TE-8105 / T-E Pharma - LARVOL DELTA

Optimized sublingual delivery of dual fatty acid-conjugated GLP-1 receptor agonist TE-8105 produces durable efficacy in diabetic mice. (PubMed, Int J Pharm) - "Although sublingual TE-8105 and semaglutide achieved similar therapeutic potency (∼7%) relative to subcutaneous routes, TE-8105's prolonged plasma half-life enabled once-every-2-days dosing for sustained glycemic control, whereas semaglutide required daily administration. These findings establish a promising sublingual delivery system for fatty acid-conjugated peptides, and position sublingual TE-8105 as a potential needle-free alternative to injectable GLP-1 therapies."

Journal • Preclinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Investigate the Safety and Tolerability of TE-8105 in Overweight/Obese Participants Without Diabetes (clinicaltrials.gov) - P1/2 | N=38 | Completed | Sponsor: Immunwork, Inc. | Active, not recruiting ➔ Completed

First-in-human • Trial completion • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

A Study to Investigate the Safety and Tolerability of TE-8105 in Overweight/Obese Participants Without Diabetes (clinicaltrials.gov) - P1/2 | N=38 | Active, not recruiting | Sponsor: Immunwork, Inc. | Trial completion date: Oct 2025 ➔ Jun 2025 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

2FA-Platform Generates Dual Fatty Acid-Conjugated GLP-1 Receptor Agonist TE-8105 with Enhanced Diabetes, Obesity, and NASH Efficacy Compared to Semaglutide. (PubMed, J Med Chem) - "A distinct advantage of TE-8105 over semaglutide is its low-dose reduction of liver steatosis and improvement of liver health in nonalcoholic steatohepatitis mice. The multiarm linker technology provides a versatile platform for developing improved 2FA-peptide therapeutics."

Journal • Addiction (Opioid and Alcohol) • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

A Study to Investigate the Safety and Tolerability of TE-8105 in Overweight/Obese Participants Without Diabetes (clinicaltrials.gov) - P1/2 | N=44 | Recruiting | Sponsor: Immunwork, Inc. | Phase classification: P1 ➔ P1/2 | Trial primary completion date: Sep 2025 ➔ Jan 2025

Phase classification • Trial primary completion date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

A Study to Investigate the Safety and Tolerability of TE-8105 in Overweight/Obese Participants Without Diabetes (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Immunwork, Inc.

New P1 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity