Ulcerative Colitis
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2021-02-01Clinical Trial Update: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis [Phase 1]
Phase 1 clinical trial evaluating safety, tolerability, PK, and efficacy of GS-5745 (andecaliximab) in adults with moderate to severe active…
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FDA approval · 2021-01-29FDA Approved: MERCAPTOPURINE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for mercaptopurine by Mylan Pharmaceuticals, updating the regulatory status for the marketed product…
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FDA approval · 2021-01-25FDA Approved: MERCAPTOPURINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for mercaptopurine submitted by Hikma Pharmaceuticals USA Inc., indicating changes to the product's …
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FDA approval · 2021-01-15FDA Approved: AZULFIDINE EN-TABS — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for AZULFIDINE EN-TABS (sulfasalazine) from Pfizer, resulting in updated labeling and/or approved in…
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CLINICAL_TRIALS trial_result · 2021-01-12Clinical Trial Update: Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease. [Phase 4]
Phase 4 trial comparing loss of response between an adalimumab biosimilar and the original adalimumab in Crohn's disease and ulcerative coli…
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FDA approval · 2021-01-07FDA Approved: AZATHIOPRINE SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for azathioprine sodium from Hikma Pharmaceuticals USA Inc., updating the generic product's approval…
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CLINICAL_TRIALS trial_result · 2021-01-05Clinical Trial Update: Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis [Phase 2]
Phase 2 trial update on TJ301 IV for active ulcerative colitis reports safety and efficacy data from completed study.
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CLINICAL_TRIALS trial_result · 2020-12-22Clinical Trial Update: Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis [Phase 2]
Phase 2 clinical trial update on AEB071 in active, moderate to severe ulcerative colitis assessing efficacy, safety, and tolerability.
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CLINICAL_TRIALS trial_result · 2020-12-21Clinical Trial Update: Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) [Phase 2]
Phase 2 trial of Vedolizumab IV in pediatric patients with Ulcerative Colitis or Crohn's Disease has completed with results posted.
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CLINICAL_TRIALS trial_result · 2020-12-19Clinical Trial Update: Low Dose IL-2 for Ulcerative Colitis [Phase 1]
Phase 1 clinical trial investigating low-dose interleukin-2 for ulcerative colitis has completed with results posted.
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FDA approval · 2020-12-17FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, authorizing changes to the product labe…
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CLINICAL_TRIALS trial_result · 2020-12-17Clinical Trial Update: Evaluation of 3D Visualization for Total Colectomy [NA]
A completed clinical trial evaluating 3D visualization for total colectomy in ulcerative colitis; results posted in 2020.
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CLINICAL_TRIALS trial_result · 2020-12-14Clinical Trial Update: Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Inflammatory Bowel Disease [Phase 2]
Phase 2 trial assessing the diagnostic validity of 18F-FSPG PET for disease activity in inflammatory bowel diseases including ulcerative col…
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FDA approval · 2020-12-11FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for ustekinumab filed by Janssen Biotech, Inc. The action updates the product's labeling.
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CLINICAL_TRIALS trial_result · 2020-12-11Clinical Trial Update: Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis [Phase 2]
Phase 2 trial investigating antibiotics as an adjuvant therapy in patients with acute severe ulcerative colitis.
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FDA approval · 2020-12-01FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)
FDA approves a supplemental application for ustekinumab (Stelara) from Janssen Biotech, Inc., reflecting an approval of changes to its label…
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CLINICAL_TRIALS trial_result · 2020-11-16Clinical Trial Update: This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients [Phase 2]
This Boehringer Ingelheim Phase 2 study assessed BI 655130 in active ulcerative colitis, evaluating safety, tolerability, and potential effi…
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FDA approval · 2020-10-29FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for PENTASA (mesalamine) from Takeda Pharmaceuticals America, Inc., representing an FDA-approved…
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CLINICAL_TRIALS withdrawal · 2020-10-27Clinical Trial Update: Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study [Phase 4]
Phase 4 post-marketing study of Vedolizumab-4002 investigating drug–drug interactions has been withdrawn.
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CLINICAL_TRIALS trial_result · 2020-10-14Clinical Trial Update: Efficacy and Safety Study of Ozanimod in Ulcerative Colitis [Phase 2]
Phase 2 trial update on ozanimod for ulcerative colitis reports efficacy and safety results.
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CLINICAL_TRIALS trial_result · 2020-10-08Clinical Trial Update: Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis [Phase 3]
Phase 3 trial evaluating two dosing regimens of adalimumab in moderate to severe ulcerative colitis has completed with results posted.
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CLINICAL_TRIALS trial_result · 2020-10-08Clinical Trial Update: An Open Label Phase 4 Study to Evaluate Efficacy of Early Versus Late Use of Vedolizumab in Ulcerative Colitis [Phase 4]
Open-label Phase 4 trial evaluating early vs late use of vedolizumab in ulcerative colitis (completed).
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CLINICAL_TRIALS research · 2020-10-08Clinical Trial Update: Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD) [Phase 2, Phase 3]
A phase 2/3 clinical trial evaluated the anti-inflammatory effects of Agaricus blazei Murill in inflammatory bowel disease.
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FDA approval · 2020-10-07FDA Approved: DIPENTUM — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Dipentum (olsalazine sodium) from Viatris Specialty LLC.
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CLINICAL_TRIALS trial_result · 2020-10-05Clinical Trial Update: Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis [Phase 3]
Phase 3 trial evaluating efficacy and safety of adalimumab in pediatric patients with moderate to severe ulcerative colitis has completed wi…