Drugs / PERAMIVIR ANHYDROUS

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) RAPIVAB 2017-09-20 – 2021-01-28 fda.gov
Approved EU (EMA) Alpivab 2018-04-13 europa.eu
Approved US (FDA) RAPIVAB 2014-12-19 fda.gov

Trials 14 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00297050 Feb → Nov 2006 influenza National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01063933 ? → Aug 2011 influenza National Institute of Allergy and Infectious Diseases (NIAID) Withdrawn No outcome recorded
Phase 24 trials
Phase 2 NCT05648448 Feb 2023 → Jan 2027 expected influenza University of Oxford Recruiting No outcome recorded
Phase 2 NCT00705406 Jul 2008 → Apr 2009 influenza BioCryst Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00453999 Jul 2007 → Sep 2008 influenza BioCryst Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00419263 Jan → Sep 2007 influenza BioCryst Pharmaceuticals Completed No outcome recorded
Phase 37 trials
Phase 3 NCT02635724 Dec 2015 → Apr 2018 influenza BioCryst Pharmaceuticals Completed No outcome recorded
Phase 3 NCT02369159 Mar 2015 → Oct 2019 influenza BioCryst Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01224795 Oct → Nov 2010 influenza BioCryst Pharmaceuticals Withdrawn No outcome recorded
Phase 3 NCT00958776 Nov 2009 → Nov 2012 headache disorder, influenza, nasal cavity disorder, pharyngitis BioCryst Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT00957996 Oct 2009 → Oct 2010 headache disorder, influenza, nasal cavity disorder, pharyngitis BioCryst Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00610935 Jan → Feb 2008 influenza BioCryst Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT00486980 influenza BioCryst Pharmaceuticals Withdrawn No outcome recorded
Phase 41 trial
Phase 4 NCT02609399 Nov 2015 → May 2017 influenza Johns Hopkins University Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2/3 NCT02665351 Comparator Feb 2011 → Mar 2014 influenza Chinese University of Hong Kong Completed No outcome recorded

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

FieldValueCited text
Known as PERAMIVIR ANHYDROUS ChEMBL registry synonym — accepted as the source's own label CHEMBL139367
Known as Alpivab ChEMBL registry synonym — accepted as the source's own label CHEMBL139367
Known as BCX1812 “Placebo Peramivir (BCX1812) administered intravenously” NCT00958776
Known as Peramivir ClinicalTrials.gov intervention name — accepted as the source's own label NCT02665351
14

NCT00957996

NCT00297050

NCT05648448

NCT00610935

NCT01063933

NCT01224795

NCT00453999

NCT00958776

NCT02635724

NCT02369159

NCT00705406

NCT00419263

NCT00486980

NCT02609399

Known as Peramivir hydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL139367
Known as Peramivir trihydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL139367
Known as Rapiacta ChEMBL registry synonym — accepted as the source's own label CHEMBL139367
Known as RAPIVAB “Peramivir (RAPIVAB®)” NCT05648448
Known as RWJ-270201 ChEMBL registry synonym — accepted as the source's own label CHEMBL139367
Known as RWJ-270201-162 ANHYDROUS ChEMBL registry synonym — accepted as the source's own label CHEMBL139367
Action Inhibit “intravenous peramivir, a neuraminidase inhibitor” NCT00297050
Modality Small molecule CHEMBL139367
Route Intravenous intravenous peramivir” NCT00297050