To Download a Copy of Agencyiq's COVID-19 Development Tracker
Total Page:16
File Type:pdf, Size:1020Kb
Development tracker: The drugs and vaccines in development for COVID-19 The pharmaceutical and biopharmaceutical industry is scrambling to put products into development to potentially treat, cure or prevent COVID-19 infections. Based on a review by AgencyIQ of ClinicalTrials.gov, company announcements and media reports, there are at least 140 medical product candidates in various stages of testing to assess their potential effects against COVID-19 or SARS-CoV-2, the virus which causes the condition. Some have already been approved and are being assessed for their potential to treat COVID, while others are being repurposed from other late-stage development pipelines. Others are still in the very early stages of development and have not yet been tested in humans. Based on evidence from recent studies, the chances of clinical success are low. Of all drugs for infectious diseases that enter Phase 1 testing, just 26.7% go on to obtain approval. Just 31.6% of vaccines that enter Phase 1 testing go on to obtain approval. The size of the development pipeline and interest in COVID-19 may indicate that several of these products will go on to obtain approval, but the safety and efficacy of these products is far from guaranteed. As companies try to bring whatever compounds they have into clinical testing, it’s possible that few, if any, of these products will ultimately prove safe or effective. Highlights: 95+ 45+ 24+ 40+ Therapeutic medical Vaccines in development Products already approved Products already in clinical products in development for other indications development (6 vaccines, 34 therapies) Last updated 8 April 2020. New updates to this spreadsheet are highlighted in purple. Therapeutic Development Clinical Company Drug Name Product Type Overview/Highlights History Timeline Sources phase Ritonavir is an L- valine derivative that is an antiretroviral drug from the protease inhibitor class used to Abbott (HIV treat HIV infection and approval) prevent or treat AIDS. It is often used as a fixed- Abbott received approval AbbVie, dose combination with Approved in 1996 for for the treatment of HIV in Approved Ascletis, another protease HIV. Currently a piece of 1996 under the drug name for another Company Pharmstandard inhibitor, lopinavir. many clinical trials for Ritonavir Therapeutic Norvir. Many trials are indication; announcement , Gilead, Ritonavir is also used in COVID-19 treatments in looking at combinations of in clinical / PubChem Shionogi, combination with combination with other ritonavir and other drugs testing. Toyama dasabuvir sodium drugs. for treatment of COVID-19. Chemical, hydrate, ombitasvir and Janssen, paritaprevir (under the Biogen, Merck trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection and cirrhosis of the liver. The First Affiliated Approved Testing is taking place Hospital of Drug approved for The estimated study for another Reported in in China to assess Fujian Medical Fingolimod Therapeutics treatment of multiple completion date is July indication; media / treatment for COVID-19 University sclerosis (Novartis) 1st. in clinical Clinical Trials pneumonia. testing. Novartis Previous studies have First Affiliated shown the drug can treat Approved Currently in Phase II. Hospital of Testing taking place in H1N1 lung injury. for another Reported in Estimated study Wenzhou Thalidomide Therapeutic China for treatment of Thalidomide is approved indication; media / completion date is May Medical severe COVID-19 cases. in the US, though has a in clinical Clinical Trial 30th. University REMS due to causing birth testing. defects. Last updated 8 April 2020. New updates to this spreadsheet are highlighted in purple. Clinical Company Drug Name Product Type Overview/Highlights History Timeline Sources phase Approved FDA granted approval to for another Reported in Sildenafil Testing in China Currently in Phase III in Tongji Hospital Therapeutic Pfizer under the name indication; media / citrate currently. China. Viagra. in clinical Clinical Trial testing. Peking Union Medical Approved Currently being tested Reported in College Approved for many for another Cortico- in China and under a Trial estimated to Media / Hospital Therapeutic indications by the FDA indication; steroid phase III clinical trial for complete on April 25th Clinical Trial / including cancers. in clinical H1N1 WHO University of testing Oxford Novartis subsidiary Sandoz is donating up to 130 million doses of University of generic Minnesota hydroxychloroquine. Many groups are University of assessing the ability for Some clinical results are Oxford Company Chloroquine to treat already available but Approved announcement Chloroquine patients with Approved by the FDA for are inconclusive. HCQ for another Various / FDA / HHS / / Hydroxy- Therapeutic mild/moderate COVID- treatment of malaria was able to shorten indication; Chinese Reported in chloroquine 19 to reduce the (Novartis). recovery times in one in clinical research media / duration of symptoms study. testing sponsors Clinical Trial and decrease viral shedding. The FDA issued an EUA Novartis to allow the drug to be distributed from the Mylan national stockpile and used on hospitalized patients. Prior FDA approval for Approved Incyte’s Jakofi to treat Tongji Hospital Currently being tested Study in China set to for another Reported in “steroid-refractory acute Ruxolitinib Therapeutic in China for COVID-19 complete by end of indication; media / WHO / GVHD in adult and Incyte Corp. treatment. year in clinical Clinical Trial pediatric patients 12 years testing and older.” Last updated 8 April 2020. New updates to this spreadsheet are highlighted in purple. Clinical Company Drug Name Product Type Overview/Highlights History Timeline Sources phase Wuhan Infectious Approved Diseases Testing taking place in Merck (Schering) received No timeline. Clinical for another Hospital Peginterfero China. Also studying Reported in Therapeutic approval for the treatment trials currently occurring indication; n alfa-2b the effect in MERS Media / WHO of hepatitis C previously. in China. in clinical Eiger treatment. testing BioPharmaceut ic A recombinant humanized monoclonal Amgen received prior Approved Clinical trial is currently Reported in Qilu Hospital IgG1 antibody that approval from the FDA for another Therapeutic – recruiting in China. media / of Shandong Bevacizumab binds to and inhibits the under the name Avastin indication; antibodies Report out expected in Clinical Trial / University biologic activity of which is indicated for in clinical April. DrugBank human vascular cancer treatment. testing endothelial growth factor (VEGF). Gilead Clinical trial currently taking place in China Sichian for COVID-19 Approved Academy of Approved by the FDA in treatment. It works as a for another Medical Emtricitabine Therapeutic - 2004 under name Truvada WHO / Clinical “Non-nucleoside No timeline indication; Sciences & , tenofovir antiviral (Gilead) to treat/prevent Trial reverse transcriptase in clinical Sichian HIV-1. inhibitor and testing Provincial nucleotide reverse People’s transcriptase inhibitor” Hospital Roche BARDA Approved by FDA under No timeline, but further Approved Roche is starting a the name than others studying the for another Company First Affiliated Therapeutic – Phase III clinical trial for Actemra/RoActemra Tocilizumab same drug in other indication; announcement Hospital of the antibodies treatment of COVID-19 previously, for the countries. Currently in in clinical / Clinical Trial University pneumonia. indication of rheumatoid Phase III testing of Science and artritis. Technology of China Last updated 8 April 2020. New updates to this spreadsheet are highlighted in purple. Clinical Company Drug Name Product Type Overview/Highlights History Timeline Sources phase The company already markets iNO as INOmax in the US to treat term and The company is near-term newborns exploring inhaled nitric suffering from hypoxic Currently working with oxide (iNO) as a respiratory failure caused FDA and other Approved Company Inhaled nitric supportive measure for Mallinckrodt Therapeutic by pulmonary regulatory agencies to for another announcement oxide (ino) COVID-19, particularly hypertension. Additionally, explore the treatment indication. / PubChem for patients with iNO was used in a study to possibility. pulmonary treat six SARS-CoV patients complications. and showed improvements compared to controls. Baloxavir marboxil was originally developed by Shionogi Co. and Roche for influenza A and Previously approved influenza B infections. The under another Baloxavir is an inhibitor drug was initially approved indication. Currently in Approved of the influenza cap- for use in Japan in Reported in clinical testing in China for another Baloxavir dependent February 2018. It was media / Roche Therapeutic in combination with indication; marboxil endonuclease enzyme approved by the FDA on PubChem / Favipiravir at The First in clinical and is used as therapy October 24, 2018, for the Clinical Trials Affiliated Hospital, testing of influenza A and B. treatment of acute Zhejiang University uncomplicated influenza in School of Medicine. patients 12 years of age or older who have been symptomatic for no more than 48 hours. Interferon-beta is a form of recombinant A clinical trial is BIOGEN received approval human interferon used ongoing in France, Approved in the US for this drug to Company to slow disease sponsored by the for another Interferon treat multiple sclerosis. A announceme Merck KGaA