Drug Database
SU

sublingual immunotherapy

✓ Approved

Anallergo · therapeutic agent

What is sublingual immunotherapy?

sublingual immunotherapy is a therapeutic agent developed by Anallergo. It is approved for therapeutic indications via oral (po) or sublingual (sl)/oral transmucosal.

Drug Profile

CompanyAnallergo
RouteOral (PO), Sublingual (SL)/Oral Transmucosal
StatusApproved
Sources: ClinicalTrials.gov, Anallergo

Therapeutic Indications

sublingual immunotherapy is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Immune system disordersHypersensitivity✓ Approved

Related Research Articles

PubMedFrontiers in immunology2026-10-22

Case Report: Immune-related colitis complicated by Clostridioides difficile-associated colitis.

Chen Wenjuan W, Zhang Wanqian W, Sun Chaoqun C, Meng Lin L et al.

Immune checkpoint inhibitors (ICIs) have become the standard treatment for patients with advanced microsatellite instability-high (MSI-H) gastric cancer. However, the incidence of immune-related adverse events (irAEs) has also increased accordingly. Immune-related colitis (IRC) is among the most common gastrointestinal manifestations of these irAEs. This report describes a patient with advanced MSI-H gastric cancer who received immunotherapy and developed Grade-3 IRC during treatment. The patient recovered following corticosteroid therapy. Diarrhea recurred after discontinuation of corticosteroids, a condition that may be misdiagnosed as a recurrence of IRC. Following a multidisciplinary team consultation, the patient was clinically diagnosed with Clostridioides difficile infection (CDI) based on symptoms and stool testing, and showed rapid improvement after vancomycin therapy. The patient achieved a durable complete clinical response lasting more than 5 years without further systemic anticancer therapy. This case illustrates that immunotherapy may confer long-term benefit in MSI-H advanced gastric cancer. Notably, the occurrence of immune-related adverse events coincided with sustained tumor control, suggesting a potential association that merits further exploration. However, when diarrhea recurs after discontinuation of corticosteroids, clinicians must remain highly vigilant regarding the overlap and differentiation between the reactivation of IRC and infectious colitis, the involvement of a multidisciplinary team is particularly crucial.

PMID 42903148
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PubMedZhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics2026-10-22

[Effect of the number of sensitizing allergens on the efficacy of subcutaneous immunotherapy and quality of life in children with asthma].

Xu Mo-Yu MY, Wang Yu-Die YD, Liu Jia-Yi JY, Jiang Han H et al.

To compare the efficacy of subcutaneous immunotherapy (SCIT) and its impact on quality of life between children with dust mite-allergic asthma who are monosensitized and those who are polysensitized. This prospective longitudinal cohort study enrolled 80 children with dust mite-allergic asthma, who were divided into a monosensitization group (n=40) and a polysensitization group (n=40). All children completed 3 years of standardized dust mite SCIT. Indicators compared between the two groups before and after treatment included peripheral blood eosinophil percentage, fractional exhaled nitric oxide, pulmonary function parameters, visual analog scale score, Asthma Control Test score, quality of life score, and Children's Sleep Habits Questionnaire score. After 3 years of treatment, both groups showed significant improvements in all indicators from baseline (all P<0.05). The monosensitization group demonstrated greater improvements than the polysensitization group in peripheral blood eosinophil percentage, fractional exhaled nitric oxide, maximum mid-expiratory flow as a percentage of predicted value, Asthma Control Test scores, and quality of life scores (all P<0.05). The incidence of adverse reactions did not differ significantly between the two groups (P>0.05). SCIT is effective in children with dust mite-allergic asthma, and monosensitized children show greater improvements in small airway function, asthma control, and quality of life.

PMID 42902719
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PubMedFrontiers in immunology2026-10-22

53L10 T-cell engager tribody for immunotherapy of multiple solid tumors.

Passariello Margherita M, Belardo Martina M, Inoue Toshikazu T, Kajiwara Kentaro K et al.

Cancer immunotherapy with immune checkpoint inhibitors (ICIs), i.e., antibodies targeting inhibitory ICs, such as PD-1, PD-L1, and CTLA-4, have successfully revolutionized cancer treatment. One of the most promising cancer immunotherapies is based on bi-specific T-cell engagers that simultaneously bind with one arm to a tumor-associated antigen on tumor cells and with the other one to the CD3 complex on T cells to form a TCR-MHC-independent immune synapse. We previously generated four novel tribodies, tri-specific antibody derivative constructs, made up of a Fab targeting 5T4, an oncofetal tumor antigen expressed on several types of tumors, an scFv targeting CD3 on T cells, and an additional scFv specific for an immune checkpoint. In particular, the 53L10 tribody, targeting PD-L1, displayed the best binding properties and stronger anti-tumor activity in vitro and in vivo in mouse models. Here, we further investigated the anti-tumor potential of 53L10 by testing its effects on a panel of tumor cell types with a more aggressive profile, including gastric, pancreatic, prostate, ovarian, and epidermoid tumor cells. We found that 53L10 was very effective on these cells by inducing stronger T-cell activation and tumor cell lysis than the parental bi-specific 53P lacking an ICI. To further test its therapeutic potential, we also analyzed its stability and the effects on tumor T-cell infiltration in vivo on a mouse model. 53L10 was found to be stable after incubation in serum at 37 °C for 3 days and induced a more efficient and earlier increase in tumor tissues of both CD4 and CD8 T cells than the parental bi-specific 53P. These findings support further preclinical evaluation of 53L10 as a new tool for multiple solid tumor-targeted therapeutic approaches.

PMID 42903181
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PubMedExpert opinion on pharmacotherapy2026-10-22

Extensive-stage small-cell lung cancer pharmacotherapy: what is on the horizon?

Maione Paolo P, Palma Valentina V, Pucillo Giuseppina G, Gridelli Cesare C

Extensive-stage small cell lung cancer (ES-SCLC) is yet to be considered an oncologic clinical condition characterized by a dismal prognosis. However, about 5 years ago, the introduction of immunotherapy in the first-line regimens, combined with platin-based chemotherapy, has produced an improvement of survival outcomes for this patient population. In the last year, two innovative approaches have further improved efficacy outcomes for ES-SCLC patients. The addition of lurbinectedin to the immunotherapeutic drug atezolizumab in the maintenance phase of first-line treatment, and the introduction of the bispecific T-cell engager antibody tarlatamab as second-line treatment, have established two new standards of care for the treatment of ES-SCLC. Moreover, ongoing phase III trials are testing the possibility to introduce tarlatamab in the first-line setting, as induction or as maintenance. Simultaneosusly, phase II trials have reported very promising antitumor activity for ifinitamab deruxtecan and sacituzumab govitecan, two antibody drug conjugates in the second-line setting, and phase III trials are ongoing. As never in the past, the prognosis of ES-SCLC patients seems characterized by a new light, with innovative drugs that used combined or sequentially, have the potential of a substantial change of the natural history of this aggressive disease.

PMID 42902761
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PubMedFrontiers in artificial intelligence2026-10-22

scTIME: single-cell-informed interpretable modeling of immunotherapy-associated immune states in non-small cell lung cancer.

Chen Guozhi G, You Chenqiu C, Gao Hong H, Xu Chengjie C

Immune checkpoint inhibitor response in non-small cell lung cancer (NSCLC) reflects coordinated tumor and immune states that are not fully captured by single biomarkers. We developed scTIME, an interpretable model that translates single-cell immune programs into bulk transcriptomic scores, and integrated public single-cell, T-cell receptor, transcriptomic, survival, and proteogenomic cohorts. Response modeling used two cohorts with different endpoints (40 patients) and compared six algorithms. ElasticNet was selected as a sparse reporting model, achieving a pooled five-fold out-of-fold ROC-AUC of 0.810; nested model selection yielded 0.772. Matched held-out stratification identified response-enriched scTIME groups in a direct descriptive comparison with CD274, while the fitted score emphasized cytotoxic CD8, natural killer, SPP1 macrophage, interferon-response, and antigen-presentation programs. Single-cell analyses and external projections linked these programs to CXCL10-CXCR3 recruitment, exclusion-associated states, and T-cell receptor ecology across molecular contexts. Exploratory survival and cross-omics analyses extended the framework beyond the response cohorts but were interpreted as projection rather than independent validation. Together, the results show how cell-resolved immune biology can support transparent, multi-omic biomarker development without reducing response to a single pathway. scTIME remains exploratory because model choice was post hoc, cohorts were small and clinically heterogeneous, and endpoint-matched external validation was unavailable.

PMID 42903172
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PubMedThe oncologist2026-10-22

From Efficacy to Effectiveness in Gynecologic Oncology: Social Determinants, Therapeutic Transportability, and Biological Weathering.

Zheng Ziwen Z, Chen Yamei Y, Yao Xinyu X, Wang Chao C et al.

Precision therapeutics have improved outcomes in gynecologic oncology, but their population-level impact depends on both biological efficacy and reliable treatment delivery. Randomized controlled trials establish causal effects under defined conditions; real-world evidence characterizes implementation and transportability while introducing distinct confounding and measurement challenges. This contextual narrative review integrates pivotal and updated therapeutic studies with clinical, social and translational evidence available through September 2026. Progression-free survival and overall survival are distinct endpoints, whereas effectiveness concerns benefit in routine care; cross-study interpretation requires aligned populations, treatment strategies, follow-up and estimands. The benefits of poly(ADP-ribose) polymerase inhibitors and immunotherapy are examined separately by molecular subgroup and treatment setting. Financial hardship, geographic access, caregiving and health-system constraints can affect initiation, tolerable exposure and continuity. We use the proposed term "social discontinuation" for treatment disruption with a material social contribution, while distinguishing clinical reasons and patient preference. Biological weathering provides plausible links between cumulative adversity and inflammatory, neuroendocrine, epigenetic and immune phenotypes. Human epidemiological associations, translational findings and experimental mechanisms support different inferences; mediation through treatment delivery remains distinct from biological modification of treatment effect. Priorities include justified broader eligibility, prospective social-needs and exposure measurement, responsive symptom management, navigation and hybrid care. Automated extraction and prediction tools require external validation, fairness assessment and prospective clinical-impact evaluation. Integrating randomized and real-world evidence can identify remediable barriers without diminishing the clinical value of effective therapies.

PMID 42902793
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