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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

PubMedAdvanced healthcare materials2026-07-17

Crystallinity-Gradient Etched Hollow Mesoporous Zinc Nanoparticle for Dual-Source H2O2-Driven Tumor Ferroptosis Therapy.

Cai Haobin H, Yang Jing J, Wang Zehui Z, Chen Xinyu X et al.

Zn2+ offers significant advantages for cancer therapy via mitochondrial disruption, immune activation, and metal homeostasis perturbation, but faces challenges of rapid clearance and systemic toxicity. Existing zinc‑based (e.g., zinc oxide (ZnO), and zinc peroxide) nanoparticles often lack internal voids and sufficient surface area, restricting drug loading and functionalization. In this study, we developed a crystallinity‑gradient selective etching method to tailor biodegradable hollow mesoporous zinc nanoparticle (HMZN). Typically, zinc peroxide nanoparticles with low‑crystallinity core and high‑crystallinity shell were synthesized, and ammonia water was used to selectively etch the inner low‑crystallinity core, producing HMZN. Hemin (HEM) and Gd‑poly(acrylic acid) macrochelates (GP) were then loaded to construct HEM@HMZN@GP for dual-source H2O2 surge-driven tumor ferroptosis therapy. In acidic tumor microenvironment, Zn2+, H2O2, HEM, and GP can be released from HEM@HMZN@GP. The released Zn2+ damages mitochondrial electron transport chain (ETC) and generates superoxide anions (•O2 -), which can be rapidly catalyzed by superoxide dismutase into H2O2. The dual-source of H2O2 markedly elevates local oxidative stress. HEM can be enzymatically converted by heme oxygenase‑1 to Fe2+, which reacts with the abundant H2O2 via Fenton reaction to produce hydroxyl radicals, initiating lipid peroxidation and ferroptosis. GP enhances T1‑weighted magnetic resonance imaging signals, facilitating drug delivery visualization in tumors.

PMID 42464434
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PubMedbioRxiv : the preprint server for biology2026-07-17

An engineered biofactory for efficient production of diverse recombinant superoxide dismutase isozymes loaded with specific metal ions for biochemical characterisation.

Mazgaj Rafał R, Kołpa Agnieszka A, Esmaeeli Mariam M, Pełczyńska Justyna J et al.

Biochemical, biophysical and structural characterisation of isozymes from the ubiquitous family of iron- or manganese-dependent superoxide dismutases (SodFMs) requires the purification of high-quality preparations of recombinant enzymes. Determination of their key biochemical parameter, their catalytic metal-preference, requires the comparison of the catalytic turnover of samples loaded exclusively with iron versus samples loaded exclusively with manganese. Both of these aims are inhibited by the potential contamination of recombinant preparations of SodFMs, prepared by heterologous overexpression inside Escherichia coli cells, by even low levels of endogenous SodFMs from the host, both of which show very high turnover with either manganese ( E. coli MnSOD) or iron (FeSOD). To overcome this problem, we created a strain of E. coli lacking the endogenous SodFMs. Here, we characterised this E. coli BL21 (DE3) Δ sodA Δ sodB strain, determining the physiological effects of SodFM deletion and demonstrating its utility for producing recombinant SodFMs for in vitro characterisation and use. Genomic analysis verified the targeted gene deletions, without off-target effects. Growth, expression, elemental analysis, and proteomic data confirmed a lack of physiological defects of the strain except for a known inability to grow on glucose, which is overcome by heterologous SodFM expression. We demonstrate the utility of the strain for the efficient production of diverse recombinant SodFMs, including highly divergent, understudied isozymes, including the ability to precisely control the metal-loading of the heterologously expressed protein. The E. coli strain described herein is a useful microbial cell factory for production of recombinant SodFMs, which should find widespread utility as expression host of choice, enabling more efficient production of protein for studies of the biochemical, biophysical and structural properties of this remarkable family of metalloenzymes.

PMID 42465305
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PubMedTissue & cell2026-07-17

Hydroxytyrosol attenuates STZ-induced nephropathy in pinealectomized rats: Associations with oxidative stress, inflammation, and SIRT1/Nrf2/GPX4-related responses.

Cinar Derya D, Altinoz Eyup E, Basak Feyza F, Kusat Tansu T et al.

Diabetic nephropathy (DN) is a significant microvascular disorder that develops as a serious complication of chronic diabetes. The aim of this study was to evaluate the protective effects of hydroxytyrosol (HT) against STZ-induced nephropathy in pinealectomized rats, with particular focus on oxidative stress, inflammation, and changes associated with SIRT1, Nrf2, and GPX4. In the study, both sham and pinealectomized rats were rendered diabetic through an STZ injection and subsequently treated with HT (10 mg/kg) for 15 days. The results indicated that HT treatment reduced the severity of DN, as evidenced by decreased blood urea nitrogen (BUN) and creatinine (Cr) levels. Additionally, HT enhanced renal antioxidant capacity, as demonstrated by increased activities of superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPX), along with elevated levels of reduced glutathione (GSH). Furthermore, HT suppressed renal inflammation, as reflected by reduced levels of TNF-α and IL-1β, and attenuated oxidative stress. Histopathological alterations and changes in SIRT1, Nrf2, and GPX4 immunoreactivity were associated with improvements following HT treatment in STZ-induced DN. Overall, the current study suggests that HT supplementation may exert renoprotective effects against STZ-induced nephropathy, accompanied by attenuation of oxidative stress and inflammation and associated with changes in SIRT1, Nrf2, and GPX4 immunoreactivity.

PMID 42462598
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PubMedChemico-biological interactions2026-07-17

Sex-Specific Differences in Cadmium Accumulation and Responses in the Freshwater Snail Cipangopaludina cathayensis.

Jinyou Wei W, Shanshan Xiang X, Jing Yu Y, Linli Li L et al.

Cadmium (Cd) is a non-essential element with strong toxicity to aquatic mollusks. Although sex-specific Cd accumulation has been reported, the distinct impacts on males and females and their adaptive strategies remain unclear. We exposed freshwater snails (Cipangopaludina cathayensis) to 0.5 mg/L Cd for 14 days and analyzed Cd accumulation, histology, biochemical indicators, gonadal transcriptomics, and hepatopancreatic metabolomics. Cd levels in ovaries were significantly higher than in testes, while hepatopancreatic levels showed no sex difference. Cd disrupted gonadal antioxidant defenses and induced oxidative stress: testes maintained persistently elevated total superoxide dismutase (T-SOD) and glutathione (GSH), whereas ovarian levels initially rose then declined. Structural damage (seminiferous tubule rupture, follicular wall disruption) and reduced sex steroid hormones (testosterone (T) and estradiol (E2)) further impaired gonadal function. Transcriptomic analysis revealed that testes upregulated protein metabolism pathways (e.g., Protein digestion and absorption, Protein processing in endoplasmic reticulum with HSP70/HSP90) to maintain homeostasis under Cd stress. Hepatopancreatic metabolomics showed disrupted lipid metabolism, with females displaying greater lipid droplet accumulation. Under Cd stress, males retained stronger exogenous nutrient transport and repair capacity, whereas females relied on energy-intensive endogenous synthesis. Overall, Cd effects were more severe in females, highlighting clear sex-specific differences in response and tolerance.

PMID 42462871
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PubMedBiomaterials2026-07-17

Ru/CoMn-LDH@CTP nanozymes with catalytic antioxidant activity alleviate myocardial glucolipotoxicity through inhibition of lipid peroxidation.

Zhang Susu S, Hu Wuming W, Wang Tao T, Lv Yishan Y et al.

Diabetic cardiomyopathy (DbCM), a severe complication of type 2 diabetes mellitus (T2DM), is driven by glucolipid metabolism dysregulation-induced oxidative stress and ferroptosis. Current clinical management, primarily relying on glucose-lowering agents, shows limited efficacy due to poor myocardial targeting efficiency and inability to intervene in these interconnected pro-death pathways. Here we develop a cardiac-targeting multifunctional nanozyme (Ru/CoMn-LDH@CTP) by loading Ru single atoms onto layered double hydroxides (LDHs) and conjugating with cardiac-targeting peptide (CTP) for DbCM treatment. This nanozyme exhibits synergistic superoxide dismutase/catalase-mimetic activities and acid stability for broad-spectrum reactive oxygen species (ROS) scavenging. CTP modification enables efficient myocardial targeting and lysosomal escape for mitochondrial delivery. In vitro, Ru/CoMn-LDH@CTP effectively alleviates glucolipotoxicity-induced oxidative damage, reducing mitochondrial ROS to 54.47% and cardiomyocyte apoptosis to 18.76% of those in the injury group. In a DbCM mouse model, the nanozyme selectively accumulates in cardiac lesions, attenuates oxidative damage, reduces fibrosis to 38.68% of the original level, thereby suppressing ventricular remodeling and promoting cardiac functional recovery. Mechanistically, Ru/CoMn-LDH@CTP inhibits ferroptosis by upregulating protective proteins (GPX4, xCT, and CAT), while downregulating ACSL1 and 4-HNE. This work presents a smart targeted nanozyme with multi-enzyme synergy and acid stability, offering a novel therapeutic strategy for DbCM and related cardiovascular diseases.

PMID 42462536
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PubMedMarine pollution bulletin2026-07-17

Near-infrared spectroscopy for rapid and non-destructive assessment of PFAS effects in blue mussels (Mytilus spp.): a proof-of-concept study.

Guinle Colleen C, Levasseur-Garcia Cécile C, Poirier Laurence L, Déléris Paul P et al.

Per- and polyfluoroalkyl substances (PFAS) are persistent contaminants of emerging concern known to induce various sublethal effects in aquatic organisms. This study explored the potential of near-infrared spectroscopy (NIRS) as a rapid, non-destructive method for assessing PFAS-induced biochemical alterations in blue mussels (Mytilus spp.). Mussels were exposed for 28 days to three experimental conditions: control, dietary PFAS exposure, and combined dietary and aqueous PFAS exposure. NIR spectra were acquired on 90 samples of gill and mantle tissues, and biological responses were assessed using conventional biochemical biomarkers, including protein and lipid hydroperoxide (LOOH) concentrations, and activities of superoxide dismutase (SOD), glutathione-S-transferase (GST), and acetylcholinesterase (AChE). Classification models combining principal component analysis and discriminant analysis achieved high accuracies (81-91%) in discriminating between exposed and non-exposed mussels. Partial least square regression models demonstrated that NIRS could accurately quantify protein contents (R2 = 0.86, RPD = 2.45) and provide semi-quantitative predictions of SOD activity (R2 = 0.73, RPD = 1.83). However, model's predictive performances were limited for LOOH concentrations (R2 = 0.47, RPD = 1.24), GST activity (R2 = 0.23, RPD = 1.09), and AChE activity (R2 = 0.05, RPD = 1.04). Overall, these findings provide proof-of-concept that NIRS can capture contaminant-induced molecular changes in mussel tissues, offering a promising alternative method for diagnosing the general physiological status of individuals. Future work, including further experimental studies with various contamination scenarios and field-based validation studies, could enable the deployment of NIR-based tools for rapid and environmentally friendly assessment of contaminant impacts in bivalve biomonitoring programs.

PMID 42462577
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