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Recommended dosing is once-weekly subcutaneous injection starting at 2.5 mg, titrating after four weeks up to maintenance doses of 5, 10, or 15 mg based on response and tolerability, with maximum 15 mg weekly and regulatory recommendation of approval.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/template/","Template",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/template/general/","General",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/template/clinical-review-application-217806orig1s000/563450/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/clinical-review-application-217806orig1s000/563450.png","ImageObject",442,249,{"name":42,"@type":43},"Levi","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-11-02","2026-10-12",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",13,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What drug and application are covered in this clinical review?","Question",{"text":63,"@type":64},"The review covers tirzepatide (proposed trade name Zepbound) under NDA 217806, application number 217806Orig1s000.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"What is the recommended dosing regimen for Zepbound?",{"text":68,"@type":64},"Start at 2.5 mg injected subcutaneously once weekly, increase to 5 mg after 4 weeks, then consider further 2.5 mg increments after at least 4 weeks on the current dose. Maintenance doses are 5 mg, 10 mg, or 15 mg once weekly, with a maximum of 15 mg weekly.",{"name":70,"@type":61,"acceptedAnswer":71},"Who is the proposed indication population for chronic weight management?",{"text":72,"@type":64},"Adults with a baseline BMI of at least 30 kg/m2 (obesity) or at least 27 kg/m2 (overweight) plus at least one weight-related comorbidity such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},563450,1792097037,{"code":4,"msg":82,"data":83},"success",[84,89,94,99,104,109,114,119,124],{"id":85,"doc_module":22,"doc_module_name":25,"category_name":86,"show_sort_weight":87,"slug":88},11,"Presentations",90,"presentations",{"id":90,"doc_module":22,"doc_module_name":25,"category_name":91,"show_sort_weight":92,"slug":93},12,"Resumes",80,"resumes",{"id":95,"doc_module":22,"doc_module_name":25,"category_name":96,"show_sort_weight":97,"slug":98},14,"Invoices",70,"invoices",{"id":100,"doc_module":22,"doc_module_name":25,"category_name":101,"show_sort_weight":102,"slug":103},15,"Posters",60,"posters",{"id":105,"doc_module":22,"doc_module_name":25,"category_name":106,"show_sort_weight":107,"slug":108},16,"Social Media",50,"social-media",{"id":110,"doc_module":22,"doc_module_name":25,"category_name":111,"show_sort_weight":112,"slug":113},17,"Forms",40,"forms",{"id":115,"doc_module":22,"doc_module_name":25,"category_name":116,"show_sort_weight":117,"slug":118},18,"Letters",30,"letters",{"id":120,"doc_module":22,"doc_module_name":25,"category_name":121,"show_sort_weight":122,"slug":123},21,"Paper Templates",5,"papers-templates",{"id":125,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":4,"slug":126},158,"general-158",{"code":4,"msg":82,"data":128},{"doc_id":79,"user_id":129,"nickname":42,"user_avatar":130,"doc_module":22,"category_id":125,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":136,"language":137,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":12,"update_tm":141,"read_time":142},7971461740909,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","CENTER FOR DRUG EVALUATION AND  \nRESEARCH  \nAPPLICATION NUMBER:  \n217806Orig1s000  \nCLINICAL REVIEW(S)  \nCLINICAL REVIEW  \n\n| Application Type | 505(b)(1) New Drug Application (NDA) |\n| --- | --- |\n| Application Number(s) | NDA 217806 |\n| Priority or Standard | Priority |\n| Submit Date(s) | November 17, 2022; May 8, 2023 (rolling review) |\n| Received Date(s) | May 8, 2023 |\n| PDUFA Goal Date | November 8, 2023 |\n| Division/Office | Division of Diabetes, Lipid Disorders, and Obesity (DDLO) Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN) |\n| Reviewer Name(s) | Raymond Soccio, MD, PhD |\n| Review Completion Date | November 7, 2023 |\n| Established/Proper Name | Tirzepatide |\n| (Proposed) Trade Name | Zepbound |\n| Applicant | Eli Lilly and Company (Lilly) |\n| Dosage Form(s) | Injection 2.5 mg/0 .5 mL in a single-dose pen\u003Cbr>Injection 5 mg/0 .5 mL in a single-dose pen\u003Cbr>Injection 7.5 mg/0 .5 mL in a single-dose pen\u003Cbr>Injection 10 mg/0 .5 mL in a single-dose pen\u003Cbr>Injection 12.5 mg/0 .5 mL in a single-dose pen\u003Cbr>Injection 15 mg/0 .5 mL in a single-dose pen |\n| Applicant Proposed Dosing Regimen(s) | The recommended starting dosage of ZEPBOUND is 2.5 mg injected subcutaneously once weekly. After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly. (b) (4)\u003Cbr>(b) (4)\u003Cbr>increase the dosage\u003Cbr>in 2.5 mg increments after at least 4 weeks on the current dose. The maximum dosage of ZEPBOUND is 15 mg injected subcutaneously once weekly.\u003Cbr>|\n| Applicant Proposed Indication(s)/Population(s) | As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:\u003Cbr>• 30 kg/m2 or greater (obesity) or\u003Cbr>• 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g.,\u003Cbr>(b) (4)\u003Cbr>hypertension, dyslipidemia,  , type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease) . |\n| Recommendation on Regulatory Action | Approval |\n| Recommended Dosing Regimen(s) | The recommended starting dosage of ZEPBOUND is 2.5 mg injected subcutaneously once weekly. The 2.5 mg dosage is for |\n\n1  \nReference ID: 5274339  \n\n|  | treatment initiation and is not intended for chronic weight management. After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly. The dosage may be increased in 2.5 mg increments, after at least 4 weeks on the current dose. The recommended maintenance dosages of ZEPBOUND in adults are 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly. Consider treatment response and tolerability when selecting the maintenance dosage. If patients do not tolerate a maintenance dosage, consider a lower maintenance dosage. The maximum dosage of ZEPBOUND is 15 mg injected subcutaneously once weekly. |\n| --- | --- |\n| Recommended Indication(s)/Population(s) | As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:\u003Cbr>• 30 kg/m2 or greater (obesity) or\u003Cbr>• 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease) . |\n\n2  \nReference ID: 5274339  \nTable of Contents  \nGlossary ......................................................................................................................................... 13  \n1. Executive Summary ............................................................................................................... 16  \n Product Introduction ...................................................................................................... 16  \n Conclusions on the Substantial Evidence of Effectiveness........................................ 16  \n Benefit-Risk Assessment.............................................................................................. 17  \n","cbCaintO7BJvvoaB","https://ap.wps.com/l/cbCaintO7BJvvoaB","pdf",24918171,267,"English","# Glossary\n## 1. Executive Summary\n### Product Introduction\n### Conclusions on the Substantial Evidence of Effectiveness\n### Benefit-Risk Assessment\n### Patient Experience Data\n## 2. Therapeutic Context\n### Analysis of Condition\n### Analysis of Current Treatment Options\n## 3. Regulatory Background\n### U.S. Regulatory Actions and Marketing History\n### Summary of Presubmission/Submission Regulatory Activity\n### Foreign Regulatory Actions and Marketing History\n## 4. Significant Issues from Other Review Disciplines Pertinent to Clinical Conclusions on Efficacy and Safety\n### Office of Scientific Investigations (OSI)\n### Product Quality\n### Clinical Microbiology\n### Nonclinical Pharmacology/Toxicology\n### Clinical Pharmacology\n### Devices and Companion Diagnostic Issues\n### Consumer Study Reviews","[{\"question\":\"What drug and application are covered in this clinical review?\",\"answer\":\"The review covers tirzepatide (proposed trade name Zepbound) under NDA 217806, application number 217806Orig1s000.\"},{\"question\":\"What is the recommended dosing regimen for Zepbound?\",\"answer\":\"Start at 2.5 mg injected subcutaneously once weekly, increase to 5 mg after 4 weeks, then consider further 2.5 mg increments after at least 4 weeks on the current dose. Maintenance doses are 5 mg, 10 mg, or 15 mg once weekly, with a maximum of 15 mg weekly.\"},{\"question\":\"Who is the proposed indication population for chronic weight management?\",\"answer\":\"Adults with a baseline BMI of at least 30 kg/m2 (obesity) or at least 27 kg/m2 (overweight) plus at least one weight-related comorbidity such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease.\"}]","Clinical Review - Application 217806Orig1s000 | PDF",1791835542,93]