Overview
Daptomycin is a cyclic lipopeptide antibacterial agent with a broad spectrum of activity against Gram-positive bacteria, including methicillin-susceptible and -resistant Staphylococcus aureus (MSSA/MRSA) and vancomycin-resistant Enterococci (VRE). Chemically, daptomycin comprises 13 amino acids, including several non-standard and D-amino acids, with the C-terminal 10 amino acids forming an ester-linked ring and the N-terminal tryptophan covalently bonded to decanoic acid. Daptomycin was first discovered in the early 1980s by researchers at Eli Lilly in soil samples from Mount Ararat in Turkey. Early work on developing daptomycin was abandoned due to observed myopathy but was resumed in 1997 when Cubist Pharmaceuticals Inc. licensed daptomycin; it was found that a once-daily dosing scheme reduced side effects while retaining efficacy. Daptomycin was approved by the FDA on September 12, 2003, and is marketed under the name CUBICIN® by Cubist Pharmaceuticals LLC (Merck & Co.).
Indication
Daptomycin is indicated for the treatment of complicated skin and skin structure infections (cSSSI) in patients one year of age and older. It is also indicated for the treatment of Staphylococcus aureus bloodstream infections (bacteremia) in patients one year of age and older, including in adult patients with right-sided infective endocarditis. Daptomycin is not indicated for the treatment of pneumonia or left-sided infective endocarditis due to S. aureus. Use is not recommended in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central). As with all antibacterial drugs, it is strongly suggested to perform sufficient testing before treatment initiation in order to confirm an infection caused by susceptible bacteria. Failure to do so may result in suboptimal treatment, treatment failure, and the development of drug-resistant bacteria.
Associated Conditions
- Complicated Skin and Skin Structure Infection
- Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/15 | Phase 4 | Recruiting | Todd C. Lee MD MPH FIDSA | ||
2021/07/30 | Phase 2 | Completed | |||
2021/03/01 | Phase 2 | Completed | |||
2020/09/14 | N/A | UNKNOWN | Jiangsu Hengrui Pharmaceutical Co., Ltd. | ||
2020/06/16 | Phase 1 | Completed | |||
2020/02/20 | N/A | UNKNOWN | Zhongnan Hospital | ||
2019/10/18 | N/A | UNKNOWN | |||
2019/05/23 | N/A | Completed | |||
2018/08/23 | Phase 2 | Completed | |||
2018/03/29 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| NorthStar RxLLC | 16714-892 | INTRAVENOUS | 50 mg in 1 mL | 12/26/2023 | |
| Fresenius Kabi USA, LLC | 63323-871 | INTRAVENOUS | 500 mg in 10 mL | 3/11/2024 | |
| Merck Sharp & Dohme LLC | 67919-012 | INTRAVENOUS | 500 mg in 10 mL | 3/17/2025 | |
| Baxter Healthcare Corporation | 0338-0714 | INTRAVENOUS | 500 mg in 50 mL | 2/27/2023 | |
| OSO BioPharmaceuticals Manufacturing, LLC | 70835-1001 | INTRAVENOUS | 350 mg in 350 mg | 12/19/2019 | |
| Xellia Pharmaceuticals USA LLC | 70594-066 | INTRAVENOUS | 350 mg in 7 mL | 11/7/2023 | |
| Merck Sharp & Dohme LLC | 67919-011 | INTRAVENOUS | 500 mg in 10 mL | 11/22/2022 | |
| Sagent Pharmaceuticals | 25021-179 | INTRAVENOUS | 350 mg in 7 mL | 6/17/2022 | |
| Civica, Inc. | 72572-100 | INTRAVENOUS | 350 mg in 7 mL | 10/12/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-215 | INTRAVENOUS | 350 mg in 7 mL | 1/4/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/19/2006 | ||
Authorised | 3/22/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DAPTOMYCIN-AFT POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MG/VIAL | SIN16900P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500MG/VIAL | 11/28/2023 | |
| DAPTOCCORD 500 POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MG/VIAL | SIN16071P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500mg/vial | 12/29/2020 | |
| PENMIX DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL | SIN16813P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500 mg/vial | 6/27/2023 | |
| PFIZER DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MG/VIAL | SIN16443P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500mg/vial | 3/10/2022 | |
| BEDAPT DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL | SIN16828P | INJECTION, POWDER, FOR SOLUTION | 500MG/VIAL | 7/31/2023 | |
| Cubicin (daptomycin for injection) 500mg | SIN13501P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500mg/vial | 7/28/2008 | |
| DAPTOMYCIN/ANFARM POWDER FOR SOLUTION FOR INJECTION/INFUSION 500MG/VIAL | SIN17204P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500mg/vial | 3/12/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Daptomycin for Injection | 国药准字H20223114 | 化学药品 | 注射剂 | 3/8/2022 | |
| Daptomycin for Injection | 国药准字H20244593 | 化学药品 | 注射剂 | 7/30/2024 | |
| Daptomycin for Injection | 国药准字H20243324 | 化学药品 | 注射剂 | 3/12/2024 | |
| Daptomycin for Injection | 国药准字H20163346 | 化学药品 | 注射剂 | 5/26/2021 | |
| Daptomycin for Injection | 国药准字H20213371 | 化学药品 | 注射剂 | 5/19/2021 | |
| Daptomycin for Injection | 国药准字H20153259 | 化学药品 | 注射剂 | 10/9/2020 | |
| Daptomycin for Injection | 国药准字H20223685 | 化学药品 | 注射剂 | 9/20/2022 | |
| Daptomycin for Injection | 国药准字H20223946 | 化学药品 | 注射剂 | 2/21/2023 | |
| Daptomycin for Injection | 国药准字H20213490 | 化学药品 | 注射剂 | 6/16/2021 | |
| Daptomycin for Injection | 国药准字H20223945 | 化学药品 | 注射剂 | 2/21/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DAPTOMYCIN INTAS daptomycin 500 mg powder for injection vial | 315394 | Medicine | A | 3/24/2020 | |
| Hospira, Daptomycin for Injection 350 mg/vial | 366290 | Medicine | A | 5/17/2021 | |
| PFIZER DAPTOMYCIN daptomycin 350 mg powder for injection vial | 373705 | Medicine | A | 3/8/2022 | |
| CIPLA DAPTOMYCIN daptomycin 500 mg powder for injection vial | 390971 | Medicine | A | 7/5/2023 | |
| DAPTOMYCIN LUPIN daptomycin 350 mg powder for injection vial | 383871 | Medicine | A | 2/27/2023 | |
| DAPTOMYCIN-RZ daptomycin 350 mg powder for injection vial | 337793 | Medicine | A | 4/15/2021 | |
| DAPTOMYCIN JUNO daptomycin 500 mg powder for injection vial | 300034 | Medicine | A | 4/23/2019 | |
| DAPTOMYCIN DR.REDDY'S daptomycin 350 mg powder for injection vial | 337790 | Medicine | A | 4/15/2021 | |
| DAPTOMYCIN DR.REDDY'S daptomycin 500 mg powder for injection vial | 337791 | Medicine | A | 4/15/2021 | |
| DAPTOMYCIN-DRLA daptomycin 500 mg powder for injection vial | 337789 | Medicine | A | 4/15/2021 |
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