Drug Database
MA

mannitol (Aridol / Osmohale)

✓ Approved

Syntara · Small Molecule · Small Molecule

What is mannitol?

mannitol is a small molecule developed by Syntara. It is approved for therapeutic indications via inhaled.

Drug Profile

Brand NamesAridol, Osmohale
CompanySyntara
Drug ClassSmall Molecule
RouteInhaled
StatusApproved
Sources: ClinicalTrials.gov, Syntara

Therapeutic Indications

mannitol is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Respiratory, thoracic and mediastinal disordersRespiratory failure✓ Approved

Related Research Articles

PubMedAnalytical biochemistry2026-08-30

Validation of SARS-CoV-2 neutralization assay using VSV-based pseudovirus system.

Artarini Anita A, Tan Marselina Irasonia MI, Giri-Rachman Ernawati Arifin EA, Natalia Dessy D et al.

The gold standard for SARS-CoV-2 neutralization assays involves wild-type virus, which requires Biosafety Level 3 (BSL-3) containment. To improve safety and accessibility, pseudovirus-based neutralization assays utilizing non-replicating particles like Vesicular Stomatitis Virus (VSV) expressing the SARS-CoV-2 spike protein can be conducted under BSL-2 conditions. This study aimed to perform the analytical validation of a VSV-based pseudovirus system for SARS-CoV-2 using recombinant monoclonal antibody. Pseudo-VSV carrying SARS-CoV-2 Spike proteins were produced using LentiX-293T cells. The assay system was optimized for Multiplicity of Infection (MOI) and assessed for specificity, limit of quantification (LOQ), linearity, accuracy, and precision using the neutralizing mAb BD-604. The system was optimized at an MOI of 0.25. The assay proved highly specific, as mAb BD-604 showed clear neutralizing activity while mAb 1A9 did not. The limit of quantification (LOQ) was determined to be 125 ng of mAb BD-604, with a linear range of 125 - 1000 ng. The relative accuracy remained within the 80-120% range, and the precision (%CV) ranged from 1.92% to 13.57%. Additionally, the system successfully characterized variant-specific neutralization, revealing that BD-604 was effective against the Wuhan, Delta, and Omicron BA.1/BA.2 strains but lacked activity against the Omicron XBB.1.5 variant. This validated pseudo-VSV based SARS-CoV-2 neutralization assay is a valuable bioassay for evaluating neutralizing antibody potency against various SARS-CoV-2 strains in a BSL-2 environment, thus making it useful for vaccine and therapeutic development.

PMID 42669355
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PubMedTherapeutic advances in gastroenterology2026-08-30

Prevalence of dysphagia and eosinophilic esophagitis in patients with inflammatory bowel disease or type 2 inflammation: a cross-sectional multicenter screening study.

Bäuerle Martin M, Maurer Jurij J, Pokryszka Jagoda J, Novacek Gottfried G et al.

Eosinophilic esophagitis (EoE) is a chronic, type-2 inflammation-driven disease causing dysphagia. Although patients with other type-2 inflammatory diseases (type-2 ID) or inflammatory bowel disease (IBD) may have an increased risk of EoE, there is limited information about the prevalence of EoE in these specific populations. This study aims to assess the prevalence of clinically relevant dysphagia as well as underlying EoE in patients with type-2 ID or IBD. This is a cross-sectional, multicenter study of patients with type-2 ID (asthma, rhinosinusitis with polyposis nasi, allergic rhinitis, atopic dermatitis, Immunoglobulin E (IgE)-mediated food allergies) or IBD from the Medical University of Vienna and Floridsdorf Allergy Center. Patients were screened for esophageal dysphagia using the Brief Esophageal Dysphagia Questionnaire (BEDQ). Relevant dysphagia was defined as a BEDQ score ⩾4, or having a history of bolus impaction or emergency department visit due to dysphagia within the past year. Endoscopy with esophageal biopsies was offered to all patients with relevant dysphagia to screen for EoE. A total of 687 patients (45.9% female, median age 45 years, 53.9% with IBD, 48.5% with a type 2 ID) were screened. Overall, 8.9% (n = 61) reported relevant dysphagia. Endoscopy with biopsies was performed in 22 patients, and 18 patients had undergone endoscopy the year prior to the study. In total, 6 newly diagnosed cases of EoE were observed, while 7 patients had a known history of EoE, resulting in an overall prevalence of 13 patients (1.9%). Patients with any type-2 ID had numerically more EoE (2.7%) than patients with IBD (1.9%). While the prevalence of dysphagia among patients with type-2 ID and IBD may not exceed that of the general population, the prevalence of EoE in these populations may be higher than previously recognized.

PMID 42668855
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PubMedPublic health reports (Washington, D.C. : 1974)2026-08-30

Establishment of a Clinical Quality Improvement Program for Type 2 Diabetes by the T1D Exchange QI Collaborative.

Tsai Sandra A SA, Weinstock Ruth S RS, Zupa Margaret F MF, Fantasia Kathryn L KL et al.

Implementing best practice guidelines for diabetes and cardiovascular comorbidities is important to reduce the risk of complications for people with type 2 diabetes. The T1D Exchange Quality Improvement Collaborative (T1DX-QI) established a type 2 diabetes quality improvement (T2D-QI) program to reduce cardiovascular risk for people with type 2 diabetes by improving glucose, blood pressure, and lipid management initiation. The program began in 2019 with an adult endocrine center in the Northeast and a primary care center on the West Coast. In 2023, a new equity-focused type 2 diabetes intervention began with 3 adult endocrine centers on the East Coast, with an aim to increase access to and use of continuous glucose monitors. In 2023, 4 primary care centers focused on improving screening measures for adults with type 2 diabetes, prioritizing glycated hemoglobin A1c, blood pressure, lipid, and urine albumin-to-creatinine ratio. Each clinic received training in quality improvement (QI) methodology and coaching from QI consultants to develop initiatives tailored to the needs of their clinics. Lessons gathered through qualitative interviews and reports included the importance of training the clinical team in QI methodology; adopting lower effort, higher impact interventions to build momentum and cultivate confidence and engagement among clinical teams; obtaining timely data updates; and engaging partners who could champion the work, influence practice, and navigate system complexities. The expansion of T1DX-QI to include type 2 diabetes demonstrated that standardized QI training and interventions developed through a data-driven iterative process and delivered through multidisciplinary teams can be successful.

PMID 42669157
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PubMedCancer pathogenesis and therapy2026-08-30

Efficacy and safety of SCT200 in patients with recurrent or metastatic head and neck squamous cell carcinoma after platinum failure: A phase 2 study.

Shi Yuankai Y, Zhang Qingyuan Q, Wang Wei W, Shi Jianhua J et al.

There are limited treatment options for patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) progressing after platinum-based therapy. Epidermal growth factor receptor (EGFR)-targeting monoclonal antibodies (mAbs) have demonstrated efficacy in R/M HNSCC. This phase 2 study evaluated the efficacy and safety of SCT200, a novel fully humanized EGFR mAb, in Chinese patients with R/M HNSCC progressing after platinum-based therapy. This was a single-arm, multi-center phase 2 study, which enrolled patients with R/M HNSCC who had progressed after ≥2 cycles of platinum-based therapy. All patients received SCT200 at 6.0 mg/kg weekly for the first 6 weeks, followed by 8.0 mg/kg every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was the objective response rate (ORR). Between November 14, 2018, and April 2, 2020, 36 patients were enrolled. The ORR was 13.9% (5/36, 95% confidence interval [CI]: 4.7-29.5), the complete response rate was 2.8% (1/36), while the partial response rate was 11.1% (4/36). The disease control rate was 69.4% (25/36, 95% CI: 51.9-83.7). The median time to response was 1.38 months (95% CI: 0.99-2.60). The median duration of response was 5.95 months (95% CI: 2.60-not reached [NR]). The median progression-free survival and overall survival were 3.98 months (95% CI: 2.76-5.32) and 8.77 months (95% CI: 6.64-NR), respectively. Grade ≥3 treatment-related adverse events occurred in 44.4% (16/36) of patients, with the most common being hypomagnesemia (7/36, 19.4%, 95% CI: 8.2-36.0), hypokalemia (3/36, 8.3%, 95% CI: 1.8-22.5), rash (2/36, 5.6%, 95% CI: 0.7-18.7), and anemia (2/36, 5.6%, 95% CI: 0.7-18.7). This study demonstrated promising efficacy and a manageable safety profile of SCT200 in patients with R/M HNSCC progressing after platinum-based chemotherapy. Clinical Trials.gov, NCT03713372; https://www.clinicaltrials.gov.

PMID 42668534
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PubMedJournal of molecular histology2026-08-30

Early effects of X-ray irradiation on rat incisor periodontal ligament morphology and MMP-2 expression.

Fischborn Amanda Regina AR, Sartor Letícia L, Omar Nadia Fayez NF, Gomes Jose Rosa JR

Radiotherapy is an effective treatment for head and neck cancer; however, it also induces alterations in healthy oral tissues. Although late radiation-induced damage has been extensively investigated, the early progression of morphological and extracellular matrix changes in the periodontal ligament (PDL) remains poorly understood. This study investigated early radiation-induced changes in collagen organisation, the type I-to-type III collagen ratio, and matrix metalloproteinase-2 (MMP-2) expression in the lingual PDL of rat incisors. Adult Wistar rats were allocated to four irradiated groups (n = 5 per group) and exposed to a single 15 Gy X-ray dose directed to the head. Animals were euthanized at 4, 9, 14, or 25 days after irradiation. A non-irradiated control group was euthanized on day 4. Left hemimandibles were fixed, decalcified, embedded in paraffin, and sectioned. Histological analyses were performed using hematoxylin and eosin, Masson's trichrome, and Picrosirius Red staining under polarized light. MMP-2 expression was evaluated by immunohistochemistry and quantified by grayscale pixel intensity analysis. Irradiation induced progressive alterations in the lingual periodontal ligament. Fibroblast nuclei exhibited morphological features consistent with cellular injury beginning on day 4, with increasing changes at subsequent time points. These changes were accompanied by progressive disorganisation of collagen bundles, increased interfibrillar spaces, and loss of normal extracellular matrix architecture. Picrosirius Red analysis demonstrated a reduction in the type I-to-type III collagen ratio on days 4, 9, and 14 after irradiation, supporting the morphological changes observed with H.E and Masson's trichrome staining. MMP-2 expression increased significantly on day 4, reached its highest level on day 9, and then progressively decreased on days 14 and 25. A single dose of X-ray irradiation induces early morphological and extracellular matrix alterations in the rat incisor periodontal ligament. The temporal association between increased MMP-2 expression, collagen fibre disorganisation, and a decreased type I-to-type III collagen ratio suggests that MMP-2 is associated with the early extracellular matrix remodelling observed on days 4 and 9 after irradiation. The subsequent decline in MMP-2 expression was accompanied by an apparent partial restoration of collagen fibre organisation on days 14 and 25.

PMID 42669096
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PubMedEuropean heart journal. Digital health2026-08-30

Artificial intelligence-enhanced electrocardiography for the prediction of future type 2 diabetes mellitus: a model-development and multicentre validation study.

Pastika Libor L, Patlatzoglou Konstantinos K, Sieliwonczyk Ewa E, Barker Joseph J et al.

A significant proportion of type 2 diabetes cases remain undiagnosed despite screening advances, carrying substantial cardiometabolic risk. Artificial intelligence-enhanced electrocardiography (AI-ECG) detects subtle ECG changes in subclinical disease, potentially enabling opportunistic screening. We developed AI-ECG Risk Estimator for Diabetes Mellitus (AIRE-DM), a convolutional neural network with discrete-time survival loss, for diagnosis of prevalent and prediction of incident type 2 diabetes. It was trained on 1 163 401 ECGs from 189 537 individuals from Beth Israel Deaconess Medical Center (BIDMC) and externally validated in UK Biobank (UKB; n = 65 606) and ELSA-Brasil (n = 13 739). AI-ECG Risk Estimator for Diabetes Mellitus demonstrated moderate discrimination for prevalent type 2 diabetes (area under the receiver operating characteristic curve: BIDMC 0.724, UKB 0.733, ELSA-Brasil 0.706) and incident type 2 diabetes (C-index: BIDMC 0.667, UKB 0.688, ELSA-Brasil 0.625). The highest AIRE-DM risk quartile had elevated incident diabetes risk vs. the lowest (hazard ratio: BIDMC 4.75, UKB 7.52, ELSA-Brasil 3.96). AI-ECG Risk Estimator for Diabetes Mellitus was non-inferior to the American Diabetes Association Diabetes Risk Test in BIDMC, with improved predictive accuracy when combined. In normoglycaemic patients, AIRE-DM was superior to glycated haemoglobin (HbA1c) for predicting incident diabetes in BIDMC and non-inferior in ELSA-Brasil. The highest risk quartile reached 5% cumulative type 2 diabetes mellitus incidence 5.4 years (BIDMC) and 4.8 years (ELSA-Brasil) earlier than the lowest risk quartile, after adjusting for HbA1c, age, and sex. Phenome- and genome-wide association studies revealed biologically plausible associations with glucose regulation, cardiac morphology, diastolic dysfunction, arterial stiffness, and lipid metabolism. AI-ECG Risk Estimator for Diabetes Mellitus detects prevalent type 2 diabetes and predicts incident disease, uniquely identifying high-risk individuals within the normoglycaemic range. Combined with clinical scores or biomarkers, it enhances risk stratification, enabling earlier intervention.

PMID 42668860
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