Ulcerative Colitis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-11-15FDA Approved: PREDNISONE — Original Application (ANI Pharmaceuticals, Inc.)
The FDA approves ANI Pharmaceuticals' original (generic) application for prednisone, enabling a generic prednisone product to be marketed.
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CLINICAL_TRIALS trial_result · 2019-11-06Clinical Trial Update: Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)
Post-marketing observational study evaluating the impact of AbbVie's Patient Support Program on patient-reported outcomes and health resourc…
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CLINICAL_TRIALS trial_result · 2019-11-04Clinical Trial Update: Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator [NA]
A terminated clinical trial evaluated whether response to infliximab or adalimumab could be regained with an immunomodulator in inflammatory…
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CLINICAL_TRIALS trial_result · 2019-11-01Clinical Trial Update: Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission [Phase 3]
Phase 3 trial update on long-term safety and tolerability of mesalamine pellets in participants with ulcerative colitis in remission.
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CLINICAL_TRIALS trial_result · 2019-11-01Clinical Trial Update: A Prospective Non-interventional Multicenter Study to Evaluate the Effectiveness of Adalimumab in Korean Patients With Ulcerative Colitis (UC) and Identify Potential Predictors of Clinical Response in Routine Clinical Practice
A non-interventional study assessing the effectiveness of adalimumab in Korean ulcerative colitis patients and exploring predictors of respo…
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FDA approval · 2019-10-29FDA Approved: BUDESONIDE — Supplemental Application (Rite Aid Corporation)
FDA approved a supplemental application for Budesonide by Rite Aid Corporation, expanding or modifying the approval of this generic product.
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CLINICAL_TRIALS trial_result · 2019-10-21Clinical Trial Update: Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis [Phase 3]
Phase 3 clinical trial results of TA-650 in pediatric ulcerative colitis have been completed and results posted.
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CLINICAL_TRIALS trial_result · 2019-10-15Clinical Trial Update: Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol [Phase 2]
Phase 2 trial investigating rectal dialysis to measure rectal 5-ASA levels in healthy volunteers taking Asacol; the study was terminated wit…
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CLINICAL_TRIALS trial_result · 2019-10-10Clinical Trial Update: An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis [Phase 3]
Phase 3 trial comparing vedolizumab IV to adalimumab SC in ulcerative colitis completed; results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-10-04Clinical Trial Update: Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis [Phase 2]
Phase 2 clinical trial of E6007 in Japanese patients with moderate active ulcerative colitis completed.
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FDA approval · 2019-09-24FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)
The FDA approved a supplemental application for SIMPONI (golimumab) submitted by Janssen Biotech, Inc. The approval updates the drug's label…
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CLINICAL_TRIALS trial_result · 2019-09-19Clinical Trial Update: Tolerability and Efficacy of Sodium Picosulfate/Magnesium Citrate Versus PEG/Ascorbic Acid in Ulcerative Colitis Patients [Phase 4]
Phase 4 trial comparing tolerability and efficacy of Sodium Picosulfate/Magnesium Citrate versus PEG/Ascorbic Acid in patients with Ulcerati…
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CLINICAL_TRIALS trial_result · 2019-09-06Clinical Trial Update: Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA) [Phase 3]
A Phase 3 randomized, placebo-controlled trial evaluating budesonide MMX 9 mg in ulcerative colitis patients on 5-ASA; study completed with …
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CLINICAL_TRIALS research · 2019-09-06Clinical Trial Update: A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants [Phase 1]
Phase 1 study evaluating pharmacokinetics of a single IV 300 mg dose of vedolizumab in healthy adult Chinese participants.
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FDA approval · 2019-08-30FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for XELJANZ (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc, marking an approved modif…
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CLINICAL_TRIALS trial_result · 2019-08-28Clinical Trial Update: Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis [Phase 3]
Phase 3 trial of MAX-002 suppository for mild to moderate ulcerative proctitis was terminated; results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-08-28Clinical Trial Update: Predicting Response to Standardized Pediatric Colitis Therapy [Phase 4]
Phase 4 clinical trial update on predicting response to standardized pediatric therapy for ulcerative colitis; results have been posted.
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CLINICAL_TRIALS trial_result · 2019-08-14Clinical Trial Update: Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis [Phase 4]
A Phase 4 clinical trial evaluating azathioprine based on endoscopy after clinical remission in moderate to severe ulcerative colitis was te…
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CLINICAL_TRIALS trial_result · 2019-08-02Clinical Trial Update: Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis [Phase 2, Phase 3]
Phase 2/3 clinical trial update for Beta-1,3/1,6-D-Glucan from Ganoderma Lucidum in ulcerative colitis; current status is unknown.
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FDA approval · 2019-07-25FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA entry describing a supplemental application for XELJANZ (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2019-07-25FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for XELJANZ XR (tofacitinib extended-release), expanding its formulation under Pfizer's submission.
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FDA approval · 2019-07-23FDA Approved: HADLIMA — Original Application (Organon LLC)
FDA approves Hadlima (adalimumab-bwwd) from Organon as a biosimilar to Humira under the original application BLA761059. It is indicated for …
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FDA approval · 2019-07-18FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, Inc., resulting in updated labeling…
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FDA approval · 2019-07-16FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for PENTASA (mesalamine) submitted by Takeda Pharmaceuticals America, Inc.
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CLINICAL_TRIALS trial_result · 2019-07-08Clinical Trial Update: An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis [Phase 4]
Open-label, single-arm Phase 4 trial of vedolizumab in newly diagnosed active ulcerative colitis has been withdrawn.