Daniel R. Lee

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BACKGROUND ATX-101, an injectable form of deoxycholic acid, is approved in the United States and Canada for submental fat (SMF) reduction. OBJECTIVE To report results of REFINE-1, a randomized, double-blind, placebo-controlled, Phase 3 trial investigating the efficacy and safety of ATX-101. METHODS Subjects dissatisfied with their moderate or severe SMF(More)
BACKGROUND ATX-101, an injectable form of deoxycholic acid, causes adipocytolysis when injected subcutaneously into fat. OBJECTIVE We sought to evaluate the efficacy and safety of ATX-101. METHODS In this phase III trial (REFINE-2), adults dissatisfied with their moderate or severe submental fat (SMF) were randomized to ATX-101 or placebo. Coprimary end(More)
BACKGROUND ST-246® is an antiviral, orally bioavailable small molecule in clinical development for treatment of orthopoxvirus infections. An intravenous (i.v.) formulation may be required for some hospitalized patients who are unable to take oral medication. An i.v. formulation has been evaluated in three species previously used in evaluation of both(More)
BACKGROUND ATX-101 (deoxycholic acid injection, Kythera Biopharmaceuticals, Inc.) is a proprietary formulation of pure synthetic deoxycholic acid (DCA). It is undergoing clinical investigation as an injectable drug for contouring the submental area by reducing submental fat (SMF). When injected into subcutaneous fat, ATX-101 causes focal adipocytolysis, the(More)
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