TIX100 / TIXiMED - LARVOL DELTA

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: TIXiMED, Inc.

New P1 trial • Genetic Disorders • Obesity

TIXiMED…announced the initiation of the Phase 1b Multiple Ascending Dose (MAD) study of TIX100 (NCT07675590), an investigational oral inhibitor of thioredoxin-interacting protein (TXNIP) (Businesswire) - "Phase 1b multiple ascending dose (MAD) study to evaluate safety, tolerability, and pharmacokinetics of an investigational oral disease-modifying type 1 diabetes therapy....The study will enroll 18 healthy subjects across three ascending dose cohorts at a single US center, with each cohort receiving TIX100 or placebo twice daily for 28 days, followed by a seven-day follow-up."

Trial status • Type 1 Diabetes Mellitus

Oral TIX100 Protects against Weight Rebound after Semaglutide Discontinuation (ADA 2026) - "TIX100 may represent an attractive novel, oral, muscle-sparing, non-GLP1 approach for weight maintenance after GLP1-induced weight loss, in addition to its promising antidiabetic properties."

Diabetes • Metabolic Disorders • Obesity • TXNIP

Prevention of Weight Regain After GLP1RA Cessation With Oral TIX100. (PubMed, Diabetes Obes Metab) - No abstract available

Journal • Genetic Disorders

TIXiMED Announces Promising Preclinical Data: Oral TIX100 Prevents Weight Regain After GLP-1 Cessation in Obesity Model (Businesswire) - "...Mice receiving oral TIX100 showed no significant regain and maintained their reduced body weight throughout the four-week post-GLP-1 period. Weight maintenance with TIX100 was linked to reduced fat mass, decreased food intake, and lower serum leptin levels, with no observed loss of lean mass."

Preclinical • Obesity

TIX100 Provides More Potent, Effective, and Specific TXNIP Inhibition and Antidiabetic Effects Than Verapamil (ADA 2025) - "Thus, in these preclinical studies, TIX100 provided more potent, effective and specific TXNIP inhibition as well as antidiabetic effects than verapamil, suggesting that this may ultimately translate into a safer and more effective diabetes therapy."

Diabetes • Metabolic Disorders • TXNIP

Treating Glucose Intolerance and High-Fat Diet–Induced Adiposity with the Novel Antidiabetic TIX100 (ADA 2025) - "Taken together, TIX100 may provide a novel, oral therapy for T2D that, without aggressive weight loss, provides weight control, targets underlying disease pathology and promotes metabolic health."

Diabetes • Leptin Receptor Deficiency Obesity • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • LEP • TXNIP

Target Discovery to Diabetes Therapy - TXNIP From Bench to Bedside with NIDDK. (PubMed, Endocrinology) - "This mini-review follows the discovery of thioredoxin-interacting protein inhibitors as an example of a methodical approach to identify and develop an oral beta cell treatment for T1D. It further discusses how the initial molecular findings were translated into novel clinical treatment approaches that promote the patient's own islet health and beta cell function using drug repurposing as well as new drug discovery."

Journal • Diabetes • Genetic Disorders • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus • TXNIP

Novel type 1 diabetes therapies targeting endogenous islet cells (ATTD 2025) - "Verapamil, a calcium channel blocking antihypertensive that we found also non-specifically inhibits TXNIP, provided proof-of-principle for the beneficial effects in subjects with recent onset T1D and the translatability of this approach to humans. TIX100, a new chemical entity specifically developed as an oral anti-diabetic drug to inhibit TXNIP, has demonstrated to have multiple advantages and to be safe and highly effective in preclinical studies. TIX100 has now been approved as an investigational new drug by the U.S. Food and Drug Administration (FDA) and an update on the ongoing efforts to proceed with the development of these novel beta cell-targeting, non-immunosuppressive, oral medications for T1D will be provided."

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • TXNIP

TIXiMED Inc. Announces Successful Dosing of First Cohort in the Phase 1 Clinical Trial of TIX100, its Investigational Disease-Modifying Treatment for Type 1 Diabetes (Businesswire) - "TIXiMED Inc...today announced successful dosing of the first dose cohort in the Phase 1 Single Ascending Dose (SAD) trial of TIX100, its investigational novel oral therapy targeting beta cell health and islet cell function. Additionally, based on the safety review meeting, it was recommended that the randomized, placebo-controlled quadruple-blind clinical trial continue with no modifications and the next cohort escalate to the pre-specified dose level."

Trial status • Type 1 Diabetes Mellitus

A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of TIX100 in Healthy Subjects (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: TIXiMED, Inc.

New P1 trial