Drugs / Tesamorelin

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) EGRIFTA 2010-11-10 fda.gov

Trials 19 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT02553603 Jul 2017 → Jan 2019 cognitive impairment with or without cerebellar ataxia The University of Texas Medical Branch, Galveston Completed No outcome recorded
Phase 1 NCT02012556 May → Jul 2008 HIV infectious disease Theratechnologies Completed No outcome recorded
Phase 28 trials
Phase 2 NCT07481734 Feb 2026 → Feb 2027 expected metabolic dysfunction-associated steatohepatitis Hudson Biotech Recruiting No outcome recorded
Phase 2 NCT03375788 Jan 2019 → Jul 2024 NAFLD1, abdominal obesity-metabolic syndrome, obesity disorder Massachusetts General Hospital Completed No outcome recorded
Phase 2 NCT03150511 Jun 2018 → Dec 2027 expected peripheral nerve lesion Johns Hopkins University Recruiting No outcome recorded
Phase 2 NCT02931474 Oct 2016 → Mar 2017 sleep disorder, traumatic brain injury National Institute of Nursing Research (NINR) Withdrawn No outcome recorded
Phase 2 NCT01388920 Sep → Dec 2011 chronic obstructive pulmonary disease Theratechnologies Terminated No outcome recorded
Phase 2 NCT00675506 Jul 2008 → Jan 2012 abdominal obesity-metabolic syndrome, pituitary deficiency Massachusetts General Hospital Completed No outcome recorded
Phase 2 NCT00257712 Feb 2006 → Dec 2011 cognitive impairment with or without cerebellar ataxia University of Washington Completed No outcome recorded
Phase 2 NCT01264497 Feb → Nov 2002 type 2 diabetes mellitus Theratechnologies Completed No outcome recorded
Phase 32 trials
Phase 3 NCT00608023 Aug 2007 → Oct 2008 HIV infectious disease, lipodystrophy Theratechnologies Completed No outcome recorded
Phase 3 NCT00123253 Jun 2005 → Nov 2006 HIV infectious disease, lipodystrophy Theratechnologies Completed No outcome recorded
Phase 42 trials
Phase 4 NCT03226821 Feb 2018 → Apr 2025 lipodystrophy, pituitary deficiency Columbia University Terminated No outcome recorded
Phase 4 NCT01591902 Jun 2012 → May 2018 HIV infectious disease, diabetic retinopathy Theratechnologies Terminated No outcome recorded
Phase not applicable5 trials
NCT02196831 Jul 2015 → Jan 2019 HIV infectious disease, NAFLD1, metabolic dysfunction-associated steatohepatitis Massachusetts General Hospital Completed No outcome recorded
NCT01632592 Jan 2014 Massachusetts General Hospital Withdrawn No outcome recorded
NCT01263717 Dec 2010 → Feb 2014 HIV infectious disease, lipodystrophy Massachusetts General Hospital Completed No outcome recorded
NCT00850564 Feb 2009 → Apr 2010 Massachusetts General Hospital Completed No outcome recorded
NCT00795210 Feb 2009 → Nov 2012 lipodystrophy Massachusetts General Hospital Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT06554717 Comparator Jul 2025 → Jun 2028 expected HIV infectious disease, abdominal obesity-metabolic syndrome Massachusetts General Hospital Recruiting No outcome recorded
Phase 2 NCT02572323 Comparator Feb 2017 → Oct 2023 cognitive impairment with or without cerebellar ataxia University of California, San Diego Completed No outcome recorded

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 25 sources stand behind the page.

FieldValueCited text
Known as tesamorelin “Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat” PMID 20554713 Jun 2010
19

“before and after 10 weeks of treatment with low-dose tesamorelin (1 mg; GHRH analog) or placebo.” PMID 42382101 Jun 2026

“Subjects received tesamorelin, a GHRH(1-44) analog, 2 mg once daily, or placebo for 12 months.” PMID 23015655 Sep 2012

Tesamorelin (GHRH) 2mg SC QD x 2 weeks” NCT00795210

tesamorelin (Theratechnologies Inc)” PMID 23689947 Jul 2013

NCT07481734

NCT02196831

NCT02931474

NCT01263717

NCT01388920

NCT01591902

NCT02012556

NCT06554717

NCT01632592

NCT03226821

NCT02572323

NCT03150511

NCT03375788

NCT00608023

NCT00850564

Known as Egrifta ChEMBL registry synonym — accepted as the source's own label CHEMBL1237026
Known as GHRH(1-44) “tesamorelin (GHRH(1-44)) at a dose of 2 mg or identical placebo, sc, was given daily.” PMID 20554713 Jun 2010
Known as TESAMORELIN ACETATE ChEMBL registry synonym — accepted as the source's own label CHEMBL1237026
Known as Tesamorelina ChEMBL registry synonym — accepted as the source's own label CHEMBL1237026
Known as Tesamoreline ChEMBL registry synonym — accepted as the source's own label CHEMBL1237026
Known as TH-9507 ACETATE ChEMBL registry synonym — accepted as the source's own label CHEMBL1237026
Known as TH9507 “Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat” PMID 20554713 Jun 2010
2

NCT01264497

NCT00123253

Action Activate “Tesamorelin, a growth hormone releasing hormone agonist, reduces liver fat in HIV-infected individuals.” PMID 29031905 Oct 2017
1

“Growth hormone-releasing hormone receptor agonist” CHEMBL1237026

Modality Peptide “Growth Hormone Releasing Hormone (GHRH) analog tesamorelin” NCT03226821
Route Subcutaneous “tesamorelin [2 mg subcutaneous (SC) every day] or placebo” PMID 20101189 Mar 2010
Target GHRHR “Growth hormone-releasing hormone receptor agonist” CHEMBL1237026