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ea0098c8 | Clinical – Chemo/SSA/Biologics | NANETS2023

Effect of hepatic impairment on pharmacokinetics, safety, and tolerability of oral paltusotine, a small-molecule, selective somatostatin receptor subtype 2 agonist

Luo MS Rosa , Casagrande MD, PhD Alessandra , Oun BA Sonic , Wang MSPH Yang , Scott Struthers PhD R. , Usiskin MD Keith , Krasner MD Alan

Background: Paltusotine is an investigational oral, once-daily, small molecule somatostatin receptor type 2 agonist in development for the treatment of acromegaly and carcinoid syndrome associated with neuroendocrine tumors.Methods: This multicenter, open-label, phase 1 study enrolled participants with mild, moderate, and severe hepatic impairment based on Child-Pugh classification and matched healthy participants. A single 20-mg oral dose of paltusotine...

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ea0094p399 | Neuroendocrinology and Pituitary | SFEBES2023

Paltusotine maintains IGF-1, GH, and symptom control in patients with acromegaly switched from injected octreotide or lanreotide monotherapy: Topline results from PATHFNDR-1, a phase 3, randomized, double-blind, placebo-controlled, multicenter study

R. Gadelha Monica , Casagrande, MD, PhD Alessandra , J. Strasburger MD Christian , Bidlingmaier Martin , Snyder MD Peter , Guitelman MD Mirtha , Boguszewski MD Cesar , Buchfelder MD Michael , Shimon MD Ilan , Raverot MD Gerald , Toth MD Miklos , Mezosi MD Emese , Doknic MD Mirjana , Fan PhD Xiaolin , Clemmons MD David , Keeley PhD Michael , J. Trainer MD Peter , Struthers PhD R. Scott , Krasner MD Alan , M.K. Biller MD Beverly

Paltusotine is a once-daily, oral, selectively-targeted SST2 agonist in development for the treatment of acromegaly. PATHFNDR-1 (NCT04837040) enrolled patients with acromegaly who had an IGF-1 ≤1xULN on a stable (>12 weeks) dose of lanreotide or octreotide. Patients were randomized 1:1 to receive paltusotine 40 mg/day or placebo for 36 weeks. During the first 24 weeks, the paltusotine dose was titrated (range 20-60 mg) based on IGF-1 and tolerance. Dose changes were ...

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Endocrine Abstracts

Effect of hepatic impairment on pharmacokinetics, safety, and tolerability of oral paltusotine, a small-molecule, selective somatostatin receptor subtype 2 agonist

Paltusotine maintains IGF-1, GH, and symptom control in patients with acromegaly switched from injected octreotide or lanreotide monotherapy: Topline results from PATHFNDR-1, a phase 3, randomized, double-blind, placebo-controlled, multicenter study

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