Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M5049 low dose · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| M5049 low dose + Placebo | EXPERIMENTAL | Participants with CLE (active SCLE and/or DLE) or SLE who received low dose of M5049 in WILLOW study will continue to receive M5049 low dose and matching placebo. |
| M5049 medium dose+ Placebo | EXPERIMENTAL | Participants with CLE (active SCLE and/or DLE) or SLE who received medium dose of M5049 in WILLOW study will continue to receive M5049 medium dose and matching placebo. |
| M5049 high dose + Placebo | EXPERIMENTAL | Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or high dose of M5049 in WILLOW study will receive M5049 high dose . |
| Name | Type | Description |
|---|---|---|
| M5049 low dose | DRUG | Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 194 weeks. |
| M5049 medium dose | DRUG | Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 194 weeks. |
| M5049 high dose | DRUG | Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 194 weeks. |
| Placebo | DRUG | Participants will receive M5049 matching placebo orally, BID for up to 194 weeks. |
Inclusion Criteria: * Are SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study * Have a Body Mass Index (BMI) within the less than or equal to (\<=) 40 kilograms per meter square (inclusive) at Screening * Participants who had successfully completed Week 48 of the Part...
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| Viatris, Inc. | VTRS | 5 | PHASE3 | Cenerimod |
| Novartis AG Sponsored ADR | NVS | 7 | PHASE3 | Ianalumab |
| AstraZeneca PLC | AZN | 21 | PHASE3 | Medi-546 |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Upadacitinib |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Belimumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | SAR441344 |
| Zenas BioPharma, Inc. | ZBIO | 1 | PHASE2 | Obexelimab |
| Alumis Inc. | ALMS | 1 | PHASE2 | Envudeucitinib |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| Amgen Inc. | AMGN | 1 | PHASE2 | Inebilizumab, Blinatumomab |
| Fate Therapeutics, Inc. | FATE | 2 | PHASE2 | FT819 |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY4298445 |
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| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-1045 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE1 | KITE-363, Fludarabine, Cyclophosphamide |
| Artiva Biotherapeutics, Inc. | ARTV | 2 | PHASE1 | AB-101, Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab |
| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
M5049 is an investigational small molecule being studied for Systemic Lupus Erythematosus, Coronavirus Disease 2019, and in healthy volunteers. It is developed by Merck & Company, Inc. (MRK) and is currently in Phase 2 clinical development. The drug is not approved and remains under investigation.
M5049 is a small molecule therapeutic developed by Merck & Company, Inc. (MRK). Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated in Phase 2 trials for Systemic Lupus Erythematosus and COVID-19 pneumonia.
M5049 is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker MRK. The company is conducting clinical trials of M5049 in multiple countries, including the United States, for conditions such as Systemic Lupus Erythematosus and COVID-19.
M5049 is in Phase 2 clinical development. It has completed a Phase 2 trial in COVID-19 pneumonia and a Phase 1 trial in healthy volunteers. An additional Phase 2 long-term extension study in Systemic Lupus Erythematosus is active but not recruiting participants.
M5049 has been studied in three clinical trials. NCT04448756 was a Phase 2 study in COVID-19 pneumonia. NCT04880213 was a Phase 1 study in healthy Japanese and Caucasian participants. NCT05540327 is an active Phase 2 long-term extension study in Systemic Lupus Erythematosus, with 379 participants enrolled.
M5049 is also known as M5049 low dose. The drug is being investigated by Merck & Company, Inc. (MRK) for Systemic Lupus Erythematosus and other conditions. Clinical trials reference the drug under the name M5049, and the low dose formulation is part of its development program.