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mesalazine (NKP5191 / SHP429 / Quintasa)

✓ Approved

Nisshin Pharma · PTGS1 · Small Molecule

What is mesalazine?

mesalazine is a small molecule developed by Nisshin Pharma. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesNKP5191, SHP429, Quintasa
CompanyNisshin Pharma
Drug ClassSmall Molecule
Molecular TargetPTGS1, PTGS2
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Nisshin Pharma

Mechanism of Action

Molecular Targets

mesalazine acts on 2 molecular targets:

PTGS1prostaglandin-endoperoxide synthase 1 (COX3, PCOX1)
PTGS2prostaglandin-endoperoxide synthase 2 (GRIPGHS, hCox-2)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

mesalazine is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Gastrointestinal disordersColitis ulcerative✓ Approved
Gastrointestinal disordersCrohn's disease✓ Approved

Related Research Articles

PubMedDrugs - real world outcomes2026-10-12

Real-World Epidemiology of Inflammatory Bowel Disease in Italy: Treatment Patterns, Adherence, and Costs in Patients with Ulcerative Colitis Treated with Mesalazine.

Degli Esposti Luca L, Veronesi Chiara C, Calabria Silvia S, Giannessi Lisa L et al.

Ulcerative colitis (UC) and Crohn's disease (CD) are chronic immune-mediated conditions associated with a substantial clinical and economic burden. Italian epidemiological evidence is limited. Mesalazine remains a cornerstone of UC management. This study aimed to provide updated epidemiological estimates of inflammatory bowel disease (IBD) in Italy, and to evaluate real-world treatment patterns, adherence to oral mesalazine, and healthcare costs among patients with UC initiating mesalazine therapy. A retrospective observational analysis was conducted using Italian administrative databases covering ~4 million beneficiaries. Patients with UC and CD were identified (January 2010-May 2023) using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) or exemption codes. Patients with UC who were new users of mesalazine were characterized at baseline. Mesalazine treatment patterns, adherence, and direct healthcare costs were described at follow-up. At the end of 2023, UC and CD prevalence rates were 272 (95% confidence interval [CI] 267-278) and 166/100,000 (95% CI 162-170) inhabitants, respectively. Incidence rates in 2023 of UC and CD were 18.9 (95% CI 18-20) and 10.8/100,000 (95% CI 10-12), respectively. Among 2552 patients with UC who were new mesalazine users, 69.6% of time-dependent mesalazine users were adherent (versus 56.1% pH-dependent users). Mean annual cost per patients with UC who were new mesalazine users in 2023 was €4516, mainly driven by hospitalizations. This real-world analysis provides recent epidemiological estimates of UC and CD, and describes a substantial economic burden, highlighting the need for improving adherence and therapeutic pathways.

PMID 42862468
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PubMedRespiratory medicine case reports2026-10-11

Organizing pneumonia in Crohn's disease: a case report and literature review.

Debiche Soumaya S, Cherif Hela H, Ben Rjeb Sarra S, Yangui Ferdaous F et al.

Organizing pneumonia (OP) is a rare pulmonary manifestation in patients with inflammatory bowel disease (IBD). Distinguishing between a primary extra-intestinal manifestation of Crohn's disease (CD) and mesalazine-induced lung injury remains a major clinical challenge, as both conditions are steroid-responsive. We report the case of a 31-year-old woman with CD who developed progressive dyspnea and migratory pulmonary infiltrates one month after initiating mesalazine. Laboratory findings revealed marked peripheral eosinophilia (1276/mm3) and a mixed eosinophilic bronchoalveolar lavage profile (30.8%). Histopathology confirmed OP with Masson bodies. Due to the diagnostic overlap, mesalazine was replaced by azathioprine, and systemic corticosteroid therapy (0.75 mg/kg) was initiated. Complete radiological resolution was achieved at 8 months. This case illustrates the diagnostic complexity of eosinophilic-rich OP in CD and emphasizes that while pathology confirms the pattern, the etiology often remains a dual hypothesis between systemic disease and drug toxicity.

PMID 42859623
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PubMedProbiotics and antimicrobial proteins2026-10-06

Pediococcus acidilactici ZQ-19 Ameliorates Ulcerative Colitis via Remodeling Gut Microbiota and Glutathione Redox Homeostasis.

Lu Yimeng Y, Liu Qi Q, Chen Hu H, Ding Cunhui C et al.

Ulcerative colitis (UC) is closely linked to intestinal oxidative stress, gut dysbiosis and selenium metabolism disorders. In this study, 449 lactic acid bacteria strains were isolated from yak yogurt on the Qinghai-Tibet Plateau. After H2O2 tolerance screening, 11 highly antioxidant strains were obtained, among which Pediococcus acidilactici ZQ-19 exhibited the highest intracellular GPx activity, outstanding free radical scavenging capacity and excellent probiotic characteristics. In DSS-induced UC mice, ZQ-19 significantly alleviated weight loss, colon shortening and mucosal damage, restored tight junction protein expression, and protected liver and kidney functions. 16 S rRNA sequencing revealed that ZQ-19 was associated with reshaped gut microbiota, enriched butyrate-producing taxa and reduced pro-inflammatory pathogens; such microbial shifts were positively correlated with elevated intestinal GPx activity. Mechanistically, ZQ-19 intervention coincided with enhanced intestinal ROS clearance, altered expression of GR/GST/Trx-1, and a shifted selenoprotein profile favouring GPx isoforms by upregulating colonic SELENOP and GPx1-4 while downregulating DIO1/2. It synergistically activated Nrf2/p53 protective pathways and inhibited the MyD88/COX-2/NOX1/2 pro-oxidative inflammatory axis, with superior local regulation to mesalazine. In conclusion, ZQ-19 ameliorates UC in association with the microbiota-GPx axis and dual pathways, offering a novel probiotic intervention strategy.

PMID 42836931
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PubMedJournal of natural medicines2026-10-05

Extracts of okra mucilage protect intestinal homeostasis through gut microbiota and immune responses.

Qing Mengli M, Sun Benyue B, Li Yuehan Y, Meng Zhiyi Z et al.

Okra pods (Abelmoschus esculentus (L.) Moench) are known as a vegetable, the mucilage of which possesses many bioactivities. Okra mucilage (OM) is a carbohydrate-rich natural extract containing polysaccharides and other bioactive components. However, its efficacy under different types of intestinal stress and its comparison with standard therapeutic agents remain unclear. Chemical characterization demonstrated that OM contains abundant carbohydrates and diverse chemical constituents. In this study, we evaluated the protective effects of OM in dextran sulfate sodium (DSS)-induced colitis and fasting-induced intestinal injury models in mice. Mesalazine and GA were used as a positive control in DSS and fasting-induced injury models, respectively. Generally, OM treatment significantly alleviated intestinal pathological damage, restored intestinal barrier integrity, promoted epithelial regeneration, and modulated gut microbial composition in these two models. In DSS-induced colitis, OM increased the abundance of short-chain fatty acid (SCFA)-producing bacterial families Muribaculaceae and Lachnospiraceae, while reducing pro-inflammation-associated Bacteroidaceae, and suppressed key inflammatory genes and factors, including Cxcl1, Cxcl2, Cxcl5, TNF, NF-κB. Notably, the regulatory effects of OM were comparable to mesalazine. In fasting-induced intestinal injury, OM restored microbial balance by regulating taxa such as Enterobacteriaceae and Erysipelotrichaceae, and downregulated gluconeogenesis-related genes including Klf15, Pck1, and Hmgcs2. OM upregulated genes involved in epithelial barrier function and immune homeostasis such as Btnl7, Btnl8, regulating pathways HIF-1, PI3K-Akt, MAPK and glycolysis/gluconeogenesis pathways. These findings demonstrate that OM alleviates intestinal injury by modulating gut microbiota, suppressing inflammation, and restoring intestinal immune and metabolic homeostasis, highlighting its potential as a natural mucilage-derived ingredient for maintaining intestinal homeostasis.

PMID 42830374
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PubMedBMJ case reports2026-10-05

Cutaneous leukocytoclastic vasculitis with concurrent colitis of uncertain aetiology.

Yaw Vanessa Pei Xian VPX, Korani Mohamed M, Anowar Rakibul R, Nadir Syed Mujtaba Hasnain SMH

This case presents a female in her 20s with biopsy-confirmed cutaneous leukocytoclastic vasculitis (LCV) and significant gastrointestinal (GI) symptoms, manifesting as recurrent rectal bleeding, abdominal pain and maculopapular rash. The patient's symptoms emerged shortly after treatment with phenoxymethylpenicillin for tonsillitis. Investigations revealed left-sided colitis with distinctive endoscopic findings. Skin biopsy confirmed cutaneous LCV; however, colonic biopsies demonstrated non-specific inflammation without histological evidence of vasculitis. Therefore, GI vasculitic involvement could not be confirmed. Negative autoimmune serology excluded primary autoimmune disorders. Following treatment with prednisolone and mesalazine, the patient's symptoms resolved and she showed sustained improvement. While clinical improvement occurred after corticosteroid therapy, this response is non-specific and does not confirm GI vasculitis. Given the absence of vasculitic features on GI histology, the relationship between cutaneous LCV and colitis in this case remains associative rather than proven. This case underscores the importance of diagnostic caution when extracutaneous manifestations are suspected in LCV.

PMID 42833848
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PubMedVeterinary medicine and science2026-09-29

Probiotic Intervention With Bacillus coagulans and Lactobacillus acidophilus in Small Animals Experimental Ulcerative Colitis: Insights From a Small Animal Model.

Shayesteh Fatemeh F, Shahini Shams Abadi Milad M, Rouhi Leila L, Doosti Abbas A et al.

Inflammatory bowel disease is a significant health concern not only in humans but also in companion animals and livestock, where it manifests as chronic diarrhoea, abdominal pain, and mucosal injury. Probiotics have gained increasing attention as potential therapeutic agents due to their immunomodulatory effects and ability to restore intestinal homeostasis. This study investigated the therapeutic efficacy of Bacillus coagulans and Lactobacillus acidophilus in an acetic acid-induced ulcerative colitis model in Wistar rats. Forty male rats were randomly assigned to control, colitis, mesalazine, B. coagulans, and L. acidophilus treatment groups. Disease severity was evaluated by macroscopic and histopathological scoring, colon length and weight, pro-inflammatory cytokine levels (IL-1β, IL-17), and inflammasome-associated gene expression (NLRP3, Caspase-1, IL-18, TNF-α). The results showed that colitis induction significantly increased pro-inflammatory cytokine expression and histological damage compared with controls. Both probiotics markedly reduced inflammatory markers, improved colon morphology, and attenuated inflammasome activation. Their protective effects were comparable to mesalazine, the standard treatment. These findings suggest that B. coagulans and L. acidophilus can serve as effective adjunct therapies for ulcerative colitis in veterinary practice, with potential translational applications for companion animals and livestock.

PMID 42806832
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