Drugs / Relebactam
Relebactam
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed opportunistic bacterial infectious disease 1 milestone | |||||
| Filed | US (FDA) | RECARBRIO | opportunistic bacterial infectious disease | 2020-02-03 | “Merck announced filing acceptance for priority review by the FDA for a sNDA seeking approval of RECARBRIO to treat adult patients with hospital-acquired bacterial pneumonia and...” merck.com ↗ “the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for RECARBRIO™” merck.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Approved | EU (EMA) | Recarbrio | — | 2020-02-13 | europa.eu ↗ |
| Approved | US (FDA) | RECARBRIO | — | 2019-07-16 | fda.gov ↗ |
| Filed | US (FDA) | — | — | 2019-02-05 | “FDA acceptance for priority review of a New Drug Application for the company’s investigational beta-lactamase inhibitor relebactam in combination with imipenem/cilastatin” merck.com ↗ “a NDA accepted for Priority Review for the combination of relebactam, the company’s investigational beta-lactamase inhibitor, with imipenem/cilastatin” merck.com ↗ |
Trials 12
| 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 · 2 met primary | ||||||
| Phase 2 | NCT01506271 | Jun 2012 → Aug 2014 | infectious peritonitis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2 | NCT01505634 | May 2012 → Jul 2015 | pyelonephritis | Merck Sharp & Dohme LLC | Completed | Met primary |
| 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 · 3 met primary | ||||||
| Phase 3 | NCT03583333 | Sep 2018 → Jul 2022 | bacterial pneumonia | Merck Sharp & Dohme LLC | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT02452047 | Aug 2015 → Sep 2017 | bacterial infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT04785924 | Jun 2021 → Jan 2023 | gram-negative bacterial infections | Wake Forest University Health Sciences | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT05204563 Comparator | Jul 2022 → Sep 2024 | bacterial pneumonia | Evopoint Biosciences Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2020-07-31 | Merck Sharp & Dohme LLC | Regulatory Merck Announces Second-Quarter 2020 Financial Results merck.com ↗
Merck announced FDA approval of RECARBRIO (imipenem, cilastatin, and relebactam) for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). |
| 2020-06-05 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) merck.com ↗ |
| 2020-05-06 | Merck Sharp & Dohme LLC | Results Results of Phase 3 Trial Evaluating the Efficacy and Safety of Merck’s RECARBRIO™ (Imipenem, Cilastatin, and Relebactam) Versus Piperacillin and Tazobactam in Adult Patients with HABP/VABP Now Available merck.com ↗
RECARBRIO met its primary and key secondary endpoints, demonstrating non-inferiority compared to PIP/TAZ. |
| 2020-02-03 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts For Review Supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) to treat adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative microorganisms. |
| 2019-12-16 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive EU CHMP Opinion for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Infections Due to Aerobic Gram-Negative Organisms in Adults with Limited Treatment Options merck.com ↗
The CHMP positive opinion will now be considered by the European Commission. |
| 2019-09-30 | Merck Sharp & Dohme LLC | Results Pivotal RESTORE-IMI 2 Phase 3 Study of Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) in Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Met Primary Endpoint merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 RECARBRIO™ (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) RESTORE-IMI 2 trial met its primary endpoint. |
| 2019-07-17 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) For the Treatment of Adults with Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections Where Limited or No Alternative Treatment Options Are Available merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved RECARBRIO™ (imipenem, cilastatin, and relebactam) for injection, 1.25 grams, a new combination antibacterial. |
| 2019-02-05 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts for Review New Drug Application (NDA) for Merck’s Investigational Combination of Imipenem/Cilastatin and Relebactam, and Supplemental NDA (sNDA) for ZERBAXA® (Ceftolozane and Tazobactam) merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review regulatory filings for two antibacterial agents. |
| 2016-06-20 | Merck Sharp & Dohme LLC | Results Results of Phase 2 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Presented at ASM Microbe merck.com ↗
today announced that a Phase 2 study of relebactam, the company’s investigational beta-lactamase inhibitor, in combination with imipenem/cilastatin (an approved carbapenem antibiotic), in patients with complicated urinary tract infections, met its primary endpoint. |
| 2014-09-04 | Merck Sharp & Dohme LLC | Regulatory Merck’s Investigational Beta-lactamase Inhibitor Relebactam (MK-7655) Granted Qualified Infectious Disease Product (QIDP) and Fast Track Designations by FDA merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has designated relebactam (previously known as MK-7655), the company’s investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product (QIDP) with designated Fast Track status. |
All press releases naming this drug 12 releases
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 ↗ |