TJ-0113 / PhecdaMed - LARVOL DELTA

Mass Balance Study of [14C] TJ0113 in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Hangzhou PhecdaMed Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Aug 2025 ➔ Mar 2025

Trial completion • Trial completion date

Novel Drug TJ0113 Induces Mitochondrial Autophagy to Ameliorate Murine ADPKD (KIDNEY WEEK 2025) - "To mimic the progression of ADPKD, gene deletion was induced by tamoxifen administration on postnatal day 10. Mice were randomly assigned to the following treatment groups:Wild-type (WT) groups：WT+Vehicle, WT+TJ0113 ( 10 mg/kg); Knockout (KO) groups: KO + Vehicle, KO + Tolvaptan (10mg/Kg), KO + TJ0113 ( 10 mg/kg)...Meanwhile, TJ0113 significantly inhibits renal fibrosis and EMT, downregulating multiple pro-inflammatory cytokine expression. It alleviates renal pathological damage and improves kidney function in a Pkd1 conditional knockout mouse model of ADPKD."

Preclinical • Autosomal Dominant Polycystic Kidney Disease • Fibrosis • Genetic Disorders • Immunology • Inflammation • Nephrology • Polycystic Kidney Disease • Renal Disease • PKD1 • PRKD1

Targeting Mitophagy Enhances Cytotoxicity of Autologously-Derived CAR-T Cells (ASH 2024) - "Tj-CART cells upregulate genes such TCF7, MCL-1, BCL2L1 and so on. Mechanistically, TJ0113 restore CAR-T cell function through recruiting Parkin to damage mitochondrial and inducing mitophagy, thereby leading to mitochondrial metabolic remodeling and potentially driving CAR-T cell stemness decisions via the Wnt/β-catenin pathway.ConclusionsThus, our results reveal that targeting mitophagy is a tangible pathway to optimize autologously-derived CAR-T cells with mitochondrial dysfunction, providing crucial insights into the how mitophagy regulates stemness and orchestrates mitochondrial metabolism."

CAR T-Cell Therapy • IO biomarker • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Metabolic Disorders • Multiple Myeloma • Oncology • BCL2L1 • CCR7 • MCL1 • TCF7

Mitophagy Reprograms Lactate Metabolism to Suppress THBS1 via H3K18la Reduction, Alleviating Intervertebral Disc Degeneration. (PubMed, Research (Wash D C)) - "Herein, we discovered that mitophagy activator TJ0113 drives metabolic reprogramming characterized by substantially reduced lactate production in senescent nucleus pulposus (NP) cells...Through combined genetic silencing of THBS1 and pharmacological inhibition of lactate generation, we establish the lactate-H3K18la-THBS1 axis as the essential mechanism mediating mitophagy's anti-inflammatory effects. Our work provides the first evidence that mitophagy orchestrates a metabolic-epigenetic regulatory axis (lactate-H3K18la-THBS1), unveiling novel therapeutic targets for IVDD and paving the way for epigenetic therapies against disc degeneration."

Journal • Gene Therapies • NLRP3 • STING • THBS1

Efficacy and Safety of TJ0113 Capsule in Patients With Parkinson's Disease (clinicaltrials.gov) - P2 | N=150 | Completed | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

Preclinical safety and toxicokinetic evaluation of TJ0113, a first-in-class mitophagy inducer for Parkinson's disease. (PubMed, Toxicol Appl Pharmacol) - P2 | "The NOAELs were 100 mg/kg/day in rats (26 weeks) and 60 mg/kg/day in dogs (39 weeks). These data establish a favorable nonclinical safety profile for TJ0113 and provide GLP evidence supporting further clinical development of this selective mitophagy-targeting agent."

Clinical • Journal • Preclinical • CNS Disorders • Metabolic Disorders • Movement Disorders • Parkinson's Disease

Clinical Trial of TJ0113 Capsules in the Treatment of Patients With Depressive Disorder (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Hangzhou PhecdaMed Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy and Safety of TJ0113 Capsule in Patients With Parkinson's Disease (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

Novel mitophagy inducer TJ0113 alleviates pulmonary inflammation during acute lung injury. (PubMed, Front Pharmacol) - "TJ0113 alleviates LPS-induced inflammation by inducing mitophagy and inhibiting NF-κB and inflammasome activation. Its selective action on damaged mitochondria suggests minimal side effects, positioning TJ0113 as a promising therapeutic candidate for ALI."

Journal • Acute Lung Injury • Genetic Disorders • Inflammation • Pneumonia • Respiratory Diseases

Clinical Trial of TJ0113 Capsules in the Treatment of Patients With Depressive Disorder (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Hangzhou PhecdaMed Co., Ltd.

New P2 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

A Clinical Trial of the Safety and Efficacy of TJ0113 Capsules in the Treatment of Patients With Age-related Hearing Loss (clinicaltrials.gov) - P=N/A | N=60 | Not yet recruiting | Sponsor: Yilai Shu

New trial • Otorhinolaryngology

TJ0113-induced mitophagy in acute liver failure detected by Raman microspectroscopy. (PubMed, Redox Biol) - "Innovations in this test contribute to clinical diagnosis of disease, personalized treatment, effective intraoperative guidance and accurate prognosis. The data may help in the development of a non-invasive clinical device for mitochondrial damage using bedside micro-Raman."

Journal • Hepatology • Inflammation • Liver Failure • Metabolic Disorders • ATG5 • NLRP3

TJ0113 attenuates fibrosis in metabolic dysfunction-associated steatohepatitis by inducing mitophagy. (PubMed, Int Immunopharmacol) - "TJ0113 enhances mitophagy to inhibit lipid accumulation, inflammation and fibrosis formation in MASH, and is a candidate for MASH treatment."

Journal • Fibrosis • Hepatitis B • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • ATG5 • IL1B • IL6 • NLRP3 • TGFB1 • TNFA

Mass Balance Study of [14C] TJ0113 in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Hangzhou PhecdaMed Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

Mass Balance Study of [14C] TJ0113 in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Hangzhou PhecdaMed Co., Ltd.

New P1 trial

Efficacy and Safety of TJ0113 Capsule in Patients With Parkinson's Disease (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

Efficacy and Safety of TJ0113 Capsule in Patients With Parkinson's Disease (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease