TG-1000 / TaiGen, Joincare - LARVOL DELTA

Comparison of the performance of three diagnosis scoring systems in patients with persistent chylomicronemia of different causes (NLA 2025) - "Background/Synopsis Familial chylomicronemia syndrome (FCS) is a rare syndromic cause of chylomicronemia (TG>1000 mg/dL) that persists despite treatment of secondary causes and the use of conventional lipid lowering treatment...Conclusions FCS clinical diagnosis scoring systems fairly identifiy patients presenting features of FCS without having the ability to easily distinguish beween genetically proven FCS and clinical FCS. Patients with persistent MCS present low scores but also represent an unmet medical need that should be treated similarly with respect to access to innovative precision therapies."

Clinical • Familial Chylomicronemia Syndrome

The Efficacy and Safety of a New Cap-dependent Endonuclease Inhibitor, TG-1000, in Adolescent and Adult Outpatients with Acute Uncomplicated Influenza: A Multicenter, Randomized, Placebo-controlled Phase III Trial (ChiCTR) - P3 | N=750 | Completed | Sponsor: No. 28, Qiaozhong Middle Road, Liwan District, Guangzhou; First Affiliated Hospital of Guangzhou Medical University

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

Safety, tolerability, and pharmacokinetics of TG-1000, a new molecular entity against influenza virus: first-in-human study. (PubMed, Front Pharmacol) - "No serious adverse events occurred during the studies. Overall, TG-1000 was well tolerated and exhibited an acceptable safety and PK profile, supporting further clinical investigation of TG-1000 for the treatment of influenza."

Journal • P1 data • PK/PD data • Infectious Disease • Influenza • Respiratory Diseases

Tideglusib-incorporated nanofibrous scaffolds potently induce odontogenic differentiation. (PubMed, J Biomater Appl) - "Both kinds of biomimetic nanofibrous matrices (PCLF-TG100, PCLF-TG1000) significantly stimulated cells proliferation. In contrast to current pulp capping material driving dentin repair, the sophisticated, polymeric scaffold systems with soluble and insoluble spatiotemporal cues described here can direct stem cell differentiation and dentin regeneration. Hence, bioactive small molecule-incorporated nanofibrous scaffold suggests an innovative clinical tool for dentin tissue engineering."

Journal • CTNNB1

The Enigmatic Triangle of Hypertriglyceridemia-Induced Pancreatitis and Its Association With Diabetic Ketoacidosis and Resulting Pancreatic Pseudocyst: A Case Report (ACG 2022) - "TG 1000-1999 carries a 5% risk of developing HTGP, increasing to 20% in TG >2000...4. Decreased peripancreatic and retroperitoneal fluid with 2 stents."

Clinical • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Critical care • Depression • Diabetes • Dyslipidemia • Endocrine Disorders • Gastroenterology • Hepatology • Hypertriglyceridemia • Infectious Disease • Metabolic Disorders • Obesity • Pain • Pancreatitis • Psychiatry • Septic Shock • Type 1 Diabetes Mellitus

To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection (clinicaltrials.gov) - P2 | N=202 | Completed | Sponsor: TaiGen Biotechnology Co., Ltd. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases

To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: TaiGen Biotechnology Co., Ltd.; Trial completion date: Apr 2021 ➔ Feb 2022; Trial primary completion date: Apr 2021 ➔ Feb 2022

Trial completion date • Trial primary completion date • Infectious Disease • Respiratory Diseases • PCR

[VIRTUAL] TaiGen Biotechnology Company, Ltd (BIO 2021) - "- Taigexyn® is the first to market asset and approved by the Taiwan FDA & China NMPA...TG-1000, a novel small molecular, pan-influenza antiviral, demonstrates better activity than Xofluza (Baloxavir)...- TG-1000 is effective against type A and B influenza, avian influenza H7N7, as well as Tamiflu-resistant viruses. Ph1 has been completed in China, and Ph2 expects to be completed in Q3-Q4 2021. TaiGen Biopharmaceutical Holdings Limited, the holding company of TaiGen, is listed company on the Taipei Exchange."

Infectious Disease • Respiratory Diseases

To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: TaiGen Biotechnology Co., Ltd.; Phase classification: P2/3 ➔ P2

Clinical • Phase classification • Infectious Disease • Respiratory Diseases • PCR

To Evaluate the Safety, Tolerability, and Pharmacokinetics Profiles of TG-1000 in Healthy Volunteers, and the Food Effect on Pharmacokinetics of Single Oral Dose of TG-1000 in Healthy Volunteers. (clinicaltrials.gov) - P1; N=66; Completed; Sponsor: TaiGen Biotechnology Co., Ltd.; Recruiting ➔ Completed; Trial completion date: Oct 2020 ➔ Dec 2020

Clinical • Trial completion • Trial completion date

To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection (clinicaltrials.gov) - P2/3; N=200; Recruiting; Sponsor: TaiGen Biotechnology Co., Ltd.

Clinical • New P2/3 trial • Infectious Disease • Respiratory Diseases • PCR

Correlation between Corneal Endothelial Cell Density and Central Ocular Surface Temperature in Normal and Keratoconus Eyes. (PubMed, Curr Eye Res) - "Endothelial cell density seems to have a mild impact on central ocular surface temperature in keratoconus and normal subjects. This effect is not correlated to the corneal front or back surface area."

Journal • Ophthalmology

To Evaluate the Safety, Tolerability, and Pharmacokinetics Profiles of TG-1000 in Healthy Volunteers, and the Food Effect on Pharmacokinetics of Single Oral Dose of TG-1000 in Healthy Volunteers. (clinicaltrials.gov) - P1; N=66; Recruiting; Sponsor: TaiGen Biotechnology Co., Ltd.

Clinical • New P1 trial