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famciclovir

Trade name: famvir

Small moleculeapproved

Approved

Jun 29, 1994

Famciclovir is a guanosine analogue antiviral drug used for the treatment of various herpesvirus infections, most commonly for herpes zoster (shingles). It is a prodrug form of penciclovir with improved oral bioavailability. Famciclovir is marketed under the trade name Famvir (Novartis). — Wikipedia

Clinical trial activity

20 trials · 12 clinical orgs · 11 marketing orgs

Phase 1
2
Phase 2
9
Phase 3
8
Phase 4
4

Earliest trial started Jan 1, 2003 (NCT00171990)

Timeline

1990s

  1. Jun 29, 1994

    Novartis — Earliest FDA Approval

  2. Jun 29, 1994

    Novartis — NDA Organization

  3. Jun 29, 1994

    Novartis — NDA Secondary Org

2000s

  1. Jan 1, 2003

    Novartis — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2004

    Teva — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2007

    Novartis — Earliest Phase 2 Sponsor(trial)

  4. Aug 24, 2007

    Teva — Marketing Organization

2010s

  1. Mar 21, 2011

    Aurobindo Pharma — Marketing Organization

  2. Mar 21, 2011

    Cipla — Marketing Organization

  3. Mar 21, 2011

    West-Ward Pharmaceutical — Marketing Organization

  4. Mar 21, 2011

    Hikma — Marketing Organization

  5. Mar 24, 2011

    Mylan — Marketing Organization

  6. Mar 24, 2011

    Natco Pharma — Marketing Organization

  7. Jul 22, 2011

    Apotex — Marketing Organization

  8. Jan 12, 2012

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  9. Sep 10, 2014

    Hetero Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 29, 1994

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)OCC(CCN1C=NC2=CN=C(N)N=C12)COC(C)=O
Mol. weight
321.3318 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • 2-(2-(2-amino-9h-purin-9-yl)ethyl)-1,3-propanediol diacetate
  • 2-(2-(2-amino-9h-purin-9-yl)ethyl)-1,3-propanediol diacetate
  • 9-(4-acetoxy-3-(acetoxymethyl)but-1-yl)-2-aminopurine
  • 9-[4-acetoxy-3-(acetoxymethyl)but-1-yl]-2-aminopurine
  • 9-[4-acetoxy-3-(acetoxymethyl)but-1-yl]-2-aminopurine
  • acetic acid 2-acetoxymethyl-4-(2-amino-purin-9-yl)-butyl ester
  • acetic acid 2-acetoxymethyl-4-(2-amino-purin-9-yl)-butyl ester
  • brl 42810
  • brl-42810
  • brl-42810
  • brl-42810
  • famciclovir
  • famciclovir
  • famciclovir
  • famciclovir
  • famciclovir
  • famciclovir
  • famciclovir
  • famciclovir
  • famciclovir
  • famciclovir
  • famciclovir
  • famciclovirum
  • famciclovirum
  • famcivir
  • famcyclovir
  • famtrex
  • famvir
  • famvir
  • famvir
  • famvir
  • famvir
  • famvir
  • fcv
  • fcv

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06798662N/AFeb 1, 2025Inner Mongolia Baogang Hospital
NCT05283551Phase 2Nov 25, 2020University of London
NCT03120962N/AMay 1, 2017Zhejiang University
NCT01281007Phase 3Jul 1, 2012EMS S/A
NCT01327144Phase 3Jun 1, 2012EMS S/A
NCT01526408Phase 3Dec 1, 2011House Clinic, Inc., House Research Institute
NCT00878072Phase 2/Phase 3 (Phase 3)Mar 1, 2009Novartis
NCT00448227Phase 2Oct 1, 2007Case Western Reserve University, Novartis
NCT01321515N/AJul 1, 2007Advanced Biomedical Research, Roxane Laboratories
NCT01321502N/AJul 1, 2007Roxane Laboratories
NCT00477334Phase 4Jun 1, 2007Novartis
NCT00306787Phase 3Mar 1, 2006Novartis
NCT00098046Phase 3Jul 1, 2005Novartis
NCT00098059Phase 3Feb 1, 2005Novartis
NCT00834431Phase 1Aug 1, 2004PRACS, Teva
NCT00834444Phase 1Aug 1, 2004PRACS, Teva
NCT00129818Phase 4Jul 1, 2004Novartis
NCT00248144Phase 4Oct 1, 2003Novartis
NCT00219310Phase 4Jun 1, 2003Novartis
NCT00171990Phase 3Jan 1, 2003Novartis
Showing 20 of 20 trials
Page 1 / 1

Organizations

Research & Development (12)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit101032003
EMS S/AFor profit2212012
PRACSFor profit2012004
Roxane LaboratoriesFor profit2212007
TevaFor profit2212004
Advanced Biomedical ResearchFor profit1012007
Case Western Reserve UniversityAcademic/Hospital1012007
House Clinic, Inc.Academic/Hospital1012011
House Research InstituteAcademic/Hospital1112011
Inner Mongolia Baogang HospitalAcademic/Hospital1112025
University of LondonAcademic/Hospital1112020
Zhejiang UniversityAcademic/Hospital1112017
12 organizations
Page 1 / 1

Marketing (13)

OrganizationOrg typeRelationshipDate
ApotexFor profitMKTGJul 22, 2011
Aurobindo PharmaFor profitMKTGMar 21, 2011
CiplaFor profitMKTGMar 21, 2011
Hetero Labs LtdFor profitMKTGSep 10, 2014
HikmaFor profitMKTGMar 21, 2011
HikmaFor profitSYNMar 21, 2011
Macleods Pharmaceuticals, LtdFor profitMKTGJan 12, 2012
MylanFor profitMKTGMar 24, 2011
Natco PharmaFor profitMKTGMar 24, 2011
NovartisFor profitNDAJun 29, 1994
NovartisFor profitNDA2Jun 29, 1994
TevaFor profitMKTGAug 24, 2007
West-Ward PharmaceuticalFor profitMKTGMar 21, 2011