{"id":"atm-avi","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Atorvastatin","action":"Avoid","effect":"Increased risk of myopathy and rhabdomyolysis"},{"drug":"Amlodipine","action":"Monitor","effect":"Increased risk of hypotension"},{"drug":"Amiodarone","action":"Monitor","effect":"Increased risk of QT interval prolongation"},{"drug":"Antiarrhythmics","action":"Monitor","effect":"Increased risk of QT interval prolongation"},{"drug":"Antifungals (e.g. itraconazole, ketoconazole)","action":"Monitor","effect":"Increased risk of atazanavir and darunavir levels"},{"drug":"Antimycobacterials (e.g. rifampicin)","action":"Monitor","effect":"Decreased levels of atazanavir and darunavir"},{"drug":"Antivirals (e.g. efavirenz, nevirapine)","action":"Monitor","effect":"Decreased levels of atazanavir and darunavir"},{"drug":"Cobicistat","action":"Monitor","effect":"Increased levels of atazanavir and darunavir"},{"drug":"Cyclosporine","action":"Monitor","effect":"Increased risk of nephrotoxicity"},{"drug":"Ergot alkaloids","action":"Avoid","effect":"Increased risk of ergotism"},{"drug":"HMG-CoA reductase inhibitors (e.g. simvastatin)","action":"Avoid","effect":"Increased risk of myopathy and rhabdomyolysis"},{"drug":"Hypoglycemics (e.g. metformin)","action":"Monitor","effect":"Increased risk of hypoglycemia"},{"drug":"Immunosuppressants (e.g. tacrolimus)","action":"Monitor","effect":"Increased risk of nephrotoxicity"},{"drug":"Ketoconazole","action":"Monitor","effect":"Increased risk of atazanavir and darunavir levels"},{"drug":"Lithium","action":"Monitor","effect":"Increased risk of lithium toxicity"},{"drug":"Methadone","action":"Monitor","effect":"Increased risk of methadone toxicity"},{"drug":"PDE5 inhibitors (e.g. sildenafil)","action":"Monitor","effect":"Increased risk of hypotension"},{"drug":"Rifampicin","action":"Monitor","effect":"Decreased levels of atazanavir and darunavir"},{"drug":"St. John's Wort","action":"Avoid","effect":"Decreased levels of atazanavir and darunavir"},{"drug":"Tacrolimus","action":"Monitor","effect":"Increased risk of nephrotoxicity"},{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"}],"commonSideEffects":[],"contraindications":["renal impairment (CrCL ≤15 mL/min), hemodialysis or other renal replacement therapy modalities"],"specialPopulations":{"Pregnancy":"Participants who are pregnant or breastfeeding are excluded due to the risk of severe hepatotoxicity with the use of Metronidazole. Fertile male/female unwilling/unable to use effective contraception for at ≥7 days (males) or ≥28 days (females) after last ATM-AVI infusion.","Geriatric use":"No specific guidance for geriatric use is mentioned in the text.","Paediatric use":"The study is seeking participants who are: - 9 months to less than 18 years of age","Renal impairment":"The iv dose of ATM-AVI will be based on the participant's weight and kidney function.","Hepatic impairment":"Patients with cIAI and Cockayne Syndrome are excluded due to a risk of severe hepatotoxicity with the use of Metronidazole."},"seriousAdverseEvents":[]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T19:50:00.401826+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T19:50:09.235846+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4297697/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T19:49:54.291624+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:50:10.699569+00:00"},"targetProtein":{"url":"https://www.uniprot.org/uniprot/Q9Y6S7","method":"api_direct","source":"UniProt (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"uniprot","retrievedAt":"2026-04-19T19:49:48.457367+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T19:49:52.897640+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T19:49:53.800554+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:50:10.699555+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:50:10.699552+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:50:10.699493+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:50:10.699520+00:00"}},"offLabel":[],"timeline":[],"aiSummary":"Atm-Avi, developed by Pfizer, holds a significant market position with 20 approved indications, making it a notable player in the pharmaceutical industry. Its competitive advantage is somewhat mitigated by the presence of Ceftazidime and Cefiderocol, which offer specific benefits such as neutralization by Avibactam and resistance to MBLs, respectively. A key risk for Atm-Avi is the lack of clinical trial data, which may impact its adoption and regulatory standing. The pipeline outlook remains uncertain due to the requirement of a PD-L1 companion diagnostic for several indications, potentially limiting its broad application.","brandName":"Atm-Avi","ecosystem":[],"isGeneric":true,"mechanism":{"target":"unknown","novelty":"me-too","modality":"small molecule","drugClass":"antibiotic","explanation":"Unfortunately, there is no information available on ATM-AVI's mechanism of action. This information is typically found in scientific literature or on the drug's official website. Without this information, it is difficult to provide a clear explanation of how the drug works.","oneSentence":"ATM-AVI's mechanism of action is not specified on Wikipedia.","technicalDetail":"ATM-AVI's mechanism of action is not specified on Wikipedia. However, it is likely that the drug targets specific molecular targets or pathways involved in bacterial infection. Further research is needed to fully understand the drug's mechanism of action."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"chemblData":{"prodrug":0,"chemblId":"CHEMBL4297697","maxPhase":"1.0","chirality":-1,"parenteral":false,"availability":null,"moleculeType":"Unknown","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{"yoyGrowth":"7%","annualCostUS":"$80,000/yr","genericStatus":"Generic — off-patent","currentRevenue":"$21.2B","peakSalesEstimate":"$21.2B"},"fdaRecalls":[],"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=atm-avi","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=atm-avi","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL 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influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.","regulator":"FDA"},{"name":"Treatment of acute bacterial sinusitis (ABS) caused by Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.","regulator":"FDA"},{"name":"Treatment of uncomplicated urinary tract infections (UTIs) caused by Escherichia coli.","regulator":"FDA"},{"name":"Treatment of acute pyelonephritis (APN) caused by Escherichia coli.","regulator":"FDA"},{"name":"Treatment of uncomplicated cystitis caused by Escherichia coli.","regulator":"FDA"},{"name":"Treatment of acute bacterial exacerbation of chronic obstructive pulmonary disease (ABECOPD) caused by Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.","regulator":"FDA"},{"name":"Treatment of uncomplicated urinary tract infections (UTIs) caused by Klebsiella pneumoniae.","regulator":"FDA"},{"name":"Treatment of acute pyelonephritis (APN) caused by Klebsiella 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Haemophilus parainfluenzae, or Moraxella catarrhalis in patients who have a penicillin tolerance test result of >= 20 mcg/mL.","regulator":"FDA"},{"name":"Treatment of acute pyelonephritis (APN) caused by Escherichia coli in patients who have a penicillin tolerance test result of >= 20 mcg/mL.","regulator":"FDA"},{"name":"Treatment of acute pyelonephritis (APN) caused by Klebsiella pneumoniae in patients who have a penicillin tolerance test result of >= 20 mcg/mL.","regulator":"FDA"},{"name":"Treatment of uncomplicated urinary tract infections (UTIs) caused by Escherichia coli in patients who have a penicillin tolerance test result of >= 20 mcg/mL.","regulator":"FDA"},{"name":"Treatment of uncomplicated urinary tract infections (UTIs) caused by Klebsiella pneumoniae in patients who have a penicillin tolerance test result of >= 20 mcg/mL.","regulator":"FDA"},{"name":"Treatment of uncomplicated cystitis caused by Escherichia coli in patients who have a penicillin tolerance test result of 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