Ulcerative Colitis
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2021-08-13Clinical Trial Update: A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors [Phase 3]
Phase 3 study comparing etrolizumab to infliximab in adults with moderate to severe ulcerative colitis who did not receive TNF inhibitors; t…
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FDA approval · 2021-08-12FDA Approved: MESALAMINE — Original Application (Zydus Lifesciences Limited)
FDA approved an original Abbreviated New Drug Application for mesalamine from Zydus Lifesciences Limited, adding a generic option for the tr…
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CLINICAL_TRIALS trial_result · 2021-08-05Clinical Trial Update: Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease [Phase 4]
Phase 4 trial update on proactive therapeutic drug monitoring in inflammatory bowel disease has completed.
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FDA approval · 2021-07-30FDA Approved: BALSALAZIDE DISODIUM — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for balsalazide disodium from Apotex Corp., enabling the generic product to be marketed.
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CLINICAL_TRIALS trial_result · 2021-07-21Clinical Trial Update: Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment. [Phase 4]
Phase 4 clinical trial assessing the additive effect of Mutaflor probiotic in patients with Ulcerative Colitis on 5-ASA therapy has complete…
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CLINICAL_TRIALS trial_result · 2021-07-20Clinical Trial Update: Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases [Phase 2]
Phase 2 clinical trial evaluating low-dose IL-2 to induce regulatory T cells in various autoimmune and inflammatory diseases; trial complete…
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CLINICAL_TRIALS trial_result · 2021-07-20Clinical Trial Update: An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis [Phase 2]
Phase 2 exploratory study of rebamipide in patients with active ulcerative colitis has been completed with results posted.
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CLINICAL_TRIALS trial_result · 2021-07-19Clinical Trial Update: Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis
Clinical trial investigating golimumab's effect on gut microbiota modulation in ulcerative colitis has completed with results posted.
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FDA approval · 2021-07-15FDA Approved: MESALAMINE — Original Application (Ascend Laboratories, LLC)
The FDA approved an original ANDA for mesalamine, authorizing Ascend Laboratories, LLC to market a generic version of the anti-inflammatory …
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CLINICAL_TRIALS trial_result · 2021-07-01Clinical Trial Update: Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels [Phase 4]
Phase 4 clinical trial updating the exposure-response relationship of golimumab using serum trough levels in ulcerative colitis; results pos…
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FDA approval · 2021-06-25FDA Approved: DIPENTUM — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Dipentum (olsalazine sodium) submitted by Viatris Specialty LLC.
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CLINICAL_TRIALS trial_result · 2021-06-23Clinical Trial Update: Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis. [Phase 3]
Phase 3 trial update on SPD476 assessing safety and tolerability for maintaining remission in ulcerative colitis.
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CLINICAL_TRIALS trial_result · 2021-06-23Clinical Trial Update: Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC) [Phase 2]
Phase 2 trial investigating pharmacokinetics of adalimumab with methotrexate for ulcerative colitis; study terminated with posted results.
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FDA approval · 2021-06-17FDA Approved: INFLECTRA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approves a supplemental application for INFLECTRA (infliximab-dyyb) from Pfizer Laboratories Div Pfizer Inc, marking FDA action on a bio…
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CLINICAL_TRIALS trial_result · 2021-06-15Clinical Trial Update: A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors [Phase 3]
Phase 3 trial assessing etrolizumab for maintenance of disease remission in tumor necrosis factor inhibitor-naive ulcerative colitis patient…
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CLINICAL_TRIALS trial_result · 2021-06-15Clinical Trial Update: A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors [Phase 3]
Phase 3 trial assessing the efficacy and safety of etrolizumab in ulcerative colitis patients previously treated with TNF inhibitors has com…
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CLINICAL_TRIALS trial_result · 2021-06-11Clinical Trial Update: BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis [Phase 2, Phase 3]
Phase 2/3 trial update for SPESOLIMAB (BI655130) as induction therapy in adults with moderate-to-severe ulcerative colitis; results have bee…
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CLINICAL_TRIALS trial_result · 2021-06-11Clinical Trial Update: Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis [Phase 3]
Phase 3 trial comparing twice-daily mesalazine to once-daily dosing in acute mild to moderate ulcerative colitis; completed study evaluating…
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CLINICAL_TRIALS trial_result · 2021-06-11Clinical Trial Update: Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis [Phase 3]
Phase 3 trial update comparing two daily doses of SPD476 (mesalazine) with reference therapy in acute mild-to-moderate ulcerative colitis to…
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CLINICAL_TRIALS trial_result · 2021-06-11Clinical Trial Update: Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 [Phase 2]
A Phase II dose-ranging study evaluating SPD476 in subjects with mild to moderate ulcerative colitis has completed.
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CLINICAL_TRIALS trial_result · 2021-06-09Clinical Trial Update: Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease [Phase 3]
Phase 3 trial evaluating vedolizumab in biologic-naïve Korean patients with moderate to severe inflammatory bowel disease (Crohn's disease a…
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CLINICAL_TRIALS trial_result · 2021-06-08Clinical Trial Update: A Trial of Yoga in Pediatric Inflammatory Bowel Disease [NA]
A completed clinical trial investigated yoga as an intervention for pediatric inflammatory bowel disease; results have been posted.
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CLINICAL_TRIALS trial_result · 2021-06-02Clinical Trial Update: Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission [Phase 1]
Phase 1 trial assessing berberine chloride to prevent colorectal cancer in patients with ulcerative colitis in remission has completed with …
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FDA approval · 2021-05-27FDA Approved: ZEPOSIA 7-DAY STARTER PACK — Supplemental Application (Celgene Corporation)
FDA approved a supplemental application to add a 7-day starter pack for ZEPOSIA (ozanimod hydrochloride), expanding dosing packaging for the…
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FDA approval · 2021-05-25FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Pentasa (mesalamine) submitted by Takeda Pharmaceuticals America.