Cubicin

(Daptomycin)

ApprovedSmall molecule

Daptomycin is an antibiotic used to treat serious bacterial skin infections and bloodstream infections caused by certain bacteria. It works by killing the bacteria that cause these infections.[2] Cubicin is currently approved and in use across 28 indications[4].[1]

Cubicin is one of 434 small molecule programs targeting Cellulitis. It is currently in Approved.

Indications

Total Trials

Active Trials

433

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

CellulitisActive, not recruiting

Bacterial DiseaseActive, not recruiting

NeutropeniaActive, not recruiting

Skin Disease Caused by Bacterial InfectionActive, not recruiting

Bacterial PneumoniaActive, not recruiting

ToxicityActive, not recruiting

Gram-Positive Bacterial InfectionsActive, not recruiting

Bacterial EndocarditisActive, not recruiting

Skin InfectionActive, not recruiting

Nosocomial InfectionApproved

CellulitisApproved

Active, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

NeutropeniaPhase 3

Active, not recruiting

Skin Disease Caused by Bacterial InfectionApproved

Active, not recruiting

Bacterial PneumoniaPhase 3

Active, not recruiting

ToxicityApproved

Active, not recruiting

Gram-Positive Bacterial InfectionsApproved

Active, not recruiting

Bacterial EndocarditisApproved

Active, not recruiting

Skin InfectionApproved

Active, not recruiting

Nosocomial InfectionApproved

Approved

Showing 10 of 27 indications

Competition

Competitive Landscape

540 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Cubicin

BBaxter Healthcare Corporation

Approved

70 2

Uloric

Takeda

Preclinical

3 3

Sovaldi

Gilead

Preclinical

1 4

Glucotrol

Pfizer

Preclinical

1 5

Lorelco

Sanofi

Preclinical

1 6

Miochol

BBausch Health Americas, Inc.

Preclinical

2 7

Epoetin Beta

Roche

Preclinical

5 8

Genotropin

EMD Serono

Preclinical

1 9

Januvia

ZZydus Therapeutics Inc.

Preclinical

1 10

Baraclude

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Staphylococcus Aureus Bacteremia5 trials

Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

Completed· Basilea Pharmaceutica logo

Basilea Pharmaceutica·Phase 3·NCT03138733·390 enrolled

Staphylococcus Aureus Bacteremia Antibiotic Treatment Options

Completed·HHeinrich-Heine University, Duesseldorf·Phase 3·NCT01792804·215 enrolled

Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia

Completed·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 4·NCT02972983·102 enrolled

Show 2 more trials

DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04775953·200 enrolled

Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT01728376·82 enrolled

Skin Infection4 trials

Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections

Completed·CCellceutix Corporation·Phase 2·NCT02052388·215 enrolled

China Registration Study in Patients With Skin Infections

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00772447·265 enrolled

Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT01419184·250 enrolled

Show 1 more trial

Initial Treatment for Acute Bacterial Skin Infections (ABSSSI) Caused by Staphylococcus Aureus

Completed·PPolyMedix, Inc.·Phase 2·NCT01211470·215 enrolled

Infections4 trials

Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting

Terminated· Merck & Co. logo

Merck & Co.·Phase 4·NCT01175707·80 enrolled

Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT00055198·75 enrolled

PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00679835·24 enrolled

Show 1 more trial

Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections

Completed·UUniversity of Cincinnati·Phase 4·NCT01549613·104 enrolled

Safety and Efficacy4 trials

Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections

Terminated· Novartis logo

Novartis·Phase 4·NCT00463801·52 enrolled

Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment

Terminated· Merck & Co. logo

Merck & Co.·Phase 4·NCT01104662·92 enrolled

Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00711802·396 enrolled

Show 1 more trial

Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00426933·100 enrolled

Staphylococcus Aureus3 trials

Daptomycin in the Treatment of Catheter-Related Staphylococcus Aureus

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00507247·11 enrolled

A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial

Terminated·CCumberland Pharmaceuticals·Phase 3·NCT02208063·121 enrolled

Vancomycin Versus Daptomycin for the Treatment of Methicillin Resistant Staphylococcus Aureus (MRSA) Bacteremia

Terminated·SSingapore General Hospital·Phase 2·NCT01975662·14 enrolled

38 more indications

Critically Ill Patients3 trials

Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study

Unknown status·UUniversity of Zurich·Phase 2·NCT01212432·15 enrolled

A Pharmacokinetics Study of Daptomycin in Critically Ill Patients and Effects of Daptomycin on Kidney

Unknown status·ZZhongnan Hospital··NCT04277143·120 enrolled

Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)

Completed·UUniversity of Michigan·Phase 4·NCT00663403·8 enrolled

Neutropenia3 trials

Daptomycin or Vancomycin in Treating Bacteria in the Blood in Patients With Neutropenia Caused By Chemotherapy

Withdrawn·WWake Forest University Health Sciences·N/A·NCT00296049

Daptomycin Versus Placebo in Patients With Neutropenia and Fever

Terminated·UUniversity of Rochester·Phase 3·NCT01216241·36 enrolled

Daptomycin in Treating Neutropenia and Fever in Patients With Cancer

Completed·OOHSU Knight Cancer Institute·Phase 2·NCT00335478·54 enrolled

Soft Tissue Infections2 trials

Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections

Terminated· Novartis logo

Novartis·Phase 3·NCT00430937·194 enrolled

Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections

Completed· Novartis logo

Novartis·Phase 3·NCT01184872·120 enrolled

Endocarditis2 trials

Population Pharmacokinetic (PK) Study of Multiple Doses of Cubicin® (Daptomycin) 10 mg/kg in Critical Care Patients Having Bacteremia, Endocarditis or Skin Soft Tissue Infections Due to Gram Positive Bacteria With Various Degrees of Renal Failure

Completed·PPoitiers University Hospital·Phase 3·NCT02142075

Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.

Terminated·WWeill Medical College of Cornell University·Phase 4·NCT00401960·6 enrolled

Osteomyelitis2 trials

Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01922011·149 enrolled

Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00428844·75 enrolled

Bacterial Pneumonia2 trials

Comparative Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00538694

Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia Due to S. Pneumoniae

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00540072

Vancomycin2 trials

Phase 2 Study of Safety, Efficacy, and Pharmacokinetics of Higher Doses of Daptomycin and Vancomycin in MRSA Bacteremia

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT00695903·38 enrolled

The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

Completed·HHospital Universitario Evangelico de Curitiba·Phase 4·NCT01626560·20 enrolled

Infective Endocarditis2 trials

Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)

Terminated· Merck & Co. logo

Merck & Co.·Phase 4·NCT00638157·24 enrolled

Daptomycin in the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to S. Aureus

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00093067

Antibiotic Therapy1 trial

Optimized Antibiotic Therapy in Patients With Subarachnoid Haemorrhage (ES) and Cerebral Haemorrhage (EC)

Unknown status·AAzienda Sanitaria-Universitaria Integrata di Udine··NCT04132115·104 enrolled

Tics1 trial

Cerebrospinal Fluid Pharmacokinetics of Daptomycin

Terminated·UUniversity of Pittsburgh·N/A·NCT01025271·2 enrolled

Pediatric Patients1 trial

Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00136292·33 enrolled

Peritoneal Dialysis1 trial

Safety Study to Evaluate Daptomycin in Non-infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis (MK-3009-021)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00490737·12 enrolled

Prosthetic-joint Infection1 trial

Daptomycin With Rifampin for Treatment of Staphylococcal Prosthetic Joint Infection

Unknown status·AAndrej Trampuz·Phase 2·NCT01144000·60 enrolled

Infants1 trial

An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants

Completed·—·Phase 1·NCT00942149·20 enrolled

Renal Disease1 trial

Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

Completed·UUniversity of Oklahoma·N/A·NCT01012089·6 enrolled

Surgical Wound Infection1 trial

Cubicin(R) for Complicated Post-surgical Wound Infections

Terminated· Merck & Co. logo

Merck & Co.·Phase 4·NCT00651131·69 enrolled

Pneumococcal Meningitis1 trial

Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis

Completed·—·Phase 2·NCT03480191·112 enrolled

Prospective1 trial

PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT04983901·100 enrolled

Renal Failure1 trial

Acute Renal Failure in the Surgical Intense Care Units - NTUH-SICU-ARF (NSARF) Study

Unknown status·NNational Taiwan University Hospital·N/A·NCT00451373·300 enrolled

Diabetic Foot1 trial

Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment

Terminated·RRuhr University of Bochum·Phase 3·NCT01199783·1 enrolled

Bacterial Meningitis1 trial

Daptomycin in Pediatric Patients With Bacterial Meningitis

Terminated·IInsel Gruppe AG, University Hospital Bern·Phase 1·NCT01522105·1 enrolled

Toxicity1 trial

Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients

Terminated·HHenry Ford Health System·Phase 4·NCT01734694·100 enrolled

Shoulder Arthroplasty1 trial

Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty

Terminated·MMountain Home Research & Education Corporation·Phase 4·NCT01196169·28 enrolled

Concentration1 trial

Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients

Completed·UUniversity Hospital Tuebingen··NCT03004066·9 enrolled

Antibiotic Prophylaxis1 trial

Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections

Completed·HHannover Medical School·Phase 4·NCT01080963·650 enrolled

Injury1 trial

Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury

Withdrawn·UUniversity of Zurich·Phase 4·NCT02241941

Methicillin-resistant Staphylococcus Aureus1 trial

Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)

Terminated·SSt. John Health System, Michigan·Phase 4·NCT01287832·11 enrolled

Antibiotics1 trial

Pharmacokinetics (PK) and Safety Evaluation of Daptomycin in Children Ages 3-24 Months With Proven or Suspected Gram-positive Infections or Peri-Operative Subjects Receiving Prophylactic Antibiotics

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01019395·23 enrolled

Hemodiafiltration1 trial

Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

Unknown status·UUniversity of Zurich·Phase 2·NCT01171547·15 enrolled

Renal insufficiency1 trial

Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections

Terminated· Merck & Co. logo

Merck & Co.·Phase 4·NCT00102947·72 enrolled

Bacterial Infection1 trial

The Efficacy and Safety of Daptomycin in the Treatment of Gram-positive Bacterial Infection.

Unknown status·JJiangsu Hengrui Pharmaceutical Co., Ltd.··NCT04546815·2,000 enrolled

Cellulitis1 trial

Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00295178·80 enrolled

Cardiopulmonary Bypass1 trial

Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery

Completed·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 3·NCT00701636·30 enrolled

Septic Shock1 trial

The Pharmacokinetics/Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock

Unknown status·ZZhongda Hospital·N/A·NCT02508350·12 enrolled

Dialysis1 trial

Study to Evaluate Daptomycin Given During Dialysis and After Dialysis

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00882557·16 enrolled

Bloodstream Infection1 trial

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00467272·30 enrolled

Antibiotic1 trial

IL-10 Stratifying Tool for Towards Antibiotic Selection for MRSaB

Completed·SSharp HealthCare·Phase 4·NCT02660346·40 enrolled

Unspecified3 trials

Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)

Completed·UUniversity Hospital, Caen·Phase 1·NCT04434300·12 enrolled

Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin

Completed·UUniversity of Utah·Phase 1·NCT02097953·12 enrolled

Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00858325·24 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 12, 2003

CUBICIN

NDA NDA021572

Sep 12, 2017

DAPTOMYCIN

NDA NDA208385

Oct 20, 2017

DAPTOMYCIN

NDA NDA209949

Jun 21, 2021

DAPTOMYCIN

NDA NDA210282

Jan 25, 2022

DAPZURA RT

NDA NDA213645

Jan 30, 2023

DAPTOMYCIN

NDA NDA217415

Nov 21, 2024

DAPTOMYCIN

NDA NDA217630

Sources

References

[1]
ClinicalTrials.gov — 70 trial records for Daptomycin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cubicin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Daptomycin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Daptomycin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA217630). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cubicin. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Baxter Healthcare Corporation company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBaxter Healthcare Corporation

Patent Landscape[6]

Patent Cliff

Sep 4, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8003673Sep 4, 2028

9138456Nov 23, 2030

10357535Sep 11, 2033

9655946Sep 11, 2033

11759497Aug 28, 2038

3 more patents

12053502Aug 28, 2038

11173189Mar 11, 2041

12629337Jan 9, 2043

Cubicin

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Staphylococcus Aureus Bacteremia5 trials

Skin Infection4 trials

Infections4 trials

Safety and Efficacy4 trials

Staphylococcus Aureus3 trials

Critically Ill Patients3 trials

Neutropenia3 trials

Soft Tissue Infections2 trials

Endocarditis2 trials

Osteomyelitis2 trials

Bacterial Pneumonia2 trials

Vancomycin2 trials

Infective Endocarditis2 trials

Antibiotic Therapy1 trial

Tics1 trial

Pediatric Patients1 trial

Peritoneal Dialysis1 trial

Prosthetic-joint Infection1 trial

Infants1 trial

Renal Disease1 trial

Surgical Wound Infection1 trial

Pneumococcal Meningitis1 trial

Prospective1 trial

Renal Failure1 trial

Diabetic Foot1 trial

Bacterial Meningitis1 trial

Toxicity1 trial

Shoulder Arthroplasty1 trial

Concentration1 trial

Antibiotic Prophylaxis1 trial

Injury1 trial

Methicillin-resistant Staphylococcus Aureus1 trial

Antibiotics1 trial

Hemodiafiltration1 trial

Renal insufficiency1 trial

Bacterial Infection1 trial

Cellulitis1 trial

Cardiopulmonary Bypass1 trial

Septic Shock1 trial

Dialysis1 trial

Bloodstream Infection1 trial

Antibiotic1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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