Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Entocort EC · 1 trial · 1 indication
Clinical and endoscopic remission defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.
| Arm | Type | Description |
|---|---|---|
| 1: budesonide-MMX® 6 mg | EXPERIMENTAL | One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast. |
| 2: budesonide-MMX® 9 mg | EXPERIMENTAL | One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast. |
| 3: Entocort EC® 3 mg | ACTIVE_COMPARATOR | Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast. |
| 4: Placebo | PLACEBO_COMPARATOR | Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast. |
| Name | Type | Description |
|---|---|---|
| Blood sampling, endoscopy | PROCEDURE | Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores |
| Budesonide MMX® 6 mg | DRUG | 6 mg/day, 6 mg tablets |
| Budesonide MMX® 9 mg | DRUG | 9 mg/day, 9 mg tablets |
| Entocort EC® 3 mg | DRUG | 9 mg/day, 3 mg tablets |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Patients fulfilling the following criteria at the screening visit are eligible for participation in the study: * Male and female patients, 18-75 years old, suffering from ulcerative colitis for at least 6 months. * Diagnosis of ulcerative colitis in active phase, of mild ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 10 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Upadacitinib |
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Tulisokibart |
| Pfizer Inc. | PFE | 8 | PHASE3 | Etrasimod |
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Filgotinib |
| Abivax SA Sponsored ADR | ABVX | 2 | PHASE3 | ABX464 |
| Bristol-Myers Squibb Company | BMY | 5 | PHASE2 | Ozanimod |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| AnaptysBio, Inc. | ANAB | 1 | PHASE2 | Rosnilimab |
| Palatin Technologies, Inc. | PTN | 1 | PHASE2 | PL8177 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | GSK4528287 |
| Xencor, Inc. | XNCR | 1 | PHASE1 | XmAb942 |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE2 | 627 |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Entocort EC is used for the treatment of ulcerative colitis, a form of inflammatory bowel disease. It is a small molecule drug being developed by Bausch Health Companies Inc. (BHC) and is currently in Phase 3 clinical development for this indication.
Entocort EC is a corticosteroid that works by reducing inflammation in the gastrointestinal tract. It is designed to deliver the active ingredient budesonide locally to the colon, where it helps to control the inflammation associated with ulcerative colitis.
Entocort EC is being developed by Bausch Health Companies Inc., which is publicly traded under the ticker symbol BHC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with ulcerative colitis.
Entocort EC is currently in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not yet been approved by regulatory authorities.
Entocort EC has been studied in a completed Phase 3 clinical trial with the identifier NCT00679380. This trial, titled 'Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis,' enrolled 514 participants across multiple countries.
Entocort EC contains budesonide as its active ingredient. It is a formulation of budesonide designed to release the drug in the colon, specifically for the treatment of ulcerative colitis. The drug is also known by the name budesonide-multi-matrix system (MMX).