Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VP20621 · 1 trial · 1 indication
An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| VP20621 Low Dose and Placebo | EXPERIMENTAL | - |
| VP20621 High Dose and Placebo | EXPERIMENTAL | - |
| VP20621 High Dose | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| VP20621 | BIOLOGICAL | VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days |
| Placebo | OTHER | 10 mL placebo once daily for 14 days |
Inclusion Criteria: 1. Adult subjects, 18 years of age and over, who understand the risks and benefits of participation and have provided written informed consent for the study. 2. Subjects who are experiencing a first event or first recurrence of clostridium difficile (CDI) within the last 28 days...
VP20621 is an investigational monoclonal antibody being developed for the prevention of recurrent Clostridium difficile infection. It is intended for use in patients with this infection, and it is currently in Phase 2 clinical development.
VP20621 is a monoclonal antibody, but its specific molecular target has not been disclosed. As a monoclonal antibody, it is designed to bind to a specific antigen, but the exact target is not publicly available.
VP20621 is being developed by Takeda Pharmaceutical Company Limited, which is publicly traded under the ticker symbol TAK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
VP20621 is in Phase 2 clinical development. It has completed one Phase 2 trial, and it is not yet approved by regulatory authorities. The drug is still investigational and has not been approved for any use.
VP20621 has been studied in one completed Phase 2 clinical trial, identified as NCT01259726. This trial evaluated the safety and efficacy of VP20621 for the prevention of recurrent Clostridium difficile infection, enrolling 173 participants across multiple countries.
VP20621 is the primary name for this investigational monoclonal antibody. No alternative names have been reported for this drug, and it is not known to be the same as any other marketed or investigational product.