{"id":"mecillinam","rwe":[{"pmid":"41750422","year":"2026","title":"Mapping Escherichia coli in Women with Simple Urinary Tract Infections: Phenotypic ESBL/AmpC Screening and Whole-Genome Insights from Oman.","finding":"","journal":"Antibiotics (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41724364","year":"2026","title":"New-generation antibiotics and nonantibiotic strategies against carbapenemase-producing Enterobacterales: More focus on metallo-β-lactamase producers.","finding":"","journal":"International journal of antimicrobial agents","studyType":"Clinical Study"},{"pmid":"41631853","year":"2026","title":"The mecillinam resistome in Klebsiella pneumoniae: how resistance to a one-target β-lactam triggers a diversity of responses.","finding":"","journal":"Antimicrobial agents and chemotherapy","studyType":"Clinical Study"},{"pmid":"41619913","year":"2026","title":"Resistance of uropathogens to gepotidacin: A systematic review of in vitro antimicrobial susceptibility studies.","finding":"","journal":"International journal of antimicrobial agents","studyType":"Clinical Study"},{"pmid":"41358789","year":"2026","title":"Enzymatic activity of PBP1B is required for growth rate-independent ppGpp-mediated resistance to PBP2 inhibitors in E. coli.","finding":"","journal":"Journal of bacteriology","studyType":"Clinical Study"}],"tags":[{"label":"mecillinam","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J01CA11","category":"atc"},{"label":"Active","category":"status"},{"label":"Roche","category":"company"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Infective Agents, Urinary","category":"pharmacology"}],"phase":"marketed","safety":{},"trials":[],"aliases":["Selexid","Penomax"],"company":"Roche","patents":[],"pricing":[],"allNames":"hexapen","offLabel":[],"synonyms":["mecillinam","amdinocillin","hexacillin","hexapen"],"timeline":[],"approvals":[{"date":"","orphan":false,"company":"ROCHE","regulator":"FDA"}],"brandName":"Hexapen","ecosystem":[],"mechanism":{"target":"Penicillin-binding protein 2","novelty":"First-in-class","modality":"Small Molecule","drugClass":"mecillinam","explanation":"Imagine the bacterial cell wall as a strong brick wall. Hexapen blocks the enzymes that help build this wall, making it weak and unable to protect the bacteria. This ultimately leads to the death of the bacteria.","oneSentence":"Hexapen works by inhibiting bacterial cell wall synthesis, preventing the bacteria from producing a strong cell wall.","technicalDetail":"Hexapen exerts its antibacterial effect by inhibiting the enzyme transpeptidase, which is essential for the cross-linking of peptidoglycan in the bacterial cell wall, thereby preventing cell wall synthesis and ultimately leading to bacterial cell lysis."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1648","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Mecillinam","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Mecillinam","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T12:31:23.955619","biosimilars":[],"competitors":[{"drugName":"ampicillin","drugSlug":"ampicillin","fdaApproval":"1965-12-17","genericCount":18,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"carbenicillin","drugSlug":"carbenicillin","fdaApproval":"","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"amoxicillin","drugSlug":"amoxicillin","fdaApproval":"1974-12-09","patentExpiry":"May 7, 2027","patentStatus":"Patent 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and Prevention of Bloodstream Infections After Kidney Transplantation","status":"NOT_YET_RECRUITING","sponsor":"Susanne Dam Nielsen, MD, DMSc","startDate":"2027-01-01","conditions":["Kidney Transplant Infection","Bloodstream Infection"],"enrollment":150,"completionDate":"2029-07"},{"nctId":"NCT07236944","phase":"PHASE4","title":"Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care","status":"RECRUITING","sponsor":"Uppsala University","startDate":"2025-12","conditions":["Febrile Urinary Tract Infection"],"enrollment":560,"completionDate":"2029-03"},{"nctId":"NCT04959331","phase":"PHASE4","title":"Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.","status":"COMPLETED","sponsor":"Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina","startDate":"2021-11-02","conditions":["Urinary Tract 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Oral Therapy in ESBL UTIs","status":"RECRUITING","sponsor":"Lund University","startDate":"2023-05-29","conditions":["Urinary Tract Infections","Bacteremia","Antibiotic Resistant Infection"],"enrollment":330,"completionDate":"2027-09-01"},{"nctId":"NCT03228108","phase":"PHASE4","title":"Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.","status":"COMPLETED","sponsor":"Radboud University Medical Center","startDate":"2018-04-03","conditions":["Complication","Infection","Prostate Cancer"],"enrollment":1538,"completionDate":"2021-09-26"},{"nctId":"NCT03282006","phase":"PHASE4","title":"Treating Pyelonephritis an Urosepsis With Pivmecillinam","status":"COMPLETED","sponsor":"Sykehuset i Vestfold HF","startDate":"2017-09-29","conditions":["Pyelonephritis","Urinary Tract Infections"],"enrollment":53,"completionDate":"2020-04-21"},{"nctId":"NCT01849926","phase":"PHASE4","title":"Ibuprofen Versus Mecillinam for Uncomplicated 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L/kg"},"publicationCount":603,"therapeuticAreas":["Metabolic"],"atcClassification":{"source":"DrugCentral","atcCode":"J01CA11","allCodes":["J01CA11"]},"biosimilarFilings":[],"originalDeveloper":"Roche","recentPublications":[{"date":"2026 Jan 27","pmid":"41750422","title":"Mapping Escherichia coli in Women with Simple Urinary Tract Infections: Phenotypic ESBL/AmpC Screening and Whole-Genome Insights from Oman.","journal":"Antibiotics (Basel, Switzerland)"},{"date":"2026 Feb 20","pmid":"41724364","title":"New-generation antibiotics and nonantibiotic strategies against carbapenemase-producing Enterobacterales: More focus on metallo-β-lactamase producers.","journal":"International journal of antimicrobial agents"},{"date":"2026 Mar 4","pmid":"41631853","title":"The mecillinam resistome in Klebsiella pneumoniae: how resistance to a one-target β-lactam triggers a diversity of responses.","journal":"Antimicrobial agents and chemotherapy"},{"date":"2026 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It belongs to the mecillinam class and is used to treat bacterial infections. The commercial status of Hexapen is unclear, and it is not known if it is patented or available as a generic. Key safety considerations include its short half-life of 1.1 hours and low bioavailability of 5%. Further research is needed to determine its approved indications and off-patent status.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":"ROCHE","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}