hydroxypropyl beta cyclodextrin (VAR 200) / ZyVersa - LARVOL DELTA

P2a Open Label Study to Evaluate 2-HPβCD in Subjects With Diabetic Kidney Disease (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: ZyVersa Therapeutics, Inc. | Recruiting ➔ Withdrawn

Trial withdrawal • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

From RAAS blockade to regenerative medicine: evolving treatment strategies in Alport syndrome. (PubMed, Pediatr Nephrol) - "Adjunctive commercially available metabolic modulators, including SGLT2i, mineralocorticoid receptor antagonists, ezetimibe and GLP-1 receptor agonists, may offer additional kidney protection. Ameliorating therapies being tested in Phase II trials include endothelin receptor antagonists (e.g., atrasentan), dual endothelin receptor antagonist and angiotensin II receptor inhibition (e.g., sparsentan) FXR agonists (e.g., vonafexor), inducers of cholesterol efflux (e.g., VAR200 and R3R01), and NOX1/4 inhibitors (e.g., setanaxib), several of which are currently being evaluated in clinical trials. Novel strategies such as exon skipping, gene editing, and nonsense mutation readthrough (e.g., ELX-02) are advancing toward precision medicine approaches as disease modifying agents targeting the genetic cause of AS...This review summarizes the current landscape of AS classification and treatment, highlighting both standard interventions and experimental therapies. Emphasis is placed..."

Journal • Review • Fibrosis • Gene Therapies • Genetic Disorders • Glomerulonephritis • Immunology • Renal Disease • COL4A5

P2a Open Label Study to Evaluate 2-HPβCD in Subjects With Diabetic Kidney Disease (clinicaltrials.gov) - P2 | N=8 | Recruiting | Sponsor: ZyVersa Therapeutics, Inc. | Trial completion date: Mar 2026 ➔ Aug 2026 | Trial primary completion date: Mar 2026 ➔ Aug 2026

Trial completion date • Trial primary completion date • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

P2a Open Label Study to Evaluate 2-HPβCD in Subjects With Diabetic Kidney Disease (clinicaltrials.gov) - P2 | N=8 | Recruiting | Sponsor: ZyVersa Therapeutics, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Mar 2026 | Initiation date: Mar 2025 ➔ Jun 2025 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

ZyVersa Therapeutics Reports First Quarter 2025 Financial Results and Highlights Pipeline Progress (ZyVersa Press Release) - "First patient expected to start therapy by end of Q2-2025 in Phase 2a proof-of concept clinical trial for Cholesterol Efflux Mediator VAR 200 in patients with diabetic kidney disease (DKD). Obesity-associated cardiometabolic preclinical proof-of-concept study with Inflammasome ASC Inhibitor IC 100 planned to begin by end of Q2-2025. Investigational New Drug Application (IND) for IC 100 anticipated to be submitted H2-2025, followed by initiation of a Phase 1 clinical trial in healthy overweight subjects at risk of cardiometabolic diseases. Groundbreaking data demonstrating IC 100 blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation — both key contributors to neurodegeneration and Parkinson’s disease (PD) progression, Invited MJFF grant request submitted for funding PD animal model proof-of-concept studies; response expected in June 2025. Raised approximately $2.0 million in Q1-2025."

Financing • IND • New P1 trial • New P2 trial • Preclinical • Cardiovascular • Obesity • Parkinson's Disease • Renal Disease

Cholesterol Efflux Mediator VAR 200 (GlobeNewswire) - "A phase 2a clinical trial in patients with DKD is expected to begin in the first half of 2025. The intent of the study is to obtain renal patient proof-of-concept for VAR 200 prior to initiating a larger phase 2a/b for VAR 200’s lead indication, FSGS. The DKD study will evaluate VAR 200’s safety and efficacy (% change in proteinuria from baseline to week 12) in eight patients with type 2 diabetes who have diabetic kidney disease, which will provide insights for developing the subsequent FSGS study. The DKD study will be conducted at two clinical research sites."

New P2a trial • Renal Disease

P2a Open Label Study to Evaluate 2-HPβCD in Subjects with Diabetic Kidney Disease (clinicaltrials.gov) - P2 | N=8 | Not yet recruiting | Sponsor: ZyVersa Therapeutics, Inc. | Initiation date: Jul 2024 ➔ Mar 2025 | Trial primary completion date: Feb 2025 ➔ Dec 2025 | Trial completion date: Jul 2025 ➔ Dec 2025

Trial completion date • Trial initiation date • Trial primary completion date • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

P2a Open Label Study to Evaluate 2-HPβCD in Subjects With Diabetic Kidney Disease (clinicaltrials.gov) - P2 | N=8 | Not yet recruiting | Sponsor: ZyVersa Therapeutics, Inc.

New P2 trial • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

ZyVersa Therapeutics' CEO, Stephen C. Glover to Present at the Stifel 2020 Virtual Healthcare Conference on November 18, 2020 (PRNewswire) - "ZyVersa Therapeutics, Inc....is pleased to announce that Stephen C. Glover, ZyVersa's Co-Founder, Chief Executive Officer, and President, is an invited speaker at the Stifel 2020 Virtual Healthcare Conference to be held November 16 – 18, 2020. Mr. Glover's presentation will highlight progress in advancing development of ZyVersa's inflammasome inhibitor, IC 100, and Phase 2a-ready VAR 200, a novel candidate for orphan renal disease, FSGS."

Clinical • Focal Segmental Glomerulosclerosis

ZyVersa Therapeutics featured in Business Worldwide Magazine's Winter Edition as one of the 20 most innovative companies to watch (Yahoo Finance) - "A Phase 2a clinical trial with VAR 200 is slated for initiation this quarter in patients with a rare kidney disease, focal segmental glomerulosclerosis (FSGS)....VAR 200 has potential to treat numerous other kidney diseases, including Alport syndrome and diabetic kidney disease. "

New P2a trial

ZyVersa Therapeutics' CEO, Stephen C. Glover to attend the 38th Annual J.P. Morgan Healthcare Conference 2020 (PRNewswire) - "ZyVersa's lead renal candidate is VAR 200, a cholesterol efflux mediator for treatment of renal disease; Phase 2a clinical trial scheduled to begin Q1-2020 in patients with FSGS; ZyVersa Therapeutics, Inc....is pleased to announce that Stephen C. Glover, ZyVersa's Co-Founder, Chief Executive Officer, and President, will attend the 38th Annual J.P. Morgan Healthcare Conference to be held January 13-16, 2020, at the Westin St. Francis Hotel in San Francisco."

New P2a trial