Approval Probability
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Also known as RPX7009
RPX7009 and RPX2014 · 4 trials · 4 indications
Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis
Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
| Arm | Type | Description |
|---|---|---|
| Single dose of RPX7009 and RPX2014 | EXPERIMENTAL | Single dose of combination RPX7009 and RPX2014 |
| Single and multiple dose of RPX7009 | EXPERIMENTAL | Single and multiple dose of RPX7009 |
| Single and multiple dose of RPX2014 | EXPERIMENTAL | Single and multiple dose of RPX2014 |
| Normal Saline | PLACEBO_COMPARATOR | Single and multiple dose of normal saline |
| Combination RPX7009 and RPX2014 | EXPERIMENTAL | Single and Multiple dose of Combination RPX7009 and RPX2014 |
| Single dose IV of biapenem or RPX7009 | EXPERIMENTAL | Single dose IV infusion of biapenem or RPX7009 |
| Single dose of biapenem or RPX7009 | EXPERIMENTAL | Single IV dose of biapenem or RPX7009 (for those on active drug, this will be the drug not given in the first IV treatment) |
| Biapenem and RPX7009 in combination | EXPERIMENTAL | Single dose followed by a multiple dose of biapenem and RPX7009 in combination |
| Ascending Single and Multiple dose of RPX7009 | EXPERIMENTAL | Ascending Single and Multiple dose of RPX7009 |
| Name | Type | Description |
|---|---|---|
| RPX7009 and RPX2014 | DRUG | The study is designed to enroll approximately 32 subjects. There will be approximately 24 subjects with varying degrees of renal insufficiency and approximately 8 subjects with normal renal function. |
| RPX7009 | DRUG | Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6. |
| RPX2014 | DRUG | Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6. |
| Placebo | DRUG | Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6. |
| Combination RPX7009 and RPX2014 | DRUG | Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6. |
| Biapenem | DRUG | Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo) |
| Normal saline | DRUG | Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo) |
Inclusion Criteria: 1. Males and females aged 18 through 80 years of age 2. Willing to abstain from alcohol for 48 hours prior to dosing through discharge 3. Normal volunteer first matched by age (± 10 years), BMI (± 20%), and gender to the mean values of the moderate renal insufficiency group. 4. ...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
RPX7009 and RPX2014 is an investigational small molecule combination being developed by Novartis AG for bacterial infections. It pairs RPX7009 with RPX2014 and has been studied in Phase 1 clinical trials, including in subjects with varying degrees of renal insufficiency and in healthy adults with normal renal function.
Novartis AG is developing RPX7009 and RPX2014. Novartis trades on the New York Stock Exchange under the ticker NVS. The company has sponsored Phase 1 studies of the combination in the United States and Australia.
RPX7009 and RPX2014 is in Phase 1 clinical development. All three completed trials were Phase 1 studies, and no later-phase trials are listed. The program remains investigational and has not been approved for commercial use.
Four Phase 1 trials have studied RPX7009 and RPX2014, all completed. They include NCT02020434 in subjects with renal insufficiency, NCT01897779 in healthy adults, NCT01772836 evaluating intravenous biapenem (RPX2003) with RPX7009, and NCT01751269 studying RPX7009 alone in healthy adults.
Across the completed Phase 1 program, 204 participants have been enrolled in studies of RPX7009 and RPX2014. The trials were randomized, double-blind, and placebo-controlled, and they enrolled healthy adult volunteers as well as subjects with varying degrees of renal insufficiency.