Abstract: Disclosed are novel compositions, methods to improve a suboptimal therapeutic agent's performance in patients with cancer, infections, inflammatory, metabolic, immunological diseases. Describe are improvements ranging from pharmaceutical ingredients, dosage forms, excipients, solvents, diluents, drug delivery systems, preservatives, more accurate drug administrations, dose determination/schedules, toxicity monitoring and amelioration, techniques or agents. Using suboptimal therapeutic(s)s in conjunction with radiation(s) and/or conventional chemotherapeutic agent(s)s or biotherapeutic agent(s) including antibodies, vaccines, cytokines, lymphokines, gene and antisense RNA therapies, etc., would provide unique approaches, significant treatment improvement circumventing or reducing toxicity, including techniques and tools identifying/predicting patients by phenotype or genotype determination(s).

Abstract: The present disclosed invention provides pharmaceutical compositions and methods of use for bisbenzylisoquinolines such as 6,6?,7,12-tetramethoxy-2,2?-dimethyl-berbaman, and analogs, derivatives, isomers, and modified forms such as crystalline, salt forms, or a salt of this compound with a pharmaceutically acceptable acid or in combination with other agents to treat acute, chronic and pre-leukemic conditions as well as lymphomas and solid tumors. These include preneoplastic and neoplastic diseases and solid tumors including but not limited to acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), atypical chronic myeloid leukemia (aCML), and acute myeloid leukemia (AML), polycythemia vera (PV), chronic lymphoblastic leukemia (CLL), myeloproliferative syndrome (MPS), myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPN), myelofibrosis (MF), and polycythemia vera (PV).

Abstract: Provided herein are pharmaceutical compositions comprising Compound (I), wherein Compound (I) is of the formula: or a pharmaceutically acceptable salt, polymorph, solvate, tautomer, stereoisomer, or isotopically labeled derivative thereof. Also disclosed are polymorphs of Compound (I) and methods of using the pharmaceutical compositions and polymorphs of Compound (I) as described herein to treat a disease (e.g., cystic fibrosis, and fibrotic diseases, such as pulmonary fibrosis) comprising administering to a subject in need thereof a therapeutically effective amount of a polymorph of Compound (I) or a pharmaceutical composition comprising Compound (I) as described herein. In some aspects, the compositions are formulated for inhalation (e.g., oral or nasal inhalation).

Abstract: An object of this invention is to provide a pharmaceutical composition for preventing and/or treating acute kidney injury, and an autophagy activator. The invention relates to, for example, a pharmaceutical composition for preventing and/or treating acute kidney injury, comprising a compound represented by formula (1), a salt thereof, or a prodrug thereof: wherein A is an optionally substituted benzene ring; B is an optionally substituted aryl or an optionally substituted heteroaryl; X is an oxygen atom or a sulfur atom; Y is a nitrogen atom or a carbon atom; of is a single or double bond when Y is a carbon atom, or of is a single bond when Y is a nitrogen atom; each R1 independently represents lower alkyl, or two R1s may be bound to each other to form a spiro ring or a crosslinked structure, or two R1s may be bound to each other to form a saturated fused heterocycle together with nitrogen and carbon atoms constituting a ring containing Y; p is 0, 1, or 2; or (R1)p is oxo.

Abstract: This invention relates to the use of (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridin-3-yl]methanone (NSI-189) or a pharmaceutically acceptable salt thereof in the treatment of a psychiatric condition in which depressive symptoms are prominent, including major depressive disorder, bipolar disorder, posttraumatic stress disorder, substance use disorder, and depression-related aspects of schizophrenia (e.g. negative symptoms), in a patient who is cognitively impaired or has poor or slow cognition or difficulty making decisions or exhibits certain EEG properties. The present invention also relates to the selection of patients with a biomarker (e.g., EEG) and/or clinical symptoms who would most benefit from such compounds.

Abstract: This invention relates to the use of (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridin-3-yl]methanone (NSI-189) or a pharmaceutically acceptable salt thereof in the treatment of a psychiatric condition in which depressive symptoms are prominent, including major depressive disorder, bipolar disorder, posttraumatic stress disorder, substance use disorder, and depression-related aspects of schizophrenia (e.g. negative symptoms), in a patient who is cognitively impaired or has poor or slow cognition or difficulty making decisions or exhibits certain EEG properties. The present invention also relates to the selection of patients with a biomarker (e.g., EEG) and/or clinical symptoms who would most benefit from such compounds.

Abstract: This invention relates to the use of (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridin-3-yl]methanone (NSI-189) or a pharmaceutically acceptable salt thereof in the treatment of a psychiatric condition in which depressive symptoms are prominent, including major depressive disorder (MIDD), bipolar disorder, post-traumatic stress disorder, substance use disorder, and depression-related aspects of schizophrenia (e.g. negative symptoms) in select patients who exhibit impaired learning and/or memory. The invention also relates to the use of NSI-189 or a pharmaceutically acceptable salt thereof in the treatment of a psychiatric condition in which depressive symptoms are prominent, including major depressive disorder (MDD), in select patients who exhibit impaired learning and/or memory or certain EEG characteristics.

Abstract: This invention relates to the use of (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridin-3-yl]methanone (NSI-189) or a pharmaceutically acceptable salt thereof in the treatment of a psychiatric condition in which depressive symptoms are prominent, including major depressive disorder (MIDD), bipolar disorder, post-traumatic stress disorder, substance use disorder, and depression-related aspects of schizophrenia (e.g. negative symptoms) in select patients who exhibit impaired learning and/or memory. The invention also relates to the use of NSI-189 or a pharmaceutically acceptable salt thereof in the treatment of a psychiatric condition in which depressive symptoms are prominent, including major depressive disorder (MDD), in select patients who exhibit impaired learning and/or memory or certain EEG characteristics.

Abstract: This invention relates to the use of (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridin-3-yl]methanone (NSI-189) or a pharmaceutically acceptable salt thereof in the treatment of a psychiatric condition in which depressive symptoms are prominent, including major depressive disorder (MDD), bipolar disorder, post-traumatic stress disorder, substance use disorder, and depression-related aspects of schizophrenia (e.g. negative symptoms) in select patients who exhibit impaired learning and/or memory. The invention also relates to the use of NSI-189 or a pharmaceutically acceptable salt thereof in the treatment of a psychiatric condition in which depressive symptoms are prominent, including major depressive disorder (MDD), in select patients who exhibit impaired learning and/or memory or certain EEG characteristics.

Abstract: Extended-release microsphere formulations comprising lurasidone are provided. In one aspect. the microsphere formulations are characterized in that the lurasidone is released in vivo in humans over a period of about 30 days or about 60 days. Methods for making and using the formulations are also provided.

Abstract: Provided herein are compounds, compositions, and methods useful for modulating the integrated stress response (ISR) and for treating related diseases; disorders and conditions.

Abstract: Methods for treating high proteinuria chronic kidney disease and/or at least one disease, disorder, or condition associated therewith in patients by the use of a fixed-dose combination of zibotentan and dapagliflozin are disclosed.

Abstract: Compositions and methods related to the amelioration of pancreatitis through the pharmaceutical manipulation of calcium signaling are disclosed. Such compositions and methods may be used to ameliorate symptoms of acute or chronic pancreatitis or to reduce the chance or severity of pancreatitis in an individual at risk of the condition. In other embodiments, disclosed herein are compositions and methods related to the amelioration of viral diseases through the pharmaceutical manipulation of calcium signaling. In further embodiments, disclosed herein are compositions and methods related to the amelioration of Th17-induced diseases through the pharmaceutical manipulation of calcium signaling.

Abstract: The invention relates to compounds of Formula (I) and their use in therapy, for example in the treatment of mycobacterial infections or in the treatment of diseases caused by mycobacterium, such as tuberculosis.

Abstract: The disclosure provides methods for the acute treatment of depression and/or anxiety, for the enhancement of mTOR (e.g., mTORC1) signaling, and for the reduction of neuroinflammation, comprising administering to a patient in need thereof, a therapeutically effective amount of a 5-HT2A/mu-opioid receptor or 5-HT2A/D1 and/or D2/mu-opioid receptor ligand.

Abstract: The present Invention relates to pharmaceutical compositions of (3S, 11aR)-N-[(2,4-difluorophenyl)methyl]-2,3,5,7,11,11a-hexahydro-6-hydroxy-3-methyl-5,7-dioxo-oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide, useful in the treatment or prevention of Human Immunodeficiency Virus (HIV) infections.

Abstract: Pharmaceutical carriers which provide an environment of physical and chemical stability comprising a therapeutically effective amount of an active pharmaceutical ingredient (API) compound of structure I, one or more antioxidants, one or more chelators and a vehicle base comprising water and one or more pharmaceutically acceptable non-aqueous solvents, one or more absorption enhancers, one or more gelling agents and one or more pH buffering agents are described.

Abstract: The present disclosure describes a method of treating a respiratory enterovirus infection in a human subject with COPD which includes administering to the subject a therapeutically effective amount of vapendavir or a pharmaceutically acceptable salt thereof, thereby treating the respiratory enterovirus infection in the subject. Pharmaceutical formulations of vapendavir are also disclosed.

Abstract: Methods of treating cancer comprising targeting the FBXO7/EYA2-SCFFBXW7 axis, such as via EYA2 Tyr phosphatase inhibitors. As EYA2 acts downstream of SCFFBXW7, FBXO7/EYA2 inhibitors can be effective in blocking immune escape pathways and immunotherapy resistance in Fbxw7 mutant tumors. Furthermore, FBXO7/EYA2 inhibitors can be effective in mitigating AXL signaling and associated immune evasion, thus enhancing antitumor immune responses.

Abstract: Provided are compounds having HDAC6 modulating activity, and methods of treating diseases, disorders or symptoms thereof mediated by HDAC6.

Abstract: The present disclosure relates generally to the use of an ERK1/2 inhibitor in combination with a EGFR inhibitor for treating cancer, specifically solid tumors. The present disclosure also relates to the use of an ERK 1/2 inhibitor in combination with a EGFR inhibitor and a BRAF inhibitor for treating cancer, specifically solid tumors.

Abstract: It is an object of the present invention to provide a composition for ameliorating, preventing or treating cancer, comprising a CDK4/6 inhibitor and a tricyclic antidepressant as active ingredients. If the composition comprising a CDK4/6 inhibitor and a tricyclic antidepressant according to the prevention invention is administered in combination, anti-cancer synergistic effects are exhibited such that the survival rate of cancer cells is remarkably reduced compared to that of a group treated with the CDK4/6 inhibitor or tricyclic antidepressant alone. In addition, since the effect of reducing side effects of CDK4/6 inhibitors is also exhibited by administration of the composition according to the present invention, the composition comprising a CDK4/6 inhibitor and a tricyclic antidepressant as active ingredients can be effectively used as a preventive or therapeutic agent for cancer.

Abstract: Compounds, pharmaceutical compositions thereof, and methods are provided for modulating MRGPR D generally, or for treating a MRGPR D dependent condition more specifically, by contacting the MRGPR D or administering to a subject in need thereof, respectively, an effective amount of a compound having the structure of Formula (1): or a pharmaceutically acceptable isomer, racemate, hydrate, solvate, isotope, or salt thereof, wherein A, X, R1 and R2 is as defined herein.

Abstract: The present invention relates to a method for treating a tumor such as a tumor with a KRAS mutation. In the method, a compound 2-fluoro-5-methoxy-4-[(4-(2-methyl-3-oxo-2,3-dihydro-1H-isoindole-4-oxy)-5-trifluoromethyl-pyrimidine-2-yl)amino]-N-(1-methyl-piperidine-4-yl)benzamide or a pharmaceutically acceptable salt thereof is used, which can be administered alone or in combination with a KRAS inhibitor and/or an MEK inhibitor.

Abstract: The present disclosure relates to methods for treating celiac disease, especially refractory celiac disease, by administering a therapeutic amount of a JAK inhibitor, or a salt or prodrug thereof, with or instead of gluten-free diet, to a subject in need thereof. Additionally, methods are presented for preventing lymphoma in a subject having or suspected of having celiac disease.

Abstract: A composition for preventing or treating peripheral T-cell lymphoma includes a compound represented by formula 1 or pharmaceutically acceptable salts thereof. Specifically, a pharmaceutical composition based on the composition is capable of effectively ameliorating peripheral T-cell lymphoma by decreasing regulatory T cells and increasing CD8+ T cells. The pharmaceutical composition may exhibit anticancer activity against peripheral T-cell lymphoma by decreasing regulatory T cells which suppress immune responses and increasing CD8+ T cells which exhibit anticancer activity. In addition, the pharmaceutical composition is used for the treatment of peripheral T-cell lymphoma due to excellent safety and tolerability.

Abstract: Embodiments of the disclosure relate generally to formulations, methods of treatment, kits, and dosage forms for treating inflammatory disorders, including atopic dermatitis, or cancer, the formulations comprising an active pharmaceutical ingredient. The formulation provided comprises granules, wherein the granules comprise: micronized active ingredient; one or more granulation binders; one or more fillers; one or more disintegrants; and one or more antioxidants. In one embodiment, the methods of treatment include orally administering the active ingredient to a subject suffering from atopic dermatitis, where the active ingredient is in an amount of about 20 mg to about 80 mg.

Abstract: The present disclosure relates to the treatment of cancer using a combination therapy comprising Compound 1 and/or tautomers thereof or a pharmaceutically acceptable salt or hydrate thereof, and one or more PARP inhibitors.

Abstract: This disclosure provides for methods, kits and pharmaceutical compositions comprising an inhibitor of EGFR signaling for the treatment of hearing loss. In particular, one such EGFR inhibitor, Dabrafenib, is a therapeutic candidate for treating cisplatin-induced and/or noise-induced hearing loss.

Abstract: A method of treating a JAK-inhibition-responsive condition in a subject in need thereof, the method comprising: administering to the subject an effective amount of a compound represented by structural formulas (I) or (II), as described herein, or a pharmaceutically acceptable salt thereof.

Abstract: The present disclosure discloses a pharmaceutical composition comprising compound of Formula I, Formula II, Formula III, Formula IV, and their pharmaceutically acceptable salts, analogs, tautomeric forms, stereoisomers, geometrical isomers, polymorphs, hydrates, solvates, metabolites, and prodrugs thereof, for the manufacture of a medicament for the treatment of a condition or disorder ameliorated by inhibition of the A2A/A2B receptor. It further discloses the use of the pharmaceutical composition of the present disclosure, for the preparation of a medicament for the treatment of a condition or disorder selected from prostate cancer, rectal cancer, renal cancer, ovarian cancer, endometrial cancer, thyroid cancer, pancreatic cancer, breast cancer, colon cancer, bladder cancer, brain cancer, glial cancer, melanoma cancer, pineal gland cancer, or lung cancer.

Abstract: The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.

Abstract: The present invention relates to a pharmaceutical composition for prevention or treatment of a muscular disease, the composition comprising dimenhydrinate, harmol and/or calcium pantothenate as active ingredients. Application of dimenhydrinate, harmol, and calcium pantothenate individually has an effect of promoting myoblast proliferation and differentiation. In particular, the combination thereof has the effect of synergistically increasing the effect of promoting myoblast proliferation and differentiation. Thus, dimenhydrinate, harmol and/or calcium pantothenate may be usefully used alone or in combination for the prevention or treatment of muscular diseases, in particular sarcopenia.

Abstract: The present disclosure provides a combination therapy for treating a liver disease or disorder and/or a lipid disease or disorder in a subject in need thereof. Specifically, the combination therapy comprises administration of rosuvastatin and resmetirom to a subject in need thereof.

Abstract: The present invention relates to aminothiolesters compounds for use for modulating the immune response in a subject. In particular, said compounds are comprised in a lipidic nanocapsule. The invention further relates to a pharmaceutical composition and to combination products comprising at least one aminothiolester compound and an immune checkpoint inhibitor, and their use for the treatment of cancer.

Abstract: Described herein are methods of treating narcolepsy with cataplexy, comprising administering reboxetine (including esreboxetine) to a human being in need thereof. Reboxetine (including esreboxetine) may also be used in the manufacture of a medicament for the treatment of narcolepsy with cataplexy. Also disclosed herein are kits comprising a pharmaceutical composition comprising reboxetine (including esreboxetine) and instructions to use the pharmaceutical composition to treat narcolepsy with cataplexy in a human being.

Abstract: Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a Tmax of meloxicam of 3 hours or less.

Abstract: Provided are an arginine methyltransferase inhibitor and a use thereof. Specifically, provided are a compound that can be used as an I-type PRMT inhibitor, a preparation method therefor, and a use thereof in the treatment of related diseases. The structure of said compound is as represented by formula (I).

Abstract: Disclosed are pharmaceutical and cosmetic compositions that include 5 Alpha Dihydrotestosterone (or alternatively, 5?-DHT, 5 Alpha-DHT, 5 Alpha DHT, 5a-DHT, DHT), and associated methods of use and treatment that can be used alone or in combination with other treatments to provide, improve, or promote general well-being and health, including mental health, in a subject. In particular the compositions, methods, and uses can provide, promote, support, and/or improve outcomes associated with gender reassignment, gender transitioning, and/or gender-affirming therapy in a subject who may be in need thereof.

Abstract: The present invention relates to compounds and methods which may be useful as treatments of diseases.

Abstract: The present disclosure relates to transdermal formulations, compositions, and methods for treating or preventing inflammation or a symptom thereof, e.g., inflammatory pain.

Abstract: This disclosure relates to extracts from the Anacardiaceae (cashew plant family) and compositions comprising compounds contained therein. In certain embodiments, the extracts are derived from the fruit of a Schinus plant. In certain embodiments, the disclosure relates to methods of treating or preventing bacterial infections, acne, and other related uses.

Abstract: This document relates to methods and materials for assessing and/or treating mammals (e.g., humans) having prostate cancer. For example, methods and materials for determining whether or not a prostate cancer is likely to respond to a particular cancer treatment (e.g., an anti-androgen agent) are provided. Methods and materials for using one or more cancer treatments to treat a mammal (e.g., a human) identified as likely to respond to a particular cancer treatment are also provided.

Abstract: A compound as represented by formula (I) or a pharmaceutically acceptable salt thereof or a pharmaceutical composition thereof, a preparation method therefor, and the use thereof in the treatment of tumors, inflammatory diseases or autoimmune diseases.

Abstract: Described herein is composition comprising salicylic acid for use as a treatment article for certain conditions and method of making such an article. The composition comprising: salicylic acid; a silicone containing film-forming polymer; a silicate tackifying resin; and an additive, wherein the additive comprises (i) a nonionic surfactant having an HLB of 5-9, (ii) a aminosilicone having an amine value greater than 60, (iii) a cationic silicone polyquaternium, or (iv) combinations thereof. Such compositions can be used for skin treatment applications.

Abstract: Disclosed herein, in part, are liquid pharmaceutical formulations comprising furosemide or a pharmaceutically acceptable salt thereof, one or more pharmaceutically acceptable excipients, and a pharmaceutically acceptable buffer. Methods of treating congestion, edema, fluid overload, or hypertension in a patient in need thereof are also provided.

Abstract: Provided are methods of treating sleep disorders in patients by transdermally administering an effective amount of cannabidiol (CBD) to a subject in need thereof.

Abstract: Compounds and treatment methods with compounds exhibiting antiviral activity and/or inhibition of viral replication against viruses, particularly those belonging to the picornavirus-like supercluster, including coronavirus.

Abstract: Provided are improved methods for treating a psychological disorder in a subject comprising administering to the subject an amount of psilocybin or psilocin sufficient to induce a dissociative state in the subject less than 30 minutes after the administration; and thereafter maintaining the mean plasma concentration of the psychedelic at a predetermined value to maintain the dissociative state during a therapeutic window.

Abstract: The present disclosure provides a lyophilized powder containing a boron complex. The lyophilized powder includes a sugar acid and a complex formed by a dehydration condensation reaction of a dihydroxyboryl compound and a sugar or a sugar alcohol. The present disclosure also provides a method of forming a lyophilized powder containing a boron complex. The method includes the following operations. A dihydroxyboryl compound and a sugar or a sugar alcohol are mixed to form a mixture, and the mixture includes a complex formed by a dehydration condensation reaction of the dihydroxyboryl compound and the sugar or the sugar alcohol. The mixture is immersed in liquid nitrogen to freeze the mixture to form a pre-frozen body. A vacuum drying process is performed to evaporate water of the pre-frozen body to form a lyophilized powder.