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Drug

Daptomycin

Approved · EMA
Emerging researchLate-stage developmentSteady momentum
Also known as Cubicin, Dapzura, Daptomicina, Daptomycine+1 more

Cubicin, Dapzura, Daptomicina, Daptomycine, Daptomycinum.

4
Research papers
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Daptomycin Hospira (EMA)

Regulatory2017-03-22EMA

Approval: Cubicin (EMA)

Regulatory2006-01-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Daptomycin
Aliases & brands
CubicinDapzuraDaptomicinaDaptomycineDaptomycinum
RxNorm CUI
22299
ChEMBL ID
CHEMBL4744444
UNII
NWQ5N31VKK
Regulatory jurisdictions
mhraema

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2006-01-19
Latest approval
2017-03-22
Authorities
EMA · MHRA
Total events
3
emaEuropean Medicines Agency· 2 events
2017-03-22Approval
Approval: Daptomycin Hospira (EMA)
Indication: Daptomycin is indicated for the treatment of the following infections. Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infectionsShow full indication

Daptomycin is indicated for the treatment of the following infections. Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It isrecommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI. Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Evidence ↗
2006-01-19Approval
Approval: Cubicin (EMA)
Indication: Cubicin is indicated for the treatment of the following infections. Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).Show full indication

Cubicin is indicated for the treatment of the following infections. Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI. Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Daptomycin: risk of eosinophilic pneumonia
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

68 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
68
registered trials across all phases
LATEST COMPLETION 2024
43
Late-stage (III+)
40
Completed
28
Discontinued
PHASE DISTRIBUTIONn = 68
Early Phase 11Phase 19Phase 215Phase 316Phase 422Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis: AddaMAP Study

CompletedPH IICentre Hospitalier Universitaire Dijonn=1122024

Early Oral Switch Therapy in Low-risk Staphylococcus Aureus Bloodstream Infection

CompletedPH IIIHeinrich-Heine University, Duesseldorfn=2152020

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20062023
Major research themes8
Anti-Bacterial Agents1Antibiotic Prophylaxis1Bacteremia1Cardiopulmonary Bypass1Coronary Artery Bypass1Daptomycin1Staphylococcal Infections1Staphylococcus aureus1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine2
  • Antimicrobial agents and chemotherapy1
  • Pediatrics1
Leading researchers
  • Boucher HW2
  • Cosgrove SE2
  • Fowler VG Jr2
  • Abrutyn E1
  • Anastasiou D1
  • Anderzhanova A1
  • Arnold SR1
  • Arrieta A1
Leading institutions
free-text, unnormalised
  • Akron Children's Hospital1
  • Children's Hospital at Montefiore1
  • Children's Hospital of Orange County1
  • College of Pharmacy1
  • Duke University (T.L.H.1
  • Duke University Medical Center1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 3 of the same disease areas as Daptomycin in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.