Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY4268989 · 4 trials · 5 indications
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module
PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989
PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989
PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989
PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989
| Arm | Type | Description |
|---|---|---|
| LY4268989 Study Dose 1 | EXPERIMENTAL | LY4268989 administered orally |
| LY4268989 Study Dose 2 | EXPERIMENTAL | LY4268989 administered orally |
| Placebo Study Dose | PLACEBO_COMPARATOR | Placebo administered orally |
| LY4268989 + Mirikizumab | EXPERIMENTAL | LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2. |
| Mirikizumab + LY4268989 Placebo | EXPERIMENTAL | Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2. |
| LY4268989 Treatment A | EXPERIMENTAL | Participants will receive LY4268989 single dose T1 orally with high-fat meal |
| LY4268989 Treatment B | EXPERIMENTAL | Participants will receive LY4268989 single dose T2 orally with high-fat meal |
| LY4268989 Treatment C | EXPERIMENTAL | Participants will receive LY4268989 single dose T2 orally in a fasted state |
| LY4268989 Treatment D | EXPERIMENTAL | Participants will receive LY4268989 single dose T3 orally with high-fat meal |
| LY4268989 Treatment E | EXPERIMENTAL | Participants will receive LY4268989 single dose T3 orally in a fasted state |
| LY4268989 Treatment F | EXPERIMENTAL | Participants will receive LY4268989 single dose T1 orally in a fasted state |
| LY4268989 or Placebo Cohort 1 (Blinded) | EXPERIMENTAL | Participants will receive LY4268989 orally or placebo single dose followed by BID administration |
| LY4268989 Cohort 2 (Open-Label) | EXPERIMENTAL | Participants will receive LY4268989 orally tablet (formulation compared to capsule formulation) in a fasted state |
| LY4268989 Cohort 3 (Open-Label) | EXPERIMENTAL | Participants will receive multiple doses of LY4268989 orally BID administration with midazolam orally and intravenously (IV). |
| LY4268989 or Placebo Cohort 4 (Blinded) | EXPERIMENTAL | Participants will receive single escalating doses of LY4268989 orally or placebo |
| LY4268989 Cohort 5 (Blinded) | EXPERIMENTAL | Participants will receive multiple doses of LY4268989 orally or placebo |
| LY4268989 Cohort 6 (Open-Label) | EXPERIMENTAL | Participants will receive LY4268989 single dose orally in a fasted and fed state |
| LY4268989 Cohort 7 (Open-Label) | EXPERIMENTAL | Participants will receive multiple doses of LY4268989 orally BID administration in a fed state |
| LY4268989 Cohort 8 (Open-Label) | EXPERIMENTAL | Participants will receive multiple doses of LY4268989 orally BID administration with midazolam IV in a fasted state. |
| Name | Type | Description |
|---|---|---|
| LY4268989 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Mirikizumab | DRUG | Administered IV then SC |
| LY4268989 Placebo | DRUG | Administered PO |
| Midazolam | DRUG | Administered orally |
Inclusion Criteria: * Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC * Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by cen...
| 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 |
LY4268989 is an investigational small molecule being studied for the treatment of moderately to severely active ulcerative colitis (UC) in adults. It is also being evaluated in healthy participants in early-phase studies to assess its safety and pharmacological properties.
LY4268989 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical trials of this investigational drug in multiple countries.
LY4268989 is in Phase 1 and Phase 2 clinical development. Phase 1 studies are evaluating the drug in healthy participants, while Phase 2 studies are assessing its efficacy and safety in adults with moderately to severely active ulcerative colitis.
LY4268989 is being studied in several clinical trials, including NCT06964776 and NCT07707375 in healthy participants, and NCT07186101 and NCT07415044 in adults with ulcerative colitis. The trials are being conducted in the United States and numerous other countries.
Yes, LY4268989 is also known as MORF-057. Clinical trial titles refer to the drug as LY4268989 (MORF-057), indicating that these names are used interchangeably for the same investigational compound.
LY4268989 is not FDA approved. It is an investigational drug currently in clinical trials, including Phase 2 studies for ulcerative colitis. Its safety and efficacy have not yet been established, and it remains under clinical development.