WebJul 21, 2024 · Jul 21, 2024. Citing deficiencies within the New Drug Application submitted for tenapanor for use in patients with chronic kidney disease, the US FDA issued a letter to Ardelyx noting these deficiencies “preclude discussion” related to labeling and post-marketing requirements. This article was originally published on HCPLive.com.

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WebThe safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. WebTenapanor (Ibsrela) is labeled for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. 1 It is a sodium/hydrogen exchanger 3 inhibitor that acts … how big is 10.6 cm

Tenapanor Nixed By FDA, Citing Deficiencies in Application

Tenapanor, used in form of tenapanor hydrochloride and sold under the brand name Ibsrela, is a treatment for adults with a disease of the gut called irritable bowel syndrome with constipation commonly referred to as IBS-C. Tenapanor is a drug developed by Ardelyx, which acts as an inhibitor of the sodium-proton exchanger NHE3. This antiporter protein is found in the kidney and intestines, and normally acts … WebTenapanor is used to treat irritable bowel syndrome with constipation (IBS-C). This medicine is a sodium/hydrogen exchanger 3 (NHE3) inhibitor. This medicine is available … WebIbsrela (tenapanor) is a sodium/hydrogen exchanger 3 (NHE3) inhibitor, which works by preventing sodium from getting absorbed back into your body from your gut. This causes more water to go into your intestines to soften stools and move them along faster. Ibsrela (tenapanor) can also work on the nerves in your gut to help to relieve stomach pain. how big is 102mm