SAN FRANCISCO, CA / ACCESSWIRE / February 12, 2024 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) has submitted an Orphan Drug Designation (ODD) application to the U.S. Food and Drug Administration (FDA) for crofelemer, the company's novel plant-based prescription drug, for the symptomatic relief and treatment of moderate-to-severe diarrhea, with or without concomitant antimicrobial therapy, from bacterial, viral, and parasitic infections including Vibrio cholerae, the bacterium that causes cholera.
Dog Study Published in PLOS ONE Shows Results for Use of Jaguar’s Crofelemer
SAN FRANCISCO, CA / ACCESSWIRE / August 23, 2022 / Jaguar Health (NASDAQ:JAGX) today announced that its Orphan Drug Designation (ODD) application for crofelemer submitted to the U.S. Food and Drug Administration for a rare congenital diarrheal disorder called microvillus inclusion disease (MVID) has been accepted by the FDA for review. A response from the FDA on the application is expected by the end of September 2022.
SAN FRANCISCO, CA / ACCESSWIRE / February 1, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX) and Napo Pharmaceuticals, the company's wholly owned subsidiary, today announced the completion of a third-party, investigator-initiated preclinical enterocyte (intestinal cell) in vitro study to evaluate the effects of crofelemer,Napo Pharmaceuticals' plant-based prescription drug, on certain genetic defects that result in specific forms of congenital diarrheal disorders. Jaguar Health believes that these study results will support certain requests received from the Office of Orphan Products Development at the U.S. Food and Drug Administration (FDA) in response to the Orphan Drug Designation (ODD) application Napo Pharmaceuticals filed with the FDA for crofelemer for congenital diarrheal disorders (CDD) in infants and children.
TEL-AVIV, Israel and RALEIGH, N.C., July 25, 2018 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal (GI) diseases, today announced that it has initiated promotion of Mytesi® (crofelemer 125 mg delayed-release tablets)1, a first-in-class anti-secretory prescription drug product of Napo Pharmaceuticals (Napo), a wholly-owned subsidiary of Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar), that is approved by the U.S. FDA for the symptomatic relief of non-infectious diarrhea in adults with HIV/AIDS on anti-retroviral therapy. RedHill’s co-promotion efforts will target gastroenterologists and select primary care physicians in the U.S., complementing the efforts of Napo’s direct sales force, which has been fully deployed since the second quarter of 2018.
RedHill has been granted the exclusive right to co-promote Mytesi® (crofelemer 125 mg delayed-release tablets) in the U.S. to certain gastroenterologists and primary care physicians for the approved indication in people living with HIV/AIDS by Napo Pharmaceuticals, a subsidiary of Jaguar Health (NASDAQ:JAGX)