{
  "data": {
    "id": "semaglutide",
    "canonicalName": "Semaglutide",
    "aliases": [],
    "exactForm": "pending",
    "route": "pending",
    "dosageForm": "pending",
    "intendedUse": "human use (unspecified)",
    "productStatus": "FDA-approved: OZEMPIC (NDA209637), OZEMPIC / RYBELSUS (NDA213051), RYBELSUS (NDA213182), WEGOVY (NDA218316), WEGOVY / WEGOVY FLEXTOUCH / WEGOVY HD (NDA215256)",
    "compoundingStatus": "Not verified",
    "evidenceTier": "FDA-approved product exists",
    "answer": "Semaglutide has FDA-approved prescription products (OZEMPIC (NDA209637), OZEMPIC / RYBELSUS (NDA213051), RYBELSUS (NDA213182), WEGOVY (NDA218316), WEGOVY / WEGOVY FLEXTOUCH / WEGOVY HD (NDA215256)). FDA's drug shortage database lists 3 Semaglutide entries (To Be Discontinued) as of 2026-07-25; that describes supply of an approved product, not whether compounding is lawful. Semaglutide is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 50 registered ClinicalTrials.gov studies cite Semaglutide (25 completed, 12 recruiting, 6 not yet recruiting, 3 active not recruiting, 2 enrolling by invitation, 2 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 5 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.",
      "Shortage listings are read from a capture dated 2026-07-25; FDA reverifies them periodically, so this reflects that date rather than today.",
      "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(%22NDA209637%22%20OR%20%22NDA213051%22%20OR%20%22NDA213182%22%20OR%20%22NDA215256%22%20OR%20%22NDA218316%22)&limit=50",
        "retrievedAt": "2026-07-25T13:21:11.842Z"
      },
      {
        "id": "fda_openfda_shortages",
        "title": "openFDA Drug Shortages",
        "authorityTier": "P0",
        "url": "https://api.fda.gov/drug/shortages.json?search=package_ndc%3A(%220169-4303-30%22%20OR%20%220169-4307-30%22%20OR%20%220169-4314-30%22)&limit=100",
        "retrievedAt": "2026-07-25T16:07:47.968Z"
      },
      {
        "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": "2026-07-25T04:39:35.683Z"
      },
      {
        "id": "clinicaltrials_gov_api",
        "title": "ClinicalTrials.gov API v2",
        "authorityTier": "P0",
        "url": "https://clinicaltrials.gov/api/v2/studies?filter.ids=NCT01766245,NCT01923181,NCT02249871,NCT02453711,NCT02863328,NCT03015220,NCT03018028,NCT03548935,NCT03631186,NCT03811561,NCT03842202,NCT04251156,NCT04865744,NCT04889183,NCT04916470,NCT04972721,NCT04982575,NCT05119179,NCT05144984,NCT05390892,NCT05486065,NCT05537233,NCT05569772,NCT05597202,NCT05616013,NCT05920889,NCT05990374,NCT06003153,NCT06072963,NCT06131437,NCT06299098,NCT06338553,NCT06409130,NCT06629688,NCT06633783,NCT06754163,NCT06790160,NCT06885736,NCT06897475,NCT06959784,NCT07030621,NCT07041983,NCT07282769,NCT07325500,NCT07581145,NCT07613437,NCT07651319,NCT07653477,NCT07668765,NCT07701005&pageSize=50&countTotal=true",
        "retrievedAt": "2026-07-25T01:36:51.828Z"
      }
    ],
    "trials": [
      {
        "nctId": "NCT07651319",
        "title": "Interleukine-2 (IL-2) Plus Semaglutide in Alzheimer's Disease",
        "status": "RECRUITING",
        "phase": "PHASE1/PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07325500",
        "title": "Incretin Microdosing for Cardiometabolic Health in People With HIV",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07282769",
        "title": "Semaglutide (Wegovy) Treatment for Trichotillomania",
        "status": "NOT_YET_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07581145",
        "title": "Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients",
        "status": "RECRUITING",
        "phase": "PHASE3",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07613437",
        "title": "GLP-1 Receptor Agonist in Primary Intracerebral Hemorrhage: A Phase 2 Randomized Trial",
        "status": "NOT_YET_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07653477",
        "title": "Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin ± Sulfonylurea/SGLT2 Inhibitor Therapy (UNIGUIDE-2)",
        "status": "NOT_YET_RECRUITING",
        "phase": "PHASE3",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07668765",
        "title": "GLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity",
        "status": "NOT_YET_RECRUITING",
        "phase": "",
        "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": "NCT07041983",
        "title": "24-h Energy Expenditure and Anti-obesity Medication",
        "status": "ENROLLING_BY_INVITATION",
        "phase": "",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06885736",
        "title": "LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy",
        "status": "RECRUITING",
        "phase": "NA",
        "startYear": "2025"
      },
      {
        "nctId": "NCT07030621",
        "title": "Efficacy of Semaglutide in Improving Neurological Outcomes After Endovascular Thrombectomy for Acute Ischemic Stroke: A Randomized Double-Blind Controlled Trial",
        "status": "NOT_YET_RECRUITING",
        "phase": "PHASE3",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06754163",
        "title": "Evaluating the Effect of the STEP@STAH Semaglutide Protocol on the Physical Health Measures of Atypical Antipsychotic-Treated Patients",
        "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": "NCT06338553",
        "title": "GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab",
        "status": "RECRUITING",
        "phase": "EARLY_PHASE1",
        "startYear": "2024"
      },
      {
        "nctId": "NCT07701005",
        "title": "Non-Invasive Hepatic and Metabolic Index Changes After Incretin Therapy in Overweight/Obesity",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06003153",
        "title": "GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH",
        "status": "RECRUITING",
        "phase": "PHASE4",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06409130",
        "title": "Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06299098",
        "title": "A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss, Fat Loss, and Lean Mass Preservation",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06959784",
        "title": "Assessing Incretin Therapy for Cardiovascular Risk Reduction and Diabetes Remission( ITCRDR Study)",
        "status": "ENROLLING_BY_INVITATION",
        "phase": "PHASE4",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06072963",
        "title": "COMMETS- Combination MCI Metabolic Syndrome",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06633783",
        "title": "A Phase III Study Comparing the Weight Loss Effects of Semaglutide Injection and Wegovy®",
        "status": "NOT_YET_RECRUITING",
        "phase": "PHASE3",
        "startYear": "2024"
      },
      {
        "nctId": "NCT05569772",
        "title": "Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes",
        "status": "RECRUITING",
        "phase": "PHASE3",
        "startYear": "2023"
      },
      {
        "nctId": "NCT05920889",
        "title": "Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2023"
      },
      {
        "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": "NCT04972721",
        "title": "SELECT-LIFE: A Research Study Looking at Long-term Effects of Semaglutide in People Who Took Part in the SELECT Cardiovascular Outcomes Trial",
        "status": "COMPLETED",
        "phase": "",
        "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": "NCT05537233",
        "title": "ADJUnct Semaglutide Treatment in Type 1 Diabetes",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2023"
      },
      {
        "nctId": "NCT06629688",
        "title": "Semaglutide and Intestinal Iron Absorption",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2023"
      },
      {
        "nctId": "NCT05597202",
        "title": "Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes",
        "status": "UNKNOWN",
        "phase": "PHASE4",
        "startYear": "2023"
      },
      {
        "nctId": "NCT05616013",
        "title": "Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2022"
      },
      {
        "nctId": "NCT04889183",
        "title": "SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2022"
      },
      {
        "nctId": "NCT05486065",
        "title": "A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2022"
      },
      {
        "nctId": "NCT05390892",
        "title": "PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes",
        "status": "RECRUITING",
        "phase": "PHASE4",
        "startYear": "2022"
      },
      {
        "nctId": "NCT05119179",
        "title": "Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes",
        "status": "RECRUITING",
        "phase": "PHASE4",
        "startYear": "2021"
      },
      {
        "nctId": "NCT04865744",
        "title": "The Effect of Semaglutide on Pituitary Function",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2021"
      },
      {
        "nctId": "NCT05144984",
        "title": "A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2021"
      },
      {
        "nctId": "NCT04982575",
        "title": "Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2021"
      },
      {
        "nctId": "NCT04916470",
        "title": "Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2021"
      },
      {
        "nctId": "NCT04251156",
        "title": "Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity.",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2020"
      },
      {
        "nctId": "NCT03811561",
        "title": "A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "PHASE3",
        "startYear": "2019"
      },
      {
        "nctId": "NCT03842202",
        "title": "A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2019"
      },
      {
        "nctId": "NCT03548935",
        "title": "STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2018"
      },
      {
        "nctId": "NCT03631186",
        "title": "A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Switzerland, as Part of Local Clinical Practice (SURE SWITZERLAND)",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2018"
      },
      {
        "nctId": "NCT03015220",
        "title": "Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2017"
      },
      {
        "nctId": "NCT03018028",
        "title": "Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2017"
      },
      {
        "nctId": "NCT02863328",
        "title": "Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02453711",
        "title": "Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2015"
      },
      {
        "nctId": "NCT02249871",
        "title": "Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2014"
      },
      {
        "nctId": "NCT01923181",
        "title": "Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2013"
      },
      {
        "nctId": "NCT01766245",
        "title": "A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2012"
      }
    ],
    "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"
      ]
    }
  }
}