{"id":"sulopenem","rwe":[{"n":null,"pmid":"38742824","year":"2024","title":"Synergistic effects of sulopenem in combination with cefuroxime or durlobactam against Mycobacterium abscessus.","finding":"1. mBio. 2024 Jun 12;15(6):e0060924. doi: 10.1128/mbio.00609-24. Epub 2024 May 14. Synergistic effects of sulopenem in combination with cefuroxime or durlobactam against Mycobacterium abscessus. Dousa KM(#)(1)(2), Shin E(#)(1)(2), Kurz SG(3), Plummer M(4), Nantongo M(5)(6), Bethel CR(1), Taracila MA","journal":"mBio","studyType":"Observational"}],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[{"drug":"Ketoprofen","severity":"Monitor closely","mechanism":"","management":"","clinicalEffect":"Concomitant use is not recommended ("},{"drug":") See full prescribing information for additional","severity":"Monitor closely","mechanism":"","management":"","clinicalEffect":"clinically significant drug interactions with ORLYNVAH ("}],"commonSideEffects":[{"notes":"","effect":"nts treated with ORLYNVAH were all female","severity":"mild","placeboRate":null,"incidenceRate":"100%"},{"notes":"","effect":"predominantly White","severity":"mild","placeboRate":null,"incidenceRate":"83%"},{"notes":"","effect":"and from the United States","severity":"mild","placeboRate":null,"incidenceRate":"83%"}],"contraindications":["ORLYNVAH is contraindicated in patients with:","A history of hypersensitivity to the components of ORLYNVAH (sulopenem etzadroxil and probenecid) or other beta-lactam antibacterial drugs [see Warnings and Precautions ( 5.1 )]","Known uric acid kidney stones [see Warnings and Precautions ( 5.3 )] Concomitant use of ORLYNVAH and ketorolac tromethamine is contraindicated [see Drug Interactions ( 7.1 )] Patients with a history of hypersensitivity to the components of ORLYNVAH (sulopenem etzadroxil and probenecid) or other beta","lactam antibacterial drugs. ( 4 ) Patients with known uric acid kidney stones. ( 4 ) Concomitant use of ORLYNVAH and ketorolac tromethamine is contraindicated. ( 4 )"],"specialPopulations":{"Pregnancy":"8.1 Pregnancy Risk Summary Sulopenem Etzadroxil There are no available data on sulopenem etzadroxil use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Sulopenem etzadroxil was orally administered during organogenesis in embryo-fetal studies in mice, rats, and rabbits. In pregnant mice, maternal toxicity and an inc","Paediatric use":"8.4 Pediatric Use The safety and effectiveness of ORLYNVAH in pediatric patients have not been established. Juvenile Animal Toxicity Data In a toxicology study with juvenile rats, sulopenem etzadroxil was orally administered from postnatal day (PND) 5 to PND 90 (85 days of dosing) in doses of 25, 75, and 225 mg/kg/day. Juvenile rats exhibited kidney toxicity including tubular epithelial degenerati","Elderly (≥65 years)":"8.5 Geriatric Use In uUTI Trial 1, there were 436 patients 65 years of age and older [see Clinical Studies ( 14.1 )]. Of the total number of ORLYNVAH-treated patients in this study, 224 (20.2%) were 65 years of age and older, while 80 (7.2%) were 75 years of age and older. No overall differences in safety or effectiveness of ORLYNVAH were observed between patients 65 years and older and younger ad"},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT00759564","NCT04682834","NCT03354598","NCT05584657","NCT00797108","NCT03357614","NCT03358576","NCT07092813","NCT04700787"],"aliases":[],"patents":[],"pricing":[],"_fixedAt":"2026-03-30T12:10:02.924567","offLabel":[],"timeline":[{"date":"2009","type":"neutral","milestone":"Phase 2 Initiated","description":"A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires  — Pneumonia, Bacterial"},{"date":"2010","type":"neutral","milestone":"Phase 1 Initiated","description":"A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form — Pneumonia"},{"date":"2019","type":"neutral","milestone":"Phase 3 Initiated","description":"Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI) — Intra Abdominal Infections"}],"brandName":"SULOPENEM","companyId":"unknown","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Small molecule","drugClass":"","explanation":"12.1 Mechanism of Action ORLYNVAH is a combination of sulopenem etzadroxil, a penem antibacterial drug [see Microbiology 12.4 ] and probenecid, a renal tubular transport inhibitor. Probenecid inhibits OAT3-mediated renal clearance of sulopenem, resulting in increased plasma concentrations of sulopenem .","oneSentence":"12.1 Mechanism of Action ORLYNVAH is a combination of sulopenem etzadroxil, a penem antibacterial drug [see Microbiology 12.4 ] and probenecid, a renal tubular transport inhibitor.","technicalDetail":"12.1 Mechanism of Action ORLYNVAH is a combination of sulopenem etzadroxil, a penem antibacterial drug [see Microbiology 12.4 ] and probenecid, a renal tubular transport inhibitor. Probenecid inhibits OAT3-mediated renal clearance of sulopenem, resulting in increased plasma concentrations of sulopenem ."},"commercial":null,"references":[],"biosimilars":[],"companyName":"","competitors":[],"genericName":"SULOPENEM","indications":{"approved":[],"offLabel":[],"pipeline":[]},"_fixedFields":["trials(9)","pubmed(56)"],"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07092813","phase":"PHASE1","title":"Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents","status":"RECRUITING","sponsor":"Iterum Therapeutics, International Limited","startDate":"2026-04","conditions":["Pharmacokinetics After Oral Intake"],"enrollment":12,"completionDate":"2026-10"},{"nctId":"NCT05584657","phase":"PHASE3","title":"Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women","status":"COMPLETED","sponsor":"Iterum Therapeutics, International Limited","startDate":"2022-10-18","conditions":["Urinary Tract Infections","Cystitis"],"enrollment":2229,"completionDate":"2023-11-21"},{"nctId":"NCT04682834","phase":"","title":"Expanded Access Use of Sulopenem Etzadroxil/Probenecid for Complicated Urinary Tract Infection","status":"NO_LONGER_AVAILABLE","sponsor":"Iterum Therapeutics, International Limited","startDate":"","conditions":["Complicated Urinary Tract Infection","Acute Pyelonephritis"],"enrollment":0,"completionDate":""},{"nctId":"NCT04700787","phase":"PHASE1","title":"Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents","status":"WITHDRAWN","sponsor":"Iterum Therapeutics, International Limited","startDate":"2021-04-30","conditions":["Urinary Tract Infections","Pyelonephritis Acute","Intraabdominal Infections"],"enrollment":0,"completionDate":"2022-04-04"},{"nctId":"NCT03354598","phase":"PHASE3","title":"Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women","status":"COMPLETED","sponsor":"Iterum Therapeutics, International Limited","startDate":"2018-08-01","conditions":["Uncomplicated Urinary Tract Infections"],"enrollment":1671,"completionDate":"2020-01-20"},{"nctId":"NCT03357614","phase":"PHASE3","title":"Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults","status":"COMPLETED","sponsor":"Iterum Therapeutics, International Limited","startDate":"2018-09-18","conditions":["Complicated Urinary Tract Infections"],"enrollment":1395,"completionDate":"2019-12-14"},{"nctId":"NCT03358576","phase":"PHASE3","title":"Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)","status":"COMPLETED","sponsor":"Iterum Therapeutics, International Limited","startDate":"2018-09-18","conditions":["Intra Abdominal Infections"],"enrollment":674,"completionDate":"2019-10-02"},{"nctId":"NCT00759564","phase":"PHASE1","title":"A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function","status":"COMPLETED","sponsor":"Pfizer","startDate":"2008-11","conditions":["Pneumonia"],"enrollment":29,"completionDate":"2010-03"},{"nctId":"NCT00797108","phase":"PHASE2","title":"A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization","status":"COMPLETED","sponsor":"Pfizer","startDate":"2009-01","conditions":["Pneumonia, Bacterial"],"enrollment":35,"completionDate":"2009-06"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"Oral","frequency":"Twice daily","formulation":"Film-coated tablet"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":56,"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"firstApprovalDate":"","recentPublications":[{"date":"2026 Feb 25","pmid":"41892400","title":"Evidentiary Standards for Newly Approved Antibiotics for Uncomplicated Urinary Tract Infections.","journal":"Antibiotics (Basel, Switzerland)"},{"date":"2026 Feb 18","pmid":"41703210","title":"A systematic review of data on the resistance of uropathogens to sulopenem.","journal":"European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology"},{"date":"2026 Jun","pmid":"41567854","title":"Understanding Pharmacokinetic-Drug Interactions With Drugs Approved by the US Food and Drug Administration in 2024 to Better Manage the Risk of Drug Interactions With Concomitant Medications: A Review of Clinical Data From New Drug Applications.","journal":"Current therapeutic research, clinical and experimental"},{"date":"2026 Jan 5","pmid":"41505597","title":"Gepotidacin (Blujepa) - a new antibiotic for uncomplicated UTI.","journal":"The Medical letter on drugs and therapeutics"},{"date":"2026 Feb 3","pmid":"41432447","title":"Exploring the activity of a novel orally bioavailable β-lactam-β-lactamase inhibitor combination, ceftibuten-ledaborbactam, against Enterobacterales-carrying bla(OXA-48).","journal":"Microbiology spectrum"}],"companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","aiSummary":"","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}