Current State Of Longevity Clinical Trials

Longevity drug development has evolved into an industry priority, as such a number of companies are working on developing therapies that target aging some of which are currently involved in clinical trials. 

Currently there aren’t any longevity drugs to have received regulatory approval, although a number of therapies have passed phase I and phase II clinical human trials, there are even a few phase III trials with all of the developers racing to be the first to go to market. 

Many companies working in the space of longevity drug development are more advanced than traditional biomedical companies. They are considered to be next generation because this space of research and development integrates numerous scientific and technical subdomains such as geroscience, artificial intelligence, and digital medicine. Advanced methods of diagnostics and prognostic assessments, and next generation techniques for conducting clinical trials are used by these companies compared to conventional standards which are largely based on in vitro experiments and model organisms. 

Developing drugs for longevity may well be one of the more complex areas in drug discovery, as longevity focuses on prevention rather than treatment which requires complete optimization of health at the deepest levels to target biological systems that control disease. 

There are 9 hallmarks of aging which are considered to be at the root causes of aging in the longevity industry, discoveries in these categories has led to clinical trials, and each trial is a step closer to ameliorating these hallmarks. 

The 9 categories of longevity drugs include: genomic instability; telomere attrition; epigenetic alterations; loss of proteostasis; cellular senescence; mitochondrial dysfunction; deregulated nutrient sensing; altered intercellular communication, and stem cell exhaustion.

Longevity drugs that are currently in preclinical development include: GDF11 by Elevian; SENSOlytics by Oisin Biotechnologies; Ectopic replacement organs by Lygenesis; Egg quality restoration drugs by Jumpstart Fertility; MitoSens by SENS Research Foundation; Telomerase gene therapy, Preclinical in vivo by CNIO; Telomerase therapy and proprietary iTR technology by AgeX Therapeutics; OSKM- OCT4, Sox2, Klf, and c-Myc by Salk; OSKMLN- Oct4, Sox2, Klf4, and c-Myc LIN28, and Nanog by Turn.Bio; Lysoclear by Ichor Therapeutics; Cardizyme and Alzyme by Covalent Bioscience; Klotho by UCSF; FOXO4-DRI by Cleara Biotech; Small molecule senolytics by Antixerene; and machine learning platforms to identify peptides by Spotlight Biosciences. 

Longevity drugs that have completed preclinical development include: NMD at Sinclair Lab; Gene therapy for restoration of short telomeres at Telocyte; UBX1967 at Unity Biotechnology; and Next Gen Apheresis at Conboy Lab.

Longevity drugs currently in clinical trials include: Fisetin at Mayo Clinic; Mesenchymal stem cell therapy at CRATUS; RTB101 at resTORbio; SRK-015 at Scholar Rock; SM04690 at Samumed; UBX1967 at Unity Biotechnology; J147 at Salk; NPT088 at The Michael J. Fox Foundation; Metformin at AFAR and the Albert Einstein College of Medicine; and Quercetin and Dasatinib at The Scripps Research Institute. 

Longevity drugs currently in phase III clinical trials include: SM04690 at Samumed; and Targeting Aging with Metformin at the American Federation for Aging Research and the Albert Einstein College of Medicine. 

Longevity drugs currently in phase II clinical trials include: UBX0101 at Unity Biotech; Quercetin and Dastinib at the Scripps Research Institute; Fisetin at the Mayo Clinic; RTB101 at resTORbio; and MSCs therapy at Cratus.

Longevity drugs currently in phase I clinical trials include: J147 at Salk; SRK-015 at Scolar Rock; and NPT088 at the Michael J. Fox Foundation and Proclara Bioscience.