Product Description
Ceftolozane is a semi-synthetic, broad-spectrum, fifth-generation cephalosporin antibiotic with bactericidal activity against certain Gram-negative and Gram-positive bacteria. Upon administration, ceftolozane binds to and inactivates penicillin-binding proteins (PBPs) located on the inner membrane of the bacterial cell wall. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Ceftolozane)
Mechanisms of Action: Cell Wall Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Merck
Company Location: KENILWORTH NJ 07033
Company CEO: Robert M. Davis
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Chile, Colombia, Estonia, Greece, Mexico, Russia, Spain, Ukraine, United States
Active Clinical Trial Count: 4
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Pneumonia
Phase 2: Bacteremia|Pseudomonas Infections
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| NCT04673175 | P2 |
Recruiting |
Pneumonia|Bacteremia|Pseudomonas Infections |
2025-12-31 |
12% |
2024-08-10 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| MK-7625A-036 | P1 |
Completed |
Pneumonia |
2024-09-14 |
88% |
2024-09-25 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| MK-7625A-036 | P1 |
Completed |
Pneumonia |
2024-05-30 |
88% |
2025-05-02 |
Treatments |
| CEFTOREA | P3 |
Active, not recruiting |
Pneumonia |
2021-07-25 |
2022-03-13 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
04/24/2025 |
News Article |
Merck Announces First-Quarter 2025 Financial Results |
|
02/04/2025 |
News Article |
Merck Announces Fourth-Quarter and Full-Year 2024 Financial Results |
|
10/31/2024 |
News Article |
Merck Announces Third-Quarter 2024 Financial Results |
|
10/16/2024 |
News Article |
Melinta Therapeutics Announces IDWeek 2024 Presentations Focused on Melinta's Portfolio of Commercial and Investigational Stage Products |