GHRH analogue

Sermorelin updates

Answer

2 changes for Sermorelin in the last 12 months. Latest: 2025-11-20.

DateTypeWhat changedSource
2025-11-20ResultsResults posted: Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular RiskTrial register ClinicalTrials.gov
2025-10-15RecallFDA recall, Class II: GenoGenix LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2024-08-15TrialNew trial registered: Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIVTrial register ClinicalTrials.gov
2023-12-04ActionCalifornia Board of Pharmacy: boardRegulator California Board of Pharmacy
2022-11-16ResultsResults posted: Adult Growth Hormone Deficiency and Cardiovascular RiskTrial register ClinicalTrials.gov
2022-09-21RecallFDA recall, Class II: Carolina Infusion. Lack of Assurance of SterilityRegulator FDA enforcement reports
2022-07-20RecallFDA recall, Class II: TMC Acquisition LLC dba Tailor Made Compounding. Lack of Assurance of SterilityRegulator FDA enforcement reports
2022-07-20RecallFDA recall, Class II: TMC Acquisition LLC dba Tailor Made Compounding. Lack of Assurance of SterilityRegulator FDA enforcement reports
2022-07-20RecallFDA recall, Class II: TMC Acquisition LLC dba Tailor Made Compounding. Lack of Assurance of SterilityRegulator FDA enforcement reports
2022-06-01RecallFDA recall, Class II: Olympia Compounding Pharmacy dba Olympia Pharmacy. Lack of assurance of sterility.Regulator FDA enforcement reports
2022-05-04RecallFDA recall, Class II: Olympia Compounding Pharmacy dba Olympia Pharmacy. CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action LRegulator FDA enforcement reports
2022-04-27RecallFDA recall, Class II: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding. Lack of Assurance of Sterility: deviations from Current Good ManuRegulator FDA enforcement reports
2022-03-30RecallFDA recall, Class II: Olympia Compounding Pharmacy dba Olympia Pharmacy. Sub PotentRegulator FDA enforcement reports
2020-01-13ResultsResults posted: Tesamorelin Effects on Liver Fat and Histology in HIVTrial register ClinicalTrials.gov
2019-11-06RecallFDA recall, Class II: Innoveix Pharmaceuticals Inc. Lack of Sterility Assurance.Regulator FDA enforcement reports
2019-10-09RecallFDA recall, Class II: KRS Global Biotechnology, Inc. Lack of Assurance of SterilityRegulator FDA enforcement reports
2019-10-09RecallFDA recall, Class II: KRS Global Biotechnology, Inc. Lack of Assurance of SterilityRegulator FDA enforcement reports
2019-10-09RecallFDA recall, Class II: KRS Global Biotechnology, Inc. Lack of Assurance of SterilityRegulator FDA enforcement reports
2019-10-09RecallFDA recall, Class II: KRS Global Biotechnology, Inc. Lack of Assurance of SterilityRegulator FDA enforcement reports
2019-10-09RecallFDA recall, Class II: KRS Global Biotechnology, Inc. Lack of Assurance of SterilityRegulator FDA enforcement reports
2019-10-09RecallFDA recall, Class II: KRS Global Biotechnology, Inc. Lack of Assurance of SterilityRegulator FDA enforcement reports
2019-10-09RecallFDA recall, Class II: KRS Global Biotechnology, Inc. Lack of Assurance of SterilityRegulator FDA enforcement reports
2019-10-09RecallFDA recall, Class II: KRS Global Biotechnology, Inc. Lack of Assurance of SterilityRegulator FDA enforcement reports
2019-07-09ResultsResults posted: The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart FailureTrial register ClinicalTrials.gov
2019-06-19RecallFDA recall, Class II: Pharm D Solutions, LLC. Lack of Sterility Assurance.Regulator FDA enforcement reports
2019-06-19RecallFDA recall, Class II: Pharm D Solutions, LLC. Lack of Sterility Assurance.Regulator FDA enforcement reports
2019-06-19RecallFDA recall, Class II: Pharm D Solutions, LLC. Lack of Sterility Assurance.Regulator FDA enforcement reports
2019-06-19RecallFDA recall, Class II: Pharm D Solutions, LLC. Lack of Sterility Assurance.Regulator FDA enforcement reports
2019-06-19RecallFDA recall, Class II: Pharm D Solutions, LLC. Lack of Sterility Assurance.Regulator FDA enforcement reports
2019-05-24ResultsResults posted: Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the ElderlyTrial register ClinicalTrials.gov
2019-04-24RecallFDA recall, Class II: Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy. Lack of sterility assurance.Regulator FDA enforcement reports
2019-04-24RecallFDA recall, Class II: Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy. Lack of sterility assurance.Regulator FDA enforcement reports
2019-02-20RecallFDA recall, Class II: Promise Pharmacy, LLC. Lack of sterility assurance.Regulator FDA enforcement reports
2019-02-20RecallFDA recall, Class II: Promise Pharmacy, LLC. Lack of sterility assurance.Regulator FDA enforcement reports
2019-02-20RecallFDA recall, Class II: Promise Pharmacy, LLC. Lack of sterility assurance.Regulator FDA enforcement reports
2019-02-20RecallFDA recall, Class II: Promise Pharmacy, LLC. Lack of sterility assurance.Regulator FDA enforcement reports
2019-02-20RecallFDA recall, Class II: Promise Pharmacy, LLC. Lack of sterility assurance.Regulator FDA enforcement reports
2018-11-07RecallFDA recall, Class II: Pharm D Solutions, LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2018-11-07RecallFDA recall, Class II: Pharm D Solutions, LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2018-11-07RecallFDA recall, Class II: Pharm D Solutions, LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2018-11-07RecallFDA recall, Class II: Pharm D Solutions, LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2018-11-07RecallFDA recall, Class II: Pharm D Solutions, LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2018-03-21RecallFDA recall, Class II: American Pharmaceutical Ingredients LLC. Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates Regulator FDA enforcement reports
2018-01-17RecallFDA recall, Class II: KRS Global Biotechnology, Inc. Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredieRegulator FDA enforcement reports
2018-01-17RecallFDA recall, Class II: KRS Global Biotechnology, Inc. Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredieRegulator FDA enforcement reports
2018-01-17RecallFDA recall, Class II: KRS Global Biotechnology, Inc. Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredieRegulator FDA enforcement reports
2018-01-17RecallFDA recall, Class II: KRS Global Biotechnology, Inc. Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredieRegulator FDA enforcement reports
2017-12-18TrialNew trial registered: Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular RiskTrial register ClinicalTrials.gov
2017-04-27ResultsResults posted: Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the ElderlyTrial register ClinicalTrials.gov
2017-01-25TrialNew trial registered: Study of Intranasal Octreotide (DP1038) in Healthy Adult VolunteersTrial register ClinicalTrials.gov
2017-01-11RecallFDA recall, Class II: Tri-Coast Pharmacy. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-11RecallFDA recall, Class II: Tri-Coast Pharmacy. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-11RecallFDA recall, Class II: Tri-Coast Pharmacy. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-11RecallFDA recall, Class II: Tri-Coast Pharmacy. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-11RecallFDA recall, Class II: Wells Pharmacy Network LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-11RecallFDA recall, Class II: Wells Pharmacy Network LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-11RecallFDA recall, Class II: Wells Pharmacy Network LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-11RecallFDA recall, Class II: Wells Pharmacy Network LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-11RecallFDA recall, Class II: Wells Pharmacy Network LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-11RecallFDA recall, Class II: Wells Pharmacy Network LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-11RecallFDA recall, Class II: Wells Pharmacy Network LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-11RecallFDA recall, Class II: Wells Pharmacy Network LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-11RecallFDA recall, Class II: Wells Pharmacy Network LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-11RecallFDA recall, Class II: Wells Pharmacy Network LLC. Lack of Assurance of SterilityRegulator FDA enforcement reports
2017-01-06TrialNew trial registered: Diagnosing Adult Growth Hormone DeficiencyTrial register ClinicalTrials.gov
2016-08-31RecallFDA recall, Class II: Talon Compounding Pharmacy. Lack of Assurance of SterilityRegulator FDA enforcement reports
2016-04-08TrialNew trial registered: Dehydroepiandrosterone Versus Growth Hormone in Women Undergoing ICSI With Expected Poor Ovarian ResponseTrial register ClinicalTrials.gov
2015-12-09RecallFDA recall, Class II: Western Drug. Lack of Assurance of SterilityRegulator FDA enforcement reports
2015-11-25RecallFDA recall, Class II: Kalman Health & Wellness, Inc. dba Essential Wellness Pharma. Lack of Assurance of Sterility: A recall of all compounded sterile preparations withiRegulator FDA enforcement reports
2015-11-25RecallFDA recall, Class II: Kalman Health & Wellness, Inc. dba Essential Wellness Pharma. Lack of Assurance of Sterility: A recall of all compounded sterile preparations withiRegulator FDA enforcement reports
2015-11-25RecallFDA recall, Class II: Kalman Health & Wellness, Inc. dba Essential Wellness Pharma. Lack of Assurance of Sterility: A recall of all compounded sterile preparations withiRegulator FDA enforcement reports
2015-10-14RecallFDA recall, Class II: Diabetes Corporation of America dba DCA Pharmacy. Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compRegulator FDA enforcement reports
2015-09-23RecallFDA recall, Class II: The Compounding Pharmacy of America. Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality Regulator FDA enforcement reports
2015-09-23RecallFDA recall, Class II: The Compounding Pharmacy of America. Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality Regulator FDA enforcement reports
2015-09-23RecallFDA recall, Class II: The Compounding Pharmacy of America. Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality Regulator FDA enforcement reports
2015-09-23RecallFDA recall, Class II: The Compounding Pharmacy of America. Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality Regulator FDA enforcement reports
2015-09-23RecallFDA recall, Class II: The Compounding Pharmacy of America. Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality Regulator FDA enforcement reports
2015-09-03TrialNew trial registered: The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive ImpairmentTrial register ClinicalTrials.gov
2015-06-03TrialNew trial registered: Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD)Trial register ClinicalTrials.gov
2014-10-17TrialNew trial registered: Estradiol-Receptor Blockade in Older Men and WomenTrial register ClinicalTrials.gov
2014-10-13ResultsResults posted: Effects of Growth Hormone Releasing Hormone in HIVTrial register ClinicalTrials.gov
2014-07-22TrialNew trial registered: Tesamorelin Effects on Liver Fat and Histology in HIVTrial register ClinicalTrials.gov
2014-01-15ResultsResults posted: TH9507 Extension Study in Patients With HIV-Associated LipodystrophyTrial register ClinicalTrials.gov
2014-01-08ResultsResults posted: Effects of Short-term Growth Hormone in HIV-infected PatientsTrial register ClinicalTrials.gov
2013-12-16TrialNew trial registered: Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive PatientsTrial register ClinicalTrials.gov
2013-12-11RecallFDA recall, Class II: Main Street Family Pharmacy, LLC. The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compoundeRegulator FDA enforcement reports
2013-12-11RecallFDA recall, Class II: Main Street Family Pharmacy, LLC. The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compoundeRegulator FDA enforcement reports
2013-12-11RecallFDA recall, Class II: Main Street Family Pharmacy, LLC. The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compoundeRegulator FDA enforcement reports
2013-12-11RecallFDA recall, Class II: Main Street Family Pharmacy, LLC. The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compoundeRegulator FDA enforcement reports
2013-09-18RecallFDA recall, Class II: Beacon Hill Medical Pharmacy, P.C.. Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control pRegulator FDA enforcement reports
2013-07-17RecallFDA recall, Class II: Lowlite Investments, Inc. D/B/A Olympia Pharmacy. Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality conRegulator FDA enforcement reports
2013-03-04Federal RegisterFederal Register notice: Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) InRegulator Federal Register
2013-01-07ResultsResults posted: Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are ObeseTrial register ClinicalTrials.gov
2012-08-22RecallFDA recall, Class II: Franck's Lab Inc., d.b.a. Franck's Compounding Lab. Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs Regulator FDA enforcement reports
2012-07-03TrialNew trial registered: Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone AnalogueTrial register ClinicalTrials.gov
2011-06-17TrialNew trial registered: Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the ElderlyTrial register ClinicalTrials.gov
2011-05-13TrialNew trial registered: VRS-317 in Adult Subjects With Growth Hormone DeficiencyTrial register ClinicalTrials.gov
2011-03-30ResultsResults posted: Effect of Short Term Growth Hormone Releasing Hormone in Healthy MenTrial register ClinicalTrials.gov
2010-12-21TrialNew trial registered: Effects of Growth Hormone Releasing Hormone in HIVTrial register ClinicalTrials.gov
2010-01-29TrialNew trial registered: Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone DeficiencyTrial register ClinicalTrials.gov

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From ClinicalTrials.gov, EU CTIS, FDA labels, recalls, shortages and warning letters, the Federal Register, and regulators' published actions. Not medical advice.

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