Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older. ( 1.1 ) Limitations of Use XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI). FDA label
Also known as Eravacycline (TP-434), TP-434
Eravacycline · 8 trials · 8 indications
Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required. Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI. Indeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI.
Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection \[cIAI\], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the End-of-Treatment (EOT) visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.
This was the co-primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to ertapenem in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to \<10\^4 colony-forming units/milliliter (CFU/mL). An outcome of Responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate.
This was the co-primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to ertapenem in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to \<10\^4 colony-forming units/milliliter (CFU/mL). An outcome of responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate.
This was the primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to levofloxacin in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to \<10\^4 colony-forming units/milliliter (CFU/mL). An outcome of Responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate.
To assess the pharmacokinetic (PK) profile of eravacycline after administration of a single intravenous (IV) dose (1.5 mg/kg) to subjects with mild, moderate, and severe impaired hepatic function compared with normal healthy subjects
Cmax, maximum observed plasma concentration
AUC0-t, area under the plasma concentration
AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time
AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose
t1/2, elimination half-life
Clast, last observed plasma concentration
CL, systemic clearance
Vd, volume of distribution
| Arm | Type | Description |
|---|---|---|
| Eravacycline | EXPERIMENTAL | - |
| Meropenem | ACTIVE_COMPARATOR | - |
| Eravacycline, 1.0 mg/kg q12h | EXPERIMENTAL | Eravacycline was administered intravenously (IV) at a dose of 1.0 milligram per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days. Eravacycline treatment was to be stopped when symptoms of complicated intra-abdominal infection (cIAI) resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. |
| Ertapenem, 1.0 g q24h | ACTIVE_COMPARATOR | Ertapenem was administered IV at a dose of 1.0 gram (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days. Ertapenem treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. |
| Eravacycline (Intravenous)/Levofloxacin (Oral) | EXPERIMENTAL | - |
| Ertapenem (Intravenous)/Levofloxacin (Oral) | ACTIVE_COMPARATOR | - |
| Levofloxacin | ACTIVE_COMPARATOR | Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO once a day for a total therapy of 7 dosing cycles. |
| 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 |
| Impaired hepatic function | EXPERIMENTAL | A single 1.5 mg/kg dose of eravacycline will be administered intravenously on Day 1 as a 60 minute infusion to each hepatically impaired subject. |
| Healthy subjects | EXPERIMENTAL | A single 1.5 mg/kg dose of eravacycline will be administered intravenously on Day 1 as a 60 minute infusion to each healthy subject. |
| Cohort 2 | EXPERIMENTAL | Eravacycline will be administered as a single 60 minute IV infusion according to age. Age group (years) Dose (mg/kg) 8 to \<12 (Cohort 2) 1.75 |
| End stage renal disease (ESRD) subjects | EXPERIMENTAL | A single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes |
| Normal healthy subjects | EXPERIMENTAL | A single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes |
| Name | Type | Description |
|---|---|---|
| Eravacycline | DRUG | - |
| Meropenem | DRUG | - |
| Placebo | DRUG | - |
| Ertapenem | DRUG | - |
| Levofloxacin | DRUG | - |
| IV Eravacycline 2mg/kg | DRUG | infused over a 60-minute period |
| IV Eravacycline 1.5mg/kg | DRUG | infused over a 60-minute period |
| Eravacycline (TP-434) | DRUG | Subjects will be stratified by age into 2 cohorts, as follows: * Cohort 1: from 12 to \<18 years of age (N=8) * Cohort 2: from 8 to \<12 years of age (N=12 or at least 60% of subjects) |
Inclusion Criteria: * Male or female participant hospitalized for cIAI * At least 18 years of age * Evidence of a systemic inflammatory response * Abdominal pain or flank pain (with or without rebound tenderness), or pain caused by cIAI that is referred to another anatomic area * Able to provide in...
Eravacycline is an antibiotic studied for treating bacterial infections, including complicated intra-abdominal infections and complicated urinary tract infections. Research has also explored its use in patients with end stage renal disease and impaired hepatic function. It is a small molecule developed by Innoviva, Inc. for infectious disease indications.
Eravacycline is developed by Innoviva, Inc., which trades under the ticker INVA. The company is responsible for the clinical development program covering pediatric and adult studies of the antibiotic in complicated intra-abdominal and complicated urinary tract infections.
Eravacycline is in clinical development, with a Phase 1 program listed as its current stage. Completed studies include Phase 1 and Phase 3 trials, and one Phase 2 pediatric trial is actively recruiting. It remains an investigational agent and is not described as approved.
Eravacycline has been studied in trials including NCT06794541, a recruiting Phase 2 pediatric study in complicated intra-abdominal infections; NCT03696550, a completed Phase 1 safety and PK study; NCT03032510, a completed Phase 3 cUTI study; and NCT02784704, a completed Phase 3 cIAI study.
Yes, eravacycline is also known as TP-434. Other names used for the compound include IV Eravacycline 2mg/kg and Eravacycline/kg, which refer to the same small molecule antibiotic. Searches for any of these names point to the same investigational agent developed by Innoviva, Inc.
Across the eravacycline clinical program, total enrollment is approximately 1,205 participants. The largest study, NCT03032510, enrolled 1,205 patients in complicated urinary tract infections, while NCT02784704 enrolled 500 patients in complicated intra-abdominal infections and NCT03696550 enrolled 19 participants.