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ustekinumab (Absimky / DMB 3115 / DA3115)

✓ Approved

Meiji Seika Pharma Co., Ltd. · IL12B · Monoclonal Antibodies

What is ustekinumab?

ustekinumab is a monoclonal antibodies developed by Meiji Seika Pharma Co., Ltd.. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesAbsimky, DMB 3115, DA3115
CompanyMeiji Seika Pharma Co., Ltd.
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetIL12B, IL23A
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Meiji Seika Pharma Co., Ltd.

Mechanism of Action

Molecular Targets

ustekinumab acts on 2 molecular targets:

IL12Binterleukin 12B (CLMF2, CLMF)
IL23Ainterleukin 23 subunit alpha (P19, SGRF)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

ustekinumab is developed for 4 unique indications across 3 therapeutic areas.

Therapeutic AreaConditionPhase
Skin and subcutaneous tissue disordersPsoriasis✓ Approved
Gastrointestinal disordersColitis ulcerative✓ Approved
Gastrointestinal disordersCrohn's disease✓ Approved
Musculoskeletal and connective tissue disordersPsoriatic arthropathy✓ Approved

Related Research Articles

PubMedThe American journal of gastroenterology2026-09-18

COMPARATIVE REAL-WORLD EFFECTIVENESS OF BIOLOGIC THERAPIES FOR PREVENTING POSTOPERATIVE ENDOSCOPIC RECURRENCE OF CROHN'S DISEASE.

Ahmed Newaz Shubidito NS, Boparai Rakhbeer R, Fida Mashal M, Wang Christine C et al.

Postoperative recurrence is common after ileocolonic resection for Crohn's disease (CD). Comparative effectiveness data for advanced treatments for preventing recurrence is limited. We conducted a population-based retrospective cohort study of adults with CD undergoing ileocolonic resection with primary anastomosis in the Calgary Health Zone, Canada (2016-2020). The primary outcome was endoscopic recurrence within 18 months, assessed using the modified Rutgeerts score as an ordinal endpoint. High-risk recurrence (modified Rutgeerts score ≥i2b) was evaluated as a secondary outcome. Propensity scores were estimated using established clinical risk factors and inverse probability of treatment weighting (IPTW) targeting the average treatment effect among treated patients was applied to ordinal and logistic regression models. Treatment effects were expressed as adjusted odds ratios (aOR) with 95% CI. Among 231 patients, 126 (54.5%) received biologic prophylaxis and 92 (39.8%) received no treatment; endoscopy was performed in 217 patients. High-risk endoscopic recurrence occurred in 42.3% (36/85) of untreated patients compared with 9.4% (6/64) receiving TNF antagonists, 27.8% (10/36) receiving ustekinumab, and 10.0% (2/20) receiving vedolizumab. After weighting for established risk factors for recurrence, all biologic strategies were associated with reduced odds of endoscopic recurrence compared to no treatment (aOR 0.15-0.31, all p<0.05). Vedolizumab was associated with lower odds of recurrence compared with ustekinumab (aOR 0.24 [0.06-0.92], p=0.04) but not TNF antagonists (aOR 0.43 [0.10-1.87], p=0.26). In this real-world cohort, biologic prophylaxis is associated with reduced endoscopic recurrence in CD. Both ustekinumab and vedolizumab are effective options, including after prior TNF exposure.

PMID 42754967
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PubMedExpert opinion on biological therapy2026-09-17

Assessing the effectiveness of biologics in biologic-naïve patients with isolated small bowel Crohn's disease by double-balloon endoscopy.

Zhou Linlin L, Wu Yumei Y, Fang Yuanyuan Y, Hu Jing J et al.

Data on the effectiveness of biologics in achieving endoscopic remission (ER) in biologic-naïve patients with isolated small bowel Crohn's disease (SB-CD) remain limited. To assess the effectiveness of biologics in achieving ER in these patients. This single‑center retrospective study included biologic‑naïve isolated SB‑CD patients who initiated infliximab (IFX) or ustekinumab (UST) between 2020 and 2025. All underwent follow‑up double‑balloon enteroscopy. ER was defined as Simple Endoscopic Score for Crohn's Disease (SES‑CD) <3. Multivariate regression identified predictors of ER. Propensity score matching (1:3) compared UST and IFX. A total of 169 patients (122 receiving IFX and 47 receiving UST) were included. The overall ER rate was 35.5% (32.8% for IFX and 42.6% for UST). Multivariate analysis identified stricturing/penetrating disease (OR =0.297, 95% CI: 0.131-0.673, p = 0.004) and moderate-to-severe endoscopic disease (OR =0.307, 95% CI: 0.112-0.839, p = 0.021) as negative predictors of ER. After matching, no significant differences were observed between the groups in the rates of endoscopic response, ER, mucosal healing, clinical remission, or biochemical remission. Among biologic-naïve patients with isolated SB-CD, the overall ER rate after biologic treatment was 35.5%. IFX and UST showed comparable effectiveness in achieving ER.

PMID 42754371
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PubMedDrugs2026-09-16

Antibiotic-Refractory Chronic Pouchitis After Ileal Pouch-Anal Anastomosis: Current and Emerging Therapeutic Strategies.

Faggiani Ilaria I, Tuttle Connor C, Danese Silvio S, Peyrin-Biroulet Laurent L et al.

Chronic inflammatory pouch disorders may affect up to 20% of patients within 5 years after ileal pouch-anal anastomosis and remains a major therapeutic challenge. Within this spectrum, chronic antibiotic-refractory pouchitis is associated with impaired quality of life, long-term pouch-related complications, and potential risk for pouch failure and excision. Current recommendations support the use of probiotics for primary and secondary prevention in selected patients. Increasingly, targeted advanced therapies, including biologics and small molecules approved for the treatment of ulcerative colitis and Crohn's disease, are being used to reduce antibiotic dependence and maintain disease control in patients with pouch inflammation. Vedolizumab is the only advanced therapy approved in Europe for chronic pouchitis, whereas evidence for tumor necrosis factor (TNF) antagonists, ustekinumab, and newer agents, such as interleukin (IL)-23p19 antagonists and Janus kinase (JAK) inhibitors is largely based on observational data from clinical practice and real-world experience. Fecal microbiota transplantation is biologically attractive but remains investigational, with early studies showing inconsistent efficacy. Dietary patterns may modify pouch inflammation; however, most evidence is observational. Overall, current management strategies for chronic pouchitis are limited by incomplete understanding of disease pathogenesis, and by persistent methodological gaps, including poorly standardized treatment outcomes and the lack of validated treat-to-target strategies for this population. Well designed prospective and controlled studies are needed to define appropriate antibiotic-sparing strategies, optimal treatment positioning, and long-term durability of response.

PMID 42745024
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PubMedClinical and experimental gastroenterology2026-09-16

Dual Therapy for Complex Inflammatory Bowel Disease: Safety, Clinical and Steroid-Free Response.

Haase Anne-Mette AM, Kelsen Jens J, Agnholt Jørgen J, Bendix Mia M

Remission in patients with inflammatory bowel disease appears to plateau at 30-50% within the first year of biological monotherapy. Patients with Crohn's disease (CD) and ulcerative colitis (UC) on monotherapy with biologics or small molecules may face this therapeutic ceiling, not reaching remission in relation to bowel inflammation and/or extraintestinal manifestations (EIM). Dual therapy, combining two advanced therapies, has been proposed for this challenging population. We aimed to investigate real-life safety, steroid free- and clinical response in dual therapy. Medical records from September 2018 to September 2023 were reviewed for CD and UC patients undergoing dual therapy with biologics and/or small molecules due to refractory bowel inflammation or EIM in outpatient gastroenterology clinics at Aarhus University Hospital and Regional Hospital Randers. Patients treated for at least three months were included and followed until treatment discontinuation or the end of the study. Patient characteristics, clinical outcomes, adverse events, and clinical response data were collected at baseline and follow-up. Seventy-four patients (47 with CD and 27 with UC) received a total of 79 dual therapies. The median dual therapy duration was 488 days for CD and 412 days for UC. The most common combinations were adalimumab/ustekinumab in CD (46%) and adalimumab/vedolizumab in UC (35%). Clinical response at follow-up was achieved in 50% of CD patients and 45% of UC patients and steroid-free follow-up in 80% of CD patients and 52% of UC patients. Severe adverse events (SAEs) occurred in eight out of 79 dual therapies. Treatment failure and adverse events within the first three months of dual therapy were not included. This study demonstrates substantial rate of clinical response and an acceptable safety profile in complex IBD patients receiving dual therapy. Still, the risk of SAEs must be balanced against the therapeutic benefit.

PMID 42746558
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PubMedJournal of clinical medicine2026-09-15

Guselkumab in Inflammatory Bowel Disease: Mechanism, Clinical Efficacy, Safety, and Treatment Positioning.

White Laura L, Sharma Esha E, Limdi Jimmy J, Din Shahida S et al.

Guselkumab is a monoclonal antibody directed against the p19 subunit of interleukin-23 (IL-23), thereby preventing IL-23 binding to the IL-23 receptor. IL-23 is a key driver of immune dysregulation and chronic inflammation in inflammatory bowel disease (IBD), making selective IL-23 inhibition an established therapeutic strategy in both Crohn's disease and ulcerative colitis. Guselkumab is the most recently approved IL-23p19 inhibitor for the treatment of both major forms of IBD. It is the first IL-23p19 inhibitor to offer a fully subcutaneous induction regimen, and preliminary phase III data has suggested potential benefits for patients with perianal Crohn's disease. In registrational trials, there were significant improvements across multiple clinical and endoscopic endpoints in comparison to ustekinumab, although these trials were not powered for formal superiority testing. This narrative review summarises the biological rationale for IL-23 blockade, reviews the available clinical evidence, discusses practical considerations for its use, and considers its place in the landscape of IBD treatments.

PMID 42739673
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PubMedJournal of clinical medicine2026-09-15

Targeted Therapies in Inflammatory Bowel Disease: Mechanisms, Comparative Evidence, and Clinical Translation.

Pavel Christopher C, Popa Ana A, Ilie Madalina M, Plotogea Oana-Mihaela OM et al.

Inflammatory bowel disease (IBD), encompassing Crohn's disease (CD) and ulcerative colitis (UC), is a chronic immune-mediated condition with substantial global burden and rising incidence, requiring an expanding range of advanced therapies. This focused narrative review examines the mechanistic rationale, comparative clinical evidence, and translational implications of approved and emerging targeted therapies for adult IBD. A structured literature search was conducted in PubMed, Scopus, and Web of Science for publications from January 2021 to March 2026. Thirty-eight articles were selected as the core evidence set with landmark trials and clinical guidelines added when needed for historical or practice context. Evidence was synthesised narratively, with an explicit distinction between direct head-to-head comparisons, placebo-controlled trials, indirect network comparisons, and observational data. In UC, VARSITY showed higher week-52 clinical remission and endoscopic improvement with vedolizumab than adalimumab; in CD after anti-tumour necrosis factor (anti-TNF) failure, SEQUENCE showed risankizumab noninferior to ustekinumab for week-24 clinical remission and superior for week-48 endoscopic remission. Agents targeting tumour necrosis factor-like cytokine 1A (TL1A) have shown encouraging activity in phase 2/2b trials, but long-term effectiveness and safety remain uncertain. The current evidence supports mechanism-informed rather than biomarker-defined treatment selection. Confidence in comparative conclusions is greatest when supported by direct randomised evidence, whereas observational and indirect comparisons require caution because of confounding, heterogeneity, and differences in populations and outcome definitions. Clinical translation therefore requires the integration of the disease phenotype, prior treatment exposure, safety risks, and patient preference, with objective reassessment after therapy initiation.

PMID 42739758
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