{
  "data": {
    "id": "oxytocin",
    "canonicalName": "Oxytocin",
    "aliases": [],
    "exactForm": "pending",
    "route": "pending",
    "dosageForm": "pending",
    "intendedUse": "human use (unspecified)",
    "productStatus": "FDA-approved: OXYTOCIN (ANDA091676), OXYTOCIN (ANDA200219), OXYTOCIN (NDA018243), OXYTOCIN (NDA018248), PITOCIN (NDA018261)",
    "compoundingStatus": "Not verified",
    "evidenceTier": "FDA-approved product exists",
    "answer": "Oxytocin has FDA-approved prescription products (OXYTOCIN (ANDA091676), OXYTOCIN (ANDA200219), OXYTOCIN (NDA018243), OXYTOCIN (NDA018248), PITOCIN (NDA018261)). Oxytocin is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 50 registered ClinicalTrials.gov studies cite Oxytocin (28 completed, 10 unknown, 4 recruiting, 4 withdrawn, 2 terminated, 1 enrolling by invitation, 1 not yet recruiting); registration is not evidence of approval, efficacy, or safety.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 7 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(%22ANDA077453%22%20OR%20%22ANDA091676%22%20OR%20%22ANDA200219%22%20OR%20%22NDA018243%22%20OR%20%22NDA018248%22%20OR%20%22NDA018261%22%20OR%20%22NDA019185%22)&limit=50",
        "retrievedAt": "2026-07-25T13:21:09.742Z"
      },
      {
        "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": "2026-07-25T04:39:34.521Z"
      },
      {
        "id": "clinicaltrials_gov_api",
        "title": "ClinicalTrials.gov API v2",
        "authorityTier": "P0",
        "url": "https://clinicaltrials.gov/api/v2/studies?filter.ids=NCT00587327,NCT00914953,NCT01123317,NCT01317862,NCT01462422,NCT01587625,NCT01608958,NCT01621737,NCT01733329,NCT01962701,NCT02058251,NCT02079558,NCT02219295,NCT02273115,NCT02318823,NCT02362945,NCT02441673,NCT02495272,NCT02564068,NCT02711189,NCT02899689,NCT02979093,NCT03326596,NCT03463993,NCT03466671,NCT03662425,NCT03777878,NCT04105140,NCT04493515,NCT04532866,NCT04645823,NCT04646486,NCT04715737,NCT04745494,NCT04747015,NCT04834622,NCT04906278,NCT05207774,NCT05298085,NCT05598008,NCT05664659,NCT05770375,NCT05782816,NCT06325007,NCT06550089,NCT06702670,NCT06730919,NCT07039539,NCT07430228,NCT07444788&pageSize=50&countTotal=true",
        "retrievedAt": "2026-07-25T01:36:48.280Z"
      }
    ],
    "trials": [
      {
        "nctId": "NCT07430228",
        "title": "Efficacy of Intravenous Oxytocin to Speed Recovery After THA",
        "status": "ENROLLING_BY_INVITATION",
        "phase": "PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07444788",
        "title": "Acute Effects of Intravenous 5-MeO-DMT in Healthy Participants",
        "status": "RECRUITING",
        "phase": "PHASE1",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07039539",
        "title": "Harm Reduction Intervention for Anabolic-androgenic Steroids Users: a Randomized Controlled Trial",
        "status": "NOT_YET_RECRUITING",
        "phase": "NA",
        "startYear": "2026"
      },
      {
        "nctId": "NCT06702670",
        "title": "Anticholinergics for Cervical Edema in Labor",
        "status": "RECRUITING",
        "phase": "PHASE2/PHASE3",
        "startYear": "2025"
      },
      {
        "nctId": "NCT05770375",
        "title": "Tolerability of MDMA in Schizophrenia",
        "status": "RECRUITING",
        "phase": "PHASE1/PHASE2",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06325007",
        "title": "Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous",
        "status": "RECRUITING",
        "phase": "NA",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06550089",
        "title": "High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth",
        "status": "WITHDRAWN",
        "phase": "PHASE2",
        "startYear": "2024"
      },
      {
        "nctId": "NCT05782816",
        "title": "Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2023"
      },
      {
        "nctId": "NCT05664659",
        "title": "Efficacy of Carbetocin Versus Oxytocin Plus Misoprostol in Decreasing Blood Loss During Cesarean Section",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2022"
      },
      {
        "nctId": "NCT05298085",
        "title": "Effect of Intranasal Oxytocin on Dysphagia in Children and Adolescents With Prader-Willi Syndrome",
        "status": "COMPLETED",
        "phase": "PHASE2/PHASE3",
        "startYear": "2022"
      },
      {
        "nctId": "NCT05598008",
        "title": "Effects of Glucagon-like-Peptide-1 Analogues on Sexuality",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2022"
      },
      {
        "nctId": "NCT04532866",
        "title": "Brain Changes in Response to Long-Duration Isolation and Confinement",
        "status": "UNKNOWN",
        "phase": "NA",
        "startYear": "2021"
      },
      {
        "nctId": "NCT04834622",
        "title": "Community Singing Interventions for Postnatal Depression: a Hybrid Type II Effectiveness-implementation Trial",
        "status": "UNKNOWN",
        "phase": "NA",
        "startYear": "2021"
      },
      {
        "nctId": "NCT04645823",
        "title": "Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2021"
      },
      {
        "nctId": "NCT04906278",
        "title": "Amniotomy for Second-trimester Pregnancy Termination",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2021"
      },
      {
        "nctId": "NCT04493515",
        "title": "Oral Oxytocin's Effects on Attention Control",
        "status": "UNKNOWN",
        "phase": "NA",
        "startYear": "2020"
      },
      {
        "nctId": "NCT04646486",
        "title": "Video Debriefing at the Delivery Ward",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2020"
      },
      {
        "nctId": "NCT05207774",
        "title": "Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission",
        "status": "UNKNOWN",
        "phase": "NA",
        "startYear": "2020"
      },
      {
        "nctId": "NCT04747015",
        "title": "Cervical Traction vs. Active Management of 3rd Stage of Labor",
        "status": "UNKNOWN",
        "phase": "NA",
        "startYear": "2020"
      },
      {
        "nctId": "NCT03777878",
        "title": "Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section",
        "status": "UNKNOWN",
        "phase": "NA",
        "startYear": "2019"
      },
      {
        "nctId": "NCT06730919",
        "title": "Risk Factors for Postpartum Hemorrhage",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2019"
      },
      {
        "nctId": "NCT03463993",
        "title": "Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2018"
      },
      {
        "nctId": "NCT03466671",
        "title": "A Trial of TTA-121 on Autism Spectrum Disorder",
        "status": "UNKNOWN",
        "phase": "PHASE2",
        "startYear": "2018"
      },
      {
        "nctId": "NCT02441673",
        "title": "Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering",
        "status": "UNKNOWN",
        "phase": "PHASE2",
        "startYear": "2018"
      },
      {
        "nctId": "NCT04105140",
        "title": "Oxytocin Effects on the Prosocial Learning",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2018"
      },
      {
        "nctId": "NCT03326596",
        "title": "Prevention of Postpartum Hemorrhage With TXA",
        "status": "WITHDRAWN",
        "phase": "PHASE4",
        "startYear": "2018"
      },
      {
        "nctId": "NCT03662425",
        "title": "Effects of Oxytocin on Negative Symptoms and Social Cognition in Schizophrenia and Its Possible Mechanisms",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2018"
      },
      {
        "nctId": "NCT04715737",
        "title": "Differential Effects of Vasopressin and Oxytocin on Attention Control",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2017"
      },
      {
        "nctId": "NCT04745494",
        "title": "Studies of Mothers With Postnatal Depression",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2017"
      },
      {
        "nctId": "NCT02979093",
        "title": "Oxytocin and Brain Responses in Maternal Addiction",
        "status": "TERMINATED",
        "phase": "PHASE2",
        "startYear": "2017"
      },
      {
        "nctId": "NCT02711189",
        "title": "Oxytocin in Alcohol Use Disorder",
        "status": "WITHDRAWN",
        "phase": "PHASE1",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02899689",
        "title": "Induction of Labor in Women With Unfavorable Cervix: Dilapan Versus Foley Bulb",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02362945",
        "title": "Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic",
        "status": "UNKNOWN",
        "phase": "PHASE3",
        "startYear": "2015"
      },
      {
        "nctId": "NCT02564068",
        "title": "Oxytocin on HR in Sleep Apnea Patient",
        "status": "COMPLETED",
        "phase": "EARLY_PHASE1",
        "startYear": "2015"
      },
      {
        "nctId": "NCT02318823",
        "title": "Effects of Beer (Alcohol) on Social Cognition",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2014"
      },
      {
        "nctId": "NCT02273115",
        "title": "Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2014"
      },
      {
        "nctId": "NCT02058251",
        "title": "Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2014"
      },
      {
        "nctId": "NCT02495272",
        "title": "Postpartum Uterotonic Administration",
        "status": "UNKNOWN",
        "phase": "NA",
        "startYear": "2014"
      },
      {
        "nctId": "NCT01587625",
        "title": "High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2013"
      },
      {
        "nctId": "NCT01962701",
        "title": "Fetal Copeptin After Oxytocin Challenge Test",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2013"
      },
      {
        "nctId": "NCT02079558",
        "title": "Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2012"
      },
      {
        "nctId": "NCT01608958",
        "title": "IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2012"
      },
      {
        "nctId": "NCT01462422",
        "title": "Misoprostol for Secondary Prevention of Postpartum Hemorrhage at the Community Level in India",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01317862",
        "title": "A Comparison of Transcervical Foley Catheter and Prostaglandins for Induction of Labor at Term",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01621737",
        "title": "Antipsychotic Effects of Oxytocin",
        "status": "TERMINATED",
        "phase": "NA",
        "startYear": "2011"
      },
      {
        "nctId": "NCT02219295",
        "title": "SEGATROM: Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01123317",
        "title": "Brain Blood Flow Changes Elicited by Oxytocin in Volunteers With and Without Schizophrenia",
        "status": "WITHDRAWN",
        "phase": "NA",
        "startYear": "2010"
      },
      {
        "nctId": "NCT00914953",
        "title": "Oxytocin and Social Behavior Over the Lifespan",
        "status": "COMPLETED",
        "phase": "EARLY_PHASE1",
        "startYear": "2010"
      },
      {
        "nctId": "NCT01733329",
        "title": "Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2008"
      },
      {
        "nctId": "NCT00587327",
        "title": "Effect of Oxytocin and Vasopressin Antagonists on Uterine Contractions",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2007"
      }
    ],
    "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"
      ]
    }
  }
}