Compound class:
Synthetic organic
Comment: OPS-2071 is a fluoroquinolone antibacterial compound, with broad-spectrum activity against both Gram-positive and Gram-negative bacteria [2]. It is a clinical candidate being developed by Otsuka Pharmaceutical (Tokyo, Japan) as a treatment for intestinal infections, particularly those caused by Clostridioides difficile. Functionally, it is a type II DNA topoisomerase inhibitor with similar activity against DNA gyrase and DNA topoisomerase 4 [1].
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No information available. |
Summary of Clinical Use |
The therapeutic effects of OPS-2071 are mainly confined to the gastrointestinal tract, due to low oral absorption, and this may help to minimize the side effects associated with quinolones [2]. A Phase 2 study to evaluate safety, efficacy and pharmacokinetics of OPS-2071 in patients with bacterial enteritis caused by Clostridium difficile infection (NCT02473393) has been completed and recruitment has commenced for a trial to assess safety and efficacy of the drug in the treatment of irritable bowel syndrome of diarrhoea type (NCT05923892). A further trial to study safety and efficacy in patients with Crohn's Disease (NCT03850509) was terminated by the sponsor. |
Clinical Trials | |||||
Clinical Trial ID | Title | Type | Source | Comment | References |
NCT03850509 | Efficacy and Safety of Oral OPS-2071 in Participants With Crohn's Disease Showing Symptoms of Active Inflammation | Phase 2 Interventional | Otsuka Pharmaceutical Development & Commercialization, Inc. | ||
NCT05923892 | Phase II Clinical Trial of OPS-2071 in the Treatment of Irritable Bowel Syndrome of Diarrhea Type | Phase 2 Interventional | Otsuka Beijing Research Institute | ||
NCT02473393 | A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis | Phase 2 Interventional | Otsuka Pharmaceutical Co., Ltd. |