Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3871801 · 5 trials · 2 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
Part 1: PK: Cmax of Methotrexate
Part 1: PK: AUC\[0-∞\] of Methotrexate
Part 2: PK: AUC\[0-∞\] of Midazolam
Part 2: PK: AUC\[0-∞\] of S-warfarin
Part 2: PK: AUC\[0-∞\] of Dextromethorphan
Part 2: PK: AUC\[0-∞\] of Repaglinide
PK: Cmax of LY3871801
PK: AUC\[0-∞\] of LY3871801
| Arm | Type | Description |
|---|---|---|
| LY3871801 Phase 2a | EXPERIMENTAL | Participants will receive LY3871801 administered orally. |
| Placebo Phase 2a | PLACEBO_COMPARATOR | Participants will receive placebo. |
| LY3871801 Dose 1 Phase 2b | EXPERIMENTAL | Participants will receive LY3871801 administered orally. |
| LY3871801 Dose 2 Phase 2b | EXPERIMENTAL | Participants will receive LY3871801 administered orally. |
| LY3871801 Dose 3 Phase 2b | EXPERIMENTAL | Participants will receive LY3871801 administered orally. |
| Placebo Phase 2b | PLACEBO_COMPARATOR | Participants will receive placebo. |
| [14C]-LY3871801 | EXPERIMENTAL | Single dose of \[¹⁴C\]-LY3871801 administered orally |
| LY3871801 (Part A) | EXPERIMENTAL | LY3871801 administered orally in Japanese and Non-Asian Participants. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo administered orally in Japanese and Non-Asian Participants. |
| LY3871801 (Part B) | EXPERIMENTAL | LY3871801 administered orally in Chinese Participants. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Placebo administered orally in Chinese Participants. |
| LY3871801 + Methotrexate (Part 1) | EXPERIMENTAL | LY3871801 administered orally in combination with methotrexate given orally. |
| LY3871801 + Repaglinide + Drug Cocktail (Part 2) | EXPERIMENTAL | LY3871801 administered orally in combination with repaglinide given orally and drug cocktail which includes warfarin, dextromethorphan and midazolam administered orally. |
| LY3871801 (Period 1) | EXPERIMENTAL | LY3871801 solid dispersion suspension administered orally. |
| LY3871801 (Period 2) | EXPERIMENTAL | LY3871801 crystalline freebase tablet administered orally. |
| Name | Type | Description |
|---|---|---|
| LY3871801 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| [14C]-LY3871801 | DRUG | Administered orally |
| Methotrexate | DRUG | Administered orally. |
| Warfarin | DRUG | Administered orally. |
| Dextromethorphan | DRUG | Administered orally. |
| Midazolam | DRUG | Administered orally. |
| Repaglinide | DRUG | Administered orally. |
Inclusion Criteria: * Have a diagnosis of adult-onset RA for at least 3 months prior to screening as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria. * Have moderately-to-severely active RA at screening and baseline, defined by the presence of * ≥6 swol...
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LY3871801 is an investigational small molecule being studied for use in healthy participants and in rheumatoid arthritis. As of the latest data, it is in Phase 1 clinical development and has not been approved by regulatory authorities. All four completed trials enrolled healthy volunteers, with no active trials currently listed.
LY3871801 is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker symbol LLY. The company has sponsored four Phase 1 clinical trials of this investigational small molecule, all of which have been completed.
LY3871801 is in Phase 1 clinical development. All four clinical trials listed for this drug are Phase 1 studies and have been completed. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any use.
LY3871801 has been studied in four completed Phase 1 trials: NCT05222399 in healthy participants in Singapore, NCT05602675 a drug interaction study in the US, NCT05960851 in healthy Asian and non-Asian participants in the US, and NCT06049108 a carbon-14 labelled study in healthy males in the US. No active trials are currently listed.
LY3871801 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, with all completed trials conducted in healthy volunteers. The drug has not yet progressed to later-stage trials or received marketing authorization for any indication.