Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tedizolid · 1 trial · 1 indication
Clinical response was evaluated by the masked investigator as clinical cure, clinical failure and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count.
Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.
| Arm | Type | Description |
|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY1192631) | EXPERIMENTAL | Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO)) |
| Linezolid | ACTIVE_COMPARATOR | Participants received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO)) |
| Name | Type | Description |
|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY1192631) | DRUG | BAY1192631 solution or tablet 200 mg, once daily, Intravenous (IV) or By Mouth (PO) for 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia. |
| Linezolid | DRUG | Linezolid solution or tablet 600 mg, twice daily, every 12 ±3 hours, Intravenous (IV) or By mouth (PO) 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia. |
Inclusion Criteria * Suspected or confirmed Methicillin-resistant Staphylococcus aureus (MRSA) infection * Japanese Male and female patients aged 18 years or above * Diagnosis of Skin and soft tissue infection with MRSA either suspected or confirmed as the major cause of infection, with/without SST...
Tedizolid is an investigational small molecule being studied for the treatment of skin and infectious diseases, specifically infections caused by methicillin-resistant Staphylococcus aureus (MRSA). It is in Phase 3 clinical development for this indication.
Tedizolid is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY.
Tedizolid is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities.
Tedizolid has one completed Phase 3 clinical trial, NCT01967225, which evaluated its safety and efficacy in Japanese patients with MRSA infections. The trial enrolled 125 participants and was active-controlled.
Yes, Tedizolid is also known as BAY1192631. The clinical trial NCT01967225 refers to the drug as BAY1192631.