Ulcerative Colitis
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2023-05-31Clinical Trial Update: Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET [Phase 4]
Phase 4 trial update evaluating intensive golimumab treatment in ulcerative colitis has completed.
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CLINICAL_TRIALS trial_result · 2023-05-31Clinical Trial Update: A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab [Phase 4]
A Phase 4 clinical trial comparing standard of care vs treat-to-target with telemonitoring and patient education in patients with ulcerative…
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FDA approval · 2023-05-30FDA Approved: MESALAMINE — Original Application (Encube Ethicals, Inc.)
FDA approved an original ANDA for mesalamine (Encube Ethicals, Inc.), a generic formulation.
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FDA approval · 2023-05-23FDA Approved: ADALIMUMAB — Original Application (CELLTRION USA, Inc.)
FDA approved ADALIMUMAB-AATY from CELLTRION USA, Inc. as a biosimilar to adalimumab under an Original Application for the same indications a…
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FDA approval · 2023-05-18FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)
FDA approved a supplemental application for ADALIMUMAB-ADBM, a biosimilar to adalimumab, from QUALLENT PHARMACEUTICALS HEALTH LLC.
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FDA approval · 2023-05-12FDA Approved: MESALAMINE — Original Application (Lannett Company Inc.)
FDA approval of a generic mesalamine product from Lannett Company Inc. (Original Application).
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FDA label_change · 2023-05-01FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for mesalamine submitted by Zydus Lifesciences Limited, typically indicating a labeling update o…
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CLINICAL_TRIALS trial_result · 2023-04-25Clinical Trial Update: PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC) [Phase 2]
Phase 2 clinical trial update for PN-943 in adults with moderate to severe active ulcerative colitis has completed.
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FDA approval · 2023-04-14FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for adalimumab-adaz, a biosimilar to adalimumab, confirming its regulatory approval for use.
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CLINICAL_TRIALS trial_result · 2023-04-14Clinical Trial Update: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC) [Phase 2]
Phase 2 trial evaluating UTTR1147A versus placebo and vedolizumab in moderate-to-severe ulcerative colitis completed with results posted in …
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CLINICAL_TRIALS trial_result · 2023-04-14Clinical Trial Update: HF2 Therapy in the Treatment of Active Ulcerative Colitis [Phase 1, Phase 2]
Phase 1/2 trial update for HF2 therapy in active ulcerative colitis has completed.
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CLINICAL_TRIALS trial_result · 2023-04-12Clinical Trial Update: the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis [Phase 3]
Phase 3 clinical trial evaluating the efficacy and safety of diosmin in patients with ulcerative colitis.
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FDA approval · 2023-03-31FDA Approved: YUSIMRY — Supplemental Application (Coherus BioSciences Inc)
FDA approved a supplemental Biologics License Application for YUSIMRY (adalimumab-aqvh) by Coherus BioSciences, authorizing the biosimilar p…
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FDA approval · 2023-03-31FDA Approved: MESALAMINE — Original Application (Aurobindo Pharma Limited)
FDA approved the Original Application for Mesalamine from Aurobindo Pharma Limited (generic Mesalamine). Indications include inflammatory bo…
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CLINICAL_TRIALS trial_result · 2023-03-17Clinical Trial Update: Saffron as Anti Inflammatory In Patients With Inflammatory Bowel Disease [Phase 4]
A Phase 4 clinical trial evaluating saffron as an anti-inflammatory treatment in patients with ulcerative colitis is underway but status is …
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CLINICAL_TRIALS trial_result · 2023-03-15Clinical Trial Update: A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy [Phase 2]
Phase 2 clinical trial evaluating Ravagalimab (ABBV-323) for moderate to severe ulcerative colitis in patients who failed prior therapy; stu…
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FDA approval · 2023-03-06FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for ustekinumab (Stelara) to expand its indications, as requested by Janssen Biotech, Inc.
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CLINICAL_TRIALS trial_result · 2023-03-03Clinical Trial Update: Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis [Phase 1, Phase 2]
Clinical trial update exploring the role of intestinal protozoa and helminths in the course of Ulcerative Colitis across Phase 1 and Phase 2…
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CLINICAL_TRIALS trial_result · 2023-03-01Clinical Trial Update: GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation ) [Phase 4]
Phase 4 trial update for an anti-TNF discontinuation strategy in Crohn's disease and inflammatory bowel disease (including ulcerative coliti…
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FDA approval · 2023-03-01FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for mesalamine from Zydus Lifesciences Limited, under an ANDA. The approval pertains to a generic pr…
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CLINICAL_TRIALS trial_result · 2023-02-08Clinical Trial Update: ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis [Phase 2]
Phase 2 trial results for ABX464 in patients with moderate to severe active ulcerative colitis have been posted. The update covers efficacy …
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CLINICAL_TRIALS withdrawal · 2023-02-01Clinical Trial Update: Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis [Phase 4]
Phase 4 trial evaluating berberine to maintain remission in ulcerative colitis has been withdrawn.
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CLINICAL_TRIALS trial_result · 2023-01-27Clinical Trial Update: A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis [Phase 2]
Phase 2 trial evaluating GLPG3970 as an oral treatment for 6 weeks in adults with ulcerative colitis has completed with results posted.
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CLINICAL_TRIALS trial_result · 2023-01-26Clinical Trial Update: GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery [Phase 1, Phase 2]
A two-phase clinical trial investigating GM-CSF, fosfomycin, and metronidazole for pouchitis in ulcerative colitis patients post-restorative…
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FDA approval · 2023-01-25FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approves a supplemental application for ENTYVIO (vedolizumab) from Takeda Pharmaceuticals America, Inc.