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ustekinumab (Qoyvolma)

✓ Approved

Celltrion, Inc. · IL12B · Monoclonal Antibodies

What is ustekinumab?

ustekinumab is a monoclonal antibodies developed by Celltrion, Inc.. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesQoyvolma
CompanyCelltrion, Inc.
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetIL12B, IL23A
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Celltrion, Inc.

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

Related Research Articles

PubMedJPGN reports2026-07-25

The safe and effective use of tofacitinib and ustekinumab combination therapy in infantile onset inflammatory bowel disease.

Mahajan Smridhi S, Wysocki Christian C, Gurram Bhaskar B

Infantile-onset inflammatory bowel disease (IOIBD) is a rare and severe subset of very-early-onset IBD, often associated with immune dysregulation and poor response to conventional therapies. Data regarding the use of Janus kinase inhibitors (JAKI) in this population is limited. We conducted a retrospective chart review of four patients treated with tofacitinib in combination with ustekinumab after failing multiple agents at a tertiary referral center. All four patients demonstrated clinical, laboratory, and endoscopic remission. No adverse events were observed. Genetic evaluation did not reveal monogenic causes in any of these patients. These findings suggest that JAKI may represent a safe and effective therapeutic option for carefully selected patients with difficult-to-treat IOIBD, either as a bridge to or in combination with ustekinumab. Larger prospective studies are warranted to better define the role of JAKI in this challenging patient population.

PMID 42499735
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PubMedGut2026-07-25

Ustekinumab for fistulising perianal Crohn's disease: a randomised placebo-controlled trial from the GETAID.

Wils Pauline P, Nancey Stéphane S, Messmer Elodie E, Bourreille Arnaud A et al.

Fistulising perianal Crohn's disease (CD) remains a debilitating condition, with few randomised controlled trials conducted so far. To evaluate the efficacy and safety of ustekinumab (UST) in patients with CD with active draining perianal fistulas (NCT04496063) in a randomised placebo-controlled trial. In this double-blind, multicentre Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives trial, patients enrolled with active fistulising perianal CD were randomised 1:1 to receive UST (6 mg/kg intravenously at baseline followed by 90 mg subcutaneously at week 8, then every 8 weeks) or placebo, after standardised surgical management. The primary endpoint was combined clinical remission (absence of drainage from all external fistula openings) and radiological remission (absence of abscesses >2 cm on blinded central MRI) at week 12. At week 12, placebo non-responders could switch to UST, and UST non-responders could be intensified during the open-label phase. 32 patients were randomised (UST: 16; placebo: 16) across 10 French centres and 69% had prior anti-tumour necrosis factor failure. At week 12, combined remission was achieved in 62% with UST versus 25% with placebo (OR=5.1 (95% CI 1.07-24.4)). Clinical remission occurred in 62.5% vs 31% (OR=3.75 (95% CI 0.84 to 16.8)) and radiological remission in 87.5% vs 75% (OR=2.7 (95% CI 0.34 to 21.1)). Nine placebo-patients switched to UST during the open-label phase. Combined remission rates at week 48 were 50% in the placebo arm and 31% in the UST arm, respectively. These findings suggest greater short-term clinical benefit with UST compared with placebo and support its use in patients with active fistulising perianal CD. NCT04496063.

PMID 42498622
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PubMedFrontiers in medicine2026-07-25

Efficacy of Ustekinumab for the treatment of perianal fistulizing Crohn's disease: a multicentre retrospective study.

Li Youran Y, Sun Xiaomei X, Wen Ke K, Lu Lu L et al.

Perianal fistulizing Crohn's disease (pfCD) is a refractory complication of Crohn's disease (CD) with limited therapeutic options, particularly for patients failing anti-tumor necrosis factor agents. Ustekinumab (UST) shows promise in pfCD, but long-term outcomes and predictive factors remain unclear. This multicenter retrospective study enrolled 163 pfCD patients treated with UST (2020-2023) with a median 15-month follow-up. Primary endpoints were fistula response and clinical remission rates. Univariate/multivariate logistic regression identified healing predictors, and a nomogram was developed for outcome prediction. At final follow-up, the fistula response rate was 88.3% and clinical remission rate 70.1%. Significant improvements were observed in inflammatory biomarkers (CRP: 21.2 ± 28.3 → 5.2 ± 8.9 mg/L; ESR: 36.6 ± 24.5 → 14.5 ± 18.3 mm/h) and hemoglobin (126.8 ± 18.5 → 148.2 ± 25.6 g/L; all p < 0.001). Definitive surgery (adjusted OR = 9.613, p < 0.001) and fewer prior biologics (adjusted OR = 0.541, p = 0.006) were independent healing predictors. The nomogram exhibited good discriminative ability (AUC = 0.852 for 24-week remission). UST was well-tolerated (adverse event rate = 7.4%) with no severe safety issues. UST demonstrated clinically meaningful efficacy within a combined multidisciplinary strategy for pfCD, with fistula response and clinical remission rates of 88.3 and 70.1%, respectively, though MRI-confirmed healing was modest (14.2%). Definitive surgery and fewer prior biologic exposures predicted better fistula healing. The developed nomogram facilitates individualized treatment decision-making.

PMID 42500534
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PubMedNature communications2026-07-25

JN.1-adapted vaccination is associated with readjustment of ancestral memory B cells toward neutralization within the JN.1 antigenic space.

Stankov Metodi V MV, Bruhn Matthias M, Hoffmann Markus M, Salam Abdus A et al.

The antigenic drift of SARS-CoV-2 toward the JN.1 lineage has prompted the development of variant-adapted COVID-19 booster vaccines. However, these boosters are thought to primarily recall pre-existing memory B cells (MBC), raising concerns about their ability to realign the immune response in highly pre-exposed populations. Here we analyze antibody and B cell responses in pre-exposed individuals (n = 42; median 4.5 prior COVID-19 vaccinations; 90% with at least one prior SARS-CoV-2 infection) following vaccination with a JN.1-adapted mRNA vaccine. Vaccination is associated with increased IgG binding and enhanced neutralization of JN.1 and related descendant variants. Longitudinal profiling of antigen-specific MBC shows that Wu01-only and Wu01/JN.1 cross-reactive cells remain dominant, while JN.1-only cells modestly increase by day 21. Single-cell RNA-sequencing of antigen-specific MBC in a representative sub-cohort (n = 7), combined with functional monoclonal antibody analyses, demonstrates that somatic hypermutation (SHM) drives intra-clonotype specialization toward improved JN.1 binding and neutralization. These findings indicate maturation of pre-existing, class-switched MBC rather than substantial de novo recruitment of naïve B cells. In conclusion, JN.1-adapted booster vaccination is associated with refinement of pre-existing MBC repertoires toward the JN.1 antigenic space and with enhanced neutralization of contemporary and antigenically proximate variants.

PMID 42498786
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PubMedNanoscale advances2026-07-25

Rice straw-derived activated carbon/ZnO nanocomposite as a high-performance electrode for asymmetric supercapacitors.

Raza Asif A, Mbs Pravin P, Rajendran Divya D, Sarwar Zartasha Z et al.

The synthesis of electrode materials from biomass waste has attracted considerable attention due to their low cost and high electrochemical performance in energy devices. Therefore, in this study, activated carbon was prepared from rice straw waste and composited with zinc oxide (ZnO) nanoparticles to enhance the electrochemical performance of an asymmetric supercapacitor. AC, ZnO, and AC-ZnO exhibit specific surface areas of 201, 255, and 578 m2 g-1, respectively, with average pore diameters of 1.37 nm, 1.73 nm, and 2.45 nm, respectively. The AC-ZnO composite exhibited a higher specific capacitance of 244 F g-1, compared with 206 F g-1 for ZnO and 137 F g-1 for AC at a current density of 0.5 A g-1. The charge-transfer resistance (R ct) values for AC, ZnO, and AC-ZnO were 0.050, 0.061, and 0.035 Ω, respectively. After 10 000 charge-discharge cycles, the corresponding capacitance retentions were 83.5%, 75.3%, and 89.9%, respectively. The AC-ZnO composite exhibits a hybrid capacitive behavior due to the electrical double-layer capacitor behavior of AC and the pseudocapacitive behavior of ZnO. The specific capacitance, energy density, and power density of the assembled device are 149 F g-1, 20.66 Wh kg-1, and 500 W kg-1, at 1 A g-1. Moreover, the assembled device exhibited 97% capacitance retention and 100% coulombic efficiency after 5000 charge-discharge cycles.

PMID 42499689
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PubMedBlood advances2026-07-25

Tenecteplase (TNK) and other TNK formulations lose PAI-1 resistance in their two-chain form: Comparison with alteplase.

Liu Zikou Z, Tippett Isabel I, McCutcheon Fiona M FM, Keragala Charithani B CB et al.

Alteplase is synthesized as a single-chain protease that requires plasmin-mediated conversion to its fully active two-chain form for maximal thrombolysis. Tenecteplase (TNK), an alteplase variant, is widely regarded as being more fibrin-selective and more resistant to plasminogen activator inhibitor-1 (PAI-1) than alteplase. However, the PAI-1 sensitivity of TNK after two-chain conversion, and that of newly available TNK formulations, has not been evaluated. Alteplase and four TNK formulations: Metalyse (Boehringer Ingelheim), Tenectase (Gennova, India), GenetPA (BioApower, China) and Mingfule (CSPC, China) were compared in their native state and after two-chain conversion. Proteolytic activity, PAI-1 resistance and binding were evaluated using amidolytic assay, fibrinolysis assays and Western blotting. Alteplase, but not Metalyse was converted into its two-chain form in plasma in a fibrinogen-dependent manner, resulting in off-target fibrinogenolysis. When directly reconstituted from the manufacturers vial (native form), TNK was ~4-fold more resistant to PAI-1 than alteplase; however, two-chain conversion significantly reduced PAI-1 resistance by ~40%, concomitant with increased PAI-1 binding. Native Metalyse contained ~3-fold more pre-existing two-chain species than the other TNK formulations, explaining its higher amidolytic activity. However, after two-chain conversion, all TNK formulations showed similar fibrinolytic activity albeit with substantially reduced PAI-1 resistance. Metalyse and all new TNK formulations display similar fibrinolytic activity in their fully active two-chain states, but this is associated with substantial loss of PAI-1 resistance, challenging the view that the fully active two-chain form of TNK maintains PAI-1 resistance during thrombolysis.

PMID 42498282
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