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Clinical Trials
16
4 active
Approvals
3
Total approvals
Agencies
1
Regulatory bodies
Founded
1996
Active, not recruiting
4
25.0%
Completed
10
62.5%
Terminated
6.3%
Withdrawn
FDA
Food and Drug Administration
- Paratek's omadacycline demonstrated significant bacterial burden reduction in a Phase II trial for nontuberculous mycobacterial pulmonary disease caused by Mycobacterium abscessus complex. - The study showed 76.5% of omadacycline-treated patients experienced decreased culture scores compared to 45.8% of placebo patients, with 53.8% achieving negative cultures at day 84. - Omadacycline addresses a critical unmet need in NTM treatment, where nearly all current therapies are used off-label, and has received FDA fast-track and orphan drug designations.
