Drugs / Omadacycline
Omadacycline
also known as
PTK 0796 · Nuzyra · Amadacycline · BAY 73-6944 · Omadaciclina · Omadacycline tosilate · OMADACYCLINE TOSYLATE
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | NUZYRA | — | 2021-05-27 – 2026-05-13 | fda.gov ↗ |
| Approved | US (FDA) | NUZYRA | — | 2018-10-02 | fda.gov ↗ |
Trials 19 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06462326 | Apr → Sep 2024 | — | Zai Lab | Completed | No outcome recorded |
| Phase 1 | NCT05217537 | Apr 2022 → Feb 2025 | bacterial infectious disease | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT06030219 | Oct 2020 → Sep 2023 | — | University of Houston | Completed | No outcome recorded |
| Phase 1 | NCT04144374 | Feb 2020 → Jul 2021 | diabetes mellitus, skin infection | Hartford Hospital | Completed | No outcome recorded |
| Phase 1 | NCT04160260 | Nov 2019 → Mar 2020 | bacterial pneumonia | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT05753215 | May 2023 → Feb 2026 overdue | bacterial infectious disease, infective arthritis, osteomyelitis | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04922554 | Oct 2021 → Jun 2024 | pulmonary non-tuberculous mycobacterial infection | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 2 | NCT03757234 | Nov 2018 → Jun 2019 | acute pyelonephritis | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 2 | NCT03425396 | Jan 2018 → May 2019 | cystitis, urinary tract infection | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 2 | NCT03716024 | Jul 2007 → Jan 2008 | skin disease caused by bacterial infection, skin infection | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT06162286 | Nov 2023 → Jan 2025 | bacterial pneumonia | Zai Lab | Unknown | No outcome recorded |
| Phase 3 | NCT04779242 | Feb 2021 → Mar 2024 | bacterial pneumonia | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 3 | NCT02877927 | Aug 2016 → May 2017 | bacterial infectious disease | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 3 | NCT02531438 | Nov 2015 → Feb 2017 | bacterial pneumonia | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 3 | NCT02378480 | Jun 2015 → Apr 2016 | bacterial infectious disease | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 3 | NCT00876850 | Jul 2009 → Jul 2010 | — | Paratek Pharmaceuticals Inc | Withdrawn | No outcome recorded |
| Phase 3 | NCT00865280 | Apr 2009 → Apr 2010 | skin infection | Paratek Pharmaceuticals Inc | Terminated | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05515562 | Mar → Jul 2023 | — | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 4 | NCT04460586 | Jul 2021 → Dec 2023 | cystic fibrosis | Paul Beringer | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07228702 Background | Jan 2026 → Oct 2027 expected | pulmonary non-tuberculous mycobacterial infection | Vancouver Coastal Health | Enrolling by invitation | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Omadacycline | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04460586 ↗ |
| Known as | Amadacycline | ChEMBL registry synonym — accepted as the source's own label CHEMBL1689772 ↗ |
| Known as | BAY 73-6944 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1689772 ↗ |
| Known as | Nuzyra | “novel tetracycline antibiotic, omadacycline (Nuzyra, Paratek Pharmaceuticals, Inc.)” NCT04144374 ↗1“Omadacycline Injection [Nuzyra]” NCT04460586 ↗ |
| Known as | Omadaciclina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1689772 ↗ |
| Known as | Omadacycline tosilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1689772 ↗ |
| Known as | OMADACYCLINE TOSYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1689772 ↗ |
| Known as | PTK 0796 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00876850 ↗ |
| Modality | Small molecule | “Omadacycline, an aminomethylcycline antibiotic” PMID 30726689 ↗ Feb 2019 |
| Route | Intravenous | “Initial treatment will be administered intravenously with the option for subsequent oral treatment.” NCT00865280 ↗ |
| Route | Oral | “Initial treatment will be administered intravenously with the option for subsequent oral treatment.” NCT00865280 ↗ |