The Marine Pharmacology and Pharmaceuticals Pipeline in 2020

Abstract

Marine organisms continue to provide significant chemical biodiversity that contributes to both the global preclinical and clinical pharmaceutical pipelines. Thus, in December 2020, the clinical marine pharmaceutical pipeline consisted of 13 marine-derived drugs approved by the United States Food and Drug Administration (FDA) and 1 drug approved in Australia: for cancer, cytarabine (Cytosar-U®, Depocyt®, FDA-approved 1969); for herpes simplex virus, vidarabine (Vira-A®, FDA-approved 1976); for pain, ziconotide (Prialt®, FDA-approved 2004); for hypertriglyceridemia, omega-3-acid ethyl esters (Lovaza®, FDA-approved 2004, Vascepa®, FDA-approved 2012, Epanova®, FDA-approved 2014); for cancer, eribulin mesylate (Halaven®, FDA-approved 2010), brentuximab vedotin (Adcetris®, FDA-approved 2011), trabectedin (Yondelis®, FDA-approved 2015), Plitidepsin (Aplidine®, approved in Australia 2018), polatuzumab vedotin (Polivy™, FDA-approved 2019), enfortumab vedotin-ejfv (PACDEV™, FDA-approved 2019), lurbinectedin (Zepzelca™, FDA-approved 2020) and belantamab mafadotin-blmf (BlenrepTM, FDA-approved 2020). Both https://www.clinicaltrials.gov/ website as well as the pharmaceutical companies websites describing the development of marine-derived compounds currently in Phase I, Phase II and Phase III of clinical development were searched. We determined that there were 33 marine-derived compounds in active clinical trials in December 2020: 4 marine-derived compounds were in Phase III, 17 compounds in Phase II, and at least 12 compounds in Phase I, many of them auristatin-containing antibody drug conjugates. Regular updates on the clinical marine pharmaceutical pipeline will be posted on the dedicated website: https://www.midwestern.edu/departments/marinepharmacology/clinical-pipeline.xml. Providing novel leads for the marine pharmaceutical clinical pipeline is the global preclinical marine pharmacology pipeline that continues to generate considerable preclinical data on multiple pharmacological classes: Mayer, A.M.S., A.J. Guerrero, A. D. Rodríguez, O. Taglialatela-Scafati, F. Nakamura and N. Fusetani. Marine Pharmacology in 2014–2015: Marine Compounds with Antibacterial, Antidiabetic, Antifungal, Anti-Inflammatory, Antiprotozoal, Antituberculosis, and Antiviral Activities; Affecting the Immune and Nervous Systems, and other Miscellaneous Mechanisms of Action. Marine Drugs 18(5), 2019. PMID: 31861527. We thus conclude that as of December 2020, both the marine pharmacology preclinical and clinical pharmaceutical pipelines remained very active.