{
  "data": {
    "id": "tirzepatide",
    "canonicalName": "Tirzepatide",
    "aliases": [],
    "exactForm": "pending",
    "route": "pending",
    "dosageForm": "pending",
    "intendedUse": "human use (unspecified)",
    "productStatus": "FDA-approved: MOUNJARO / MOUNJARO (AUTOINJECTOR) / MOUNJARO KWIKPEN (NDA215866), ZEPBOUND / ZEPBOUND (AUTOINJECTOR) / ZEPBOUND KWIKPEN (NDA217806)",
    "compoundingStatus": "Not verified",
    "evidenceTier": "FDA-approved product exists",
    "answer": "Tirzepatide has FDA-approved prescription products (MOUNJARO / MOUNJARO (AUTOINJECTOR) / MOUNJARO KWIKPEN (NDA215866), ZEPBOUND / ZEPBOUND (AUTOINJECTOR) / ZEPBOUND KWIKPEN (NDA217806)). Tirzepatide is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 50 registered ClinicalTrials.gov studies cite Tirzepatide (20 completed, 12 recruiting, 10 not yet recruiting, 5 active not recruiting, 2 enrolling by invitation, 1 unknown); registration is not evidence of approval, efficacy, or safety. CompoundedGuide is verifying compounding status, safety signals, and current evidence. This is not medical advice.",
    "uncertainty": [
      "FDA approval status read from a captured openFDA Drugs@FDA response covering 2 application numbers.",
      "Approval data is not editorially reviewed; it reports what the FDA record says.",
      "Trial counts are read from a captured ClinicalTrials.gov response citing 50 specific study records, not from an open search.",
      "503B Bulks List membership was read from the list page captured 2026-07-25; being off that list is not itself a statement that compounding is lawful or unlawful.",
      "Compounding status, shortage status, and safety profile are not yet verified.",
      "This is not a medical, legal, or professional endorsement."
    ],
    "lane": "approved",
    "commercialPolicy": "none",
    "reviewedAt": "2026-07-25",
    "sources": [
      {
        "id": "fda_openfda_drugsfda",
        "title": "openFDA Drugs@FDA",
        "authorityTier": "P0",
        "url": "https://api.fda.gov/drug/drugsfda.json?search=application_number%3A(%22NDA215866%22%20OR%20%22NDA217806%22)&limit=50",
        "retrievedAt": "2026-07-25T13:21:16.201Z"
      },
      {
        "id": "fda_503b_bulks",
        "title": "503B Bulks List and Interim Categories",
        "authorityTier": "P0",
        "url": "https://www.fda.gov/drugs/human-drug-compounding/503b-bulk-drug-substances-list",
        "retrievedAt": "2026-07-25T04:39:38.715Z"
      },
      {
        "id": "clinicaltrials_gov_api",
        "title": "ClinicalTrials.gov API v2",
        "authorityTier": "P0",
        "url": "https://clinicaltrials.gov/api/v2/studies?filter.ids=NCT03482024,NCT03730662,NCT03987919,NCT04004988,NCT04093752,NCT04184622,NCT04235959,NCT04844918,NCT05990374,NCT06131437,NCT06143956,NCT06373146,NCT06485089,NCT06517212,NCT06565611,NCT06588296,NCT06603571,NCT06606821,NCT06648031,NCT06790160,NCT06801015,NCT06861439,NCT06864026,NCT06885736,NCT06897475,NCT06914154,NCT06937203,NCT06976853,NCT06994338,NCT07041983,NCT07088718,NCT07099742,NCT07154719,NCT07176663,NCT07179120,NCT07194317,NCT07245771,NCT07265752,NCT07382180,NCT07417618,NCT07492563,NCT07573163,NCT07588984,NCT07589322,NCT07609160,NCT07638592,NCT07640139,NCT07668765,NCT07671391,NCT07701005&pageSize=50&countTotal=true",
        "retrievedAt": "2026-07-25T01:36:57.642Z"
      }
    ],
    "trials": [
      {
        "nctId": "NCT07573163",
        "title": "Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion",
        "status": "NOT_YET_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07265752",
        "title": "Tirzepatide for the Treatment of Cannabis Use Disorder",
        "status": "NOT_YET_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07668765",
        "title": "GLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity",
        "status": "NOT_YET_RECRUITING",
        "phase": "",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07492563",
        "title": "Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay",
        "status": "NOT_YET_RECRUITING",
        "phase": "",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07176663",
        "title": "Efficacy and Safety of Tirzepatide (Spartina) in Chronic Kidney Failure",
        "status": "NOT_YET_RECRUITING",
        "phase": "NA",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07588984",
        "title": "GLP-1 Medication & Behavioral Health Programs on Weight & Metabolic Outcomes: FLOURISH and THRIVE Prospective Cohort Study",
        "status": "NOT_YET_RECRUITING",
        "phase": "",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07179120",
        "title": "Can Fat-Burning Shots Boost Fertility? Comparing Weight-Loss Injections vs. Healthy Habits for Obese Men With Low Sperm Health",
        "status": "NOT_YET_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07417618",
        "title": "INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07671391",
        "title": "A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body in Obese Participants",
        "status": "NOT_YET_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07640139",
        "title": "Estimating the Impact of Obesity Medications on Clinical and Economic Outcomes",
        "status": "ENROLLING_BY_INVITATION",
        "phase": "",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07609160",
        "title": "Effectiveness of Combined GLP-1/GIP Dual Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals",
        "status": "NOT_YET_RECRUITING",
        "phase": "NA",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07589322",
        "title": "Comparative Observation of Metabolic and Pharmacologic Adipose Remodeling With Enhanced Incretin AgonisTs",
        "status": "RECRUITING",
        "phase": "NA",
        "startYear": "2026"
      },
      {
        "nctId": "NCT06897475",
        "title": "A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2025"
      },
      {
        "nctId": "NCT07154719",
        "title": "GLP-1R Actions on Muscle and the Skeleton",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "PHASE4",
        "startYear": "2025"
      },
      {
        "nctId": "NCT07041983",
        "title": "24-h Energy Expenditure and Anti-obesity Medication",
        "status": "ENROLLING_BY_INVITATION",
        "phase": "",
        "startYear": "2025"
      },
      {
        "nctId": "NCT07382180",
        "title": "Real-World Tirzepatide Therapy in Post-Bariatric Weight Regain and Preoperative Obesity Patients",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06976853",
        "title": "Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06885736",
        "title": "LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy",
        "status": "RECRUITING",
        "phase": "NA",
        "startYear": "2025"
      },
      {
        "nctId": "NCT07638592",
        "title": "Tirzepatide-Based Prehabilitation Before Elective Ventral and Incisional Hernia Repair in Patients With Obesity",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06864026",
        "title": "A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)",
        "status": "RECRUITING",
        "phase": "PHASE4",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06861439",
        "title": "GLP-1s to Enhance Lasting Optimal Weight",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "PHASE4",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06790160",
        "title": "Study of Patients Being Treated With Anti-obesity Medication",
        "status": "RECRUITING",
        "phase": "",
        "startYear": "2025"
      },
      {
        "nctId": "NCT07194317",
        "title": "A Feasibility Study to Determine the Most Appropriate Digital Dietary Assessment Tool in Patients With Obesity Initiating GLP-1 Receptor Agonist Treatment",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06801015",
        "title": "Effects of Long-Acting GLP-1 (Glucagon-like Peptide-1) or Dual Incretin (GLP-1 and GIP [Glucose-dependent Insulinotropic Peptide]) Modulation on Gastric Motor Functions",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "PHASE4",
        "startYear": "2025"
      },
      {
        "nctId": "NCT07245771",
        "title": "Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy and in Combination With Tirzepatide in Adults With Overweight and Obesity",
        "status": "RECRUITING",
        "phase": "PHASE1/PHASE2",
        "startYear": "2025"
      },
      {
        "nctId": "NCT07099742",
        "title": "Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)",
        "status": "NOT_YET_RECRUITING",
        "phase": "",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06937203",
        "title": "A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus",
        "status": "RECRUITING",
        "phase": "PHASE1/PHASE2",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06994338",
        "title": "Tirzepatide for Alcohol Use Disorder",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06914154",
        "title": "Emulation of the SUMMIT Heart Failure Trial in Healthcare Claims Data",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2025"
      },
      {
        "nctId": "NCT07701005",
        "title": "Non-Invasive Hepatic and Metabolic Index Changes After Incretin Therapy in Overweight/Obesity",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06588296",
        "title": "Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06485089",
        "title": "Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06603571",
        "title": "A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06565611",
        "title": "A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06606821",
        "title": "The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease",
        "status": "RECRUITING",
        "phase": "PHASE4",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06648031",
        "title": "Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2024"
      },
      {
        "nctId": "NCT07088718",
        "title": "Prediction of the SURPASS-CVOT Cardiovascular Outcome Trial in Healthcare Claims Data",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06517212",
        "title": "Tirzepatide Weight Loss for MRD+ Early Breast Cancer",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06373146",
        "title": "A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2024"
      },
      {
        "nctId": "NCT05990374",
        "title": "Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years",
        "status": "UNKNOWN",
        "phase": "NA",
        "startYear": "2023"
      },
      {
        "nctId": "NCT06131437",
        "title": "A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2023"
      },
      {
        "nctId": "NCT06143956",
        "title": "A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2023"
      },
      {
        "nctId": "NCT04844918",
        "title": "A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2021"
      },
      {
        "nctId": "NCT04235959",
        "title": "A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2020"
      },
      {
        "nctId": "NCT04004988",
        "title": "A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2019"
      },
      {
        "nctId": "NCT04184622",
        "title": "A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2019"
      },
      {
        "nctId": "NCT04093752",
        "title": "A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2019"
      },
      {
        "nctId": "NCT03987919",
        "title": "A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2019"
      },
      {
        "nctId": "NCT03730662",
        "title": "A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2018"
      },
      {
        "nctId": "NCT03482024",
        "title": "A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney Function",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2018"
      }
    ],
    "pendingResources": {
      "identity": [
        "FDA/NCATS GSRS or equivalent canonical identity source"
      ],
      "product_status": [
        "Drugs@FDA, Purple Book, Orange Book, DailyMed, or applicable primary FDA record"
      ],
      "compounding_status": [
        "FDA 503A/503B pages, Federal Register, docket, or applicable final/interim policy"
      ],
      "safety": [
        "FDA safety communication, warning, recall, FAERS signal context, or explicit absence statement"
      ],
      "evidence": [
        "ClinicalTrials.gov and PubMed/primary publication search"
      ],
      "state_or_facility": [
        "State board or FDA facility record when relevant"
      ]
    }
  }
}