Egrifta SV (tesamorelin acetate) / Theratechnologies, Massachusetts General Hospital - LARVOL DELTA

Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk (clinicaltrials.gov) - P2 | N=51 | Completed | Sponsor: Massachusetts General Hospital | Active, not recruiting ➔ Completed | N=76 ➔ 51

Enrollment change • Trial completion • Cardiovascular • Colon Cancer • Genetic Disorders • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Johns Hopkins University | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Muscular Atrophy

Analysis of growth hormone releasing hormone and its analogs in urine using nano liquid chromatography coupled with quadrupole/orbitrap mass spectrometry. (PubMed, J Pharm Biomed Anal) - "The present study aimed to develop a robust nano-LC quadrupole/orbitrap mass spectrometry (nano-LC-Q/Orbitrap MS) method for both screening and confirmation analyses of GHRH and its synthetic analogs (sermorelin/CJC-1293, tesamorelin, and CJC-1295) and the primary metabolite of sermorelin in urine, in accordance with WADA requirements...The validation results confirmed the method's suitability and robustness for anti-doping testing. Achieved LODs (≤ 0.5 ng/mL) and LOIs (0.5-0.75 ng/mL) demonstrated sufficient sensitivity for effective detection and confirmation analysis of the target peptides in urine."

Journal

TRIUMPH: Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Massachusetts General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity

Carpal Tunnel Syndrome Attributed to Medication Use: A Pharmacovigilance Study. (PubMed, Cureus) - "Several drugs were disproportionately associated with CTS in the FAERS database, including enzyme replacement therapies (ERTs), aromatase inhibitors, bisphosphonates, growth hormone (GH)-releasing factor analogs, GHB, rofecoxib, and tafamidis. These findings highlight the critical need for increased vigilance and monitoring of new-onset or worsening CTS in high-risk populations prescribed the aforementioned medications. Clinicians should carefully scrutinize pharmacological history when evaluating patients in this context."

Adverse events • Journal • Musculoskeletal Pain • Pain

Metabolic dysfunction-associated steatotic liver disease in people with HIV. (PubMed, Curr Opin HIV AIDS) - "MASLD is a key contributor to liver-related and cardiovascular-morbidity in PWH. While there have been exciting advances to improve diagnosis and management of MASLD in the general population, differences in MASLD pathophysiology demonstrate the need to tailor our approach specifically for PWH."

Journal • Cardiovascular • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Lipodystrophy • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Body Composition and Adipose Tissue in HIV (clinicaltrials.gov) - P4 | N=5 | Completed | Sponsor: Columbia University | Recruiting ➔ Completed | N=24 ➔ 5

Enrollment change • Trial completion • Endocrine Disorders • Growth Hormone Deficiency • Human Immunodeficiency Virus • Infectious Disease • Lipodystrophy • Metabolic Disorders • CD4

TRIUMPH: Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Massachusetts General Hospital | Initiation date: Mar 2025 ➔ Jul 2025

Trial initiation date • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity

Therapeutic potential of a GHRH analog in experimental MASLD (EASL 2025) - "Tesamorelin administration induced a reduction of adipose tissue with consequent weight loss. Also, it improved liver enzymes, lipid profile and insulin resistance. Further experiments are needed to better understand and isolate peripherical GH effects from IGF-1-mediated liver protection."

Fibrosis • Genetic Disorders • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • IGF1

Theratechnologies Receives FDA Approval for EGRIFTA WR (Tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy (GlobeNewswire) - "Theratechnologies...announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The Company will commercialize the new formulation under the tradename EGRIFTA WR....The new formulation, EGRIFTA WR, is a daily injectable but only needs weekly reconstitution. It requires less than half the administration volume as the current F4 formulation, sold in the U.S. as EGRIFTA SV, which is reconstituted daily. Pharmacokinetic studies have shown bioequivalence of EGRIFTA WR to the original F1 formulation of tesamorelin for injection (previously sold under the trade name EGRIFTA)....EGRIFTA WR will be supplied as four single-patient-use vials, each containing 11.6 mg of tesamorelin, sufficient for seven doses."

FDA approval • Lipodystrophy

Theratechnologies Reports Financial Results for the Fourth Quarter and Full Year of Fiscal 2024 (GlobeNewswire) - "'We witnessed unprecedented demand for EGRIFTA SV this past year resulting in full-year sales of $60.1 million dollars, which represents 12% growth year-over-year.'...On December 10, 2024, the Company announced that the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 25, 2025 to the Company’s supplemental Biologics License Application for the F8 formulation of tesamorelin ('F8 Formulation'), submitted on November 26, 2024."

PDUFA • Sales • Lipodystrophy

Effects of Tesamorelin on Neurocognitive Impairment in Abdominally Obese Persons with HIV. (PubMed, J Infect Dis) - "While tesamorelin reduced WC, the cognitive benefits did not significantly differ between groups. Recognizing the limitations of insufficient power and no placebo arm, this study suggests no clear benefit of short-term AO reduction with tesamorelin on NCI."

Journal • Alzheimer's Disease • Cognitive Disorders • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity • Oncology • IGF1

TRIUMPH: Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Massachusetts General Hospital

New P2 trial • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity

Efficacy and safety of tesamorelin in people with hiv on integrase inhibitors. (PubMed, AIDS) - "The current analysis provides the first dedicated data on the efficacy and safety of tesamorelin among PWH on INSTI-based regimens. Despite the association of INSTI use with weight gain and adipose tissue dysfunction, tesamorelin had beneficial effects on body composition with no exacerbation of glycemic control."

Journal • Diabetes • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease

Body Composition and Adipose Tissue in HIV (clinicaltrials.gov) - P4 | N=24 | Recruiting | Sponsor: Columbia University | Trial completion date: Apr 2023 ➔ Apr 2025 | Trial primary completion date: Apr 2023 ➔ Apr 2025

Trial completion date • Trial primary completion date • Endocrine Disorders • Growth Hormone Deficiency • Human Immunodeficiency Virus • Infectious Disease • Lipodystrophy • Metabolic Disorders • CD4

Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons (clinicaltrials.gov) - P2 | N=73 | Completed | Sponsor: University of California, San Diego | Active, not recruiting ➔ Completed | Trial completion date: May 2023 ➔ Oct 2023 | Trial primary completion date: May 2023 ➔ Oct 2023

Trial completion • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Human Immunodeficiency Virus • Infectious Disease

No Neurocognitive Benefit of Tesamorelin Immediate vs Delayed Treatment in Virally-Suppressed PWH (CROI 2024) - "These findings indicate that Tesa did not significantly improve NCI in VS PWH with AO compared to delayed initiation, but the study was underpowered to confidently show a relationship. Other limitations were that the study was unblinded and did not include a concomitant placebo arm. These findings do not support the hypothesis that AO contributes significantly to NCI in PWH."

Alzheimer's Disease • Cognitive Disorders • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity • Oncology • IGF1

Dietary regimens appear to possess significant effects on the development of combined antiretroviral therapy (cART)-associated metabolic syndrome. (PubMed, PLoS One) - "The obesogenic activities of the LPHC diet exceeded that of the NPHC diet and interacted with both integrase-containing and classical cART drug regimens to reproduce cART associated metabolic dysregulation. The effects were however reversed by co-administration with tesamorelin, a synthetic growth hormone releasing hormone analogue."

Journal • Metabolic Disorders • Obesity

Theratechnologies Receives Update from FDA on Tesamorelin F8 Supplemental Biologic License Application (GlobeNewswire) - "Theratechnologies Inc...has received correspondence from the U.S. Food and Drug Administration (FDA) regarding the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin. The FDA has notified the Company that it is continuing its review of the application beyond the Prescription Drug User Fee Act (PDUFA) goal date of January 22, 2024. Further information will be provided in due course."

PDUFA date • sBLA • Lipodystrophy • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Chromatographic-mass spectrometric analysis of peptidic analytes (2-10 kDa) in doping control urine samples. (PubMed, J Mass Spectrom) - "With urine samples representing still the most frequently collected doping control specimens, efficient extraction of peptidic analytes from this matrix was a major goal of this method, as demonstrated for the included compounds such as insulins (human, lispro, aspart, glulisine, tresiba, glargine metabolite, bovine insulin, porcine insulin), growth hormone-releasing hormones (sermorelin, CJC-1295, tesamorelin) incl. Nearly all requirements of the recent technical documents from the World Anti-Doping Agency (WADA) considering their minimum required performance levels (MRPL) are fulfilled, and the method was validated for its utilisation as initial testing procedure in doping controls. Finally, the approach was applied to authentic post-administration study urine samples (for insulins and gonadorelin) in order to provide proof of principle."

Journal • IGF1

Cationic exchange SPE combined with triple quadrupole UHPLC-MS/MS for detection of GHRHs in urine samples. (PubMed, Anal Biochem) - "The present developed and validated method for some GHRHs (tesamorelin, CJC-1295, sermorelin (GRF 1-29), sermorelin (3-29)-NH, somatorelin) is based on the triple quadrupole UHPLC/MS-MS method with solid phase extraction (SPE) with weak cation exchange and is able to detect concentrations as low as 0.2 ng/mL (LOD), a limit of quantification (LOQ) at 0.6 ng/mL, and linearity across the range of 0.1 ng/mL to 1.2 ng/mL. The present method developed by our doping control laboratory was validated according to WADA technical documents for selectivity, limit of detection (LOD), carryover, reliability of detection, stability and recovery. The results show that the method has adequate recoveries and sensitivity, hence, it can be employed for routine screening in anti-doping laboratories."

Journal

Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Johns Hopkins University | Active, not recruiting ➔ Recruiting

Enrollment open • Muscular Atrophy

Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk (clinicaltrials.gov) - P2 | N=76 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Colon Cancer • Genetic Disorders • Hepatology • Non-alcoholic Fatty Liver Disease • Obesity • Solid Tumor • CRP

Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons (clinicaltrials.gov) - P2 | N=73 | Active, not recruiting | Sponsor: University of California, San Diego | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Human Immunodeficiency Virus • Infectious Disease

Effect of tesamorelin in people with HIV with and without dorsocervical fat: Post hoc analysis of phase III double-blind placebo-controlled trial. (PubMed, J Clin Transl Sci) - "Among tesamorelin responders, VAT and waist circumference (WC) decreased in both dorsocervical fat groups and did not statistically differ (VAT P = 0.657, WC P = 0.093). These data demonstrate that tesamorelin is equally effective and should be considered in the treatment of excess VAT regardless of the presence of dorsocervical fat."

Journal • P3 data • Retrospective data • Human Immunodeficiency Virus • Infectious Disease