LG5640 / Viking Therap, Ligand - LARVOL DELTA

Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer (clinicaltrials.gov) - P1; N=19; Terminated; Sponsor: EMD Serono; N=48 ➔ 19; Recruiting ➔ Terminated

Enrollment change • Trial termination • Biosimilar • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin, 10 mg + 1000 mg Versus the Combined Use of Forxiga™, 10 mg and Two Glucophage® Long, ER Tablets, 500 mg Co-administered to... (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: AstraZeneca

New P1 trial • Biosimilar • Diabetes

A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis (clinicaltrials.gov) - P3; N=189; Completed; Sponsor: Symbiomix Therapeutics; Active, not recruiting ➔ Completed

Trial completion • Biosimilar

PAS003: Post-Approval 'Real Conditions of Use' Study (clinicaltrials.gov) - P=N/A; N=345; Not yet recruiting; Sponsor: Paradigm Spine; Initiation date: Dec 2015 ➔ Jun 2016

Trial initiation date • Biosimilar • Pain • Rheumatoid Arthritis

Acid-Base and Point of Care Ultrasound in Severe Preeclampsia (clinicaltrials.gov) - P=N/A; N=84; Recruiting; Sponsor: University of Cape Town

New trial • Biosimilar • Gene Therapies

Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression (clinicaltrials.gov) - P2; N=232; Completed; Sponsor: Women and Infants Hospital of Rhode Island; N=100 ➔ 232

Enrollment change • Biosimilar • Depression

EXPANDHeart: International EXPAND Heart Pivotal Trial (clinicaltrials.gov) - P3; N=75; Recruiting; Sponsor: TransMedics; Active, not recruiting ➔ Recruiting

Enrollment open • Biosimilar

Vitamin D Supplementation and TB (clinicaltrials.gov) - P=N/A; N=200; Not yet recruiting; Sponsor: Cornell University; Initiation date: Sep 2015 ➔ Jun 2016; Trial primary completion date: Mar 2016 ➔ Sep 2017

Trial initiation date • Trial primary completion date • Biosimilar • Immunology

Predicting Hypotension Related to Spinal Anesthesia for Caesarean Section With Ultrasonography (clinicaltrials.gov) - P=N/A; N=40; Recruiting; Sponsor: Assistance Publique Hopitaux De Marseille; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar

Nutrition Interventions to Support the Immune System in Response to Stress (clinicaltrials.gov) - P=N/A; N=80; Recruiting; Sponsor: United States Army Research Institute of Environmental Medicine; Trial primary completion date: Feb 2016 ➔ Aug 2016

Trial primary completion date • Biosimilar • Immunology

Cyclophosphamide Therapy for Refractory Antibody-Mediated Rejection (AMR) in Kidney Transplants (clinicaltrials.gov) - P2; N=4; Active, not recruiting; Sponsor: University of Manitoba; Recruiting ➔ Active, not recruiting; N=20 ➔ 4; Trial primary completion date: Jan 2017 ➔ Jun 2016

Enrollment change • Enrollment closed • Trial primary completion date • Antibody-mediated Rejection • Biosimilar • Complement-mediated Rare Disorders • Immunology

Improving Parent Understanding of Instructions About Asthma Care (clinicaltrials.gov) - P2; N=500; Active, not recruiting; Sponsor: New York University School of Medicine; Trial primary completion date: Jan 2016 ➔ Apr 2016

Trial primary completion date • Asthma • Biosimilar • Immunology

AWAKEN: Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates (clinicaltrials.gov) - P=N/A; N=2186; Completed; Sponsor: University of Alabama at Birmingham; Enrolling by invitation ➔ Completed

Trial completion • Acute Kidney Injury • Biosimilar • Renal Disease

Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests (clinicaltrials.gov) - P=N/A; N=24; Active, not recruiting; Sponsor: Queen's University; Trial primary completion date: Jan 2016 ➔ Jan 2017

Trial primary completion date • Asthma • Biosimilar • Immunology

Tolerability, Safety, and Activity of SRX246 in Irritable Subjects With Huntington's Disease (clinicaltrials.gov) - P2; N=108; Not yet recruiting; Sponsor: Azevan Pharmaceuticals; Initiation date: Jan 2016 ➔ Apr 2016; Trial primary completion date: Oct 2017 ➔ Apr 2018

Trial initiation date • Trial primary completion date • Biosimilar

Magnetic Resonance Elastography of Cardiac Transplant Rejection (clinicaltrials.gov) - P=N/A; N=10; Active, not recruiting; Sponsor: Ohio State University; Recruiting ➔ Active, not recruiting; Trial primary completion date: Dec 2015 ➔ Dec 2017

Enrollment closed • Trial primary completion date • Biosimilar

Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions (clinicaltrials.gov) - P2; N=70; Completed; Sponsor: University Medicine Greifswald

New P2 trial • Biosimilar

Comparison Study in Pancreatic Fiducial Placement (clinicaltrials.gov) - P4; N=30; Active, not recruiting; Sponsor: Parkview Health; Recruiting ➔ Active, not recruiting; Trial primary completion date: Feb 2016 ➔ Feb 2017

Enrollment closed • Trial primary completion date • Biosimilar • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback (clinicaltrials.gov) - P=N/A; N=60; Not yet recruiting; Sponsor: University Hospital, Basel, Switzerland; Initiation date: Oct 2015 ➔ May 2016

Trial initiation date • Biosimilar

Mindfulness & Stress Management Study for Cardiac Patients (clinicaltrials.gov) - P=N/A; N=72; Not yet recruiting; Sponsor: University of Minnesota - Clinical and Translational Science Institute

New trial • Acute Coronary Syndrome • Biosimilar • Cardiovascular • Heart Failure

Fatstim: Cause and Consequence of Neural Fatigue (clinicaltrials.gov) - P=N/A; N=216; Not yet recruiting; Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

New trial • Biosimilar

Trial of Individual Psychosocial Interventions for Cancer Patients (clinicaltrials.gov) - P=N/A; N=414; Recruiting; Sponsor: Memorial Sloan Kettering Cancer Center; Trial primary completion date: Mar 2016 ➔ Mar 2017

Trial primary completion date • Biosimilar • Oncology

Evaluation of APAP With SensAwake in OSA and Insomnia Patients (clinicaltrials.gov) - P=N/A; N=48; Not yet recruiting; Sponsor: Fisher and Paykel Healthcare

New trial • Biosimilar

Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Oregon Health and Science University; Not yet recruiting ➔ Recruiting; Initiation date: Jun 2015 ➔ Jan 2016; Trial primary completion date: Dec 2015 ➔ Dec 2016

Enrollment open • Trial initiation date • Trial primary completion date • Biosimilar

Cycling in Parkinson's Disease (clinicaltrials.gov) - P=N/A; N=24; Recruiting; Sponsor: Rehabilitation Institute of Chicago; Trial primary completion date: Jun 2016 ➔ Jun 2017

Trial primary completion date • Biosimilar • Gene Therapies • Parkinson's Disease