One measure of impact is the number of innovations progressing towards the market as well as those already on the market and impacting lives. For therapeutics, diagnostics and devices, the pipeline of innovations in various stages of clinical approval illustrates the breadth and depth of University of Michigan innovation.

Clinical Drug Pipeline

These drugs were created by faculty at the University of Michigan. There are many in different stages with several already in the market.

Therapeutic Company Phase I Phase I/II Phase II Phase III Marketed Indication FDA Approval Year 
Auryxia (ferric citrate) Akebia Therapeutics     Iron-deficient anemia for patints with Chronic Kidney Disease not on dialysis, Hyperphosphatemia for CKD on dialysis 2014 
ALXN1840 (formerly WTX101) Alexion Pharmaceuticals    Wilson Disease   
APG-115 Ascentage Pharma Acute Myelogenous Leukemia; Myelodysplastic Syndrome; T-Prolymphocytic Leukemia Melanoma; Advanced Solid Tumors; Malignant Salivary Gland Cancer; Liposarcoma     
APG-1252 Ascentage Pharma Small Cell Lung Cancer; Solid Tumors; EGFR-positive Non-Small Cell Lung Cancer Small Cell Lung Cancer; Myelofibrosis     
APG-1387 Ascentage Pharma Chronic Hepatitis B; Advanced Solid Tumors and Hematologic Malignancies Advanced Solid Tumors Hepatitis B    
APG-2449 Ascentage Pharma Advanced Solid Tumors      
APG-2575 Ascentage Pharma Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma; Hematologic Malignancies; Small Lymphocytic Lymphoma; Waldenstrom Macroglobulinemia; T-Prolymphocytic Leukemia Acute Myelogenous Leukemia; Chronic Lymphocytic Leukemia; Small Lymphocytic Leukemia     
AT-101 Ascentage Pharma   Chronic Lymphocytic Leukemia    
BAX930 (rADAMTS13) Baxalta (part of Takeda Pharmaceuticals)    Congenital Thrombotic Thrombocytopenic Purpura   
ZYBK2 Cadilla Healthcare Rheumatoid Arthritis      
CLR 131 Cellectar Biosciences Pediatric Solid Tumors and Lymphomas  Multiple Myeloma, Chronic Lymphocytic Leukemia, and lymphomas    
Debio 1143 Debiopharm Non-Small Cell Lung Cancer Solid Tumors  Head & Neck Cancer   
Reparixin Dompe Farmaceutici   Metastatic Triple-Negative Breast Cancer    
Cerdelga eliglustat Genzyme Corp (part of Sanofi)    Gaucher’s Disease Type III Gaucher’s Disease Type I 2014 
KO-539 Kura Oncology Acute Myelogenous Leukemia      
FluMist Quadrivalent MedImmune (part of AstraZeneca)     Influenza Vaccine 2012 
ONL1204 ONL Therapeutics Rhegmatogenous Retinal Detachment – Macula Off      
P-188 NF Phrixus Pharmaceuticals   Duchenne Muscular Dystrophy    
TAK-620 (SHP620, maribavir, GW1263, VP 41263) Shire (part of Takeda Pharmaceuticals) Healthy Volunteers   Cytomegalovirus Infection in Transplant Recipients   
SGT-001 Solid Biosciences  Duchenne Muscular Dystrophy    


Diagnostic Pipeline

How we diagnose disease and conditions evolves as technology evolves. A number of the tests and tools used in healthcare today have been created here at the University of Michigan.

Company Preclinical CLIA 510K PMA Product on Market Condition/Market 
Arctic DX         Macula Risk Macular Degeneration 
Armune   Apifiny       Tumor Specific Non-PSA Blood Test for Prostate Cancer 
Athena Diagnostics         Atlastin (SPG3A) DNA Sequencing Test (#531), Complete Hereditary Spastic Paraplegia Evaluation (#650), Autosomal Dominant HSP Evaluation (#651) Autosomal Dominant Hereditary Spastic Paraplegia 
Athena Diagnostics         NIPA1 (SPG6) DNA Sequencing Test (#532), Complete Hereditary Spastic Paraplegia Evaluation (#650), Autosomal Dominant HSP Evaluation (#651) 
Athena Diagnostics         MR-1 (PNKD) DNA Sequencing Test (#617) Paroxysmal Nonkinesignenic Dyskinesia 
Athena Diagnostics         FIG4 DNA Sequencing Test (#224), Partial CMT Evaluation – Recessive Only (#409), Complete CMT Evaluation (#723) 
Athena Diagnostics         FIG4 DNA Sequencing Test (#224), Complete ALS Evaluation (#704) Amyotrophic Lateral Sclerosis 
Becton Dickinson HandyLab         Microfluidic Diagnostic System *BD MAX™ Nucleic acid and protein diagnostic 
GenomeDX PCATS       Decipher™ Prostate Cancer 
Hologic   TMPRSS2 Gene Fusions       Prostate Cancer 
Janssen Diagnostics       CTC-Endocrine Index COMETI P2   Metastatic Breast Cancer 
Multiple Non Exclusive Licenses         Delta 508 Mutation Cystic Fibrosis 
Novelos (Cellectar)     I-131NM404 / I124NM404     Pet Imaging Agent for Non-Small Cell Lung Cancer and other Solid Tumors 
Ventana     ERG IVD     Prostate Cancer 
ViraCor IBT         Reg3alpha, ST2 biomarkers Graft Versus Host Disease (GVHD) 

Device Pipeline

These medical devices were created to help improve medical care and everyday life. We’re tracking their progress as they make their way to the patient.

Company Prototype Safety/ Efficacy Trial(s) 501(k) / PMA Application FDA Approval Product on Market Condition on Market 
Abbott Medical Optics (IntraLase)       2002 IntrLase FS Laser LASIK eye surgery 
Great Batch Probes         Neuromodulation 
Histosonics   VortxRx®       Benign Prostate Hyperplasia 
Imbio       2014 Lung Density Analysis COPD Analysis 
Invia       2001 4D MSPECT Processing and diagnostic display of reconstructed cardiac emission 
Medtronic (Ablation Frontiers)         Pulmonary Vein Ablation Catheter (PVAC); Multi-channel Radiofrequency Generator GENius Paroxysmal Atrial Fibrilation (PAF) 
Securus Medical   Esophageal Temperature Mapping       Cardiac and Tumor Tissue Ablation 
Tissue Regeneration System (TRS)       2013 Cranial Bone Filler Skeletal Reconstruction / Bone Regeneration Technology