Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Asacol · 1 trial · 1 indication
Clinical and endoscopic remission defined as a 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 two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. |
| 2: budesonide-MMX® 9 mg | EXPERIMENTAL | One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. |
| 3: Placebo | PLACEBO_COMPARATOR | Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. |
| 4: Asacol® 400 mg | ACTIVE_COMPARATOR | Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. |
| 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 |
| Placebo | DRUG | Placebo |
| Asacol® 400 mg | DRUG | 2400 mg/day, 400 mg tablets |
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 |
Asacol is used for the treatment of ulcerative colitis, a chronic inflammatory bowel disease affecting the colon and rectum. It is a small molecule therapeutic developed for this gastrointestinal condition. Asacol is intended to help manage the symptoms and inflammation associated with ulcerative colitis.
Asacol targets the gastrointestinal tract, specifically the colon, to deliver its active ingredient locally to the inflamed tissue. The drug is designed to release mesalamine, an anti-inflammatory agent, directly at the site of inflammation in the colon, which helps reduce the symptoms of ulcerative colitis.
Asacol is developed by Bausch Health Companies Inc., a company traded on the stock exchange under the ticker symbol BHC. Bausch Health is responsible for the research, development, and potential commercialization of Asacol for the treatment of ulcerative colitis.
Asacol is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, placebo-controlled study. The drug is still investigational and has not yet been approved by regulatory authorities. It is being studied for its efficacy and safety in patients with ulcerative colitis.
Asacol has been studied in a Phase 3 clinical trial with the identifier NCT00679432. This trial was a randomized, placebo-controlled study that evaluated the drug in 510 patients with ulcerative colitis. The trial was completed and included participants from the United States, Canada, India, and Mexico.
Asacol is not the same as budesonide MMX. The clinical trial NCT00679432 studied budesonide-multi-matrix system (MMX) at doses of 6 mg and 9 mg, which is a different drug from Asacol. Asacol contains mesalamine, while budesonide MMX is a corticosteroid. They are distinct medications for ulcerative colitis.