growth hormone releasing hormone analogue

Tesamorelin updates

Answer

8 changes for Tesamorelin in the last 12 months. Latest: 2026-07-29.

DateTypeWhat changedSource
2026-07-29LabelFDA label revised: EGRIFTA SV (BLA022505)Regulator FDA drug label register
2026-07-29LabelFDA label revised: EGRIFTA WR (BLA022505)Regulator FDA drug label register
2026-05-19ResultsResults posted: Body Composition and Adipose Tissue in HIVTrial register ClinicalTrials.gov
2026-04-16ActionOhio Board of Pharmacy: boardRegulator Ohio Board of Pharmacy
2026-03-19TrialNew trial registered: Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)Trial register ClinicalTrials.gov
2026-03-12ResultsResults posted: Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected PersonsTrial register ClinicalTrials.gov
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
2020-01-13ResultsResults posted: Tesamorelin Effects on Liver Fat and Histology in HIVTrial register ClinicalTrials.gov
2019-01-30TrialNew trial registered: Growth Hormone Dynamics and Cardiac Steatosis in HIVTrial register ClinicalTrials.gov
2018-11-14RecallFDA recall, Class II: Tailor Made Compounding. Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expRegulator 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
2017-07-24TrialNew trial registered: Body Composition and Adipose Tissue in HIVTrial register ClinicalTrials.gov
2017-05-12TrialNew trial registered: Tesamorelin to Improve Functional Outcomes After Peripheral Nerve InjuryTrial register ClinicalTrials.gov
2016-10-13TrialNew trial registered: Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current InsomniaTrial register ClinicalTrials.gov
2015-10-08TrialNew trial registered: Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected PersonsTrial register ClinicalTrials.gov
2015-09-03TrialNew trial registered: The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive ImpairmentTrial 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
2014-05-07ResultsResults posted: Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle WastingTrial 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
2013-02-11TrialNew trial registered: Egrifta Replacement and Sleep Disordered BreathingTrial register ClinicalTrials.gov
2013-01-07ResultsResults posted: Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are ObeseTrial register ClinicalTrials.gov
2012-07-03TrialNew trial registered: Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone AnalogueTrial register ClinicalTrials.gov
2012-05-04Federal RegisterFederal Register notice: Determination of Regulatory Review Period for Purposes of Patent Extension; EGRIFTARegulator Federal Register
2012-05-04TrialNew trial registered: Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®Trial register ClinicalTrials.gov
2012-04-18TrialNew trial registered: Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®Trial register ClinicalTrials.gov
2011-07-07TrialNew trial registered: Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle WastingTrial 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
2010-12-17TrialNew trial registered: Safety Study of TH9507 in Subjects With Stable, Type 2 DiabetesTrial register ClinicalTrials.gov
2010-03-22Federal RegisterFederal Register notice: Endocrinologic and Metabolic Drugs Advisory Committee; Notice of MeetingRegulator Federal Register
2010-01-19Federal RegisterFederal Register notice: Endocrinologic and Metabolic Drugs Advisory Committee; Notice of MeetingRegulator Federal Register
2009-02-25TrialNew trial registered: Effect of Short Term Growth Hormone Releasing Hormone in Healthy MenTrial register ClinicalTrials.gov
2008-11-20TrialNew trial registered: Effects of Short-term Growth Hormone in HIV-infected PatientsTrial register ClinicalTrials.gov
2008-05-07TrialNew trial registered: Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are ObeseTrial register ClinicalTrials.gov
2008-02-06TrialNew trial registered: TH9507 Extension Study in Patients With HIV-Associated LipodystrophyTrial register ClinicalTrials.gov
2005-11-21TrialNew trial registered: SMART: Somatotrophics, Memory, and Aging Research TrialTrial register ClinicalTrials.gov
2005-07-20TrialNew trial registered: TH9507 in Patients With HIV-Associated LipodystrophyTrial register ClinicalTrials.gov

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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