Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PL8177 · 1 trial · 4 indications
Adverse events (AEs) will be collected from the time of signing the informed consent form (ICF). All subjects who are randomized will be monitored for AEs until the time they leave the study.
Efficacy will be determined through the use of the Mayo Endoscopic Subscore.
| Arm | Type | Description |
|---|---|---|
| PL8177 | EXPERIMENTAL | PL8177 will be given orally and daily from baseline until end of study. |
| Placebo | PLACEBO_COMPARATOR | Approximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177. |
| Name | Type | Description |
|---|---|---|
| PL8177 Placebo | DRUG | Approximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177. |
| PL8177 | DRUG | Approximately 3/4 of randomized patients will receive active PL8177. |
Inclusion Criteria: * Age ≥18 to ≤75 years of age at Screening. * Has a history of UC diagnosis prior to screening; confirmed by endoscopic and histologic evidence in the subject chart. If the historical evidence is not available, then endoscopic and histologic evidence can be confirmed during the ...
| 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 |
PL8177 is an investigational small molecule being studied for the treatment of ulcerative colitis, including acute ulcerative colitis and ulcerative colitis flare. It is currently in Phase 2 clinical development and has not been approved by the FDA.
PL8177 targets the melanocortin-1 receptor, a receptor involved in modulating inflammatory responses. By acting on this receptor, the drug is being evaluated for its potential to treat ulcerative colitis, though its exact mechanism in this condition is still under investigation.
PL8177 is being developed by Palatin Technologies, Inc., a biopharmaceutical company traded on the NYSE American under the ticker PTN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with ulcerative colitis.
PL8177 is in Phase 2 clinical development. It is currently being evaluated in a Phase 2a trial for active ulcerative colitis. The drug is investigational and has not received FDA approval for any indication.
PL8177 is being studied in one active clinical trial, NCT05466890, a Phase 2a study in subjects with active ulcerative colitis. This randomized, double-blind, placebo-controlled trial has an enrollment of 16 participants and is being conducted in the United States.
Yes, PL8177 is also referred to as PL-8177. The clinical trial NCT05466890 uses the name PL-8177 in its title, and both names refer to the same investigational drug being developed by Palatin Technologies for ulcerative colitis.