MedPath

Zoliflodacin

Generic Name
Zoliflodacin
Drug Type
Small Molecule
Chemical Formula
C22H22FN5O7
CAS Number
1620458-09-4
Unique Ingredient Identifier
FWL2263R77
Background

Zoliflodacin has been used in trials studying the basic science and treatment of Gonorrhoea.

FDA Approves Blujepa, First New Class of Oral Antibiotic for UTIs in Nearly 30 Years

• GSK's Blujepa (gepotidacin) has received FDA approval for treating uncomplicated urinary tract infections, marking the first new class of oral antibiotics for UTIs in nearly three decades. • The novel triazaacenaphthylene antibiotic demonstrated non-inferiority or superiority to nitrofurantoin in clinical trials, offering a new treatment option amid rising antibiotic resistance concerns. • Blujepa works through a unique dual-enzyme inhibition mechanism that may reduce the potential for resistance development, with commercial availability expected in the second half of 2025.

FDA Approves Zevtera for S. aureus Bacteremia, Marking First New Treatment in 15 Years

• Basilea Pharmaceutica's Zevtera (ceftobiprole) receives FDA approval for three indications, becoming the first beta-lactam antibiotic approved for Staphylococcus aureus bacteremia. • The approval addresses a significant medical need, with approximately 120,000 S. aureus bloodstream infections occurring annually in the US according to CDC data. • The drug's approval includes coverage for antimicrobial-resistant infections, particularly MRSA, targeting a market projected to reach $5.5 billion by 2030.

FDA Gears Up for Key Decisions on Vaccines and Novel Therapies in H1 2025

• The FDA is set to decide on Bavarian Nordic's CHIKV VLP vaccine for chikungunya, potentially the first VLP-based option in the U.S. • GSK's ABCWY vaccine, targeting multiple strains of Neisseria meningitidis, awaits FDA decision for primary care and pediatric use. • Innoviva Specialty Therapeutics' zoliflodacin, a novel antibiotic for gonorrhea, is under FDA review amid rising antimicrobial resistance. • Merck's clesrovimab, a monoclonal antibody for COVID-19, is being reviewed by the FDA for pediatric patients.

New Oral Antibiotics Show Promise Against Drug-Resistant Gonorrhea

• Phase 3 trials indicate zoliflodacin and gepotidacin as potential oral treatments for gonorrhea, including drug-resistant strains, addressing the urgent need for new antimicrobials. • Zoliflodacin demonstrated a 90.9% microbiological cure rate at urogenital sites, compared to 96.2% with ceftriaxone/azithromycin, offering a new single-dose oral option. • Gepotidacin showed a 92.6% microbiological success rate versus 91.2% for ceftriaxone/azithromycin, with a higher rate of adverse effects, mainly diarrhea and nausea. • Both drugs target different mechanisms in bacterial DNA replication, potentially overcoming resistance to existing antibiotics like fluoroquinolones and ceftriaxone.

Zoliflodacin Shows Promise Against Resistant Gonorrhea in Phase 3 Trial

• Zoliflodacin, a novel oral antibiotic, demonstrated non-inferiority to ceftriaxone plus azithromycin for uncomplicated gonorrhea in a Phase 3 trial. • The trial showed a 90.9% urogenital microbiological cure rate with zoliflodacin, compared to 96.2% with the combination therapy. • Innoviva Specialty Therapeutics plans to submit a New Drug Application to the FDA in Q1 of next year, seeking priority review. • The rise of multidrug-resistant gonorrhea strains underscores the urgent need for new treatment options like zoliflodacin.
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