Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Granulated mesalamine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 2 | PLACEBO_COMPARATOR | Placebo |
| 1 | ACTIVE_COMPARATOR | Granulated mesalamine |
| Name | Type | Description |
|---|---|---|
| Granulated mesalamine | DRUG | 0.375 g of mesalamine granules were encapsulated in a hard gelatin shell. 1.5 g of eMG (4 capsules) were administered orally QD, in the morning |
| Placebo | DRUG | Matching placebo capsules (4 capsules) were administered orally QD, in the morning |
Inclusion Criteria: * Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month. * Greater than 18 years of age. Exclusion Criteria: * Allergy/intolerance to aspirin, mesalamine or other salicylates. * Prior bowel surgery other than appendectomy. * Pregnancy, at risk of preg...
| 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 |
Granulated mesalamine is an investigational small molecule being developed for ulcerative colitis. It is being studied to maintain remission of mild to moderate ulcerative colitis in adult patients. The drug is currently in Phase 3 clinical development and has not been approved by the FDA.
Granulated mesalamine is being developed by Bausch Health Companies Inc., which trades under the ticker symbol BHC. The company is conducting Phase 3 clinical trials to evaluate the drug for maintaining remission in patients with mild to moderate ulcerative colitis.
Granulated mesalamine is in Phase 3 clinical development. Two Phase 3 trials have been completed, both evaluating the drug for maintaining remission of mild to moderate ulcerative colitis. The drug is investigational and has not received FDA approval.
Granulated mesalamine has been studied in two completed Phase 3 trials: NCT00744016 with 305 participants and NCT00767728 with 256 participants. Both trials were randomized, double-blind, placebo-controlled studies conducted in the United States, enrolling adults aged 18 years and older with ulcerative colitis.
Granulated mesalamine is a small molecule that works locally in the gastrointestinal tract to reduce inflammation in the colon. It is being studied for its ability to maintain remission in patients with mild to moderate ulcerative colitis.