Data updated: May 26, 2026
DAPZURA RT (daptomycin)
Infectious Disease
Approved 2022-01-25
2
Indications
--
Phase 3 Trials
4
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2022-01-25
- Patent Cliff
- 2041
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
DAPZURA RT Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2022 to 2025 · 1 indication expansions
What DAPZURA RT Treats
2 FDA approvalsOriginally approved for its first indication in 2022 . Covers 2 distinct patient populations.
- Other (2)
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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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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
DAPZURA RT FDA Label Details
View full patent landscape →
1 OB patents · 1 families ·
12 international docs across 8 countries
DAPZURA RT Patents & Exclusivity
Latest Patent: Mar 2041
Patents (1 active)
US11173189
Expires Mar 11, 2041
Source: FDA Orange Book
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Patent Timeline
- • Cliff: 2041
- • 1 active patents
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.