15 completed, 1 active not recruiting, 1 enrolling by invitation, 1 not yet recruiting. 6 Phase 1, 6 Phase 3, 5 Phase 2, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 5, Enrolling by invitation 1 |
| Phase 3 | 6 | Completed 4, Terminated 1, Unknown 1 |
| Phase 2 | 5 | Completed 3, Active not recruiting 1, Not yet recruiting 1 |
| Phase 4 | 2 | Completed 2 |
Follow omadacycline: new trials by email Literature Review of omadacycline trials Research Report on omadacycline
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Omadacycline for Treatment Refractory Mycoplasma Genitalium Urethritis Omadacycline Oral Tablet - Mycoplasma Genitalium Infection, Urethritis | Phase 2 | Not yet recruiting | Montefiore Medical Center | 10 | 2026-10-01 | 2026-10-02 |
| Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection Mycobacteriophage Muddy_HRMN0052, Amikacin Injection, Clofazimine - Non-Tuberculous Mycobacterial (NTM) Pneumonia, Mycobacterium Abscessus Infection | Phase 1 | Enrolling by invitation | Vancouver Coastal Health | 1 | 2026-01-11 | 2026-06-03 |
| A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers Moxifloxacin Oral Tablet, Omadacycline Oral Tablet - Healthy Volunteer | Phase 1 | Completed | Zai Lab (Hong Kong), Ltd. | 24 | 2024-04-16 | 2024-11-01 |
| A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP Omadacycline, Moxifloxacin - Community-acquired Bacterial Pneumonia | Phase 3 | Unknown | Zai Lab (Hong Kong), Ltd. | 100 | 2023-11-17 | 2024-06-14 |
| Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection Omadacycline Pill, Standard of Care - Bone Infection, Joint Infection | Phase 2 | Active not recruiting | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | 180 | 2023-05-09 | 2026-01-14 |
| Effects of Intravenous (IV) Omadacycline on Gut Microbiome Omadacycline Injection - Microbial Colonization | Phase 4 | Completed | Wake Forest University Health Sciences | 8 | 2023-03-20 | 2025-03-17 |
| Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections Omadacycline Injection [Nuzyra], Omadacycline Oral Tablet - Bacterial Infections | Phase 1 | Completed | Paratek Pharmaceuticals Inc | 23 | 2022-04-06 | 2026-03-09 |
| Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc) Omadacycline Oral Tablet, Placebo - Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection | Phase 2 | Completed | Paratek Pharmaceuticals Inc | 66 | 2021-10-15 | 2025-07-30 |
| Pharmacokinetics of Omadacycline in Cystic Fibrosis Omadacycline Injection [Nuzyra], Omadacycline Oral Tablet [Nuzyra] - Cystic Fibrosis | Phase 4 | Completed | Paul Beringer | 9 | 2021-07-01 | 2026-05-08 |
| Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia Omadacycline, Moxifloxacin - Community-acquired Pneumonia, Bacterial Pneumonia | Phase 3 | Completed | Paratek Pharmaceuticals Inc | 670 | 2021-02-25 | 2025-04-09 |
| Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis Omadacycline - Diabetic Foot Infection | Completed | Methodist Health System | 42 | 2020-11-05 | 2026-03-27 | |
| Microbiome Effect of Omadacycline on Healthy Volunteers Omadacycline, Vancomycin Pill, Moxifloxacin - Healthy Volunteers | Phase 1 | Completed | University of Houston | 32 | 2020-10-12 | 2025-03-25 |
| Omadacycline Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis Omadacycline, Microdialysis Catheter Insertion - Diabetes, Wound Infection | Phase 1 | Completed | Hartford Hospital | 14 | 2020-02-10 | 2021-08-25 |
| Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia Omadacycline - Community-acquired Pneumonia | Phase 1 | Completed | Paratek Pharmaceuticals Inc | 18 | 2019-11-28 | 2021-11-03 |
| IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis Omadacycline, Levofloxacin - Acute Pyelonephritis | Phase 2 | Completed | Paratek Pharmaceuticals Inc | 201 | 2018-11-19 | 2020-07-07 |
| Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis Omadacycline tablets, Nitrofurantoin capsules - Uncomplicated Urinary Tract Infection, Cystitis | Phase 2 | Completed | Paratek Pharmaceuticals Inc | 225 | 2018-01-04 | 2020-06-09 |
| Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI Omadacycline, Linezolid - Bacterial Infections, Skin Structures and Soft Tissue Infections | Phase 3 | Completed | Paratek Pharmaceuticals Inc | 735 | 2016-08-01 | 2018-11-30 |
| Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13) Omadacycline, Moxifloxacin - Bacterial Pneumonia, Community-Acquired Infections | Phase 3 | Completed | Paratek Pharmaceuticals Inc | 774 | 2015-11-01 | 2019-01-16 |
| Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23) Omadacycline, Linezolid - Bacterial Infections, Skin Structures and Soft Tissue Infections | Phase 3 | Completed | Paratek Pharmaceuticals Inc | 655 | 2015-06-01 | 2019-03-21 |
| Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI) PTK 0796, linezolid, moxifloxacin - Skin Diseases, Infectious | Phase 3 | Terminated | Paratek Pharmaceuticals Inc | 143 | 2009-04-04 | 2021-03-12 |
Bacterial Infections (3) · Community-Acquired Pneumonia (2) · Mycobacterium Infections, Nontuberculous (2) · Pneumonia, Bacterial (2) · Soft Tissue Infections (2) · Abscess (1) · Cellulitis (1) · Communicable Diseases (1) · Community-Acquired Infections (1) · Cystic Fibrosis (1) · Cystitis (1) · Diabetes Mellitus (1) · Lung Diseases (1) · Pneumonia (1) · Skin Diseases, Infectious (1)
Paratek Pharmaceuticals Inc (10) · Zai Lab (Hong Kong), Ltd. (2) · Hartford Hospital (1) · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (1) · Methodist Health System (1) · Montefiore Medical Center (1) · Paul Beringer (1) · University of Houston (1) · Vancouver Coastal Health (1) · Wake Forest University Health Sciences (1)
United States (15) · Ukraine (4) · Bulgaria (3) · Croatia (3) · Georgia (3) · Hungary (3) · Latvia (3) · Poland (3) · Russia (3) · China (2) · Greece (2) · Israel (2) · Peru (2) · Romania (2) · South Africa (2)
Amy Manley (4) · Adupa P Rao, M.D. (1) · Amy Y. Kang, PharmD, BCIDP (1) · David P Nicolau, PharmD (1) · Eric A Meyerowitz, MD (1) · Haihui Huang, PhD (1) · Jian Liu (1) · John C Williamson, PharmD (1) · Kevin W Garey (1) · Loren G. Miller, MD, MPH (1) · Mary West (1) · Matthew Crotty, PharmD (1) · Yonghong Xiao (1)
PMID 33326848, PMID 35776862, PMID 31367742, PMID 33458763, PMID 39461915, PMID 30726689, PMID 30726692, PMID 31367741, PMID 31474458, PMID 37575994, PMID 37720564, PMID 38051631, PMID 39581957, PMID 39819014, PMID 41081530, PMID 42836951