TheraRadar
Data updated: May 26, 2026

DAPTOMYCIN

Infectious Disease Approved 2014-09-12

DAPTOMYCIN is indicated for the treatment of Skin and Skin Structure Infections; Staphylococcus Aureus Bloodstream Infections; Bacteremia; Infective Endocarditis.

Source: FDA Label • SAGENT PHARMS INC • Lipopeptide Antibacterial
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How DAPTOMYCIN Works

Daptomycin binds to bacterial cytoplasmic membranes in a calcium-dependent manner, resulting in rapid depolarization of the membrane potential. This loss of membrane potential leads to the inhibition of DNA, RNA, and protein synthesis, resulting in rapid bacterial cell death (bactericidal activity). It is specifically active against Gram-positive bacteria.

Source: FDA Label
30
Indications
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2014-09-12
Patent Cliff
2038

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Routes
INTRAVENOUS
Dosage Forms
POWDER

Companies

SAGENT PHARMS INC HENGRUI PHARMA HISUN PHARM HANGZHOU HAINAN POLY PHARM BIOCON PHARMA Pfizer EUGIA PHARMA MEITHEAL HANGZHOU ZHONGMEI QILU PHARM HAINAN ACCORD HLTHCARE BE PHARMS Viatris ASPIRO Teva Hikma XELLIA PHARMS APS MAIA PHARMS INC Fresenius Kabi Dr. Reddy's
Active Ingredient: DAPTOMYCIN

DAPTOMYCIN Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
94 FDA actions from 2014 to 2026 · 1 indication expansions
Mar 2026 SUPPL
Label · Labeling
Jan 2026 SUPPL
Label · Labeling
Jan 2026 SUPPL
Label · Labeling

What DAPTOMYCIN Treats

4 indications

DAPTOMYCIN is approved for 4 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Skin and Skin Structure Infections
  • Staphylococcus Aureus Bloodstream Infections
  • Bacteremia
  • Infective Endocarditis
Source: FDA Label

DAPTOMYCIN Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

DALBAVANCIN HYDROCHLORIDE
Fresenius Kabi
2025 1 indic.
PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
B BRAUN
2025 7 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to DAPTOMYCIN

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

TYZAVAN
VANCOMYCIN HYDROCHLORIDE
2 shared
Hikma
Shared indications:
Infective EndocarditisSkin and Skin Structure Infections
ZEVTERA
CEFTOBIPROLE MEDOCARIL SODIUM
2 shared
ISTX
Shared indications:
BacteremiaInfective Endocarditis
AMOXICILLIN AND CLAVULANATE POTASSIUM
AMOXICILLIN
1 shared
DEVA HOLDING AS
Shared indications:
Skin and skin structure infections
View all 20 similar drugs Pro
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Clinical Trial Registry

39 trials
Trial Sponsor ID Phase Status Title
NCT04434300 DAPTOSC 2019-004884-32 Ph 1 completed Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)
NCT04983901 results posted 2020-0074 NCI-2021-01957, 2020-0074 Ph 2 completed PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
NCT04775953 results posted 20-0002 5UM1AI104681-12 Ph 2 completed DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia
NCT03480191 AddaMAP CHAVANET-PHRC-2016 Ph 2 completed Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis
NCT01199783 results posted MCBC134ADE02T Ph 3 terminated Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment
NCT03138733 results posted BPR-CS-009 Ph 3 completed Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
NCT01734694 STOP-NT results posted 7089 Ph 4 terminated Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients
NCT00638157 results posted 3009-010 DAP-4IE-06-03 Ph 4 terminated Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)
NCT02972983 DASH 2017-2666 Ph 4 completed Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia
NCT01792804 SABATO Uni-Koeln-1400 2013-000577-77 Ph 3 completed Staphylococcus Aureus Bacteremia Antibiotic Treatment Options
NCT02208063 results posted 0112 Ph 3 terminated A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial
NCT00679835 3009-023 DAP-PEDS-07-02 Ph 1 completed PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections
NCT01019395 3009-018 DAP-PEDS-09-01 Ph 1 completed 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
NCT01175707 results posted 3009-009 DAP-4HOME-09-05 Ph 4 terminated Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting
NCT00695903 HDSAB results posted 3009-013 DAP-HDSAB-07-05 Ph 2 terminated Phase 2 Study of Safety, Efficacy, and Pharmacokinetics of Higher Doses of Daptomycin and Vancomycin in MRSA Bacteremia
NCT01522105 046/11 2012DR1007, 2049 Ph 1 terminated Daptomycin in Pediatric Patients With Bacterial Meningitis
NCT02052388 CTIX-BRI-204 Ph 2 completed Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections
NCT01104662 RENSE results posted 3009-022 DAP-RENSE-08-05 Ph 4 terminated Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment
NCT00711802 results posted 3009-017 DAP-PEDS-07-03 Ph 4 completed Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
NCT01419184 DAPHEOR1006 results posted 3009-015 DAP-HEOR-10-06 Ph 4 completed Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA
NCT01728376 results posted 3009-005 DAP-PEDBAC-11-02 Ph 4 completed Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)
NCT01922011 results posted 3009-006 DAP-PEDOST-11-03, 2013-000864-28 Ph 3 completed Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)
NCT00882557 results posted 3009-027 DAP-RENID-08-06 Ph 1 completed Study to Evaluate Daptomycin Given During Dialysis and After Dialysis
NCT02660346 IL-10 MRSaB Ph 4 completed IL-10 Stratifying Tool for Towards Antibiotic Selection for MRSaB
NCT02241941 Dapto-ICU-09 EK-1748 Ph 4 withdrawn Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
NCT02142075 DAPTOREA DAPTOREA Ph 3 completed 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
NCT00701636 results posted 12903-01 IIS 0003-07-2007 Ph 3 completed Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery
NCT01975662 SIDI-MRSA-001 Ph 2 terminated Vancomycin Versus Daptomycin for the Treatment of Methicillin Resistant Staphylococcus Aureus (MRSA) Bacteremia
NCT01626560 daptocina Ph 4 completed The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin
NCT00772447 results posted D1790C00003 Ph 3 completed China Registration Study in Patients With Skin Infections
NCT01549613 results posted 11-11-03-06 Ph 4 completed Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections
NCT01216241 results posted DAPNEUT Ph 3 terminated Daptomycin Versus Placebo in Patients With Neutropenia and Fever
NCT01287832 results posted SJ1210-01 IND 109,614 Ph 4 terminated Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)
NCT01196169 0310.7f Ph 4 terminated Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty
NCT00942149 results posted Pro00019311 dapto1 Ph 1 completed An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants
NCT01184872 results posted CCBC134A2404 2009-014391-22 Ph 3 completed Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections
NCT01211470 PROTOCOL PMX63-203 Ph 2 completed Initial Treatment for Acute Bacterial Skin Infections (ABSSSI) Caused by Staphylococcus Aureus
NCT01080963 DaPro CCBC134ADAPRO 2007-004611-61 Ph 4 completed Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections
NCT00858325 D1790C00002 Ph 1 completed Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DAPTOMYCIN FDA Label Details

Indications & Usage

FDA Label (PDF)

DAPTOMYCIN is indicated for the treatment of Skin and Skin Structure Infections; Staphylococcus Aureus Bloodstream Infections; Bacteremia; Infective Endocarditis.

View full patent landscape →
4 OB patents · 2 families · 59 international docs across 24 countries

DAPTOMYCIN Patents & Exclusivity

Latest Patent: Aug 2038

Patents (4 active)

US12053502 Expires Aug 28, 2038
US11759497 Expires Aug 28, 2038
US10357535 Expires Sep 11, 2033
US9655946 Expires Sep 11, 2033
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • • Cliff: 2038
  • • 16 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA208385 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.