Iterum Therapeutics PLC is a clinical-stage biopharmaceutical company dedicated to addressing the global threat of antibiotic resistance. Headquartered in Dublin, Ireland, with an operational presence in New Jersey, Iterum focuses on the development and commercialization of novel anti-infective agents designed to combat serious bacterial infections. The company’s research emphasizes oral and intravenous therapies that can be deployed in both hospital and outpatient settings.
The centerpiece of Iterum’s pipeline is sulopenem, a broad-spectrum penem antibiotic being developed for the treatment of complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI) and other serious infections caused by multidrug-resistant Gram-negative pathogens. Sulopenem’s oral formulation is intended to offer an alternative to existing intravenous therapies, potentially reducing hospitalization time and improving patient compliance. Iterum has completed multiple Phase III clinical trials evaluating the safety and efficacy of sulopenem and is preparing for regulatory submissions in key markets.
In addition to its lead program, Iterum is exploring other potential indications and collaborating with academic institutions and contract research organizations to expand its anti-infective portfolio. The company’s development strategy encompasses the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with plans to extend its reach to regions where antibiotic resistance presents a growing healthcare challenge. Iterum’s manufacturing partnerships aim to ensure scalable production and timely supply of its investigational therapies.
Formed as a spin-out in 2018, Iterum has assembled a leadership team with deep expertise in antimicrobial drug development. Under the guidance of Co-Founder and Chief Executive Officer Mary Claire Haver, supported by a board of directors and senior executives with backgrounds in biotechnology, pharmaceuticals and clinical research, the company remains committed to delivering innovative solutions that address unmet medical needs in infectious disease.
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