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Last update 20 Mar 2025

Balsalazide Disodium

Last update 20 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(E)-5-((4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxybenzoic acid, (E)-5-({p-[(2-carboxyethyl)carbamoyl]phenyl}azo)-2-salicylic acid, 5-[4-(2-carboxy-ethylcarbamoyl)-phenylazo]-2-hydroxy-benzoic acid

+ [22]

Target

COXs

Action

inhibitors

Mechanism

COX inhibitors(Cyclooxygenases inhibitors)

Therapeutic Areas

Immune System DiseasesDigestive System Disorders

Active Indication

Colitis, Ulcerative

Inactive Indication-

Originator Organization

Salix Pharmaceuticals, Inc.

Active Organization

Salix Pharmaceuticals, Inc.

Bausch Health Cos., Inc.Fresenius Kabi Australia Pty Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United Kingdom (01 Jan 1997),

Colitis, Ulcerative

RegulationOrphan Drug (United States)

Structure/Sequence

Molecular FormulaC17H17N3NaO7

InChIKeyBOSZHNPGTSMVQB-LLIZZRELSA-N

CAS Registry150399-21-6

View All Structures (2)

Clinical Trials associated with Balsalazide Disodium

NCT00649480

/ CompletedPhase 1

Single-Dose Fed Bioequivalence Study of Balsalazide Disodium Capsules (750 mg; Mylan) and Colazal® Capsules (750 mg; Salix) in Healthy Volunteers

The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules to Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fed conditions.

Start Date01 Jan 2007

Sponsor / Collaborator

Mylan Pharmaceuticals, Inc.

NCT00486031

/ CompletedPhase 3

A Multicenter, Open-label Trials to Evaluate the Long-term Safety and Tolerability of a New Balsalazide Disodium Tablet Formulation in Patients With Ulcerative Colitis

The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.

Start Date01 Oct 2006

Sponsor / Collaborator

Bausch Health Americas, Inc.

NCT00408174

/ CompletedPhase 3

A Multicenter, Randomized, Double-Blind, Actively-Controlled Trial to Evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 g Bid Versus Mesalamine (5-ASA) as Asacol® 0.8 g Tid in Mildly to Moderately Active Ulcerative Colitis

To establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 6 weeks of therapy.

Start Date01 May 2006

Sponsor / Collaborator

Bausch Health Americas, Inc.

100 Clinical Results associated with Balsalazide Disodium

100 Translational Medicine associated with Balsalazide Disodium

100 Patents (Medical) associated with Balsalazide Disodium

252

Literatures (Medical) associated with Balsalazide Disodium

04 Mar 2025·Expert Opinion on Drug Safety

Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database

Article

Author: Zheng, Guanqun ; Yan, Liyuan

BACKGROUNDThis investigation aims to identify and evaluate the most common and critical drugs associated with the risk of noninfectious myocarditis utilizing the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.METHODSData pertaining to noninfectious myocarditis from 2004 Q1 to 2024 Q2 were extracted. Following data standardization, multiple signal quantification techniques, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio, were employed for analysis.RESULTSThe study identified a total of 10,763 adverse event reports associated with noninfectious myocarditis. Disproportionality analysis revealed that the top 5 drugs by ROR were phendimetrazine tartrate (ROR 104.64), trimethoprim + sulfamethoxazole (ROR 67.65), aldesleukin (ROR 52.67), mesalazine (ROR 49.73), and balsalazide disodium (ROR 45.26). Notably, among the 30 drugs with the strongest ROR signals, 8 drugs lacked myocarditis risk information in their package inserts.CONCLUSIONThrough comprehensive analysis of the FAERS database, our study identified drugs with a strong signal for myocarditis that are not currently indicated on their labels. The findings suggest that the potential risk of myocarditis associated with these medications is significant and warrants close monitoring in clinical practice.

01 Mar 2025·Acta Biomaterialia

Orally-administrable supramolecular probiotic capsules enable cooperative colon-targeted inflammation inhibition for ameliorating ulcerative colitis

Article

Author: Wang, Ting ; Shen, Xinkun ; Chen, Jie ; Fu, Yuanyuan ; Shu, Chuandong ; Li, Menghuan ; Luo, Zhong

Ulcerative colitis (UC) is a prevalent gastrointestinal disease characterized by the chronical and refractory inflammation of colorectal mucosa and walls, which severely impairs overall well-being of individuals. Probiotics has shown tremendous promise for UC therapy due to its multifaceted mucosal barrier restoration and immunomodulation capabilities. Nevertheless, the successful administration of probiotics remains a clinical obstacle. Herein, we report a multifunctional supramolecular probiotic capsule based on clinically-tested biopolymers for UC therapy, which not only allow colon-targeted probiotic delivery via oral route but also enable concurrent delivery of hemostatic and anti-inflammatory drugs. Specifically, Clostridium butyricum (CB) was first engineered with protective norepinephrine (NE) coating and then encapsulated by self-assembled gelatin-based nanocomplexes modified with balsalazide and matrix metalloproteinase 2/9 (MMP2-/9)-responsive fibronectin peptides. The released balsalazide and fibronectin could induce rapid hemostasis and anti-inflammation actions to alleviate inflammation damage of the UC-affected colons in the short term, while CB could restore gut microbiota homeostasis to remodel intestinal immunocomposition and repair mucosal barrier for reducing UC risk in the long term. Overall, this study provides a promising option for UC treatment with good efficacy and minimal invasiveness. STATEMENT OF SIGNIFICANCE: This study reports a supramolecular probiotic capsule with nanointegrative hemostatic and anti-inflammatory capacities for ulcerative colitis (UC) therapy, which could be orally administrated and activated in the inflamed colorectal sites. The probiotic capsules enable immediate UC symptom relief while also accelerating mucosal repair and preventing UC relapse in the long-term, offering an approach for UC treatment in the clinic.

01 Sep 2024·International Immunopharmacology

RNA modification Regulators’ Co-Expression Score (RMRCoeS) predicts biochemical recurrence and therapy response in prostate cancer: A multi-omics and experimental validation study

Article

Author: Cai, Zhouda ; Zhang, Le ; Wang, Shuo ; Zhong, Chuanfan ; Mo, Shanshan ; Li, Songbo ; Jiang, Zhaojun ; Lu, Jianming ; Tan, Xiao ; Deng, Junhong ; Liang, Min ; Zhong, Weide

BACKGROUNDOwing to the heterogeneity of prostate cancer (PCa), the clinical indicators traditionally fall short of meeting the requirements for personalized medicine. The realm of RNA modification has emerged as an increasingly relevant domain, shedding light on its pivotal role in tumor heterogeneity. However, the specific contributions of RNA modification regulators within the context of PCa remain largely unexplored.METHODSIn this study, we undertook a literature review to summarize the common 8 types of RNA modifications (ac4c, AI, APA, m1A, m5c, m6A, m7G, Ψ) encompassing a total of 84 regulators. Moreover, we integrated multi-center cohorts with Ridge regression to develop the Regulators' Co-Expression Score (RMRCoeS). Then we assessed the role of RMRCoeS in several clinical aspects such as biochemical recurrence (BCR), responses to chemotherapy, androgen receptor signaling inhibitor (ARSI) therapy and immunotherapy in PCa. Finally, we validated the cancer-promoting performance of five hub genes through immunohistochemistry and in vitro assays.RESULTSWithin the mutation landscape of RNA modification regulators, we observed a relatively low overall mutation rate. Remarkably, RMRCoeS, comprising 81 RNA modification regulators, exhibited a notable capability for accurately predicting the prognosis and therapeutic responses in PCa patients subjected to BCR, chemotherapy, ARSI therapy, and immunotherapy. A high RMRCoeS was indicative of a poor prognosis and unfavorable therapy responses. Functional enrichment analysis unveiled that RMRCoeS may exert its influence on PCa progression through various metabolic pathways. Furthermore, a higher RMRCoeS showed a positive correlation with elevated CNV mutations. Lastly, we validated the oncogene effects of CPSF4, WBSCR22, RPUSD3, TRMT61A, and NSUN5-five hub regulators-within the context of PCa.CONCLUSIONThe function of different RNA modifications is interconnected. Comprising eight distinct RNA modifications' regulators, RMRCoeS exhibits multifaceted roles in various aspects of PCa, including disease progression, prognosis, and responses to multiple therapies. Furthermore, we provide the initial validation of the oncogene effect associated with WBSCR22, RPUSD3, TRMT61A and NSUN5 in PCa. Our findings offer novel insights into the significance of RNA modifications in PCa personalized medicine.

News (Medical) associated with Balsalazide Disodium

14 May 2021

·www.biospace.com

Radiation Proctitis Treatment Market to Grow At 7% CAGR; High Demand for Oral Treatment Options Boosts Growth, Fact.MR

Rising popularity of anti-inflammatory drugs for treating radiation induced rectal bleeding is facilitating radiation proctitis treatment market growth. Fact.MR, New York: As per a study by Fact MR, the global radiation proctitis treatment market is expected to surpass the valuation of US$750 Mn by the end of 2031. Hyperbaric oxygen treatment has yielded promising results during treatment of severe radiation induced symptoms. Research and development in the field of oncology and medicine will escalate the demand for radiation proctitis treatment. According to report published by the World Health Organization (WHO), around 600,000 women are diagnosed with cervical cancer by 2020. That is around 6.5% of all female cancers. Radiotherapy is usually recommended as a main treatment option. Cancer recurrence is also treated by employing radiotherapy. Extensive use of radiation therapy will lead to radiation proctitis boosting the radiation proctitis treatment market growth. “Soaring incidence of cervical cancer and encouragement towards using radiation therapy as treatment option have led to jump in radiation proctitis cases. Market players are constantly working towards developing highly efficient treatment, thus driving the market growth”, said a lead analyst at Fact.MR. Request Sample of the 170-page report on the radiation proctitis treatment market Radiation proctitis treatment market: Key Findings Growing prevalence of prostate cancer and other pelvic malignancies in US has fuelled the demand for radiation proctitis treatment. Surging demand for use of high energy x-ray to treat various forms of cancer in UK will assist in radiation proctitis treatment market growth. High dependence on radiotherapy for cancer treatment and increasing funding towards cancer research in Germany will drive the market growth. Growing customer preference towards minimal invasive and oral therapy using Sulfasalazine and balsalazide will further propel the market growth. Increasing use of microbiotics towards treatment of chronic radiation proctitis will drive the market expansion. Explore 84 tables and 112 figures of the study. Request ToC of the report at Radiation proctitis treatment market – Key Driving Factors Introduction of anti inflammatory drugs for treating severe radiation symptoms and side effects fuels the market growth. Increasing use of hyperbaric oxygen therapy for treatment of severe proctitis boosts the market demand. Soaring demand of radiation therapy in pharmaceutical sector for treating cervical, rectal and prostate cancer boosts market growth. Radiation proctitis treatment market – Key Restraints Expensive radiation proctitis treatment procedure along with grim radiation induced symptoms hinders the market growth. Consistent efforts towards developing alternative treatments for radiation proctitis will impede the market growth in future. Lack of healthcare infrastructure coupled with low awareness regarding the treatment in developing countries hampers the market expansion. Radiation proctitis treatment market – COVID-19 Impact COVID-19 pandemic stressed the global healthcare system to its core. The impact of the pandemic varied on regional basis. Redirection of skilled staff towards COVID patients and reduced funding slowed the radiation proctitis treatment market. Disruption of supply chain led to delay in raw material procurement negatively affecting the market growth. Lockdown led to closure of manufacturing sectors leading to shortage of radiation proctitis treatment equipments further hampering the market sales. Competitive Landscape Some of the leading radiation proctitis treatment manufacturers are Allergan Plc., Amneal Pharmaceuticals Inc., Mylan Inc. (Viatris), Johnson & Johnson (Johnson & Johnson Consumer Inc.), Environmental Tectonics Corporation, Teva Pharmaceutical Industries Ltd., Pfizer Inc., Sanofi SA, Pharmaceutical Industries Ltd., Sun , Sechrist Industries Ltd. The market is highly consolidated and is forcing market players towards developing new products to strengthen their foothold. They are also collaborating and doing strategic merger to further their market reach and working towards regulatory approvals from concerned agencies. For instance, Sanofi SA acquired Kiadis Pharma in April 2021 to strengthen its market position in the immuno-oncology sector. Pfizer Inc. collaborated with Myovant Sciences in December 2020 with the mission to develop and commercialize ORGOVYXTM for advanced prostate cancer and gonadotrophin-releasing hormone (GnRH) receptor antagonist to advance women’s health. Get Customization on this Report for Specific Research Solutions More Insights on the radiation proctitis treatment market In its latest report, Fact.MR offers unbiased analysis of the radiation proctitis treatment market. In order to understand the global market potential, its growth, and scope, the market is segmented on the basis of indication (Acute Radiation Proctitis Treatment, Chronic Radiation Proctitis Treatment), Therapy (Oral Therapy, Ablative Procedures, Hyperbaric Oxygen Therapy, Formalin, Surgery) across five regions (North America, Latin America, Europe, Asia Pacific, MEA). Explore Fact.MR’s Coverage on the Healthcare Domain Radiation nephropathy treatment and management market: The global radiation nephropathy treatment and management market study published by Fact.MR offers an unbiased analysis of the prominent drivers, opportunities and trends expected to shape future expansion outlook. The report provides a comprehensive assessment on the prominent segments and geographies which are likely to benefit market players in forthcoming years. MRI-guided radiation therapy systems market: Fact. MR’s extensive coverage on the MRI-guided radiation therapy systems market offers in-depth insights about the prominent growth dynamics that are likely to aid expansion of growth prospects in the near future. Data has been presented in the form of key segments across prominent geographies, along with important information concerning key manufacturers operating within the industry. Peritoneal cancer treatment market: A recent study by Fact.MR on the peritoneal cancer treatment market offers a 10-year forecast analysis for the period 2018 to 2028. The study analyzes key trends that are currently determining the growth of the market. This report covers key dynamics, including drivers, restraints, and opportunities for leading market players along with key stakeholders and emerging players. About Fact.MR Market research and consulting agency with a difference! That’s why 80% of Fortune 1,000 companies trust us for making their most critical decisions. We have offices in US and Dublin, whereas our global headquarter is in Dubai. While our experienced consultants employ the latest technologies to extract hard-to-find insights, we believe our USP is the trust clients have on our expertise. Spanning a wide range – from automotive & industry 4.0 to healthcare & retail, our coverage is expansive, but we ensure even the most niche categories are analyzed. Reach out to us with your goals, and we’ll be an able research partner. Contact: Mahendra Singh US Sales Office: 11140 Rockville Pike Suite 400 Rockville, MD 20852 United States Tel: +1 (628) 251-1583 E: sales@factmr.com Follow Us: LinkedIn | Twitter Source: Fact.MR

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100 Deals associated with Balsalazide Disodium

External Link

KEGG	Wiki	ATC	Drug Bank
D02715	Balsalazide Disodium	A07EC04	DB01014

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Colitis, Ulcerative	United Kingdom	Salix Pharmaceuticals, Inc.	01 Jan 1997

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P309 (ECCO2013)	Not Applicable	Colitis, Ulcerative	-	MMX Multi-Matrix System ® [MMX] mesalamine	apskokezdp(mcmkpobhud) = toqqvngntw dqtjkrywdm (kzbwpkpvft ) View more	Positive	01 Feb 2013
				Delayed release mesalamine [DRM] 800 mg	apskokezdp(mcmkpobhud) = icpbtwcxuq dqtjkrywdm (kzbwpkpvft ) View more
ASTRO2004	Not Applicable	Enteritis	-	Balsalazide 2250 mg	wrlcfzqozn(glchrcznbd) = seen in 2 patients on BSZ and 1 on placebo pkvjsqhxtp (tfwakfmjjm ) View more	-	01 Sep 2004
				Placebo

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