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Omadacycline

Generic Name
Omadacycline
Brand Names
Nuzyra
Drug Type
Small Molecule
Chemical Formula
C29H40N4O7
CAS Number
389139-89-3
Unique Ingredient Identifier
090IP5RV8F
Background

Omadacycline has been used in trials studying the treatment of Bacterial Pneumonia, Bacterial Infections, Community-Acquired Infections, and Skin Structures and Soft Tissue Infections. Omadacycline represents a significant advance over the well-known tetracycline family, and has been shown to be highly effective in animal models at treating increasingly problematic, clinically prevalent infections caused by gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), and by gram-negative, atypical and anaerobic bacteria, including those resistant to currently available classes of antibiotics and known to cause diseases such as pneumonias, urinary tract infections, skin diseases and blood-borne infections in both the hospital and community settings.

Indication

Omadacycline is indicated for the treatment of community acquired bacterial pneumonia and acute bacterial skin and skin structure infections caused by omadacycline-susceptible organisms in adults.

Associated Conditions
Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Community-Acquired Bacterial Pneumonia (CABP)
Clinical Trials
Related News

Paratek to Present Groundbreaking Clinical Data on NUZYRA for NTM and CABP at ATS 2025

• Paratek Pharmaceuticals will present results from two significant clinical studies of NUZYRA (omadacycline) at the ATS 2025 International Conference, including the first-ever placebo-controlled trial in Mycobacterium abscessus complex pulmonary disease. • The Phase 2b study in nontuberculous mycobacterial pulmonary disease (NTM PD) addresses a significant unmet need, while the Phase 3 OPTIC-2 study confirms NUZYRA's efficacy and safety profile in community-acquired bacterial pneumonia. • NUZYRA, a next-generation tetracycline designed to overcome resistance, has established the largest clinical trial dataset in pneumonia across all antibiotics approved by the FDA in the last decade.

Zai Lab's Augtyro Included in China's National Reimbursement Drug List for ROS1+ NSCLC

• Zai Lab's Augtyro (repotrectinib) has been added to China's National Reimbursement Drug List (NRDL) for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). • The NRDL update also includes the renewal of Nuzyra (omadacycline) for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). • Qinlock (ripretinib) is also renewed for advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors. • The inclusion of these drugs in the NRDL aims to improve patient access to innovative treatments at more affordable costs throughout China.

Zai Lab Reports Strong Q3 2024 Growth, Highlights Pipeline Advances Including KarXT and ZL-1310

• Zai Lab's Q3 2024 net product revenue reached $101.8 million, a 47% year-over-year increase, driven by VYVGART, ZEJULA, and NUZYRA sales. • A China bridging study of KarXT in schizophrenia showed positive results, with regulatory submission expected in early 2025, potentially expanding treatment options. • Phase 1 data for ZL-1310, a DLL3-targeted ADC for extensive-stage SCLC, demonstrated promising antitumor activity, suggesting best-in-class potential. • The company anticipates launching three products in mainland China by the end of 2024 and aims for up to four regulatory submissions to the NMPA in the next six months.

Paratek's Nuzyra Shows Promise in Phase IIb Trial for NTM Pulmonary Disease

• Paratek Pharmaceuticals' Nuzyra (omadacycline) demonstrated positive topline results in a Phase IIb trial for nontuberculous mycobacterial (NTM) pulmonary disease. • The trial showed a trend favoring omadacycline, with at least 50% improvement in NTM symptoms in 34.1% of participants, compared to 12-20% in the placebo group. • Nuzyra also improved microbiological endpoints, with 56.4% of the treatment group achieving negative sputum cultures versus 29.2% in the placebo group. • Gastrointestinal symptoms were the most common adverse events, but the company plans to present and publish complete data later.

Paratek Presents New Omadacycline (NUZYRA) Data Across Various Serious Infections at IDWeek 2024

• Paratek Pharmaceuticals is presenting new data on NUZYRA (omadacycline) at IDWeek 2024, highlighting its potential in treating various serious infections. • Interim results from a non-inferiority trial of NUZYRA in bone and joint infections show promising safety data compared to standard-of-care oral antibiotics. • A real-world study assesses NUZYRA's clinical and microbiological outcomes in treating pulmonary Mycobacterium abscessus complex, a rare pulmonary disease. • A five-year microbiologic surveillance study of NUZYRA will be presented, along with data from clinical, non-clinical, and microbiology programs.
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