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superoxide dismutase (bSOD, OXIS / Orgotase / Peroxinorm)

✓ Approved

GT Biopharma, Inc. · therapeutic agent

What is superoxide dismutase?

superoxide dismutase is a therapeutic agent developed by GT Biopharma, Inc.. It is approved for therapeutic indications.

Drug Profile

Brand NamesbSOD, OXIS, Orgotase, Peroxinorm
CompanyGT Biopharma, Inc.
StatusApproved
Sources: ClinicalTrials.gov, GT Biopharma, Inc.

Therapeutic Indications

superoxide dismutase is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Nervous system disordersAmyotrophic lateral sclerosis✓ Approved
Musculoskeletal and connective tissue disordersArthritis✓ Approved

Related Research Articles

PubMedFrontiers in pharmacology2026-09-19

Effects of adenosine triphosphate and reduced glutathione on biochemical, histopathological and immunofluorescence alterations associated with atezolizumab-induced cardiac tissue injury.

Yasar Yesim Kaya YK, Sezgin Esra Tuba ET, Suleyman Bahadir B, Mammadov Renad R et al.

In this study, the potential protective effects of adenosine triphosphate (ATP) and glutathione (GSH) against atezolizumab-induced cardiac injury in rat heart tissue were investigated. A total of 24 male albino Wistar rats were used in the experiment. The animals were divided into four groups: healthy group adenosine triphosphate + atezolizumab (ATAZ), GSH + atezolizumab (GHAZ), and atezolizumab alone (ATZ). ATP was administered intraperitoneally at a dose of 4 mg/kg, while GSH was administered orally at a dose of 200 mg/kg for 7 days. Atezolizumab was administered intraperitoneally to the experimental groups at a dose of 10 mg/kg twice weekly. At the end of the experiment, malondialdehyde total glutathione (tGSH), superoxide dismutase catalase, interleukin-1β (IL-1β), and interleukin-6 (IL-6) levels in heart tissues were measured using biochemical methods. In addition, histopathological and immunofluorescence examinations were performed. The results showed that oxidative stress and inflammation markers increased, whereas antioxidant parameters decreased in the atezolizumab-treated group. ATP and GSH administration significantly attenuated these changes and exerted protective effects on cardiac tissue. Overall, ATP and GSH ameliorated the biochemical, histopathological, and immunofluorescence changes associated with atezolizumab-induced cardiac injury in this experimental model.

PMID 42761064
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PubMedDrug development research2026-09-19

Comparative Evaluation of Plumbagin and Sorafenib in NDEA-TAA-Induced Hepatocellular Carcinoma: Effects on Hepatic Function, Redox Homeostasis and Histopathology.

Adetola Akinade K AK, Ugbaja Regina N RN, Adeyi Olubisi E OE, Thomas Funmilola C FC et al.

Hepatocellular carcinoma (HCC) is a major contributor to cancer-related mortality worldwide and is closely linked to oxidative stress and progressive hepatic dysfunction. This study investigated the effects of plumbagin on antioxidant defense systems and hepatic function markers in an N-nitrosodiethylamine-thioacetamide (NDEA-TAA)-induced experimental model of HCC and compared its efficacy with that of sorafenib. Male Wistar rats were assigned to five groups: normal control, plumbagin-only, HCC control, HCC treated with plumbagin, and HCC treated with sorafenib. Hepatocarcinogenesis was induced using NDEA-TAA, after which antioxidant parameters including reduced glutathione (GSH), glutathione-S-transferase (GST), glutathione peroxidase (GPx), catalase (CAT), superoxide dismutase (SOD), and malondialdehyde (MDA) were evaluated alongside hepatic function markers alanine aminotransferase (ALT) and albumin (ALB). The HCC control group exhibited significant reductions in GSH, GST, GPx, CAT, and SOD activities, accompanied by elevated MDA and ALT levels and decreased ALB concentrations (p ≤ 0.05), indicating severe oxidative stress and hepatic injury. Treatment with plumbagin significantly restored antioxidant enzyme activities, reduced lipid peroxidation, and improved hepatic function relative to the untreated HCC group. These effects were comparable to, and in certain parameters exceeded, those observed following sorafenib administration. The findings demonstrate that plumbagin possesses substantial antioxidative and hepatoprotective properties capable of mitigating oxidative damage and improving liver function in experimental HCC. These findings support further investigation of plumbagin as a redox-modulating candidate in HCC and a basis for future studies incorporating combination treatment, molecular validation and translational models.

PMID 42760844
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PubMedApplied biochemistry and biotechnology2026-09-19

Biocompatibility and Multifunctional Biological Evaluation of Flower-Shaped Ag₂CO₃ and Ag/Ag₂CO₃ Nanostructures in Diabetic Albino Mice.

Umar Ali A, Roy Dibakar D, Khan Misbah Ullah MU, Imanov Huseyn H et al.

The present study aimed to synthesize Ag₂CO₃ and Ag/Ag₂CO₃ nanostructures and to systematically investigate their physicochemical characteristics, biocompatibility, metabolic effects, wound healing potential, antioxidant activity, and antibacterial efficacy. Both nanostructures were synthesized using a controlled chemical reduction method. X-ray diffraction analysis confirmed the crystalline Ag₂CO₃ phase and the successful incorporation of metallic silver in the Ag/Ag₂CO₃ composite, while zeta potential analysis revealed enhanced colloidal stability for Ag/Ag₂CO₃ (approximately - 38 mV) compared with Ag₂CO₃ (approximately - 28 mV). Biocompatibility and safety evaluation in non-diabetic mice, including complete blood count, liver and renal function tests, and lipid profiling, demonstrated that both nanostructures were well tolerated at the administered doses without evidence of severe toxicity. In alloxan-induced diabetic mice, treatment with Ag₂CO₃ and Ag/Ag₂CO₃ resulted in significant glucose-lowering effects from Day 7 onward. Serum insulin, triiodothyronine (T3), and thyroxine (T4) levels were significantly improved at Days 14 and 28 compared with diabetic controls. Antioxidant assessment after 28 days showed reduced malondialdehyde levels and enhanced activities of superoxide dismutase, catalase, and reduced glutathione. In a diabetic excision wound model with an initial wound area of 1.2 cm2, complete wound healing occurred by Day 19 in diabetic controls, Day 17 in Ag₂CO₃-treated mice, and Day 14 in Ag/Ag₂CO₃-treated mice. Additionally, both nanostructures exhibited concentration-dependent antibacterial activity against Staphylococcus aureus and Escherichia coli, with Ag/Ag₂CO₃ producing inhibition zones of up to approximately 17 mm at 100 µg/mL. Overall, Ag/Ag₂CO₃ nanostructures demonstrated superior multifunctional biomedical performance.

PMID 42760450
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PubMedBMC sports science, medicine & rehabilitation2026-09-19

Physical activity and oxidative stress biomarkers in humans: a systematic review and quantitative meta-analysis.

Wahib Hassan Rahim HR, Afroundeh Roghayyeh R, Farzizadeh Reza R, Malekzadeh Reza R

The effects of physical activity on oxidative stress biomarkers in humans remain heterogeneous. This systematic review and meta-analysis quantified exercise-induced changes in key redox biomarkers. Following PRISMA 2020 (PROSPERO: CRD420251144711), a systematic search of PubMed, Scopus, and Web of Science (2000-2025) identified human studies assessing malondialdehyde (MDA), superoxide dismutase (SOD), catalase (CAT), glutathione (GSH), total antioxidant capacity (TAC), and total antioxidant status (TAS). Random-effects models estimated pooled standardized mean differences (SMD) with 95% confidence intervals (CI). Subgroup analyses, meta-regression, sensitivity analyses, publication bias, and risk-of-bias assessments were fully performed. Among 98 eligible studies (up to 31 meta-analyzed, n = 4,742), physical activity significantly reduced MDA (SMD = -1.02; 95% CI: -1.95 to -0.09; p = 0.032; I² = 94.6%) and increased TAS (SMD = 0.76; 95% CI: 0.38 to 1.15; p < 0.001; I² = 0.0%). GSH showed a non-significant trend toward reduction (SMD = -0.58; p = 0.075; I² = 88.5%), while CAT, SOD, and TAC demonstrated no significant pooled effects. Subgroup analyses identified effect modification by age, BMI, and duration, though meta-regression found no linear relationships with age or duration. Sensitivity analyses confirmed robustness for SOD, GSH, and TAS, while MDA, CAT, and TAC were influenced by influential studies. Publication bias was detected for GSH (Egger's p = 0.006). Heterogeneity was substantial (I² = 87-97%), and most studies were of moderate methodological quality. Physical activity selectively reduces lipid peroxidation and enhances non-enzymatic antioxidant capacity without uniformly upregulating enzymatic defenses. However, due to substantial heterogeneity, moderate methodological quality, and potential publication bias for GSH, these findings should be interpreted cautiously as exploratory. PROSPERO CRD420251144711.

PMID 42760575
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PubMedReproduction in domestic animals = Zuchthygiene2026-09-19

Effects of Post-Thaw Toll-Like Receptor 1/2 Agonist and Antagonist Exposure on Motility Subpopulations and Functional Characteristics of Bovine Spermatozoa.

Kanno Chihiro C, Oshima Toju T, Sato Shogo S, Maeda Yosuke Y et al.

Toll-like receptor 2 (TLR2) has been implicated in fertilization-related functions of bovine spermatozoa, but post-thaw responses to pharmacological TLR1/2 modulation across kinematic and membrane-related characteristics remain less defined. One ejaculate from each of four Holstein bulls was used and semen was exposed after thawing to a TLR1/2 agonist, a TLR1/2 antagonist or no additive. Five independent experimental repetitions per bull were performed using separate straws from the same ejaculate; therefore, the biological donor sample size was four bulls. Computer-assisted sperm analysis and k-means clustering identified six kinematically defined motility subpopulations and flow cytometry assessed plasma membrane and acrosomal integrity, membrane fluidity and mitochondrial superoxide-related fluorescence using MitoSOX Red. At 3 h, antagonist exposure reduced total motility compared with control and agonist treatments (30.1% ± 6.3% vs. 40.4% ± 5.6% and 37.7% ± 5.8%, respectively; adjusted p = 0.001). Conversely, antagonist-treated samples contained more spermatozoa with intact plasma membrane and acrosome than agonist-treated samples (52.4% ± 3.4% vs. 48.4% ± 3.1%; adjusted p = 0.001) and more viable spermatozoa with low MitoSOX fluorescence (31.1% ± 6.1% vs. 22.4% ± 4.7%; adjusted p = 0.001). Agonist exposure increased the proportion of viable spermatozoa with high membrane fluidity and was associated with higher MitoSOX fluorescence than antagonist exposure. These findings describe distinct post-thaw functional profiles following pharmacological TLR1/2 agonist and antagonist exposure; they do not establish TLR2-specific causality or effects on fertilizing competence.

PMID 42760863
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PubMedClinical laboratory2026-09-18

Correlation between Polymorphisms of the Superoxide Dismutase Gene and Idiopathic Nephrotic Syndrome in Chinese Children.

Lin Shudan S, Li Liucen L, Wang Bili B, Zhu Zhouyue Z et al.

Genetic mutations are closely linked to childhood idiopathic nephrotic syndrome (INS). This study aimed to explore the associations between superoxide dismutase (SOD) gene polymorphisms and susceptibility to INS, as well as response to steroid therapy, in Chinese children. Five single nucleotide polymorphisms (SNPs; rs4816407, rs1041740, rs4880, rs2758346, and rs3798215) in the SOD1 and SOD2 genes were genotyped using multiplex PCR combined with next-generation sequencing in 183 pediatric patients with INS and 100 healthy controls. The genotypic distributions of the tested SOD SNPs did not differ significantly between the INS group and healthy controls. Patients carrying the CC genotype of SOD1 rs1041740 exhibited a significantly higher risk of steroid-dependent (SD) nephrotic syndrome than those with steroid-sensitive (SS) nephrotic syndrome (p = 0.002, OR = 2.247, 95% CI = [1.191 - 4.239]). However, no significant differences in these five SNPs were observed between the SS and steroid-resistant (SR) subgroups (all p > 0.05). Our findings indicate that SOD gene polymorphisms are not associated with susceptibility to INS in Chinese children. Notably, SOD1 rs1041740 variants may increase the risk of steroid dependence in this pediatric population.

PMID 42758897
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