Product Description
Omadacycline is a novel aminomethylcycline antibiotic developed as a once-daily, intravenous and oral treatment for acute bacterial skin and skin structure infection (ABSSSI) and community-acquired bacterial pneumonia (CABP). Omadacycline, a derivative of minocycline, has a chemical structure similar to tigecycline with an alkylaminomethyl group replacing the glycylamido group at the C-9 position of the D-ring of the tetracycline core. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/31970713/)
Mechanisms of Action: 30S Ribosomal Subunit Inhibitor,Protein Synthesis Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral,Intravenous
FDA Designation: Fast Track - Abscess|Nontuberculous Mycobacterial Lung DiseaseOrphan Drug - Nontuberculous Mycobacterial Lung Disease *
Approval Status: Approved
Approved Countries: China | United States
Approved Indications: Pneumonia, Bacterial | Pneumonia
Known Adverse Events: Hypertension | Headache | Insomnia | Constipation | Diarrhea
Company: Gurnet Point Capital (GPC)/ Novo Holdings (NH)
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Bulgaria, China, Croatia, Georgia, Hungary, Poland, Russia, Serbia, Ukraine, United States
Active Clinical Trial Count: 9
Highest Development Phases
Phase 3: Pneumonia, Bacterial
Phase 2: Arthritis, Infectious|Bone Diseases, Infectious|Communicable Diseases|Lung Abscess|Mycobacterium Infections, Nontuberculous|Nontuberculous Mycobacterial Lung Disease
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| CORGI | P2 |
Recruiting |
Bone Diseases, Infectious|Communicable Diseases|Arthritis, Infectious |
2025-05-01 |
|
| public | P3 |
Recruiting |
Pneumonia, Bacterial |
2025-01-01 |
60% |
| 2020-002986-32 | P3 |
Active, not recruiting |
Pneumonia, Bacterial |
2024-11-21 |
|
| ZL-2401-005 | P1 |
Completed |
Healthy Volunteers |
2024-09-29 |