Clinical Trials

Numerous clinical trials spanning Phase I through Phase IV evaluate omadacycline's safety, therapeutic efficacy, and pharmacokinetic profile across conditions including community-acquired bacterial pneumonia, skin and soft tissue infections, bone and joint infections, non-tuberculous mycobacterial pneumonia, and gut microbial colonization. Encompassing both completed and active studies, these investigations are supported by commercial entities such as Paratek Pharmaceuticals Inc. and Zai Lab, alongside academic medical centers including Wake Forest University Health Sciences and the Lundquist Institute.

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)

Check the Omadacycline hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Omadacycline hydrochloride selectively binds to the bacterial 30S ribosomal subunit, preventing the insertion of aminoacyl-tRNA into the ribosomal acceptor site. This inhibition halts peptide chain elongation and disrupts overall protein synthesis, resulting in broad-spectrum bacteriostatic activity that directly inhibits the bacterial pathogens responsible for community-acquired bacterial pneumonia and severe skin infections.

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>).

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Note: Technical data last updated: Sep 1, 2026.