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peramivir

Trade name: rapivab

Small moleculeapprovedFast Track FDA

Approved

Dec 19, 2014

Peramivir is a transition-state analogue and a potent, specific influenza viral neuraminidase inhibitor. Rapivab (peramivir injection) is indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 2 days. Efficacy of Rapivab is based on clinical trials in which the predominant influenza virus type was influenza A and a limited number of subjects infected with influenza B virus were enrolled. Since influenza viruses change over time emergence of resistance substitutions could decrease drug effectiveness. Other factors such as changes in viral virulence might also diminish clinical benefit of antiviral drug. Efficacy could not be established in patients with serious influenza requiring hospitalization. — NCATS

Clinical trial activity

15 trials · 56 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
12
Phase 3
8
Phase 4
1

Earliest trial started Feb 23, 2006 (NCT00297050)

Timeline

2000s

  1. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2007

    BioCryst — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2007

    BioCryst — Earliest Phase 3 Sponsor(trial)

2010s

  1. Dec 19, 2014

    BioCryst — Earliest FDA Approval

  2. Dec 19, 2014

    BioCryst — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFast trackDec 19, 2014

Chemistry & pharmacology

Loading structure…

SMILES

CCC(CC)[C@H](NC(C)=O)[C@@H]1[C@H](O)[C@@H](C(=O)O)C[C@H]1NC(=N)N.O.O.O
Mol. weight
382.46 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 3-(1-acetamido-2-ethyl-butyl)-4-guanidino-2-hydroxy-cyclopentane-1-carboxylic acid
  • 3-(1'-acetylamino-2'-ethyl)butyl-4-((aminoimino)methyl)amino-2-hydroxycyclopentane-1-carboxylic acid
  • bcx1812
  • bcx 1812
  • bcx-1812
  • bcx-1812
  • bcx-1812
  • bcx-1812
  • peramavir
  • peramivir
  • peramivir
  • peramivir
  • peramivir
  • peramivir
  • peramivir
  • peramivir
  • peramivir
  • peramivir
  • peramivir
  • peramivir
  • peramivir hydrate
  • rapiacta
  • rapivab
  • rapivab
  • rapivab
  • rapivab
  • rapivab
  • rapivab
  • rapivab
  • rwj270201
  • rwj 270201
  • rwj-270201
  • rwj-270201

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05648448Phase 2Dec 22, 2022University of Oxford
NCT02635724Phase 3Dec 1, 2015BioCryst, Oakland University
NCT02609399Phase 4Nov 1, 2015Department of Health and Human Services, Johns Hopkins University
NCT02369159Phase 3Feb 1, 2015BioCryst, Louisiana State University
NCT02665351Phase 2/Phase 3 (Phase 3)Feb 1, 2011BioCryst, Chinese University of Hong Kong
NCT01224795Phase 3Oct 1, 2010BioCryst, Department of Health and Human Services
NCT01063933Phase 1/Phase 2 (Phase 2)Feb 4, 2010National Institute of Allergy and Infectious Diseases (NIAID)
NCT00958776Phase 3Nov 1, 2009BioCryst, Department of Health and Human Services
NCT00957996Phase 3Oct 1, 2009BioCryst, Department of Health and Human Services
NCT00705406Phase 2Jul 1, 2008BioCryst
NCT00453999Phase 2Jul 1, 2007BioCryst
NCT00486980Phase 3Jun 14, 2007BioCryst
NCT00610935Phase 3Jan 1, 2007BioCryst
NCT00419263Phase 2Jan 1, 2007Advanced Clinical Research Inc., Alliance Medical Center, Alpine Clinical Research Center, Balbir Chahal M.D. ,P.A., Bascom Palmer Eye Institute, Baylor University, Belvedere Medicentre, Benchmark Research, BioCryst, Bozeman Urgent Care Center, Castledowns Medicentre, Central Kentucky Research Assoc, Inc, Clinical Research of South Florida, Clinique medicale des Campus, DM Clinical Research, Gain Medical Research Centre, George Washington University, Georgia Clinical Research, Hermitage Medicentres, Hillcrest Family Practice, Integrated Medical Research, PC, Jacksonville Center for Clinical Research, J. Lewis Research, Inc, Kentucky Pediatric and Adult Research, Manna Research, MEDEX, New England Center for Clinical Research, Inc, Omega Medical Research, Omnispec Clinical Research Inc, Mirabel, Canada, Orange County Clinical Trials, Pacific Sleep Medicine, Palm Beach Research Center, Paragon Clinical Research, Inc., Prairie Clinical, Primary Physicians Research, Inc, Q & T Research, Radiant Research, Research Across America, RJA Medicentres, Sterling Research Group, Ltd, Summa Emergency Associates Inc., The Brooklyn Hospital Center, Towngate Plaza Medical Center, University Clinical Research-Deland, LLC, University of Calgary, University of Medicine and Dentistry of New Jersey, Wake Research Associates, Washington University in St. Louis, Wishard Hospital
NCT00297050Phase 1Feb 23, 2006National Institute of Allergy and Infectious Diseases (NIAID)
Showing 15 of 15 trials
Page 1 / 1

Organizations

Research & Development (56)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BioCrystFor profit111022007
Department of Health and Human ServicesGovernment4022009
National Institute of Allergy and Infectious Diseases (NIAID)Government2222006
Advanced Clinical Research Inc.For profit1012007
Alliance Medical CenterAcademic/Hospital1012007
Alpine Clinical Research CenterFor profit1012007
Balbir Chahal M.D. ,P.A.Academic/Hospital1012007
Bascom Palmer Eye InstituteAcademic/Hospital1012007
Baylor UniversityAcademic/Hospital1012007
Belvedere MedicentreAcademic/Hospital1012007
Benchmark ResearchFor profit1012007
Bozeman Urgent Care CenterAcademic/Hospital1012007
Castledowns MedicentreAcademic/Hospital1012007
Central Kentucky Research Assoc, IncFor profit1012007
Chinese University of Hong KongAcademic/Hospital1112011
Clinical Research of South FloridaFor profit1012007
Clinique medicale des CampusAcademic/Hospital1012007
DM Clinical ResearchFor profit1012007
Gain Medical Research CentreAcademic/Hospital1012007
George Washington UniversityAcademic/Hospital1012007
56 organizations
Page 1 / 3

Marketing (1)

OrganizationOrg typeRelationshipDate
BioCrystFor profitNDADec 19, 2014