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mecasermin

Trade name: Increlex

Recombinant proteinapprovedOrphan Drug FDA

Approved

Aug 30, 2005

Mecasermin rinfabate, also known as rhIGF-1/rhIGFBP-3, is a drug consisting of recombinant human insulin-like growth factor 1 (IGF-1) and recombinant human insulin-like growth factor binding protein-3 (IGFBP-3) which is used for the treatment of amyotrophic lateral sclerosis. — Wikipedia

Clinical trial activity

39 trials · 35 clinical orgs · 3 marketing orgs

Phase 1
11
Phase 2
21
Phase 3
10
Phase 4
0

Earliest trial started Jan 1, 1990 (NCT00571727)

Timeline

1990s

  1. Jan 1, 1990

    Ipsen — Earliest Phase 2 Sponsor(trial)

  2. Dec 12, 1995

    Orphan Drug Designation

2000s

  1. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  3. Aug 30, 2005

    Tercica — Earliest FDA Approval

  4. Aug 30, 2005

    Ipsen — NDA Secondary Org

  5. Aug 30, 2005

    Tercica — NDA Organization

  6. Dec 12, 2005

    Insmed, Inc. — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAug 30, 2005

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • cep-151
  • cep-151
  • human insulin-like growth factor i
  • igf1
  • igf1
  • igf1
  • igf-1
  • igf-1
  • igfbp-3
  • igf-i
  • igf-i-igfbp-3 complex
  • increlex
  • increlex
  • increlex
  • increlex
  • increlex
  • insulin growth factor 1
  • insulin-like growth factor 1
  • insulin-like growth factor 1
  • insulin-like growth factor-1
  • insulin-like growth factor i
  • insulin like growth factor, type 1
  • iplex
  • iplex
  • mecasermin
  • mecasermin
  • mecasermin
  • mecasermin
  • mecasermin
  • mecasermin
  • mecasermin
  • mecasermin recombinant
  • mecasermin recombinant
  • mecasermin recombinant
  • mecasermin recombinant
  • mecasermin recombinant
  • mecasermin rinfabate
  • mecasermin rinfabate
  • mecasermin rinfabate [rdna origin]
  • mecasermin rinfabate recombinant
  • mecasermin rinfabate recombinant
  • mecasermin rinfabate recombinant
  • mechano growth factor
  • mescamerin recombinant
  • myotrophin
  • rhigf-i/rhigfbp-3
  • somatokine
  • somatomedin c
  • somatomedin-c
  • somatomedin-c

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03932162Early Phase 1 (Phase 1)Jun 30, 2019Wright State University
NCT02636270Phase 1/Phase 2 (Phase 2)Dec 1, 2015University of Cincinnati
NCT01970345Phase 2May 1, 2014Autism Science Foundation, Icahn School of Medicine at Mount Sinai
NCT01834989Early Phase 1 (Phase 1)Apr 1, 2013Aarhus University, Government of Denmark, University of Copenhagen
NCT01777542Phase 2Jan 1, 2013Harvard University, International Rett Syndrome Foundation
NCT01525901Phase 2Feb 1, 2012Icahn School of Medicine at Mount Sinai, National Institute of Mental Health (NIMH)
NCT01438086Phase 1/Phase 2 (Phase 2)Oct 1, 2011National University of Ireland
NCT01406444N/AOct 1, 2011Harvard University
NCT01446783N/ASep 1, 2011University of Copenhagen
NCT01314508N/AJun 1, 2011University of California, Los Angeles
NCT01329744Phase 1Jun 1, 2011The University of Texas, Dallas
NCT01588093N/AApr 1, 2011Karolinska Institute
NCT01301183Phase 3Feb 1, 2011Harvard University
NCT01253317Phase 1Dec 1, 2010Autism Speaks, Harvard University, International Rett Syndrome Foundation
NCT01207908Phase 1/Phase 2 (Phase 2)Nov 1, 2010Charley's Fund, Ipsen, University of Cincinnati
NCT01096784Phase 2Jun 1, 2010Shire
NCT01020955Phase 3Oct 1, 2009Karolinska Institute
NCT00764699Phase 2/Phase 3 (Phase 3)Oct 1, 2008Ohio State University, Tercica
NCT00720122Phase 2Jul 1, 2008Harvard University
NCT00566241Phase 1Jun 1, 2008Stony Brook University
Showing 20 of 39 trials
Page 1 / 2

Organizations

Research & Development (35)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Harvard UniversityAcademic/Hospital7741998
IpsenFor profit6521990
Insmed, Inc.For profit4322005
National Institute of Neurological Disorders and Stroke (NINDS)Government3121997
TercicaFor profit3032007
University of PennsylvaniaAcademic/Hospital3221995
Icahn School of Medicine at Mount SinaiAcademic/Hospital2212012
International Rett Syndrome FoundationAcademic/Hospital2022010
Karolinska InstituteAcademic/Hospital2222009
The University of Texas, DallasAcademic/Hospital2122002
University of CincinnatiAcademic/Hospital2212010
University of CopenhagenAcademic/Hospital2222011
University of RochesterAcademic/Hospital2112005
Aarhus UniversityAcademic/Hospital1012013
ALS AssociationAcademic/Hospital1012003
Autism Science FoundationAcademic/Hospital1012014
Autism SpeaksAcademic/Hospital1012010
CephalonFor profit1012003
Charley's FundAcademic/Hospital1012010
Columbia UniversityAcademic/Hospital1112008
35 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
Insmed, Inc.For profitNDA2Dec 12, 2005
IpsenFor profitNDA2Aug 30, 2005
TercicaFor profitNDAAug 30, 2005