Abstract: Provided herein are tablet(s) comprising N-acetylcysteine amide (NACA) and a NACA-acceptable, biocompatible excipient and optionally one or more pharmaceutically acceptable additives, binders, or fillers. Also provided are pharmaceutical composition(s) in the form an oral tablet comprising N-acetylcysteine amide (NACA), wherein the composition has a pharmacokinetic (PK) profile comprising mean plasma concentrations of NACA range from about 200 to 1200 ng/mL after administration of the pharmaceutical composition to a human.

Abstract: Provided herein are compositions and methods for treating patients with Usher syndrome associated retinitis pigmentosa (UARP) comprising identifying that the subject has UARP and administering to the animal or human an effective amount of an N-acetylcysteine amide (NACA) sufficient to protect vision and inhibit degradation of Ellipsoid Zone (EZ) area and retinal sensitivity. In one example, the NACA formulation is doses at 50, 100, 200, 201, 210, 225, 250, 275, 300, 350, 400, 450, 500, 600, 700, 750, 800, 900, or 1,000 mg/day.

Abstract: The present disclosure provides a pharmaceutical composition comprising ebselen, wherein the composition is formulated for oral administration. Also provided are pharmaceutical dosage forms including the same. In some embodiments, the dosage form is a solid dosage form, such as a tablet (e.g., an uncoated pressed tablet). Also provided are methods of delivering the subject ebselen pharmaceutical dosage forms to a subject to achieve an enhanced maximum blood plasma concentration (Cmax) with respect to a control ebselen formulation, and a maximum blood plasma concentration (Cmax) for ebselen within 4 hours or less of administration.

Abstract: Provided herein are methods for the treatment of retinitis pigmentosa in a human that comprises administering to the human a therapeutically effective amount of N-acetylcysteine amide (NACA).

Abstract: The present disclosure provides an amorphous solid dispersion (ASD) comprising an amorphous form of ebselen. Also provided are pharmaceutical compositions and pharmaceutical dosage forms including the subject amorphous solid dispersion. Also provided are methods of delivering the subject ebselen pharmaceutical dosage forms to a subject to achieve an enhanced maximum blood plasma concentration (Cmax) for ebselen with respect to a control ebselen formulation, and an area under the curve (AUC) for both ebselen and an ebselen metabolite that is greater than that achieved with a control ebselen formulation.

Abstract: The present invention includes a method for the use of N-acetylcysteine (NAC), N-acetylcysteine amide (NAC A) or (2R,2R?)-3,3?-disulfanediylbis(2-acetamidopropanamide) (diNACA) for the prevention and treatment of radiation dermatitis, radiation damage to the skin, xeroderma pigmentosa or protect patients with xeroderma pigmentosa from skin damage caused by exposure to the sun or other radiation, bioweapons, chemical burns, heat burns, contact damage caused by friction, contact dermatitis, hypersensitivity reactions and skin wrinkles and dehydration, skin lightening, skin whitening, and/or skin improvement in a human that comprises administering to the human a therapeutically effective amount of NAC, NACA or diNACA.

Abstract: Provided herein are tablet(s) comprising N-acetylcysteine amide (NACA) and a NACA-acceptable, biocompatible excipient and optionally one or more pharmaceutically acceptable additives, binders, or fillers. Also provided are methods for making the tablets comprising N-acetylcysteine amide (NACA) and a NACA-acceptable, biocompatible excipient and optionally one or more pharmaceutically acceptable additives, binders, or fillers, e.g., comprising slugged tablets, wherein the slugged tablets have greater than 90, 91, 92, 93, 94, 95, 96, 97, 98, or 100% of the slugged tablets meet specifications; target width of 10 to 12 mm, or 11 mm; target weight of approximately 475 to 525 mg; and thickness range of approximately 4 to 6 mm, 4.5 to 5.5 mm or 5 mm. Pharmaceutical composition(s) in the form an oral tablet or capsule comprising N-acetylcysteine amide (NACA) for administration of the pharmaceutical composition to a human.

Abstract: The present invention includes a method for the use of N-acetylcysteine amide (NACA) or (2R,2R?)-3,3?-disulfanediyl bis(2-acetamidopropanamide) (diNACA) for prevention and treatment of radiation pneumonitis and treatment of pulmonary function in Cystic Fibrosis (CF), chronic obstructive pulmonary disease (COPD), or bronchitis in a human that comprises administering to the human a therapeutically effective amount of NACA or diNACA sufficient to treat, reduce the symptoms, or prevent radiation pneumonitis and treatment of pulmonary function in Cystic Fibrosis (CF), chronic obstructive pulmonary disease (COPD), bronchitis, or respiratory disorder due to oxidative stress, and diNACA for the reduction of mucus viscosity and/or elasticity.

Abstract: Provided herein are compositions and methods of providing an effective amount of an N-acetylcysteine amide (NACA) or diNACA sufficient to increase the concentration of NACA or diNACA in the affected tissue to biochemically reduce oxidative stress-related damage to tissue; utilizing NACA or diNACA that comprises at least one of impurities B1 or B2, which are indicative of NACA or diNACA manufactured by a process comprising: contacting cystine with methanol and a chlorinating reagent to form an organic solution containing cystine dimethylester dihydrochloride and optionally isolating and drying the cystine dimethylester dihydrochloride; combining the dried or undried cystine dimethylester dihydrochloride with triethylamine, acetic anhydride, and acetonitrile to form di-N-acetylcystine dimethylester; mixing the di-N-acetylcystine dimethylester with ammonium hydroxide to form di-N-acetylcystine amide (diNACA or NPI-002); and reducing the di-N-acetylcystine amide to N-acetylcysteine, NACA or NPI-001 with a reducin

Abstract: Provided herein are compositions and methods of providing an effective amount of an N-acetylcysteine amide (NACA) or diNACA sufficient to increase the concentration of NACA or diNACA in the affected tissue to biochemically reduce oxidative stress-related damage to tissue; utilizing NACA or diNACA that comprises at least one of impurities B1 or B2, which are indicative of NACA or diNACA manufactured by a process comprising: contacting cystine with methanol and a chlorinating reagent to form an organic solution containing cystine dimethylester dihydrochloride and optionally isolating and drying the cystine dimethylester dihydrochloride; combining the dried or undried cystine dimethylester dihydrochloride with triethylamine, acetic anhydride, and acetonitrile to form di-N-acetylcystine dimethylester; mixing the di-N-acetylcystine dimethylester with ammonium hydroxide to form di-N-acetylcystine amide (diNACA or NPI-002); and reducing the di-N-acetylcystine amide to N-acetylcysteine, NACA or NPI-001 with a reducin

Abstract: The present invention includes pharmaceutical composition comprising deuterated NACA-d3, deuterated di-NACA-d6, combinations thereof, or a physiologically acceptable salt thereof, having a deuterium enrichment above the natural abundance of deuterium, and derivatives or solids thereof, and methods of using NACA-d3, di-NACA-d6, or combinations thereof, to treat eye diseases and other diseases associated with oxidative damage including, e.g., antivenom, beta-thallassemia, cataract, chronic obstructive pulmonary disease, macular degeneration, contrast-induced nephropathy, asthma, lung contusion, methamphetamine-induced oxidative stress, multiple sclerosis, Parkinson's disease, platelet apoptosis, Tardive dyskinesia, Alzheimer disease, HIV-1-associated dementia, mitochondrial diseases, myocardial myopathy, neurodegenerative diseases, pulmonary fibrosis, skin pigmentation, skin in need of rejuvenation, antimicrobial infection, Friedreich's ataxia.

Abstract: The present invention relates in general to compositions and methods for treating an animal or human patient in need of treatment for ophthalmic diseases or conditions involving oxidative stress and treatment with an ophthalmic implant containing (2R,2R?)-3,3?-disulfanediyl bis(2-cetamidopropanamide) (diNACA), wherein such ophthalmic diseases or conditions include but not limited to cataracts, cataracts in a subject that does not have diabetes, corneal endothelial cell loss, age-related macular degeneration, presbyopia, retinitis pigmentosa (RP), Usher syndrome, Stargardt syndrome, glaucoma, diabetic retinopathy, and/or retinal disease.

Abstract: The present invention includes a method for the treatment of age-related macular degeneration, glaucoma, or diabetic retinopathy in a human that comprises administering to the human a therapeutically effective amount of N-acetylcysteine amide (NACA) or (2R,2R?)-3,3?-disulfanediyl bis(2-acetamidopropanamide) (diNACA) sufficient to treat or reduce the symptoms of the age-related macular degeneration, glaucoma, or diabetic retinopathy.

Abstract: The present invention includes pharmaceutical composition comprising (2R,2R?)-3,3?-disulfanediyl bis(2-acetamidopropanamide) (diNACA), deuterated NACA-d3, deuterated di-NACA-d6, combinations thereof, or a physiologically acceptable salt thereof, having a deuterium enrichment above the natural abundance of deuterium, and derivatives or solids thereof, and methods of using diNACA, NACA-d3, di-NACA-d6, or combinations thereof, to treat eye diseases and other diseases associated with oxidative damage including, e.g.

Abstract: The present invention includes a method for the treatment of age-related macular degeneration, glaucoma, or diabetic retinopathy in a human that comprises administering to the human a therapeutically effective amount of N-acetylcysteine amide (NACA) or (2R,2R?)-3,3?-disulfanediyl bis(2-acetamidopropanamide) (diNACA) sufficient to treat or reduce the symptoms of the age-related macular degeneration, glaucoma, or diabetic retinopathy.

Abstract: The present invention includes pharmaceutical composition comprising (2R,2R?)-3,3?-disulfanediyl bis(2-acetamidopropanamide)(diNACA) or D3-N-acetyl cysteine amide, or a physiologically acceptable salt thereof, having a deuterium enrichment above the natural abundance of deuterium, and derivatives or solids thereof, and methods of using diNACA to treat eye diseases and other diseases associated with oxidative damage including, e.g., antivenom, beta-thallassemia, cataract, chronic obstructive pulmonary disease, macular degeneration, contrast-induced nephropathy, asthma, lung contusion, methamphetamine-induced oxidative stress, multiple sclerosis, Parkinson's disease, platelet apoptosis, Tardive dyskinesia, Alzheimer disease, HIV-1-associated dementia, mitochondrial diseases, myocardial myopathy, neurodegenerative diseases, pulmonary fibrosis, skin pigmentation, skin in need of rejuventation, antimicrobial infection, Friedreich's ataxia.

Abstract: Presented herein are methods for making, isolating, and purifying N-acetylcysteine amide, (2R,2R?)-3,3?-disulfanediyl bis(2-acetamidopropanamide, diNACA), intermediates and derivatives thereof comprising: alternatively contacting cystine with methanol and a chlorinating reagent to form an organic solution containing L-cystine dimethylester dihydrochloride; combining dried or undried L-cystine dimethylester dihydrochloride with a triethylamine, an acetic anhydride, and an acetonitrile to form a di-N-acetylcystine dimethylester; mixing dried di-N-acetylcystine dimethylester with ammonium hydroxide to form a di-N-acetylcystine amide (diNACA); and separating dried di-N-acetylcystine dimethylester into N-acetylcysteine amide with dithiothreitol, triethylamine, and an alcohol.

Abstract: The present invention includes methods for making and isolating N-acetylcysteine amide, (2R,2R?)-3,3?-disulfanediyl bis(2-acetamidopropanamide, diNACA), intermediates and derivatives thereof comprising: contacting cystine with an alcohol and a chlorinating reagent to form an organic solution containing L-cystine dimethylester dihydrochloride; combining dried or undried L-cystine dimethylester dihydrochloride with a triethylamine, an acetic anhydride, and an acetonitrile to form a di-N-acetylcystine dimethylester; mixing dried di-N-acetylcystine dimethylester with ammonium hydroxide to form a di-N-acetylcystine amide (diNACA); and separating dried di-N-acetylcystine dimethylester into N-acetylcysteine amide with dithiothreitol, triethylamine and an alcohol.

Abstract: The present invention relates in general to the field of compositions and methods for using N-acetylcysteine amide (NACA) or (2R,2R?)-3,3?-disulfanediyl bis(2-acetamidopropanamide) (diNACA) for treating or alleviating a disorder or condition associated with ferroptosis, which can cause or contribute to diseases, disorders and conditions including aging associated with declining cognition, cognitive impairment, declining physical function, physical decline, elevated inflammation, endothelial dysfunction, insulin resistance, central obesity, loss of muscle mass (sarcopenia), neurological diseases and disorders, including neurodegeneration, stroke, including ischemic stroke and post-hemorrhagic stroke damage, and neurotrauma, including traumatic brain injury, Alzheimers disease, Huntington's disease, Niemann-Pick disease, Parkinson's disease, motor neuron disease, Amyotrophic Lateral Sclerosis, Sedaghatian-type spondylo-metaphyseal dysplasia, cancer, including breast cancer, kidney injuries including ischemia-re

Abstract: The present invention includes a method for the use of N-acetylcysteine (NAC), N-acetylcysteine amide (NAC A) or (2R,2R?)-3,3?-disulfanediylbis(2-acetamidopropanamide) (diNACA) for the prevention and treatment of radiation dermatitis, radiation damage to the skin, xeroderma pigmentosa or protect patients with xeroderma pigmentosa from skin damage caused by exposure to the sun or other radiation, bioweapons, chemical burns, heat burns, contact damage caused by friction, contact dermatitis, hypersensitivity reactions and skin wrinkles and dehydration, skin lightening, skin whitening, and/or skin improvement in a human that comprises administering to the human a therapeutically effective amount of NAC, NACA or diNACA.