Omadacycline has been evaluated across multiple clinical trials spanning Phase 1 through Phase 4, primarily investigating bacterial conditions—such as community-acquired bacterial pneumonia, bone and joint infections, non-tuberculous mycobacterial pneumonia, and skin and soft tissue infections—alongside gut microbiome assessments in healthy volunteers. Conducted by academic and industry sponsors including Paratek Pharmaceuticals, Zai Lab, Wake Forest University Health Sciences, and the Lundquist Institute, these studies encompass recruitment statuses ranging from completed protocols to active, non-recruiting trials and those enrolling by invitation.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07228702 | ENROLLING_BY_INVITATION | Non-Tuberculous Mycobacterial (NTM) Pneumonia; Mycobacterium Abscessus Infection |
Vancouver Coastal Health |
2026-01-11 | PHASE1 |
| NCT05753215 | ACTIVE_NOT_RECRUITING | Bone Infection; Joint Infection; Bone and Joint Infection |
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center |
2023-05-09 | PHASE2 |
| NCT05217537 | COMPLETED | Bacterial Infections |
Paratek Pharmaceuticals Inc |
2022-04-06 | PHASE1 |
| NCT06162286 | UNKNOWN | Community-acquired Bacterial Pneumonia |
Zai Lab (Hong Kong), Ltd. |
2023-11-17 | PHASE3 |
| NCT06462326 | COMPLETED | Healthy Volunteer |
Zai Lab (Hong Kong), Ltd. |
2024-04-16 | PHASE1 |
| NCT04922554 | COMPLETED | Mycobacterium Infections, Nontuberculous; Mycobacterium Abscessus Infection; Nontuberculous Mycobacterial Lung Disease; Nontuberculous Mycobacterial Pulmonary Infection |
Paratek Pharmaceuticals Inc |
2021-10-15 | PHASE2 |
| NCT04779242 | COMPLETED | Community-acquired Pneumonia; Bacterial Pneumonia |
Paratek Pharmaceuticals Inc |
2021-02-25 | PHASE3 |
| NCT04460586 | COMPLETED | Cystic Fibrosis |
Paul Beringer |
2021-07-01 | PHASE4 |
| NCT06030219 | COMPLETED | Healthy Volunteers |
University of Houston |
2020-10-12 | PHASE1 |
| NCT05515562 | COMPLETED | Microbial Colonization |
Wake Forest University Health Sciences |
2023-03-20 | PHASE4 |
| NCT04144374 | COMPLETED | Diabetes; Wound Infection; Healthy Volunteers |
Hartford Hospital |
2020-02-10 | PHASE1 |
| NCT04160260 | COMPLETED | Community-acquired Pneumonia |
Paratek Pharmaceuticals Inc |
2019-11-28 | PHASE1 |
| NCT03757234 | COMPLETED | Acute Pyelonephritis |
Paratek Pharmaceuticals Inc |
2018-11-19 | PHASE2 |
| NCT03425396 | COMPLETED | Uncomplicated Urinary Tract Infection; Cystitis |
Paratek Pharmaceuticals Inc |
2018-01-04 | PHASE2 |
| NCT02877927 | COMPLETED | Bacterial Infections; Skin Structures and Soft Tissue Infections |
Paratek Pharmaceuticals Inc |
2016-08 | PHASE3 |
| NCT02531438 | COMPLETED | Bacterial Pneumonia; Community-Acquired Infections |
Paratek Pharmaceuticals Inc |
2015-11 | PHASE3 |
| NCT02378480 | COMPLETED | Bacterial Infections; Skin Structures and Soft Tissue Infections |
Paratek Pharmaceuticals Inc |
2015-06 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-06-03)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).