Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 181 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Placebo arm | ACTIVE_COMPARATOR | Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. |
| Active arm | ACTIVE_COMPARATOR | Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. |
| Name | Type | Description |
|---|---|---|
| AMG 181 | DRUG | Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. |
| Placebo for AMG 181 | OTHER | Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. |
Inclusion Criteria: * Body Mass Index (BMI) between 18 and 34 kg/m2 * Normal physical and neurological examination, clinical laboratory values and ECG * Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 10 (inclusive), with a minimum sigmoidoscopy score of 1; (for subj...
| 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 |
AMG 181 is an investigational small molecule being developed for ulcerative colitis, a form of inflammatory bowel disease. It was studied in a Phase 1 clinical trial that also included patients with Crohn's disease, another inflammatory bowel condition. The drug is not approved and remains in clinical development.
AMG 181 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company sponsored a Phase 1 clinical trial of the drug in patients with ulcerative colitis and Crohn's disease.
AMG 181 is in Phase 1 clinical development. A Phase 1 study of the drug has been completed, and it is not approved for any use. The drug remains investigational, and no later-phase trials have been reported.
AMG 181 has one completed clinical trial, identified as NCT01290042, titled "Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181." This Phase 1 study enrolled 43 participants with ulcerative colitis or Crohn's disease, as well as healthy volunteers, at sites in the United States and Australia.
AMG 181 is the only name provided for this drug, and no alternative names have been reported. It is an investigational small molecule developed by Amgen Inc. for ulcerative colitis and Crohn's disease.