Press Releases

Asklepion Pharmaceuticals Announces Special Protocol Assessment (SPA) Agreement with FDA for Phase 3 Program of Intravenous Citrulline

BALTIMORE, Dec. 19, 2017 (GLOBE NEWSWIRE) — Asklepion Pharmaceuticals, LLC (“Asklepion” or “the Company”) announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase 3 trial for intravenous citrulline.

Read more

Asklepion Pharmaceuticals Presents Phase 1b/2a Clinical Trial Data for IV-Citrulline at the Pediatric Cardiac Intensive Care Society 13th Annual International Meeting

BALTIMORE, MD, December 8, 2017 (GlobeNewswire) – Asklepion Pharmaceuticals, LLC (“Asklepion” or “the Company”), a biotechnology company focused on the development of IV-citrulline for rare pediatric diseases, announced detailed results from a Phase 1b/2a double blind, randomized, placebo controlled, clinical trial to determine the pharmacokinetics and safety

Read more

Asklepion Pharmaceuticals, LLC announces receipt of Orphan Drug Designation from U.S. FDA

Asklepion Pharmaceuticals, LLC announces receipt of Orphan Drug Designation from the U.S. FDA for the prevention of clinical sequelae of acute lung injury induced by cardiopulmonary bypass in pediatric patients. On January 9, 2017, Asklepion Pharmaceuticals, LLC announced that the U.S. Food and Drug Administration (FDA) has

Read more

News Release: March 17, 2015 FDA approves Cholbam to treat rare bile acid synthesis disorders

March 17, 2015, FDA approves Cholbam to treat rare bile acid synthesis disorders.

Read more