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Also known as RPX2003 (Biapenem), Biapenem
RPX2003 · 1 trial · 2 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.
| Arm | Type | Description |
|---|---|---|
| RPX2003 (Biapenem) | EXPERIMENTAL | Single and multiple dose of RPX2003 (Biapenem). |
| Normal Saline | PLACEBO_COMPARATOR | Single and multiple doses of normal saline. |
| Name | Type | Description |
|---|---|---|
| RPX2003 (Biapenem) | DRUG | Six (6) cohorts of 3 active or 8 subjects of 6 active are planned for evaluation. Single dose followed by multiple dose, three times a day. |
| Placebo | DRUG | Six (6) cohorts of 1 placebo or 8 subjects of 2 placebo are planned for evaluation. Single dose followed by multiple dose, three times a day. |
Inclusion Criteria: * Healthy adult males and/or females, 18 to 55 years of age * Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive). * Medically healthy with clinically insignificant screening results * Non-tobacco/nicotine-containing product users for...
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 |
RPX2003 is an investigational small molecule antibiotic being developed by Novartis AG for bacterial infections. It is also known as RPX2003 (Biapenem). It has completed a Phase 1 clinical trial in healthy adult volunteers in the United States. RPX2003 is not approved and remains in clinical development.
RPX2003 is being developed for the treatment of bacterial infections. Its only recorded clinical trial enrolled healthy adult volunteers to assess safety, tolerability, and pharmacokinetics rather than to treat patients. RPX2003 is investigational and has not been approved for any indication.
RPX2003 is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the Phase 1 trial of RPX2003 (Biapenem) conducted in the United States. No other developer or partnership for RPX2003 is recorded.
RPX2003 is in Phase 1 clinical development. Its single recorded trial, NCT01702649, was a Phase 1 study that has been completed. The trial enrolled 36 healthy adult subjects. RPX2003 is investigational and has not been approved by the FDA for any use.
RPX2003 has been studied in one clinical trial, NCT01702649, titled Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects. The Phase 1 trial was completed, enrolled 36 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States.
Yes, RPX2003 is also known as RPX2003 (Biapenem). Biapenem is the alternative name used for this investigational antibiotic developed by Novartis AG. Searches for either name refer to the same Phase 1 asset studied in trial NCT01702649 for bacterial infections.