Drugs / Daptomycin
Daptomycin
also known as
Cubicin · Cidecin · Cubicin (daptomycin for injection) · Cubicin rf · Dapcin · Daptomicina · Daptomycin hospira · daptomycin: cubicin 350 mg vial. · +6 more
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | — | 2023-02-27 | fda.gov ↗ |
| Label expansion | US (FDA) | DAPTOMYCIN | — | 2021-05-05 | fda.gov ↗ |
| Label expansions (4) | US (FDA) | CUBICIN | — | 2006-05-25 – 2017-09-01 | fda.gov ↗ |
| Approved | EU (EMA) | Cubicin | — | 2006-01-19 | europa.eu ↗ |
| Approved | US (FDA) | CUBICIN | — | 2003-09-12 | fda.gov ↗ |
Trials 70 · started per year
today
US approved 2003
EU approved 2006
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Also used as a comparator or background therapy in 19 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 26 trials | ||||||
| Phase 2 | NCT04983901 Background | Sep 2021 → Oct 2023 | cancer, hematopoietic and lymphoid cell neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT04775953 Comparator | Apr 2021 → Oct 2023 | staphylococcal infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT02168816 Comparator | Mar 2014 → Feb 2017 | osteomyelitis | Loyola University | Terminated | No outcome recorded |
| Phase 2 | NCT02052388 Comparator | Feb → Oct 2014 | bacterial infectious disease, skin infection | Cellceutix Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01756924 Comparator | Dec 2012 → Jul 2014 | periprosthetic joint infection | Arrevus Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01211470 Comparator | Oct 2010 → Dec 2011 | methicillin-susceptible staphylococcus aureus infectious disease | PolyMedix, Inc. | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT03138733 Comparator | Aug 2018 → Mar 2022 | staphylococcus aureus infection | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 3 | NCT02208063 Comparator | Dec 2014 → Apr 2018 | bacterial infectious disease | Cumberland Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT01216241 Comparator | Apr 2011 → Apr 2013 | neutropenia | University of Rochester | Terminated | No outcome recorded |
| Phase 49 trials | ||||||
| Phase 4 | NCT07072923 Comparator | Sep 2025 → Jul 2027 expected | osteomyelitis | University of Arizona | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05977868 Comparator | Aug 2023 → Feb 2025 | digestive system infectious disorder | West Virginia University | Terminated | No outcome recorded |
| Phase 4 | NCT04141787 Comparator | Jul 2019 → Jul 2023 | abscess, bacterial arthritis, infectious disorder of the nervous system, osteomyelitis +1 | Vancouver Island Health Authority | Unknown | No outcome recorded |
| Phase 4 | NCT01549613 Comparator | May 2012 → Jul 2013 | cellulitis, skin infection | University of Cincinnati | Completed | No outcome recorded |
| Phase 4 | NCT01734694 Comparator | Oct 2011 → Sep 2012 | bacterial infectious disease, endocarditis, nosocomial infection, osteomyelitis | Henry Ford Health System | Terminated | No outcome recorded |
| Phase 4 | NCT01612052 Comparator | May 2011 → Mar 2013 | methicillin-resistant staphylococcus aureus infectious disease | CAMC Health System | Unknown | No outcome recorded |
| Phase 4 | NCT01133600 Comparator | Aug 2010 → Aug 2012 | — | Clinical Alliance for Research & Education - Infectious Diseases, LLC. | Terminated | No outcome recorded |
| Phase 4 | NCT00638157 Comparator | Feb 2009 → Nov 2011 | infective endocarditis | Merck & Co., Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT01080963 Comparator | Nov 2008 → Mar 2012 | skin infection | Hannover Medical School | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00451373 Background | Jul 2006 → Dec 2012 | acute kidney injury, infectious disease with sepsis | National Taiwan University Hospital | Unknown | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2016-09-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Strengthens Injectables Portfolio with the Launch of an Authorized Generic of Cubicin® (Daptomycin for Injection) in the United States tevapharm.com ↗ |
| 2001-01-07 | Gilead Sciences | Cubist Pharmaceuticals and Gilead Sciences Announce European Commercialization Agreement for Investigational Antibacterial Agent Cidecin™ gilead.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 91 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Daptomycin | “The investigators want to compare whether Methicillin-resistant Staphylococcus Aureaus (MRSA) antibiotic prophylaxis with Cefazolin plus Daptomycin is superior to Cefazolin...” NCT01612052 ↗88“The purpose of the study is to evaluate the overall burden to the participant (economic, quality of life, patients satisfaction and freedom from side effects) when treating...” NCT01133600 ↗ “Calcium sulfate beads will be loaded with best available antibiotics based on surgeon/infectious disease specialist determination from the following options (vancomycin,...” NCT07072923 ↗ “This therapy is usually one of the following intravenous medications: (i) piperacillin/tazobactam (Zosyn), (ii) cefepime, (iii) metronidazole, (iv) aztreonam, (v) vancomycin,...” NCT02168816 ↗ “Participant given IV daptomycin plus ceftaroline dosing per standard of care.” NCT07148960 ↗ “Vancomycin or daptomycin, per discretion of the treating physician” NCT07376889 ↗ “INTERVENTIONS: Daptomycin at 8 mg/kg intravenously over 30 mins.” PMID 20890189 ↗ Jan 2011 “Daptomycin 8-10mg/kg per day intravenously.” NCT05137119 ↗ “Daptomycin: 8-10 mg/kg/day (i.v).” NCT05394298 ↗ |
| Known as | Cidecin | “Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia Due to S. Pneumoniae” NCT00540072 ↗1“Comparative Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia” NCT00538694 ↗ |
| Known as | Cubicin | “Daptomycin (Cubicin¨, Novartis Pharma AG, Basel Switzerland) is a cyclic lipopeptide antimicrobial agent active against most Gram-positive bacteria including strains that are...” NCT01522105 ↗3“Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.” NCT04775953 ↗ “Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas” NCT00295178 ↗ “10 mg/kg of daptomycin (Cubicin®)” NCT02142075 ↗ |
| Known as | Cubicin (daptomycin for injection) | “Cubicin (daptomycin for injection)” NCT00651131 ↗ |
| Known as | Cubicin rf | ChEMBL registry synonym — accepted as the source's own label CHEMBL387675 ↗ |
| Known as | Dapcin | ChEMBL registry synonym — accepted as the source's own label CHEMBL387675 ↗ |
| Known as | Daptomicina | ChEMBL registry synonym — accepted as the source's own label CHEMBL387675 ↗ |
| Known as | Daptomycin hospira | ChEMBL registry synonym — accepted as the source's own label CHEMBL387675 ↗ |
| Known as | daptomycin: cubicin 350 mg vial. | “daptomycin: cubicin 350 mg vial.” NCT01592032 ↗ |
| Known as | Daptomycine | ChEMBL registry synonym — accepted as the source's own label CHEMBL387675 ↗ |
| Known as | Dapzura rt | ChEMBL registry synonym — accepted as the source's own label CHEMBL387675 ↗ |
| Known as | DPT | “To evaluate the efficacy of Daptomycin (DPT) lock therapy in the treatment of Grampositive long-term catheter-related bloodstream infections (LT-CRBI).” PMID 22340450 ↗ Mar 2012 |
| Known as | LY 146032 | ChEMBL registry synonym — accepted as the source's own label CHEMBL387675 ↗ |
| Known as | LY-164032 | ChEMBL registry synonym — accepted as the source's own label CHEMBL387675 ↗ |
| Known as | MK-3009 | “A Phase III Randomized, Open-labeled Clinical Trial of MK-3009 (Daptomycin) in Patients With Skin and Soft Tissue Infections, Septicemia and Right-sided Infective Endocarditis...” NCT00770341 ↗ |
| Action | Inhibit | “inhibits gram-positive bacteria” NCT04775953 ↗ |
| Modality | Other / unclassified | “cyclic lipopeptide antimicrobial agent” NCT01522105 ↗ |
| Route | Intravenous | “daptomycin appears to be well tolerated and can be administered once every 24 hours by i.v. infusion” NCT00093067 ↗ |