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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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02097953 | May 2014 → Jun 2015 | — | University of Utah | Completed | No outcome recorded |
| Phase 19 trials | ||||||
| Phase 1 | NCT04434300 | Oct 2020 → Jan 2021 | — | University Hospital, Caen | Completed | No outcome recorded |
| Phase 1 | NCT01522105 | Apr 2012 → Jun 2018 | meningitis | Insel Gruppe AG, University Hospital Bern | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01019395 | Jan 2010 → Mar 2012 | gram-positive bacterial infections | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00942149 | Jan 2010 → Dec 2011 | infectious disease with sepsis | Duke University | Completed | No outcome recorded |
| Phase 1 | NCT00882557 | Apr → Jul 2009 | end stage renal failure, kidney failure | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00858325 | Feb → Mar 2009 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00679835 | Jun → Nov 2008 | gram-positive bacterial infections | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00490737 | Aug 2007 → May 2008 | end stage renal failure | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00136292 | Aug 2005 → Aug 2006 | gram-positive bacterial infections | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 212 trials · 1 missed | ||||||
| Phase 2 | NCT03643952 | Dec 2018 → Apr 2020 | skin disease caused by bacterial infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT03480191 | Jun 2018 → May 2024 | pneumococcal meningitis | Centre Hospitalier Universitaire Dijon | Completed | No outcome recorded |
| Phase 2 | NCT01975662 | Jan 2014 → Dec 2015 | staphylococcus aureus infection | Singapore General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01144000 | Jun 2012 → Jun 2014 | staphylococcal infection | Andrej Trampuz | Unknown | No outcome recorded |
| Phase 2 | NCT01171547 | Feb 2010 | bacterial infectious disease | University of Zurich | Unknown | No outcome recorded |
| Phase 2 | NCT01212432 | Dec 2009 → Mar 2010 | gram-positive bacterial infections | University of Zurich | Unknown | No outcome recorded |
| Phase 2 | NCT00695903 | Sep 2008 → Aug 2010 | bacterial endocarditis | Merck & Co., Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00428844 | Jun 2007 → Mar 2010 | osteomyelitis | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00467272 | Mar 2007 → Sep 2012 | bacterial infectious disease | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00426933 | Jan → Sep 2007 | — | Merck & Co., Inc. | Completed | Missed primary |
| Phase 2 | NCT00335478 | Dec 2006 → Oct 2008 | cancer of unknown primary site, infectious disease, neutropenia | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00507247 | May 2006 → Oct 2007 | staphylococcus aureus infection | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01455246 | Oct 2010 → Apr 2014 | cirrhosis of liver | University of Padova | Terminated | No outcome recorded |
| Phase 315 trials · 2 met primary · 4 missed | ||||||
| Phase 3 | NCT02142075 | Mar 2014 → Sep 2015 | critical illness polyneuropathy, gram-positive bacterial infections, kidney failure | Poitiers University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01792804 | Dec 2013 → Mar 2020 | staphylococcus aureus infection | Heinrich-Heine University, Duesseldorf | Completed | Met primary |
| Phase 3 | NCT01898338 | Dec 2013 → Jan 2018 | methicillin-resistant staphylococcus aureus infectious disease | Miquel Pujol | Completed | Missed primary |
| Phase 3 | NCT01922011 | Sep 2013 → Jun 2016 | osteomyelitis | Merck & Co., Inc. | Completed | Missed primary |
| Phase 3 | NCT01515020 | May 2012 → Jun 2013 | nosocomial infection | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded |
| Phase 3 | NCT01199783 | Jul 2011 → Oct 2013 | — | Ruhr University of Bochum | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01184872 | Mar 2010 → Mar 2011 | skin infection | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00772447 | Sep 2008 → Sep 2010 | infectious disease, skin disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00770341 | Sep 2008 → Feb 2010 | staphylococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00701636 | Jul 2008 → Oct 2010 | staphylococcus aureus infection | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00430937 | Apr 2006 → Mar 2008 | skin infection | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00055198 | Dec 2002 → Jan 2004 | gram-positive bacterial infections | Merck & Co., Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00093067 | Mar 2002 → Nov 2004 | bacterial endocarditis | Merck & Co., Inc. | Completed | Met primary |
| Phase 3 | NCT00540072 | Jul 2001 → Feb 2002 | bacterial pneumonia | Merck & Co., Inc. | Completed | Missed primary |
| Phase 3 | NCT00538694 | Oct 2000 → Sep 2001 | bacterial pneumonia | Merck & Co., Inc. | Completed | Missed primary |
| Phase 425 trials · 1 missed | ||||||
| Phase 4 | NCT07376889 | Feb 2026 → Jan 2029 expected | staphylococcus aureus infection | Intermountain Health Care, Inc. | Recruiting | No outcome recorded |
| Phase 4 | NCT07148960 | Sep 2025 → Jul 2027 expected | staphylococcus aureus infection | West Virginia University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06637332 | Nov 2024 → Jan 2029 expected | bacterial infectious disease with sepsis, infective endocarditis, staphylococcus aureus infection | Todd C. Lee MD MPH FIDSA | Recruiting | No outcome recorded |
| Phase 4 | NCT05394298 | Jul 2022 → Jul 2024 | Enterococcus infectious disease | Andalusian Public Foundation for Health Research in Seville | Unknown | No outcome recorded |
| Phase 4 | NCT05156437 | Mar 2022 → Oct 2024 | endocarditis | West Virginia University | Terminated | No outcome recorded |
| Phase 4 | NCT05137119 | Feb 2022 → Dec 2028 expected | staphylococcus aureus infection | University of Melbourne | Recruiting | Mixed |
| Phase 4 | NCT02972983 | Dec 2016 → Jul 2019 | methicillin-susceptible staphylococcus aureus infectious disease | McGill University Health Centre/Research Institute of the McGill University Health Centre | Completed | No outcome recorded |
| Phase 4 | NCT02660346 | Nov 2015 → Sep 2017 | bacterial infectious disease | Sharp HealthCare | Completed | No outcome recorded |
| Phase 4 | NCT02241941 | Sep 2014 → Oct 2016 | — | University of Zurich | Withdrawn | No outcome recorded |
| Phase 4 | NCT01728376 | Nov 2012 → Jan 2016 | bacterial infectious disease | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01626560 | Jul 2012 → Mar 2015 | cellulitis | Hospital Universitario Evangelico de Curitiba | Completed | No outcome recorded |
| Phase 4 | NCT01592032 | May 2012 → Jan 2015 | bacterial infectious disease, prosthesis-related infectious disease | Clinica Universidad de Navarra, Universidad de Navarra | Unknown | No outcome recorded |
| Phase 4 | NCT01419184 | Sep 2011 → Sep 2012 | staphylococcus aureus infection | Merck & Co., Inc. | Completed | Missed primary |
| Phase 4 | NCT01287832 | Jun 2011 → Jan 2012 | bacterial infectious disease | St. John Health System, Michigan | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01196169 | Oct 2010 → Mar 2014 | methicillin-resistant staphylococcus aureus infectious disease | Mountain Home Research & Education Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01175707 | Jul 2010 → Nov 2011 | — | Merck & Co., Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT01104662 | Apr 2010 → Jun 2012 | impaired renal function disease, staphylococcus aureus infection | Merck & Co., Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00711802 | Jul 2008 → Oct 2013 | skin disease caused by bacterial infection | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00572260 | Jan → Sep 2008 | — | Duke University | Terminated | No outcome recorded |
| Phase 4 | NCT00663403 | Feb 2007 → Apr 2009 | — | University of Michigan | Completed | No outcome recorded |
| Phase 4 | NCT00463801 | Jan → Nov 2007 | staphylococcal infection | Novartis | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00401960 | Sep 2006 → Oct 2008 | bacterial endocarditis | Weill Medical College of Cornell University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00295178 | Feb → Aug 2006 | cellulitis | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00102947 | Jan 2005 → Nov 2006 | — | Merck & Co., Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00651131 | Jun 2004 → Mar 2005 | — | Merck & Co., Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable7 trials | ||||||
| — | NCT06189885 | Aug 2024 → Jul 2026 overdue | periprosthetic joint infection | Chang Gung Memorial Hospital | Not yet recruiting | No outcome recorded |
| — | NCT02508350 | Jan → Dec 2015 | infectious disease with sepsis | Zhongda Hospital | Unknown | No outcome recorded |
| — | NCT02000414 | Sep 2013 → Dec 2017 | infectious peritonitis | University Hospital, Caen | Completed | No outcome recorded |
| — | NCT01025271 | May 2010 → May 2011 | meningitis | University of Pittsburgh | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01012089 | Nov 2009 → Apr 2014 | bacterial infectious disease, chronic kidney disease | University of Oklahoma | Completed | No outcome recorded |
| — | NCT00296049 | Jul 2005 → Mar 2006 | bacterial infectious disease, childhood malignant neoplasm, neutropenia | Wake Forest University Health Sciences | Withdrawn | No outcome recorded |
| — | NCT00261807 | Jun 2005 → May 2008 | fournier gangrene, necrotizing fasciitis, necrotizing soft tissue infection | University of Maryland, Baltimore | Completed | No outcome recorded |
| Comparator or background therapy19 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 | Missed primary |
| Phase 2 | NCT02168816 Comparator | Mar 2014 → Feb 2017 | osteomyelitis | Loyola University | Terminated | No outcome recorded Stop: Enrollment |
| 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 3 | NCT03138733 Comparator | Aug 2018 → Mar 2022 | staphylococcus aureus infection | Basilea Pharmaceutica | Completed | Met primary |
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 |
| — | NCT00451373 Background | Jul 2006 → Dec 2012 | acute kidney injury, infectious disease with sepsis | National Taiwan University Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-05-03 | Basilea Pharmaceutica | Results Basilea reports presentation of new data for ceftobiprole (Zevtera®) at ESCMID Global 2024 basilea.com ↗
In the group treated with ceftobiprole, fewer patients had Staphylococcus aureus-positive blood cultures after ten days compared to the comparator treatment group. |
| 2023-09-28 | Basilea Pharmaceutica | Results Basilea announces New England Journal of Medicine publication of phase 3 data on ceftobiprole for the treatment of Staphylococcus aureus bacteremia basilea.com ↗
Using a pre-defined non-inferiority margin of 15%, treatment with ceftobiprole was non-inferior to daptomycin with overall treatment success achieved in 69.8% of patients in the ceftobiprole group compared to 68.7% in the daptomycin group. |
| 2022-10-24 | Basilea Pharmaceutica | Results ERADICATE phase 3 study results highlight the potential role of ceftobiprole in the treatment of Staphylococcus aureus bacteremia (SAB) basilea.com ↗
As presented at IDWeek, ceftobiprole met the primary endpoint by demonstrating non-inferiority versus daptomycin, with or without aztreonam. |
| 2022-06-28 | Basilea Pharmaceutica | Results Basilea announces positive results of phase 3 ERADICATE study with ceftobiprole in Staphylococcus aureus bacteremia (SAB) basilea.com ↗
The overall success rate was 69.8% with ceftobiprole compared to 68.7% with daptomycin, with or without aztreonam. |
All press releases naming this drug 10 releases
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 ↗ |