Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GB004 · 1 trial · 1 indication
To evaluate the safety and tolerability of GB004 for 56 days in terms of incidence of treatment emergent adverse events reported.
| Arm | Type | Description |
|---|---|---|
| GB004 | EXPERIMENTAL | GB004 for oral administration daily |
| Placebo | PLACEBO_COMPARATOR | Placebo for oral administration daily |
| Name | Type | Description |
|---|---|---|
| GB004 | DRUG | GB0004 high dose |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation. Exclusion Criteria: * Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection. * Patient...
| 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 |
GB004 is an investigational small molecule being developed for the treatment of ulcerative colitis, a form of inflammatory bowel disease. It is intended for adult subjects with active ulcerative colitis. The drug is currently in clinical development and has not been approved by regulatory authorities.
GB004 is being developed by Gossamer Bio, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol GOSS. The company is conducting clinical research to evaluate the safety and efficacy of GB004 in patients with ulcerative colitis.
GB004 is in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 34 participants. The drug remains investigational and has not received regulatory approval for any use. Further clinical studies may be needed to establish its safety and effectiveness.
GB004 has one completed clinical trial registered as NCT03860896, titled 'GB004 in Adult Subjects With Active Ulcerative Colitis.' This Phase 1 study was placebo-controlled, double-blind, and randomized, enrolling 34 participants across the United States, Georgia, and Moldova. The trial has been completed.
GB004 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for ulcerative colitis. The completed Phase 1 trial represents an early stage of research, and the drug has not yet demonstrated sufficient evidence to support regulatory approval.