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Daptomycin

Phase 4FDA approved

Skin Diseases | Small molecule | Infectious Disease |AstraZeneca PLC|Trials Updated: Mar 9, 2015

Daptomycin development status

FDA approval on record Sep 12, 2003
Approval holderCubist Pharms Llc
ApplicationNDA021572
Highest phase Phase 4 run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (NCT00638157)
Phase scored for AZNPhase 3
Registered trials 38 across 15 sponsors since Feb 2003

Daptomycin target and mechanism

ModalitySmall molecule

Also known as Cubicin®

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment265

FDA Designations

No designations recorded

Daptomycin clinical trials

Daptomycin · 1 trial · 2 indications

Phase 3 1
NCT00772447China Registration Study in Patients With Skin InfectionsSkin Diseases
COMPLETED265 Analytics
PHASE3COMPLETED
China Registration Study in Patients With Skin Infections
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Study Endpoints

Primary Endpoints

Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)
baseline to TOC(test of cure), for up to 4 weeks

Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood

Change in Creatinine Clearance
baseline to TOC(test of cure), for up to 4 weeks
Change in Serum Total Creatine Phosphokinase (CPK)
baseline to TOC(test of cure), for up to 4 weeks
Change in Urine pH
baseline to TOC(test of cure), for up to 4 weeks
Shift in ECG
baseline to TOC(test of cure), for up to 4 weeks

percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline

Secondary Endpoints

Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)
baseline and TOC, for up to 4 weeks
Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)
baseline and EOT(end of therapy), for up to 2 weeks
Microbiological Response at TOC(Test of Cure)
baseline and TOC, for up to 4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZ drugEXPERIMENTALDaptomycin
ComparatorACTIVE_COMPARATORVancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin

Interventions

NameTypeDescription
DaptomycinDRUG4mg/kg IV ; Q 24 hr (once every 24 hours)
VancomycinDRUGVancomycin - 1g per 12 hrs, for 7-14 days Or switch to Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin: \- 1 g every 6 hours or 2 g every 8 hours
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Provision of inform consent * A diagnosis of of complicated skin and skin structure infection known or suspected to be due to Gram-positive bacteria * Diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor, including infections inv...

Countries:China
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Competitive Landscape -General Cardiovascular Diseases 67 trials (matched to "Skin Diseases")

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Frequently asked questions about Daptomycin

What is Daptomycin used for?

Daptomycin is being developed for the treatment of skin diseases, specifically skin infections. It is an investigational small molecule in the infectious disease therapeutic area. AstraZeneca PLC is advancing it through Phase 3 clinical development, with a completed registration study conducted in China in patients with skin infections.

Who makes Daptomycin?

Daptomycin is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is responsible for the clinical development program, including the Phase 3 registration study in China that evaluated the drug in patients with skin infections.

What phase is Daptomycin in?

Daptomycin is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The completed study was a randomized, active-controlled registration trial in China that enrolled 265 patients with skin infections.

What clinical trials is Daptomycin in?

Daptomycin has been studied in one completed Phase 3 trial, NCT00772447, titled China Registration Study in Patients With Skin Infections. The trial enrolled 265 adults aged 18 years and older of all sexes, was randomized and active-controlled, and was conducted in China.

Is Daptomycin FDA approved?

Daptomycin is an investigational drug and has not been approved by the FDA for the skin infection indication described here. It remains in clinical development, with a completed Phase 3 registration study in China serving as the key trial data for this asset.