Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Eravacycline/kg · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Eravacycline intravenous (IV) will be administered every 12 hours for participants 12 to \<18 years of age |
| Cohort 2a | EXPERIMENTAL | Eravacycline IV will be administered every 12 hours for participants 10 to \<12 years of age |
| Cohort 2b | EXPERIMENTAL | Eravacycline IV will be administered every 12 hours for participants aged 8 to \<10 years of age |
| Name | Type | Description |
|---|---|---|
| IV Eravacycline 2mg/kg | DRUG | infused over a 60-minute period |
| IV Eravacycline 1.5mg/kg | DRUG | infused over a 60-minute period |
Inclusion Criteria: 1. Children from 8 to \<18 years of age (as of the day of the informed consent \[and assent, if applicable\] is obtained), hospitalized for cIAI with one of the following diagnoses: 1. Intra-abdominal abscess (including hepatic and splenic abscesses). 2. Gastric or intest...
Eravacycline is an investigational small molecule antibiotic being studied for bacterial infections, including complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), and in patients with end stage renal disease or impaired hepatic function. It is in clinical development and has not been confirmed as FDA approved.
Eravacycline is being developed by Innoviva, Inc., a biopharmaceutical company traded on NASDAQ under the ticker INVA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various patient populations.
Eravacycline is in Phase 1 clinical development, though it has also completed Phase 3 trials for complicated intra-abdominal infections and complicated urinary tract infections. A Phase 2 trial in pediatric patients is currently recruiting. The drug remains investigational and is not yet approved.
Eravacycline has been studied in several trials, including NCT01844856, a completed Phase 3 study comparing it with ertapenem in complicated intra-abdominal infections, and NCT01978938, a completed Phase 3 study versus levofloxacin in cUTI. A Phase 1 trial, NCT02135276, assessed its pharmacokinetics in end stage renal disease, and NCT06794541 is an ongoing Phase 2 pediatric trial.
Yes, Eravacycline is also known as IV Eravacycline 2mg/kg and Eravacycline/kg. These names refer to the same drug, which is administered intravenously at a dose of 2 mg per kilogram of body weight in clinical studies.
Eravacycline is a small molecule antibiotic that targets bacterial infections. It is being evaluated for its ability to treat complicated urinary tract infections and complicated intra-abdominal infections, among other conditions. Its specific molecular target has not been disclosed in the available information.