Data updated: May 26, 2026
CUBICIN RF (daptomycin)
Trial Activity: Declining
Infectious Disease
Approved 2003-09-12
Development Insights
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) conducting 12 trials (29%)
54 indications explored (Broad Platform)
→ bacteremia (6 trials)
→ antibiotics (2 trials)
→ subcutaneous injection (2 trials)
5
Indications
--
Phase 3 Trials
4
Priority Reviews
22
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2003-09-12
- Patent Cliff
- 2030
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
CUBICIN RF Approval History
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
48 FDA actions from 2003 to 2025 · 3 indication expansions
Mar 2016 SUPPL
Label
Jul 2015 SUPPL Priority
Mfg
Feb 2015 SUPPL Priority
Mfg
Sep 2014 SUPPL Priority
Mfg
Jun 2013 SUPPL Priority
Mfg
Mar 2013 SUPPL Priority
Mfg
Dec 2010 SUPPL Priority
Mfg
What CUBICIN RF Treats
5 FDA approvalsOriginally approved for its first indication in 2003 . Covers 5 distinct patient populations.
- Other (5)
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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.
CUBICIN RF FDA Label Details
View full patent landscape →
2 OB patents · 2 families ·
76 international docs across 33 countries
Pro Intelligence Preview
Deep insights for CUBICIN RF
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 2 active patents
Trial Analysis
- • 42 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment