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Also known as M5049 low dose
M5049 · 2 trials · 2 indications
Time to recovery was defined as the time from first dose (Day 1) to first occurrence of World Health Organization (WHO) 9-point ordinal scale 3 or less. The scoring is assessed with the following ordinal scale: 0. Uninfected: no clinical or virological evidence of infection; 1. Ambulatory: no limitation of activities; 2. Ambulatory: limitation of activities; 3. Hospitalized, mild disease: hospitalized, no oxygen therapy; 4. Hospitalized, mild disease: oxygen by mask or nasal prongs; 5. Hospitalized, severe disease: noninvasive ventilation or high-flow oxygen; 6. Hospitalized, severe disease: intubation and mechanical ventilation; 7. Hospitalized, severe disease: ventilation plus additional organ support for example: vasopressors or Extracorporeal membrane oxygenation (ECMO); 8. Death.
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on treatment period. TEAEs included serious TEAEs and non-serious TEAEs.
Laboratory investigation included hematology and biochemistry. The number of participants with clinically significant changes from baseline in laboratory parameters were reported. Clinical significance was determined by the investigator.
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.
| Arm | Type | Description |
|---|---|---|
| M5049 50 mg | EXPERIMENTAL | - |
| M5049 100 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Japanese: M5049 Dose A (low dose) | EXPERIMENTAL | - |
| Japanese: M5049 Dose B (medium dose) | EXPERIMENTAL | - |
| Japanese: M5049 Dose C (high dose) | EXPERIMENTAL | - |
| Caucasian: M5049 Dose A (low dose) | EXPERIMENTAL | - |
| Caucasian: M5049 Dose B (medium dose) | EXPERIMENTAL | - |
| Caucasian: M5049 Dose C (high dose) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| M5049 | DRUG | Participants received M5049 50 milligram (mg) orally twice daily for 14 days. |
| Placebo | DRUG | Participants received placebo tablets matched to M5049 daily for 14 days. |
Inclusion Criteria: * Participant provides signed informed consent prior to the initiation of any study assessments * Has laboratory-confirmed SARS-CoV-2 Infection as determined by nucleic acid amplification test, polymerase chain reaction, antigen test or other commercial or public health assay (b...
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.