mesalamine delayed release capsule / Generic mfg. - LARVOL DELTA

Amneal Launches Mesalamine... (Businesswire) - "Amneal Pharmaceuticals, Inc...today announced the launch of mesalamine 800 mg delayed-release tablets, an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults."

Launch US • Ulcerative Colitis

A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis (clinicaltrials.gov) - P3 | N=80 | Not yet recruiting | Sponsor: AbbVie | Trial completion date: Sep 2024 ➔ Jul 2026 | Trial primary completion date: Sep 2024 ➔ Jul 2026

Adverse events • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Expanded table: Some drugs for inflammatory bowel disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Drugs for inflammatory bowel disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis (clinicaltrials.gov) - P3 | N=80 | Not yet recruiting | Sponsor: AbbVie | Initiation date: Jun 2022 ➔ Dec 2022

Adverse events • Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis (clinicaltrials.gov) - P3 | N=80 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P3 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Ozanimod (Zeposia) for ulcerative colitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M (clinicaltrials.gov) - P1/2; N=51; Not yet recruiting; Sponsor: Holy Stone Healthcare Co. Ltd Healthcare Co. Ltd

New P1/2 trial • Biosimilar • Immunology • Inflammation • Inflammatory Bowel Disease

The Association of Mesalamine With Kidney Disease. (PubMed, Adv Chronic Kidney Dis) - "The package inserts for products containing 5-aminosalicylic acid, or mesalamine, include the following language regarding the risk of adverse kidney effects: "renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and rarely renal failure, has been reported in patients given products such as mesalamine delayed-release tablets that contain mesalamine or are converted to mesalamine." In this article, we review the data regarding this nephrotoxicity and the recommendations regarding appropriate monitoring. No convincing studies demonstrate efficacy of treatment with corticosteroids. Frequent monitoring of serum creatinine, especially in the first years after initiation of therapy, is recommended."

Journal • Review

A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M (clinicaltrials.gov) - P2a; N=51; Completed; Sponsor: Holy Stone Healthcare Co., Ltd; Recruiting ➔ Completed

Clinical • Trial completion

"@hankgreen there is now a generic delzicol !!! Thanks @TevaUSA https://t.co/iA8rIjGdtO" (@Kastnerd)

". @TevaUSA debuts generics of Delzicol and Tarceva in the USA https://t.co/DlV6BooyNO #gastroenterology #Israel #oncology @Roche" (@ThePharmaLetter)

Teva announces the launch of a generic version of Delzicol (mesalamine) delayed-release capsules in the United States (Businesswire) - "Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the launch of a generic version of Delzicol®1 (mesalamine) delayed-release capsules, 400 mg, in the U.S....Mesalamine Delayed-Release Capsules are an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older, and for the maintenance of remission of ulcerative colitis in adults."

Generic launch

A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M (clinicaltrials.gov) - P2a; N=51; Recruiting; Sponsor: Holy Stone Healthcare Co., Ltd; Trial completion date: Dec 2018 ➔ Mar 2019; Trial primary completion date: Nov 2018 ➔ Mar 2019

Clinical • Trial completion date • Trial primary completion date