Ulcerative Colitis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-03-14FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for ENTYVIO (vedolizumab) submitted by Takeda Pharmaceuticals America, Inc. The action updates the p…
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FDA approval · 2024-03-14FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for ENTYVIO (vedolizumab) from Takeda Pharmaceuticals America, Inc., approving a modification to the…
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CLINICAL_TRIALS trial_result · 2024-03-12Clinical Trial Update: Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease [Phase 1, Phase 2]
Clinical trial update on fluorescence imaging of adalimumab-680LT in inflammatory bowel disease (Crohn's disease and ulcerative colitis) acr…
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CLINICAL_TRIALS trial_result · 2024-03-05Clinical Trial Update: Phase 2 Dose-finding IMU-838 for Ulcerative Colitis [Phase 2]
Phase 2 dose-finding study of IMU-838 in ulcerative colitis has been terminated with results posted.
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FDA approval · 2024-03-01FDA Approved: MESALAMINE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Mesalamine from Mylan Pharmaceuticals Inc. The action grants a supplemental approval for this ge…
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CLINICAL_TRIALS trial_result · 2024-02-28Clinical Trial Update: Top Down Versus Step up in Pediatric Ulcerative Colitis [Phase 4]
Phase 4 pediatric trial comparing top-down versus step-up strategies in ulcerative colitis patients treated with infliximab is currently rec…
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CLINICAL_TRIALS trial_result · 2024-02-26Clinical Trial Update: Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis [Phase 1]
Phase 1 trial evaluating MDGN-002 in adults with Crohn's disease or ulcerative colitis has been terminated.
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FDA approval · 2024-02-23FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for ENTYVIO (vedolizumab) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2024-02-23FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for ENTYVIO (vedolizumab) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2024-02-22FDA Approved: ZYMFENTRA — Supplemental Application (CELLTRION USA Inc.)
The FDA approved a supplemental application for ZYMFENTRA (infliximab-dyyb) submitted by Celltrion USA Inc.
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FDA approval · 2024-02-16FDA Approved: BALSALAZIDE DISODIUM — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for balsalazide disodium filed by Apotex Corp.
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FDA approval · 2024-02-16FDA Approved: BALSALAZIDE DISODIUM — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for balsalazide disodium submitted by Zydus Lifesciences Limited, marking approval of a supplement t…
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CLINICAL_TRIALS trial_result · 2024-02-15Clinical Trial Update: Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC) [Phase 1]
Phase 1b double-blind, placebo-controlled study of RO7049665 in ulcerative colitis terminated; results posted.
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FDA approval · 2024-02-05FDA Approved: MESALAMINE — Original Application (NorthStar RxLLC)
FDA approved the original ANDA for mesalamine submitted by NorthStar RxLLC, a generic formulation intended for the treatment of ulcerative c…
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FDA approval · 2024-01-31FDA Approved: MESALAMINE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' supplemental application for mesalamine (generic), approving changes to an existing approved product.
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CLINICAL_TRIALS trial_result · 2024-01-31Clinical Trial Update: Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis [Phase 3]
A Phase 3 trial comparing Sucrosomial Iron to oral iron sulfate for iron deficiency anemia in patients with ulcerative colitis is underway, …
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FDA approval · 2024-01-12FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for Mesalamine filed by Zydus Lifesciences Limited under the ANDA pathway.
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CLINICAL_TRIALS trial_result · 2024-01-09Clinical Trial Update: A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis [Phase 3]
Phase 3 trial evaluating etrasimod in moderately to severely active ulcerative colitis is underway.
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CLINICAL_TRIALS trial_result · 2023-12-27Clinical Trial Update: The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis [Phase 3]
Phase 3 trial update on cobitolimod for moderate to severe active left-sided ulcerative colitis; study terminated.
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FDA approval · 2023-12-26FDA Approved: RENFLEXIS — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Renflexis (infliximab) submitted by Organon LLC.
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CLINICAL_TRIALS trial_result · 2023-12-19Clinical Trial Update: Phase III Multicentre Trial of Oral Mesalazine in Patients With Mild to Moderate Ulcerative Colitis. [Phase 3]
Phase III multicentre trial of oral mesalazine in patients with mild to moderate ulcerative colitis is ongoing with unknown status.
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FDA approval · 2023-12-15FDA Approved: HULIO — Supplemental Application (Biocon Biologics Inc)
The FDA approved a supplemental application for HULIO, Biocon Biologics' biosimilar adalimumab (adalimumab-fkJP).
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CLINICAL_TRIALS trial_result · 2023-12-12Clinical Trial Update: A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis [Phase 2]
Phase 2 clinical trial evaluating the efficacy and safety of combining guselkumab with golimumab in moderately to severely active ulcerative…
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FDA approval · 2023-12-11FDA Approved: MESALAMINE — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approved a supplemental application for mesalamine from Upsher-Smith Laboratories, LLC, as part of an Abbreviated New Drug Application.
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CLINICAL_TRIALS trial_result · 2023-12-06Clinical Trial Update: Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease [Phase 2]
A Phase 2 study evaluating the testicular safety of filgotinib in adult males with inflammatory bowel disease was terminated; results have b…