Drugs / Relebactam
Relebactam
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Recarbrio | — | 2020-02-13 | europa.eu ↗ |
| Approved | US (FDA) | RECARBRIO | — | 2019-07-16 | fda.gov ↗ |
Trials 12 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04493151 | Jan 2021 → May 2023 | infectious disease with sepsis | Joseph L. Kuti, PharmD | Completed | No outcome recorded |
| Phase 1 | NCT04147221 | Feb 2020 → Sep 2021 | infectious disease with sepsis | Hartford Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03230916 | Nov 2017 → Jul 2020 | gram-negative bacterial infections | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01275170 | Jan 2011 → Mar 2012 | infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01506271 | Jun 2012 → Aug 2014 | infectious peritonitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT01505634 | May 2012 → Jul 2015 | pyelonephritis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03969901 | Oct 2019 → May 2024 | gram-negative bacterial infections | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT03583333 | Sep 2018 → Jul 2022 | bacterial pneumonia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03293485 | Oct 2017 → Sep 2018 | urinary tract infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02493764 | Nov 2015 → Apr 2019 | bacterial pneumonia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02452047 | Aug 2015 → Sep 2017 | bacterial infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04785924 | Jun 2021 → Jan 2023 | gram-negative bacterial infections | Wake Forest University Health Sciences | Withdrawn | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05204563 Comparator | Jul 2022 → Sep 2024 | bacterial pneumonia | Evopoint Biosciences Inc. | Completed | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Relebactam | “Imipenem/cilastatin/relebactam (IMI/REL), a fixed-dose combination of imipenem/cilastatin with the β-lactamase inhibitor relebactam, has broad gram-negative coverage.” PMID 42400209 ↗ Jul 202611“Imipenem/cilastatin/relebactam is approved for the treatment of serious gram-negative bacterial infections in adults.” PMID 37562063 ↗ Sep 2023 “500 mg Imipenem, 500 mg Cilastatin and 250 mg Relebactam powder FDC provided in a single vial” NCT03583333 ↗ |
| Known as | (-)-relebactam anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL3112741 ↗ |
| Known as | (-)-relebactam monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3112741 ↗ |
| Known as | MK-7655 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01275170 ↗ |
| Known as | MK-7655 MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3112741 ↗ |
| Known as | REL | “plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose” NCT03230916 ↗ |
| Known as | Relebactam component of mk-7655a | ChEMBL registry synonym — accepted as the source's own label CHEMBL3112741 ↗ |
| Known as | Relebactam component of recarbrio | ChEMBL registry synonym — accepted as the source's own label CHEMBL3112741 ↗ |
| Known as | Relebactam component of recarbrio monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3112741 ↗ |
| Known as | Relebactam hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3112741 ↗ |
| Action | Inhibit | “The β-lactamase inhibitor relebactam can restore imipenem activity” PMID 28575389 ↗ Sep 2017 |
| Modality | Small molecule | — CHEMBL3112741 ↗ |
| Route | Intravenous | “125 mg intravenous (IV) over 30 minutes as a single dose” NCT01275170 ↗ |