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Zyesami FDA Approval Status

FDA Approved: No
Brand name: Zyesami
Generic name: aviptadil
Company: NRx Pharmaceuticals
Treatment for: COVID-19

Zyesami (aviptadil) is an inhaled formulation of synthetic human Vasoactive Intestinal Polypeptide (VIP) in development for the treatment of patients with critical COVID-19 respiratory failure.

Development timeline for Zyesami

DateArticle
Nov  4, 2021US Food and Drug Administration Declines Emergency Use Authorization for Zyesami (aviptadil) for Patients with Critical COVID-19 with Respiratory Failure
Oct 14, 2021Journal of Infectious Diseases and Treatment Publishes Positive Trial Data of Aviptadil in High Comorbidity Patients Suffering from Critical COVID-19 with Respiratory Failure
Aug 18, 2021NRx Pharmaceuticals Announces Positive Safety Report for Zyesami (aviptadil) in NIH Sponsored ACTIV-3 Critical Care Study in Patients with Life-Threatening COVID-19
Apr  6, 2021NeuroRx Announces Zyesami (Aviptadil) Has Been Selected for Inclusion in NIH-Sponsored Global Clinical Trial to Include Aviptadil and Remdesivir
Sep 23, 2020NeuroRx Submits Request for Emergency Use Authorization for RLF-100™ (aviptadil) in the Treatment of Patients with Critical COVID-19 and Respiratory Failure Who Have Exhausted Approved Therapy
Aug  6, 2020FDA Grants Inhaled Use IND for RLF-100 (aviptadil) to Treat Patients with Moderate and Severe COVID-19 Aiming to Prevent Progression to Respiratory Failure
Aug  3, 2020RLF-100 (aviptadil) Clinical Trial Showed Rapid Recovery from Respiratory Failure and Inhibition of Coronavirus Replication in Human Lung Cells
Jun 24, 2020NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19
May  6, 2020Relief Therapeutics Holding Drug Aviptadil Enters FDA Trial at NYU Langone Health, New York, to Treat COVID-19-induced Acute Respiratory Distress
May  4, 2020Relief Therapeutics Holding Drug Aviptadil Enters FDA Trial at University of California Irvine, to Treat COVID-19-Induced Acute Respiratory Distress
Apr  9, 2020Relief Therapeutics Drug Aviptadil Enters FDA Trial at Thomas Jefferson University Hospital in Philadelphia, to treat COVID-19-Induced Acute Respiratory Distress
Apr  7, 2020Relief Therapeutics' Drug Aviptadil Enters FDA Trial at University of Miami to Treat COVID-19-Induced Respiratory Distress

Further information

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