epaminurad (URC102) / JW Pharma, Simcere - LARVOL DELTA

EPIC: A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients (clinicaltrials.gov) - P3 | N=612 | Completed | Sponsor: JW Pharmaceutical | Active, not recruiting ➔ Completed

Trial completion • Gout • Inflammatory Arthritis • Rheumatology

To Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: JW Pharmaceutical | Recruiting ➔ Completed

Trial completion

To Evaluate the Mass Balance Recovery, Metabolite Profile and Metabolite Identification in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: JW Pharmaceutical | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Sep 2025

Trial completion • Trial completion date

PK,PD and DDI of Epaminurad and C2406 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: JW Pharmaceutical | Active, not recruiting ➔ Completed

Trial completion

PK,PD and DDI of Epaminurad and Naproxen in Healthy Volunteers (clinicaltrials.gov) - P1 | N=57 | Completed | Sponsor: JW Pharmaceutical | Enrolling by invitation ➔ Completed

Trial completion

EPIC: A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients (clinicaltrials.gov) - P3 | N=588 | Active, not recruiting | Sponsor: JW Pharmaceutical | Trial completion date: Aug 2025 ➔ Apr 2026 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Gout • Inflammatory Arthritis • Rheumatology

To Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers (clinicaltrials.gov) - P1 | N=34 | Recruiting | Sponsor: JW Pharmaceutical

New P1 trial

To Evaluate the Mass Balance Recovery, Metabolite Profile and Metabolite Identification in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: JW Pharmaceutical | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

PK,PD and DDI of Epaminurad and C2406 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: JW Pharmaceutical | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Feb 2025 ➔ Sep 2025 | Initiation date: Nov 2024 ➔ Mar 2025 | Trial primary completion date: Feb 2025 ➔ May 2025

Enrollment closed • Trial completion date • Trial initiation date • Trial primary completion date

PK,PD and DDI of Epaminurad and Naproxen in Healthy Volunteers (clinicaltrials.gov) - P1 | N=48 | Enrolling by invitation | Sponsor: JW Pharmaceutical | Trial completion date: Sep 2025 ➔ Jan 2026 | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date

To Evaluate the Mass Balance Recovery, Metabolite Profile and Metabolite Identification in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: JW Pharmaceutical

New P1 trial

Impact of Renal Impairment on the Pharmacodynamic and Pharmacokinetic Profiles of Epaminurad, a Novel Uric Acid Transporter 1 Inhibitor. (PubMed, Clin Transl Sci) - "Furthermore, no notable differences were observed in these profiles between the fasted and fed states. Patients with moderate renal impairment can receive (eGFR of 30-59 mL/min/1.73 m2) 9 mg epaminurad without dose adjustment, and the drug may be administered regardless of food intake."

Clinical • Journal • PK/PD data • Gout • Inflammatory Arthritis • Renal Disease • Rheumatology

PK,PD and DDI of Epaminurad and Naproxen in Healthy Volunteers (clinicaltrials.gov) - P1 | N=48 | Enrolling by invitation | Sponsor: JW Pharmaceutical | Not yet recruiting ➔ Enrolling by invitation | N=28 ➔ 48 | Trial completion date: Aug 2024 ➔ Sep 2025 | Trial primary completion date: Aug 2024 ➔ Aug 2025

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date

Efficacy and safety of epaminurad, a potent hURAT1 inhibitor, in patients with gout: a randomized, placebo-controlled, dose-finding study. (PubMed, Arthritis Res Ther) - P2b | "Epaminurad was effective at reducing sUA levels in patients with gout. The study also confirmed the safety and tolerability profile during 12 weeks of treatment."

Clinical • Journal • Gout • Immunology • Inflammatory Arthritis • Rheumatology

PK,PD and DDI of Epaminurad and C2406 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: JW Pharmaceutical

New P1 trial

PK,PD and DDI of Epaminurad and Naproxen in Healthy Volunteers (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: JW Pharmaceutical

New P1 trial

Cardiovascular Health Awareness and Risk Assessment in Schoolteachers in Calcutta, India (EPI-LIFESTYLE 2023) - "of QuestionsMax ScoreScore (%)Prevalence11042Spectrum11018Nature11025Risk Factors33032Benefit of Healthy Lifestyle44038Total1010033Although most (86%) were at mild risk for CVD with ASCVD scores below five, nine percent had moderate risk, and five percent had high risk of CVD... Cardiovascular health awareness among schoolteachers in Calcutta is suboptimal, many of whom are at risk for CVD. Awareness of the disease, detection of risk factors at an early stage, and adoption of a healthy lifestyle may help reduce CVD in this community."

Atherosclerosis • Cardiovascular • Dyslipidemia • Myocardial Infarction

Vaccines for the common cold. (PubMed, Cochrane Database Syst Rev) - "Additionally, data from Europe show that the total cost per episode may be up to EUR 1102...We identified a need for well-designed, adequately powered RCTs to investigate vaccines for the common cold in healthy people. Future trials on interventions for preventing the common cold should assess a variety of virus vaccines for this condition, and should measure such outcomes as common cold incidence, vaccine safety, and mortality (all-cause and related to the vaccine)."

Journal • Review • Cough • Infectious Disease • Otorhinolaryngology • Respiratory Diseases

A Safety, PK, PD and Food Effect Study of URC102 in Healthy Adults and Patients With Renal Impairment (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: JW Pharmaceutical | Recruiting ➔ Completed

Trial completion • Renal Disease

A Safety, PK, PD and Food Effect Study of URC102 in Healthy Adults and Patients With Renal Impairment (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: JW Pharmaceutical

Clinical • New P1 trial • Renal Disease

Study of of URC102 to Assess the Efficacy and Safety in Gout Patients (clinicaltrials.gov) - P2b; N=171; Completed; Sponsor: JW Pharmaceutical

Clinical • New P2b trial • Gout • Inflammatory Arthritis • Rheumatology

Main contribution of UGT1A1 and CYP2C9 in the metabolism of UR-1102, a novel agent for the treatment of gout. (PubMed, Xenobiotica) - "We clarified its metabolic pathway, estimated the contribution of each metabolic enzyme, and assessed the impact of genetic polymorphisms using human in vitro materials.Glucuronide, sulfate, and oxidative metabolites of UR-1102 were detected in human hepatocytes.The intrinsic clearance by glucuronidation or oxidation in human liver microsomes was comparable, but sulfation in the cytosol was much lower, indicating that the rank order of contribution was glucuronidation ≥ oxidation > sulfation.Recombinant UGT1A1 and UGT1A3 showed high glucuronidation of UR-1102. We took advantage of a difference in the inhibitory sensitivity of atazanavir to the UGT isoforms and estimated the fraction metabolised (fm) with UGT1A1 to be 70%.Studies using recombinant CYPs and CYP isoform-specific inhibitors showed that oxidation was mediated exclusively by CYP2C9.The effect of UGT1A1 and CYP2C9 inhibitors on UR-1102 metabolism in hepatocytes did not differ markedly between the wild type..."

Journal • Gout • Inflammatory Arthritis • Rheumatology • CYP2C9 • UGT1A1

URC102, a potent and selective inhibitor of hURAT1, reduced serum uric acid in healthy volunteers. (PubMed, Rheumatology (Oxford)) - P1 | "URC102 was safe and effectively lowered serum uric acid, which should be tested and confirmed in patients with hyperuricaemia and/or gout through further studies."

Clinical • Journal • Gout • Immunology • Inflammation • Metabolic Disorders • Rheumatology