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ME

mesalazine (Rowasa / Pentasa enema / Pentasa foam enema)

✓ 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 rectal.

Drug Profile

Brand NamesRowasa, Pentasa enema, Pentasa foam enema
CompanyNisshin Pharma
Drug ClassSmall Molecule
Molecular TargetPTGS1, PTGS2
RouteRectal
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

PubMedJournal of pediatric endocrinology & metabolism : JPEM2026-10-14

Iodine exposure and thyroid function after prophylactic intragastric iodinated contrast administration for meconium obstruction of prematurity in extremely low birth weight infants.

Shimokaze Tomoyuki T, Toyoshima Katsuaki K, Hawaka Hideyuki H, Noguchi Takahiro T et al.

Maternal hypertensive disorders of pregnancy (HDP) increase the risk of meconium obstruction of prematurity in small-for-gestational-age (SGA) extremely low birth weight (ELBW) infants. While prophylactic intragastric amidotrizoate (Gastrografin®) promotes meconium excretion, concerns persist regarding iodine load and thyroid dysfunction. We retrospectively analyzed infants (<30 weeks, <700 g) born 2016-2024. The treated group (n=20) comprised SGA infants of mothers with HDP receiving prophylactic 5-fold diluted Gastrografin (iodine: 148-222 mg/kg) after stabilization. Controls included nontreated SGA infants (n=17), mostly lacking maternal HDP (thus not meeting prophylaxis criteria), and an appropriate-for-gestational-age (AGA) reference cohort (n=48). A 2018-2022 unexposed subcohort (n=21) provided baseline urinary iodine concentration (UIC) data. Treatment failure, necessitating therapeutic enema, occurred in 1/20 treated infants (5 %). Baseline UIC was 32 (IQR 25-127) vs. 25 (IQR 25-35) µg/L in combined controls (p=0.23). Day 1 postadministration, UIC surged to 326,000 (IQR 201,500-455,350) µg/L; by 2 weeks, it normalized to 348 vs. 267 μg/L (p=0.51). At 2 weeks, thyroid function was comparable between treated and nontreated SGA groups for TSH (5.8 vs. 5.1 μIU/mL; p=0.94), free T3 (1.56 vs. 1.55 pg/mL; p=0.68), and free T4 (0.98 vs. 0.78 ng/dL; p=0.31), though baseline HDP differences necessitate careful interpretation. Levothyroxine supplementation rates were 26 % vs. 13 %, respectively (p=0.42). Early postnatal iodine levels in preterm infants are low. Prophylactic intragastric Gastrografin facilitated meconium evacuation in high-risk SGA ELBW infants. The associated iodine elevation is transient. A nonsignificant numerical increase in levothyroxine supplementation within our small cohort necessitates further large-scale studies.

PMID 42872568
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PubMedZhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica2026-10-13

[Mechanism of total iridoids from Gardeniae Fructus in treating ulcerative colitis based on "bitterness drying dampness" theory].

Fu Xiao-Mei XM, Xu Rui-Xiang RX, Fan Yu-Ying YY, Zhang Zhou Z et al.

This study aimed to explore the mechanism of total iridoids from Gardeniae Fructus in treating ulcerative colitis(UC) in rats from the perspective of the " bitterness drying dampness" theory in TCM. SD rats were randomly divided into a blank group, a model group, groups of high-and low-dose total iridoids from Gardeniae Fructus(200 and 100 mg·kg~(-1), respectively), and a positive drug group, with 10 rats per group. Except for the blank group, UC model was induced in all other groups via enema administration of 2,4, 6-trinitrobenzene sulfonic acid(TNBS) solution(100 mg·kg~(-1)). During the administration period, the appearance of the rats was observed and recorded daily, and the disease activity index(DAI) was scored. Colon length and spleen weight were measured, and the colon mucosal damage index(CMDI) was scored. Microscopic pathological damage in the colon was observed via HE staining and AB staining, and the histopathological index(HI) was scored. The levels of inflammatory cytokines tumor necrosis factor-α(TNF-α), interleukin-6(IL-6), interleukin-10(IL-10), and 3',5'-cyclicade-nosine monophosphate(cAMP) in colon tissue were detected by ELISA. The expression levels and distribution/damage of intercellular tight junction proteins E-cadherin, claudin-1, and occludin in the colon mucosal layer were detected using Western blot and immunofluorescence. The expression levels of bitter taste receptor 38(TAS2R38), phospholipase C β2( PLCβ2), inositol 1,4,5-trisphos-phate( IP3), and α-gustducin(GNAT3) were detected by Western blot and RT-qPCR. The results showed that compared with the blank group, rats in the model group exhibited a significant decrease in body weight and a significant increase in DAI score. Furthermore, colon length was significantly shortened, while the spleen index, CMDI, and HI scores were all significantly increased. Concomitantly, the levels of TNF-α and IL-6 in colon tissue were significantly elevated, while IL-10 levels were significantly decreased. Additionally, the protein expression levels of E-cadherin, claudin-1, and occludin were significantly reduced. The protein expression level of TAS2R38 was significantly downregulated, and the protein and mRNA expression levels of PLCβ2, IP3, GNAT3 in colon tissue were significantly downregulated, and the content of cAMP was significant reduced. Administration of total iridoids from Gardeniae Fructus significantly improved all the above indicators in UC rats. These treatments significantly enhanced TAS2R38 protein expression in colonic tissues, restored the protein and mRNA expression of PLCβ2, IP3 and GNAT3, and raised cAMP content. In conclusion, total iridoids from Gardeniae Fructus may alleviate colonic epithelial barrier damage and inflammatory responses by activating TAS2R38 and regulating the GNAT3/cAMP and PLCβ2/IP3 signaling pathways, thereby improving symptoms in UC rats.

PMID 42869808
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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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PubMedHuman reproduction (Oxford, England)2026-10-09

Ovarian reserve after chemotherapy in premenopausal women with breast cancer undergoing fertility preservation counselling with and without unilateral ovarian tissue cryopreservation.

Yde Anna Mathilde AM, Colmorn Lotte Berdiin LB, Pinborg Anja A, Forman Julie Lyng JL et al.

What is the impact of chemotherapy on the ovarian reserve in premenopausal women diagnosed with breast cancer, and how is this impacted by fertility preservation (FP) strategy and age at diagnosis? Chemotherapy reduces ovarian reserve in women with breast cancer, with the greatest reductions observed among women who underwent ovarian tissue cryopreservation (OTC) and those of advanced reproductive age (≥35 years). Breast cancer is the most prevalent cancer among women of reproductive age, and in recent decades increasing emphasis has been placed on FP, including ovarian tissue, embryo, and oocyte cryopreservation. However, few large prospective studies have evaluated the effect of chemotherapy on ovarian reserve in patients with breast cancer using both anti-Müllerian hormone (AMH) and antral follicle count (AFC), and no large studies have assessed the impact by choice of FP. In this combined retro and prospective cohort study, we included 152 premenopausal women diagnosed with breast cancer who received FP counselling at Rigshospitalet, Copenhagen University Hospital, between 1 January 2018 and 31 August 2023. Women aged 18-42 years scheduled for FP counselling before chemotherapy were included. Exclusion criteria were previous chemotherapy, oophorectomy, and death or emigration within 2 years of inclusion. Medical and gynecological history, and oncological treatment plans were recorded. Ovarian reserve was assessed using AMH and AFC at baseline and at 6, 12, and 24 months after chemotherapy. Changes over time were analyzed using linear mixed models adjusted for age at baseline and hormonal contraceptive use. Of 152 women, 57 underwent OTC, while 41 underwent oocyte/embryo cryopreservation and 54 had no FP. Baseline median AMH was 13.9 [95% CI: 10.7, 18.1] pmol/l among women who did not undergo OTC and 13.3 [10.9, 16.3] pmol/l among those who did. A marked reduction in both AMH and AFC was observed after chemotherapy, with partial recovery within 2 years after treatment. The reduction was more pronounced, and recovery more limited, in women with OTC and in those of advanced reproductive age (≥35 years). Compared to baseline, the adjusted reduction in median AMH was 90% [95% CI: 85%, 93%] at 6 months and 75% [95% CI: 63%, 83%] at 24 months in women without OTC and 93% [95% CI: 85%, 95%] and 85% [95% CI: 78%, 90%] in women with OTC, respectively. Similar patterns, however, not as profound, were seen for AFC. Not all women completed assessments at all three follow-up visits, likely reflecting emotional exhaustion, hospital fatigue, reluctance to attend additional appointments, or changes in reproductive intentions. Furthermore, the observed reduction in ovarian reserve may, to some extent, also reflect the natural age-related decline in ovarian reserve. These findings may support counselling women with breast cancer about chemotherapy-related ovarian damage and thus the need for FP. The study is funded by the Independent Research Fund Denmark (Grant ID 10.46540/4308-00130B). A.P. has received grants (paid to the institution) and consulting fees from Gedeon Richter, Ferring Pharmaceuticals, Merck A/S, and Cryos; honoraria from Gedeon Richter, Ferring Pharmaceuticals, Merck A/S, and Organon; and support for meeting attendance and/or travel (paid to the institution) from Gedeon Richter. A.T.P. received speaker fees from Astellas, Gedeon-Richter, and Novo Nordisk. These companies had no role in the study. The other authors have no conflicts or interests to declare. N/A.

PMID 42853979
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PubMedVeterinary journal (London, England : 1997)2026-10-08

Gastrointestinal transit time of healthy dogs before and after enema assessed by contrast radiographs with barium-impregnated polyethylene spheres.

de Souza Murilo Rodrigues MR, da Silva Wanessa Patrícia Rodrigues WPR, Xavier Rafael Antônio Lopes RAL, da Silva Carolina Castro Lyra CCL et al.

In this prospective experimental study, we aimed to assess the gastrointestinal (GI) transit of healthy dogs with and without an enema, using barium-impregnated polyethylene spheres (BIPS). Six healthy dogs underwent two experimental steps: evaluation of the GI transit using BIPS (BIPS group) before and after enema (BIPS+ENEMA group). All animals were fasted for 12 h, the transit was assessed in serial radiographs from 0 to 12 h, and BIPS were counted in each segment of the GI tract, calculating the gastric emptying time and the time the spheres reached the descending colon. Blood cell count, serum biochemistry, electrolytes, and blood glucose levels were assessed during the experiment to evaluate the safety of both BIPs and enema. BIPS were easily identified in all segments of the GI tract. The BIPS group presented gastric emptying starting at H0 and H1, ending around H8. BIPS + ENEMA group showed a delayed gastric emptying, which began around H1 and extended to more than H12, and had a lower percentage of spheres in the descending colon at the end of the evaluation; however, the differences were not statistically significant. BIPS and enema did not cause changes in laboratory evaluation, and the 12-hour fast did not cause hypoglycemia. Based on the findings, when using BIPS for radiographic contrast, an enema is not a required procedure. The use of the enema and BIPS can be considered safe, with no apparent adverse effects in dogs.

PMID 42849778
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