Abstract: The present invention relates to, inter alia, methods of treatment and combinations of (R)-2-(7-(4- cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid (Compound 1) useful for the treatment of primary biliary cholangitis (PBC). In some embodiments, the methods further comprise administering Compound 1, or a pharmaceutically salt, solvate, or hydrate thereof, in combination with a compound selected from the group consisting of: an antihistamine (diphenhydramine), cholestyramine (questran, prevalite), rifampin, an opioid antagonist (naloxone), pilocarpine (isopto carpine, salagen), cevimeline (evox-ac), calcium and/or vitamin D supplement, and vitamin A, D, E and/or K supplement. Other embodiments, relate to titration packages for enabling compliance with a regimen of changing dosage of a medication over a period of time for the treatment of primary biliary cholangitis (PBC).

Abstract: The present invention relates to, inter alia, methods of treatment and combinations of (R)-2-(7-(4-cyclopentyl-3-(tri-fluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid (Compound 1) useful for the treatment of primary biliary cholangitis (PBC). In some embodiments, the methods further comprise administering Compound 1, or a pharmaceutically salt, solvate, or hydrate thereof, in combination with a compound selected from the group consisting of: an antihistamine (diphenhydramine), cholestyramine (questran, prevalite), rifampin, an opioid antagonist (naloxone), pilocarpine (isopto carpine, salagen), cevimeline (evoxac), calcium and/or vitamin D supplement, and vitamin A, D, E and/or K supplement. Other embodiments, relate to titration packages for enabling compliance with a regimen of changing dosage of a medication over a period of time for the treatment of primary biliary cholangitis (PBC).

Abstract: The present invention relates to 4-[6-(6-Methanesulfonyl-2-methyl-pyridin-3-ylamino)-5-methoxy-pyrimidin-4-yloxy]-piperidine-1-carboxylic acid isopropyl ester (Compound 1), pharmaceutically acceptable salts, solvates, and hydrates thereof that modulate the activity of the GPR119 receptor. Compound 1 and pharmaceutical compositions thereof are directed to methods useful in the treatment of non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), and conditions related thereto.

Abstract: The present invention relates to, inter alia, methods of treatment and combinations of (R)-2-(7-(4-cyclopentyl-3-(tri-fluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid (Compound 1) useful for the treatment of primary biliary cholangitis (PBC). In some embodiments, the methods further comprise administering Compound 1, or a pharmaceutically salt, solvate, or hydrate thereof, in combination with a compound selected from the group consisting of: an antihistamine (diphenhydramine), cholestyramine (questran, prevalite), rifampin, an opioid antagonist (naloxone), pilocarpine (isopto carpine, salagen), cevimeline (evoxac), calcium and/or vitamin D supplement, and vitamin A, D, E and/or K supplement. Other embodiments, relate to titration packages for enabling compliance with a regimen of changing dosage of a medication over a period of time for the treatment of primary biliary cholangitis (PBC).

Abstract: The present invention relates generally to the novel use of cardioprotective incretin compounds (CICs) such as GLP-1 and exendin and agonists thereof, including analogs and derivatives to prevent, delay, attenuate, or ameliorate cardiac remodeling. The present invention relates to methods for using CICs for the treatment of conditions associated with cardiac remodeling. The present invention further relates to methods for using CICs for the reduction of the risk or severity of congestive heart failure.

Abstract: Provided herein is the use of GLP-1 molecules or agonists and analogs thereof, and the use of exendin molecules or agonists and analogs thereof, including their derivatives and active fragments, for the prevention or treatment of congestive heart failure. Pharmaceutical compositions for use in the methods described herein are also disclosed. Further provided are compositions and methods for the treatment and/or prevention of diabetes mellitus, hyperglycemia, insulin resistance and obesity, and for the reduction of food intake and suppression of appetite of subjects.

Abstract: The present invention relates generally to the novel use of cardioprotective incretin compounds (CICs) such as GLP-1 and exendin and agonists thereof, including analogs and derivatives to prevent, delay, attenuate, or ameliorate cardiac remodeling. The present invention relates to methods for using CICs for the treatment of conditions associated with cardiac remodeling. The present invention further relates to methods for using CICs for the reduction of the risk or severity of congestive heart failure.