Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA, Silver Spring, MD, USA.
Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, CDER, FDA, Silver Spring, MD, USA.
Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.
Division of STD Prevention, National Center for HIV/AIDs, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
Division of STD Prevention, NCHHSTP, CDC, Atlanta, GA, USA.
European Medicines Agency, Amsterdam, The Netherlands.
Melinta Therapeutics, Parsippany, NJ, USA.
Debiopharm International SA, Lausanne, Switzerland.
Enteric and Sexually Transmitted Infections Branch, Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.
Institute for Therapeutic Innovation, College of Medicine, University of Florida, Lake Nona, FL, USA.
Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), Boston University, Boston, MA, USA.
Office of Biodefense, Research Resources & Translational Research, DMID, NIAID, NIH, Bethesda, MD, USA.
Nabriva Therapeutics plc, Fort Washington, PA, USA.
Enteric and Sexually Transmitted Infections Branch, DMID, NIAID, NIH, Bethesda, MD, USA.
Department of Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA.
Department of Microbiology and Immunology, Uniformed Services University, Bethesda, MD, USA.
Department of Medicine, Section on Infectious Diseases, Wake Forest University School of Medicine, Southeast STD/HIV PTC, Forsyth County Department of Public Health, and North Carolina Strengthening the United States Response to Resistant Gonorrhea, Winston-Salem, NC, USA.
Enteric and Sexually Transmitted Infections Branch, DMID, NIAID, NIH, Rockville, MD, USA.
Global Antibiotic Research & Development Partnership (GARDP), Geneva, Switzerland, USA.
GlaxoSmithKline, Collegeville, PA, USA.
Washington University School of Medicine in St. Louis, St. Louis STD/HIV Prevention Training Center, St. Louis STI Regional Response Coalition, St. Louis, MO, USA.
Division of STD Prevention, NCHHSTP, CDC, Atlanta, GA, USA.
Pharmaceuticals and Medical Devices Agency (PMDA) Tokyo, Japan.
Global HIV, Hepatitis and STIs Programmes, World Health Organization (WHO), Geneva, Switzerland.
Division of Infectious Diseases, Emory University, Atlanta, GA, USA.
DRT Strategies, Inc., 1001 19th Street N, Suite 1200, Arlington, VA, USA.
Office of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, MD, USA.
Office of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, MD, USA.
University of Chicago Press, 2025. Vol. 81, no 6, p. 1201-1208
Antimicrobial drugs, antimicrobial resistance, drug development, gonorrhea, unmet need
This workshop was supported by the Center for Drug Evaluation and Research, US Food and Drug Administration. Research on Debio 1453 reported in this article is supported by CARB-X. CARB-X’s funding for this project is provided in part by federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (agreement 75A50122C00028). It is also supported by awards from the Wellcome Trust (WT224842) and the Federal Ministry of Education and Research (BMBF) of the Federal Republic of Germany.