	Increasing MDR-TB cases
Europe & US	15%	Low due to preference for newer drugs
Rest of world	15%	Variable, mainly generic supply

What are the market projections for Aminosalicylic Acid?

Given current trends, the global market for PAS is expected to decline modestly, with minimal new growth prospects. The demand for PAS in MDR-TB treatment is likely to be constrained by the availability of newer drugs with better efficacy and safety profiles.

Forecast summary:

• 2023-2028 CAGR: Less than 1%, reflecting market stagnation.
• Market size in 2028: Estimated between USD 50 million and USD 70 million.
• Growth drivers:
  • Persistent MDR-TB cases in high-burden countries.
  • Limited alternative options in regions with weak healthcare infrastructure.
• Constraints:
  • Toxicity issues limit broader use.
  • Emergence of novel therapeutics reduces reliance on older drugs.

Sources influencing market outlook:

• WHO Global TB Report 2022 suggests sustained need for second-line drugs in key regions.
• Industry reports cite declining demand for older TB drugs like PAS due to safety profiles and regulatory pressures.
• Patent status and regulatory approvals remain unchanged, with no significant incentives for reformulation or new clinical research.

Key Takeaways

• PAS has minimal recent clinical trial activity, mostly retained in legacy treatment protocols.
• The global market remains niche, driven by MDR-TB prevalence, mainly in Asia and Africa.
• Future growth prospects are limited; market size is expected to decline or stagnate through 2028.
• The primary drivers are regional TB burdens and the limited availability of newer, safer alternatives.
• Market dynamics favor generic supply, with little innovation or large-scale investment expected.

FAQs

1. Why has clinical trial activity for Aminosalicylic Acid decreased?
Because newer, more effective TB drugs have replaced PAS, and safety concerns limit further research.

2. Is Aminosalicylic Acid approved for indications beyond TB?
No. Its primary use remains in TB, chiefly for MDR cases, with no recent approvals for new indications.

3. What factors could change the market outlook for PAS?
Emergence of resistance to newer drugs, regulatory changes, or safety improvements through reformulation could influence demand.

4. Who are the main manufacturers currently producing PAS?
Most are generic pharmaceutical companies based in India, China, and other emerging markets.

5. What alternative drugs are replacing PAS in MDR-TB treatment?
Bedaquiline, delamanid, and linezolid are preferred due to better safety and efficacy profiles.

References

[1] Grandview Research. (2023). Tuberculosis Drugs Market Size, Share & Trends Analysis.