Drugs / Omadacycline
Omadacycline
also known as
PTK 0796 · Nuzyra · Amadacycline · BAY 73-6944 · Omadaciclina · Omadacycline tosilate · OMADACYCLINE TOSYLATE
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed primary bacterial infectious disease 1 milestone | |||||
| Filed | EU (EMA) | — | primary bacterial infectious disease | 2018-10-04 | “today announced the acceptance of the submission to the European Medicines Agency (EMA) of the Marketing Authorization Application (MAA) for omadacycline.” paratekpharma.com ↗ “The European Marketing Authorization Application for oral and Intravenous omadacycline was submitted in October 2018 and the review has been initiated.” paratekpharma.com ↗ “Paratek has submitted a marketing authorization application of omadacycline in the European Union.” paratekpharma.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansions (2) | US (FDA) | NUZYRA | — | 2021-05-27 – 2026-05-13 | fda.gov ↗ |
| Approved | US (FDA) | NUZYRA | — | 2018-10-02 | fda.gov ↗ |
Trials 20
| 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 26 trials · 1 missed | ||||||
| Phase 2 | NCT07853742 | Oct 2026 → Apr 2027 expected | Mycoplasmoides infection, urethritis | Montefiore Medical Center | Not yet recruiting | No outcome recorded |
| 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 | Mixed |
| Phase 2 | NCT03757234 | Nov 2018 → Jun 2019 | acute pyelonephritis | Paratek Pharmaceuticals Inc | Completed | Missed primary |
| 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 | Mixed |
| Phase 37 trials · 3 met primary | ||||||
| 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 | Met primary |
| Phase 3 | NCT02531438 | Nov 2015 → Feb 2017 | bacterial pneumonia | Paratek Pharmaceuticals Inc | Completed | Met primary |
| Phase 3 | NCT02378480 | Jun 2015 → Apr 2016 | bacterial infectious disease | Paratek Pharmaceuticals Inc | Completed | Met primary |
| 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT07228702 Background | Jan 2026 → Oct 2027 expected | pulmonary non-tuberculous mycobacterial infection | Vancouver Coastal Health | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 52
| Date | Issuer | Release |
|---|---|---|
| 2026-02-24 | Paratek Pharmaceuticals Inc | Results Paratek Pharmaceuticals Announces Positive Results for NUZYRA® Therapeutic Efficacy Studies in Inhalation Anthrax Triggering Additional Procurement under BARDA Project BioShield Contract paratekpharma.com ↗
today announced positive top-line results in two important animal studies supporting the Animal Rule Development program for the Treatment of Pulmonary Anthrax. |
| 2025-12-07 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Updates to China’s National Reimbursement Drug List zailaboratory.com ↗
NUZYRA® (omadacycline) is renewed for its oral formulation for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI); |
| 2024-11-27 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces the Inclusion of AUGTYRO® (repotrectinib) for ROS1+ NSCLC and Other Updates in China’s National Reimbursement Drug List zailaboratory.com ↗ |
| 2024-11-08 | Paratek Pharmaceuticals Inc | Results Paratek Pharmaceuticals Announces Positive Top-Line Data from Phase 2b Study of Oral Omadacycline (OMC) in Nontuberculous Mycobacterial (NTM) Abscessus Pulmonary Disease paratekpharma.com ↗
Symptom-based endpoints showed favorable improvement in frequency and severity of the most common symptoms |
| 2024-07-31 | Paratek Pharmaceuticals Inc | Results Paratek Pharmaceuticals Completes Five-Year Microbiologic Surveillance Study of NUZYRA® (omadacycline) Demonstrating No Change in In Vitro Potency Against Indicated Pathogens paratekpharma.com ↗
Omadacycline demonstrated consistent in vitro potency against the isolates evaluated with no emergence of resistance reported (i.e. MIC values remained unchanged with no year-on-year increases). |
| 2024-07-18 | Paratek Pharmaceuticals Inc | Results Paratek Pharmaceuticals Announces Positive Top-line Efficacy and Safety Data from Post-Marketing Study of NUZYRA® (omadacycline) for Patients with Moderate to Severe Community-Acquired Bacterial Pneumonia paratekpharma.com ↗ |
| 2024-03-05 | Paratek Pharmaceuticals Inc | Results Paratek Pharmaceuticals Announces Positive Efficacy Data for NUZYRA® as Post-Exposure Prophylaxis of Inhalational Anthrax, Triggering Additional Procurement under BARDA Project BioShield Contract paratekpharma.com ↗
today announced positive top-line efficacy data for NUZYRA® (omadacycline) as post-exposure prophylaxis (PEP) in a non-human primate (NHP) model of inhalational anthrax. |
| 2023-12-13 | Paratek Pharmaceuticals Inc | Regulatory Paratek Pharmaceuticals Announces Inclusion of Oral NUZYRA® in China's National Reimbursement Drug List paratekpharma.com ↗
This inclusion further expands China's antibiotic armamentarium to address antimicrobial resistance, an ever-growing, urgent, global public health crisis. |
| 2023-12-12 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces the First Listing of VYVGART® (efgartigimod alfa injection) and Other Updates in China’s National Reimbursement Drug List zailaboratory.com ↗
NUZYRA® (omadacycline) is included for its oral formulation for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI); |
| 2023-06-27 | Paratek Pharmaceuticals Inc | Regulatory European Medicines Agency COMP Recommends Positive Opinion on Orphan Medicinal Product Designation for NUZYRA® (omadacycline) for Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease paratekpharma.com ↗
today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has recommended a positive opinion for orphan medicinal product designation for NUZYRA ® (omadacycline) for the treatment of nontuberculous mycobacterial (NTM) lung disease. |
| 2023-01-18 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Inclusion of QINLOCK® (ripretinib) and NUZYRA® (omadacycline) in China’s National Reimbursement Drug List zailaboratory.com ↗
The inclusion of both QINLOCK and NUZYRA in the NRDL is another opportunity for us to achieve that mission. |
| 2022-12-19 | Paratek Pharmaceuticals Inc | Results Paratek Pharmaceuticals Announces Positive Top Line Data from Pilot Efficacy Study for the Treatment of Pulmonary Anthrax and Acceptance of the Second Procurement of NUZYRA® (omadacycline) under BARDA Project BioShield paratekpharma.com ↗
In the study, a 100% survival rate was observed in omadacycline-treated rabbits at the specified endpoint of 35-45 days post Bacillus anthracis (anthrax) challenge, while all rabbits treated with placebo died due to anthrax infection within three days. |
| 2022-06-21 | Paratek Pharmaceuticals Inc | Regulatory Paratek Pharmaceuticals' NUZYRA® Receives FDA Fast Track Designation for the Treatment of Pulmonary Nontuberculous Mycobacterial (NTM) Disease Caused by Mycobacterium Avium Complex (MAC) and Mycobacterium Abscessus (MAB) paratekpharma.com ↗ |
| 2022-03-08 | Paratek Pharmaceuticals Inc | Results Paratek Pharmaceuticals Announces the Publication of Data from an Investigator-Initiated Study of NUZYRA® (omadacycline) in a Hollow Fiber System Model Against Pulmonary Mycobacterium avium complex paratekpharma.com ↗
Subsequent simulations conducted to identify the optimal dose of oral omadacycline predicted that standard clinical doses would be bactericidal in the treatment of pulmonary MAC. |
| 2021-12-16 | Paratek Pharmaceuticals Inc | Regulatory China's National Medical Products Administration Approves NUZYRA® (omadacycline) for the Treatment of Bacterial Pneumonia and Skin Infections paratekpharma.com ↗ |
| 2021-12-16 | Zai Lab (Shanghai) Co., Ltd. | Regulatory China NMPA Approves NUZYRA® as a Category 1 Innovative Drug for the Treatment of Patients with Community-Acquired Bacterial Pneumonia (CABP) and Acute Bacterial Skin and Skin Structure Infections (ABSSSI) zailaboratory.com ↗
NUZYRA was approved as a Category 1 innovative drug by the NMPA and is locally manufactured in China. |
| 2021-08-18 | Paratek Pharmaceuticals Inc | Regulatory Paratek Pharmaceuticals Announces FDA Orphan Drug Designation for NUZYRA® (omadacycline) for the Treatment of Infections Caused by Nontuberculous Mycobacteria paratekpharma.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for NUZYRA ® (omadacycline) for the treatment of infections caused by Nontuberculous Mycobacteria (NTM). |
| 2021-06-01 | Paratek Pharmaceuticals Inc | Regulatory Paratek Pharmaceuticals Announces FDA Approval of NUZYRA® (omadacycline) Oral Only Dosing Regimen for the Treatment of Community-Acquired Bacterial Pneumonia (CABP) paratekpharma.com ↗
Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and for other public health threats for civilian, government and military use, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for the oral-only dosing regimen of NUZYRA ® for the treatment of adults with CABP. |
| 2020-05-06 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces NDA for Omadacycline Granted Priority Review by China’s NMPA zailaboratory.com ↗ |
| 2020-03-10 | Paratek Pharmaceuticals Inc | Regulatory Paratek Pharmaceuticals Announces the Submission of the pre-Emergency Use Authorization Application to the FDA for NUZYRA (omadacycline) paratekpharma.com ↗
today announced that a pre-emergency use authorization (EUA) application for NUZYRA • (omadacycline) has been submitted to the U.S. Food and Drug Administration (FDA). |
| 2020-02-10 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Acceptance of NDA Submission of Omadacycline in China by the NMPA zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, today announced that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). |
| 2019-10-31 | Paratek Pharmaceuticals Inc | Results Paratek Announces Top Line Results of Phase 2 Clinical Studies of Omadacycline in Urinary Tract Infections paratekpharma.com ↗
In both studies, omadacycline showed generally comparable levels of clinical success to either nitrofurantoin or levofloxacin, as determined by the investigator's assessment of clinical response at the post-treatment evaluation. |
| 2019-10-17 | Paratek Pharmaceuticals Inc | Regulatory Paratek Withdraws European Marketing Authorization Application for Oral and Intravenous NUZYRA in Skin Infections and Pneumonia paratekpharma.com ↗
Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, announced today that the company has withdrawn its submission to the European Medicines Agency (EMA) of the Marketing Authorization Application (MAA) for NUZYRA® (omadacycline). |
| 2019-08-30 | Paratek Pharmaceuticals Inc | Results The Lancet Infectious Diseases Publishes Results from Paratek's Phase 3 Oral only Dosing Study of NUZYRA® (omadacycline) for Skin Infections paratekpharma.com ↗
Once-daily, oral NUZYRA met all primary and secondary clinical study endpoints and was shown to be safe and effective for the treatment of acute bacterial skin and skin structure infections (ABSSSI). |
| 2019-04-15 | Paratek Pharmaceuticals Inc | Results Paratek Pharmaceuticals Broadens Clinical Profile of NUZYRA™ (Omadacycline) with New ECCMID 2019 Data Presentations paratekpharma.com ↗ |
| 2019-02-06 | Paratek Pharmaceuticals Inc | Results New England Journal of Medicine Publishes Results from Pivotal Phase 3 Studies of Paratek's NUZYRA™ (Omadacycline) For Pneumonia and Skin Infections paratekpharma.com ↗
OPTIC demonstrated that NUZYRA was non-inferior to moxifloxacin for the treatment of adults with CABP and was safe and well-tolerated. |
| 2018-10-04 | Paratek Pharmaceuticals Inc | Regulatory Paratek Announces Acceptance of European Marketing Authorization Application for Oral and Intravenous Omadacycline paratekpharma.com ↗
Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced the acceptance of the submission to the European Medicines Agency (EMA) of the Marketing Authorization Application (MAA) for omadacycline. |
| 2018-10-02 | Paratek Pharmaceuticals Inc | Regulatory Paratek Announces FDA Approval of NUZYRA™ (Omadacycline) paratekpharma.com ↗
Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced that the U.S. Food and Drug Administration (FDA) has approved NUZYRA™ (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). |
| 2018-08-08 | Paratek Pharmaceuticals Inc | Regulatory FDA Advisory Committee Recommends Approval of Paratek's Omadacycline paratekpharma.com ↗
Today's recommendations from the Advisory Committee move us one step closer to making this important new treatment option available to patients and physicians. |
| 2018-06-20 | Paratek Pharmaceuticals Inc | Regulatory Paratek Announces FDA Advisory Committee Date for Omadacycline paratekpharma.com ↗
today announced that a meeting of the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for August 8, 2018 to review the Company's New Drug Applications (NDAs) for once-daily, oral and intravenous omadacycline. |
| 2018-06-11 | Paratek Pharmaceuticals Inc | Results Paratek Presents New Analysis from Combined Phase 3 Skin Infection Studies Highlighting Efficacy of Omadacycline in Treating Drug Resistant S. aureus at ASM Microbe 2018 paratekpharma.com ↗
The rate of clinical success at post-treatment evaluation (PTE) with omadacycline was 81.0% when MDR SA was present and was comparable to SA overall at 83.0%. |
| 2018-05-22 | Paratek Pharmaceuticals Inc | Results Paratek Presents New Analysis Highlighting Efficacy of Omadacycline in Treating Community-Acquired Bacterial Pneumonia by Measures of Disease Severity paratekpharma.com ↗
The data showed similar, high rates of response for the early clinical response (ECR) and post therapy evaluation (PTE, also known as test-of-cure) endpoints in both the omadacycline and moxifloxacin treatment groups, regardless of the severity of disease. |
| 2018-04-23 | Paratek Pharmaceuticals Inc | Results Paratek Pharmaceuticals Presents New Microbiology Efficacy Data of Oral-only Omadacycline Against the Most Common Pathogens Associated with Skin Infections paratekpharma.com ↗
An additional OASIS-2 sub-analysis showed that treatment with omadacycline led to rapid and continual reduction in lesion size, results that were similar to those observed with linezolid. |
| 2018-04-23 | Paratek Pharmaceuticals Inc | Results Paratek Pharmaceuticals Presents Data Supporting Potential Approval of Omadacycline for Treatment of Community-Acquired Bacterial Pneumonia Based on the EMA Guidelines at ECCMID paratekpharma.com ↗
An additional sub-analysis of OPTIC reported on the efficacy of omadacycline in CABP across geographic regions. |
| 2018-04-04 | Paratek Pharmaceuticals Inc | Regulatory Paratek's New Drug Applications for Oral and Intravenous Omadacycline Accepted for Priority Review by FDA paratekpharma.com ↗
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Applications (NDAs) and granted a priority review for omadacycline, an investigational once-daily oral and intravenous (IV) broad spectrum antibiotic. |
| 2018-02-05 | Paratek Pharmaceuticals Inc | Regulatory Paratek Completes Submission of New Drug Applications to U.S. Food and Drug Administration for Oral and Intravenous Omadacycline for Pneumonia and Skin Infections paratekpharma.com ↗ |
| 2018-01-03 | Paratek Pharmaceuticals Inc | Regulatory Paratek Provides Update on Pipeline Progress paratekpharma.com ↗
Rolling NDA submission underway for omadacycline in pneumonia and skin infections |
| 2017-10-06 | Paratek Pharmaceuticals Inc | Results Phase 3 Optic Study Microbiology Data Demonstrate Omadacycline has Potent In vitro Activity Against Multiple Pneumonia Pathogens, Including Resistant Bacteria paratekpharma.com ↗
Omadacycline showed potent in vitro activity across all isolates. |
| 2017-10-06 | Paratek Pharmaceuticals Inc | Results Consistent Efficacy and Safety Profile Observed in New Analyses of OASIS-1 Phase 3 Study of Omadacycline in Patients with Difficult to Treat Comorbid Conditions paratekpharma.com ↗
In addition to omadacycline demonstrating a consistent efficacy and safety profile compared to linezolid, these data suggest that no dose adjustments for omadacycline are required in patients with these comorbid conditions. |
| 2017-09-21 | Paratek Pharmaceuticals Inc | Regulatory Omadacycline Receives Qualified Infectious Disease Product Designation from FDA for an Additional Indication in Uncomplicated Urinary Tract Infections paratekpharma.com ↗ |
| 2017-07-17 | Paratek Pharmaceuticals Inc | Results Paratek Announces Phase 3 Study of Oral-Only Dosing of Omadacycline Met All Primary and Secondary FDA and EMA Efficacy Endpoints in Acute Bacterial Skin Infections paratekpharma.com ↗
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today positive top-line results from a pivotal Phase 3 clinical study comparing its once-daily, oral investigational antibiotic, omadacycline, to twice-daily oral linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI). |
| 2017-06-03 | Paratek Pharmaceuticals Inc | Results New Microbiology Data Reinforce Activity of Paratek's Omadacycline Against Pathogens of Importance in Respiratory, Skin and Urinary Tract Infections paratekpharma.com ↗
These data reinforce the results of clinical and microbiologic data presented earlier this year at ECCMID. |
| 2017-04-25 | Paratek Pharmaceuticals Inc | Results Omadacycline Concentrations Exceed Tigecycline Levels in Lungs and Epithelial Lining Fluid According to Pharmacokinetic/Pharmacodynamic (PK/PD) Data paratekpharma.com ↗
Intravenous dosing of omadacycline at 100 mg produced steady-state concentrations in the plasma, epithelial lining fluid (ELF), and alveolar cells (AC) that were three-fold higher than tigecycline in healthy subjects. |
| 2017-04-24 | Paratek Pharmaceuticals Inc | Results New Microbiology Data from Paratek Pharmaceuticals Show Omadacycline Effective Against Most Common Skin Infections and Pathogens, Including MRSA paratekpharma.com ↗
The full results demonstrate the efficacy and safety of omadacycline compared to linezolid in acute bacterial skin and skin structure infections (ABSSSI). |
| 2017-04-24 | Paratek Pharmaceuticals Inc | Results New Health Economics Studies Highlight the Potential for Paratek Pharmaceuticals' Omadacycline to Provide Cost-Savings Compared to Standard of Care for the Treatment of Patients with Acute Bacterial Skin and Skin Structure Infections paratekpharma.com ↗
The first analysis evaluated the potential economic impact of IV-to-oral omadacycline among hospitalized ABSSSI patients with =2 comorbidities and no life-threatening conditions. |
| 2017-04-03 | Paratek Pharmaceuticals Inc | Results Paratek Announces Positive Phase 3 Study of Omadacycline in Community-Acquired Bacterial Pneumonia paratekpharma.com ↗
Omadacycline met all FDA primary and secondary endpoints and EMA co-primary endpoints |
| 2016-11-02 | Paratek Pharmaceuticals Inc | Results Paratek Pharmaceuticals, Inc. Reports Third Quarter 2016 Financial Results and Provides Clinical Updates paratekpharma.com ↗
Results showed that omadacycline achieved high steady state concentrations in urine for all treatment regimens, demonstrating proof-of-principle for the use of omadacycline in UTI. |
| 2016-06-16 | Paratek Pharmaceuticals Inc | Results Paratek Announces that Omadacycline Met All Primary and Secondary Efficacy Outcomes Designated by FDA and EMA in a Phase 3 Study in Acute Bacterial Skin Infections; Omadacycline was Generally Safe and Well-Tolerated paratekpharma.com ↗
In addition, the study met the two European Medicines Agency (EMA)-specified co-primary efficacy endpoints for post-treatment evaluation. |
| 2016-05-10 | Paratek Pharmaceuticals Inc | Regulatory Paratek Receives FDA Affirmation for Design of Proposed Omadacycline Oral-Only Skin Infection Phase 3 Study: Opportunity to Accelerate Access to Broader Oral-Only Markets paratekpharma.com ↗
In their feedback, the FDA confirmed that the proposed comparator is acceptable and that the proposed study design would meet the requirements established in the FDA's guidance for ABSSSI studies 1 . |
| 2016-04-11 | Paratek Pharmaceuticals Inc | Results Paratek Presents Data from Omadacycline Clinical Development Program at ECCMID paratekpharma.com ↗
Data from a separate, single-dose study showed that omadacycline had no impact on QTc interval. |
| 2016-04-11 | Paratek Pharmaceuticals Inc | Results Paratek Presents Pre-Clinical Data on the Effects of Omadacycline on Clostridium Difficile paratekpharma.com ↗
A well-validated model showed that omadacycline, while extensively disrupting flora in the gastrointestinal tract, has a low propensity to induce C. difficile infection. |
| 2015-11-04 | Paratek Pharmaceuticals Inc | Regulatory Paratek Receives FDA Fast Track Designation for Omadacycline paratekpharma.com ↗ |
All press releases naming this drug 109 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 109 releases opens the full record — a long page | ||
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Omadacycline | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05515562 ↗ |
| 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 NCT00865280 ↗ |
| 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 ↗ |