{
 "checked": "2026-10-24 (America/New_York)",
 "page": "https://jabbitapp.com/research/sermorelin-growth-hormone-peptide-evidence-teardown.html",
 "drugs_at_fda": {
  "query": "https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22SERMORELIN%20ACETATE%22",
  "applications": [
   {
    "application": "NDA019863",
    "brand": "GEREF",
    "sponsor": "EMD SERONO",
    "marketing_status": [
     "Discontinued"
    ],
    "original_approval": "19901228",
    "submissions": [
     {
      "type": "ORIG",
      "number": "1",
      "status_date": "19901228",
      "class": "Type 1 - New Molecular Entity"
     },
     {
      "type": "SUPPL",
      "number": "2",
      "status_date": "19910528",
      "class": "Manufacturing (CMC)"
     },
     {
      "type": "SUPPL",
      "number": "1",
      "status_date": "19910826",
      "class": "Manufacturing (CMC)"
     },
     {
      "type": "SUPPL",
      "number": "5",
      "status_date": "19980327",
      "class": "Labeling"
     },
     {
      "type": "SUPPL",
      "number": "4",
      "status_date": "19980403",
      "class": "Manufacturing (CMC)"
     },
     {
      "type": "SUPPL",
      "number": "6",
      "status_date": "20011002",
      "class": "Labeling"
     }
    ]
   },
   {
    "application": "NDA020443",
    "brand": "GEREF",
    "sponsor": "EMD SERONO INC",
    "marketing_status": [
     "Discontinued"
    ],
    "original_approval": "19970926",
    "submissions": [
     {
      "type": "ORIG",
      "number": "1",
      "status_date": "19970926",
      "class": "Type 3 - New Dosage Form"
     }
    ]
   }
  ],
  "note": "openfda.generic_name is not populated for these discontinued applications, so a generic-name search returns no match."
 },
 "federal_register_2013": {
  "citation": "78 FR 14095-14096 (Mar 4, 2013), Docket FDA-2012-P-1071",
  "url": "https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams",
  "facts": [
   "NDA 20-443 (0.5 and 1.0 mg vials) initially approved September 26, 1997, for idiopathic GHD in children with growth failure",
   "NDA 19-863 (0.05 mg ampule) initially approved December 28, 1990, for evaluating pituitary GH secretion",
   "EMD Serono discontinuation letters July 11, 2008 and December 2, 2008; withdrawal of both NDAs effective June 18, 2009 (74 FR 23407)",
   "FDA determined neither product was withdrawn from sale for reasons of safety or effectiveness; ANDAs may be approved if other requirements are met"
  ]
 },
 "emd_serono_2008": {
  "url": "https://www.biospace.com/emd-serono-inc-to-discontinue-geref-diagnostic",
  "text": "EMD Serono, Inc. annouces it has made a business decision to discontinue Geref Diagnostic effective October 2008. The drug will be discontinued because the active ingredient used to produce Gerer Diagnostic is no longer being manufactured."
 },
 "recalls": {
  "query": "https://api.fda.gov/drug/enforcement.json?search=product_description:%22sermorelin%22&limit=100",
  "note": "Each recall event can cover many products from one firm; a sterility-assurance recall usually reflects facility conditions, not a test result on sermorelin. Firms are counted, not named.",
  "product_entries": 93,
  "events": 32,
  "firms": 28,
  "class_counts": {
   "Class II": 30,
   "Class I": 2
  },
  "reason_groups": {
   "sterility or contamination": 27,
   "firm-wide recall after adverse event reports tied to a different product": 1,
   "labeling, stability data or manufacturing-control problems": 3,
   "potency": 1
  },
  "events_with_blends": 19,
  "by_year": {
   "2012": {
    "sterility": 1
   },
   "2013": {
    "sterility": 3,
    "other": 1
   },
   "2015": {
    "sterility": 6
   },
   "2016": {
    "sterility": 4
   },
   "2017": {
    "other": 1
   },
   "2018": {
    "other": 1,
    "sterility": 2
   },
   "2019": {
    "sterility": 4
   },
   "2021": {
    "sterility": 1
   },
   "2022": {
    "sterility": 4,
    "other": 2
   },
   "2025": {
    "sterility": 1
   },
   "2026": {
    "sterility": 1
   }
  },
  "latest_event": {
   "initiated": "20260910",
   "report_date": "20261014",
   "classification": "Class II",
   "reason_text": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product."
  },
  "events_detail": [
   {
    "initiated": "20120521",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.",
    "sermorelin_product_entries": 1,
    "any_blend": true
   },
   {
    "initiated": "20130415",
    "classification": "Class I",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.",
    "sermorelin_product_entries": 1,
    "any_blend": true
   },
   {
    "initiated": "20130528",
    "classification": "Class II",
    "reason_group": "firm-wide recall after adverse event reports tied to a different product",
    "reason_text": "The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.",
    "sermorelin_product_entries": 4,
    "any_blend": true
   },
   {
    "initiated": "20130529",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes",
    "sermorelin_product_entries": 1,
    "any_blend": true
   },
   {
    "initiated": "20130726",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance",
    "sermorelin_product_entries": 1,
    "any_blend": false
   },
   {
    "initiated": "20150602",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility",
    "sermorelin_product_entries": 5,
    "any_blend": true
   },
   {
    "initiated": "20150724",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility; all sterile human compounded drugs within expiry",
    "sermorelin_product_entries": 3,
    "any_blend": true
   },
   {
    "initiated": "20150903",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility:  A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.",
    "sermorelin_product_entries": 3,
    "any_blend": false
   },
   {
    "initiated": "20150923",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.",
    "sermorelin_product_entries": 1,
    "any_blend": false
   },
   {
    "initiated": "20151016",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility",
    "sermorelin_product_entries": 1,
    "any_blend": true
   },
   {
    "initiated": "20151019",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility",
    "sermorelin_product_entries": 1,
    "any_blend": false
   },
   {
    "initiated": "20160719",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility",
    "sermorelin_product_entries": 1,
    "any_blend": true
   },
   {
    "initiated": "20160801",
    "classification": "Class I",
    "reason_group": "sterility or contamination",
    "reason_text": "Non-Sterility; microbial contamination identified as Bacillus circulans",
    "sermorelin_product_entries": 1,
    "any_blend": true
   },
   {
    "initiated": "20160921",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility",
    "sermorelin_product_entries": 12,
    "any_blend": true
   },
   {
    "initiated": "20161117",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility",
    "sermorelin_product_entries": 8,
    "any_blend": true
   },
   {
    "initiated": "20171116",
    "classification": "Class II",
    "reason_group": "labeling, stability data or manufacturing-control problems",
    "reason_text": "Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.",
    "sermorelin_product_entries": 4,
    "any_blend": true
   },
   {
    "initiated": "20180307",
    "classification": "Class II",
    "reason_group": "labeling, stability data or manufacturing-control problems",
    "reason_text": "Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.",
    "sermorelin_product_entries": 1,
    "any_blend": false
   },
   {
    "initiated": "20180910",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility",
    "sermorelin_product_entries": 7,
    "any_blend": true
   },
   {
    "initiated": "20181217",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of sterility assurance.",
    "sermorelin_product_entries": 6,
    "any_blend": true
   },
   {
    "initiated": "20190402",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of sterility assurance.",
    "sermorelin_product_entries": 2,
    "any_blend": false
   },
   {
    "initiated": "20190523",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Sterility Assurance.",
    "sermorelin_product_entries": 6,
    "any_blend": true
   },
   {
    "initiated": "20190912",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility",
    "sermorelin_product_entries": 8,
    "any_blend": true
   },
   {
    "initiated": "20191010",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Sterility Assurance.",
    "sermorelin_product_entries": 1,
    "any_blend": true
   },
   {
    "initiated": "20211012",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of assurance of sterility",
    "sermorelin_product_entries": 3,
    "any_blend": true
   },
   {
    "initiated": "20220307",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility",
    "sermorelin_product_entries": 3,
    "any_blend": false
   },
   {
    "initiated": "20220308",
    "classification": "Class II",
    "reason_group": "potency",
    "reason_text": "Sub Potent",
    "sermorelin_product_entries": 1,
    "any_blend": false
   },
   {
    "initiated": "20220404",
    "classification": "Class II",
    "reason_group": "labeling, stability data or manufacturing-control problems",
    "reason_text": "CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated",
    "sermorelin_product_entries": 1,
    "any_blend": false
   },
   {
    "initiated": "20220405",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.",
    "sermorelin_product_entries": 2,
    "any_blend": true
   },
   {
    "initiated": "20220509",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of assurance of sterility.",
    "sermorelin_product_entries": 1,
    "any_blend": false
   },
   {
    "initiated": "20220826",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility",
    "sermorelin_product_entries": 1,
    "any_blend": false
   },
   {
    "initiated": "20250730",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility",
    "sermorelin_product_entries": 1,
    "any_blend": false
   },
   {
    "initiated": "20260910",
    "classification": "Class II",
    "reason_group": "sterility or contamination",
    "reason_text": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
    "sermorelin_product_entries": 1,
    "any_blend": false
   }
  ]
 },
 "faers": {
  "query": "https://api.fda.gov/drug/event.json?search=patient.drug.medicinalproduct:%22sermorelin%22+patient.drug.medicinalproduct:%22sermorelin%20acetate%22+patient.drug.medicinalproduct:%22geref%22&limit=100",
  "total_reports_naming_sermorelin": 59,
  "reports_with_sermorelin_as_suspect": 30,
  "suspect_serious": 23,
  "suspect_death_flag": 0,
  "suspect_by_receive_year": {
   "2009": 1,
   "2016": 6,
   "2017": 1,
   "2018": 1,
   "2019": 1,
   "2020": 1,
   "2022": 2,
   "2023": 2,
   "2024": 1,
   "2025": 10,
   "2026": 4
  },
  "suspect_top_reactions": [
   [
    "Pruritus",
    7
   ],
   [
    "Nausea",
    4
   ],
   [
    "Hypersensitivity",
    4
   ],
   [
    "Injection site urticaria",
    3
   ],
   [
    "Anaphylactic reaction",
    3
   ],
   [
    "Injection site pruritus",
    3
   ],
   [
    "Erythema",
    3
   ],
   [
    "Wrong product administered",
    3
   ],
   [
    "Product dispensing error",
    3
   ],
   [
    "Hypoaesthesia",
    3
   ],
   [
    "Vomiting",
    2
   ],
   [
    "Urticaria",
    2
   ]
  ]
 },
 "clinicaltrials": {
  "query": "ClinicalTrials.gov API v2 query.term=sermorelin, 2026-10-24",
  "returned": 42,
  "naming_sermorelin_or_geref": [
   {
    "nct": "NCT00448747",
    "title": "Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.",
    "status": "COMPLETED",
    "enrollment": 101
   },
   {
    "nct": "NCT00324064",
    "title": "Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing",
    "status": "COMPLETED",
    "enrollment": 90
   },
   {
    "nct": "NCT03018886",
    "title": "Diagnosing Adult Growth Hormone Deficiency",
    "status": "COMPLETED",
    "enrollment": 160
   }
  ],
  "note": "The registry expands the term to GHRH and related drugs; most returned studies use tesamorelin, other analogs or unspecified GHRH. The 3 that name sermorelin or Geref use it in a diagnostic GH stimulation test."
 },
 "ndc_bulk_listings": {
  "file": "FDA NDC unfinished-drug listings, downloaded 2026-10-16 (https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory)",
  "sermorelin_listings": 17,
  "distinct_labelers": 16,
  "by_category": {
   "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING": 13,
   "BULK INGREDIENT": 4
  }
 },
 "wada_2026": {
  "url": "https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf",
  "text": "S2.2.4 Growth hormone releasing factors, including, but not limited to: growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)"
 },
 "pubmed": {
  "sermorelin_all_fields": 334,
  "sermorelin_mesh": 316,
  "sermorelin_tiab_rct_pt": 0,
  "checked": "2026-10-24"
 }
}