MT921 / Medytox - LARVOL DELTA

Comparison of Cholic Acid (MT921) and Deoxycholic Acid (DCA) in Fat Reduction Efficacy and Skin Adverse Reactions in Mini Pigs and Rodent Models. (PubMed, Pharmaceuticals (Basel)) - "DCA is the active pharmaceutical ingredient found in several fat-dissolving injectables, such as Kybella®, V-OLET®, and Bellacholine®. Notably, MT921 evoked milder ADR based on lower incidence of hematoma and absence of nodules in mini pigs, less severe UD in mice, and reduced edema in rats. Local injections of 1.5% MT921 demonstrated fat-reduction efficacy comparable to 1% DCA while eliciting fewer and milder ADRs, supporting MT921 as a promising alternative lipolytic agent."

Journal • Preclinical • Dermatitis • Dermatology • Fibrosis • Immunology • Obesity

Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat (clinicaltrials.gov) - P3 | N=240 | Completed | Sponsor: Medy-Tox | Recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Feb 2023

Trial completion • Trial completion date

Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat (clinicaltrials.gov) - P3; N=240; Recruiting; Sponsor: Medy-Tox; Trial completion date: Dec 2022 ➔ Jun 2023; Trial primary completion date: Aug 2022 ➔ Feb 2023

Clinical • Trial completion date • Trial primary completion date • MRI

Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat (clinicaltrials.gov) - P3; N=240; Recruiting; Sponsor: Medy-Tox

Clinical • New P3 trial • MRI

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cholic Acid (MT921) after a Subcutaneous Injection in the Submental Area to Humans. (PubMed, Pharmaceuticals (Basel)) - "Systemic exposure to cholic acid increased as the dose increased. Blood lipid profiles and deoxycholic acid levels were not affected by MT921 treatment."

Clinical • Journal • PK/PD data • Pain

Evaluation for Potential Drug-Drug Interaction of MT921 Using In Vitro Studies and Physiologically-Based Pharmacokinetic Models. (PubMed, Pharmaceuticals (Basel)) - "In conclusion, MT921 could be administered without a DDI risk based on in vitro study and related in silico simulation. Further clinical studies are needed to validate this finding."

Journal • PK/PD data • Preclinical • Diabetes • Dyslipidemia • Hypertension • Metabolic Disorders

A Phase II Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat (clinicaltrials.gov) - P2; N=176; Completed; Sponsor: Medy-Tox; Trial completion date: Sep 2020 ➔ Apr 2020; Trial primary completion date: Jul 2020 ➔ Mar 2020

Clinical • Trial completion date • Trial primary completion date