AP303 / Alebund - LARVOL DELTA

Randomized Clinical Trials of Deutaleglitazar in Healthy Participants and in Patients with Diabetic Kidney Disease. (PubMed, Kidney Int Rep) - "Deutaleglitazar (AP303) is a novel dual peroxisome proliferator-activated receptor (PPAR) α and γ agonist, which has the potential to offer the combined clinical benefit on diabetic kidney disease (DKD) management by normalizing the elevated glomerular capillary pressure, ameliorating podocyte depletion, as well as correcting diabetic dyslipidemia and hyperglycemia. Few adverse events were reported; only neutropenia was dose related. The PPARα and PPARγ related effects occurred over similar dose ranges, indicating that deutaleglitazar is a balanced agonist of the 2 receptor subtypes targeting on the root cause and multi-pathway of DKD progression."

Clinical • Journal • Diabetes • Diabetic Nephropathy • Dyslipidemia • Hematological Disorders • Metabolic Disorders • Nephrology • Neutropenia • Renal Disease • PPARA • PPARG

AP303-PK-03: A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Alebund Pharmaceuticals | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2025 ➔ Sep 2025 | Initiation date: Nov 2024 ➔ Feb 2025 | Trial primary completion date: Jan 2025 ➔ Sep 2025

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Diabetic Nephropathy • Nephrology • Renal Disease

A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Alebund Pharmaceuticals

New P1 trial • Diabetic Nephropathy • Nephrology • Renal Disease

A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Alebund Pharmaceuticals | Not yet recruiting ➔ Completed

Trial completion

Alebund's Innovative Investigational Drug AP303 Receives FDA Orphan Drug Designation (ODD) for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) (PRNewswire) - "Alebund Pharmaceuticals...announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AP303 for the treatment of autosomal dominant polycystic kidney disease (ADPKD)....This Orphan Drug Designation reflects the need for more new treatment options and the potential for AP303 to address the pressing needs of people living with ADPKD."

Orphan drug • Autosomal Dominant Polycystic Kidney Disease • Polycystic Kidney Disease • Renal Disease

A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Alebund Pharmaceuticals

New P1 trial

A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects (clinicaltrials.gov) - P1 | N=62 | Completed | Sponsor: Alebund Pty Ltd | Recruiting ➔ Completed

Trial completion

A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects (clinicaltrials.gov) - P1 | N=62 | Recruiting | Sponsor: Alebund Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open

A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects (clinicaltrials.gov) - P1 | N=62 | Not yet recruiting | Sponsor: Alebund Pty Ltd

New P1 trial