CDEK
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corticotropin

Trade name: acthar

Biologicalapproved

Approved

Jul 3, 1950

Seractide is a polypeptide hormone corresponding to thirty-nine amino acids of human corticotropin that differs from full-length human corticotropin at four positions. Seractide is potent endogenous melanocortin receptor 2 (MC ) agonist. Seractide stimulates the cortex of the adrenal gland and boosts the synthesis of corticosteroids, mainly glucocorticoids but also sex steroids (androgens). Seractide, was approved by FDA in 1978, but was never marketed. The Seractide, that was ultimately withdrawn by FDA in 2014 for safety reasons. — NCATS

Clinical trial activity

120 trials · 111 clinical orgs · 12 marketing orgs

Phase 1
11
Phase 2
26
Phase 3
15
Phase 4
54

Earliest trial started Nov 1, 1993 (NCT00004758)

Timeline

1950s

  1. Jul 3, 1950

    Sanofi-Aventis — Earliest FDA Approval

  2. Jul 3, 1950

    Sanofi-Aventis — NDA Secondary Org

  3. Jul 3, 1950

    Sanofi-Aventis — NDA Organization

  4. Mar 14, 1952

    Parke-Davis — NDA Secondary Org

  5. Apr 29, 1952

    Mallinckrodt — NDA Secondary Org

  6. Apr 29, 1952

    Mallinckrodt — Marketing Organization

  7. Jun 16, 1954

    Ani Pharmaceuticals — Marketing Organization

  8. Jun 16, 1954

    Ani Pharmaceuticals — NDA Secondary Org

  9. Sep 12, 1957

    AbbVie — NDA Secondary Org

1970s

  1. Apr 22, 1970

    Amphastar Pharmaceuticals — NDA Secondary Org

1990s

  1. Jan 1, 1993

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Feb 21, 2008

    Sandoz — NDA Secondary Org

  2. Feb 21, 2008

    Novartis — NDA Secondary Org

  3. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

  4. Dec 17, 2009

    Mylan — Marketing Organization

  5. Dec 17, 2009

    PHARMOBEDIENT — Marketing Organization

2010s

  1. Jan 1, 2010

    Earliest Phase 3 Sponsor(trial)

  2. Oct 15, 2010

    Questcor Pharmaceuticals — NDA Secondary Org

  3. Jun 29, 2012

    Sandoz — Marketing Organization

  4. Jun 29, 2012

    Novartis — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJul 3, 1950

Chemistry & pharmacology

Loading structure…

SMILES

CSCC[C@H](NC(=O)[C@H](CO)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@@H](N)CO)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]cn1)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N1CCC[C@H]1C(=O)N[C@H](C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N1CCC[C@H]1C(=O)N[C@H](C(=O)N[C@@H](CCCCN)C(=O)N[C@H](C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N1CCC[C@H]1C(=O)O)C(C)C)C(C)C)C(C)C
Mol. weight
2933.49 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • acth
  • acth
  • acth
  • acth
  • acth
  • acthar
  • acthar
  • acthar
  • acthar
  • acthar gel
  • acthar gel
  • acthar gel
  • acthar gel
  • acthar gel-synthetic
  • acthar gel-synthetic
  • acthar gel-synthetic
  • acth-z
  • acth zinc
  • adrenocorticotrophic hormone
  • adrenocorticotrophin
  • adrenocorticotrophin
  • adrenocorticotropic hormone
  • adrenocorticotropic hormone
  • adrenocorticotropic hormone
  • adrenocorticotropic hormone
  • adrenocorticotropic hormone 1-24
  • adrenocorticotropic hormone 1-24
  • adrenocorticotropic hormone fragment 1-24 human, rat
  • adrenocorticotropin
  • adrenocorticotropin
  • adrenocorticotropin zinc
  • adrenomone
  • alpha(1-24)-corticotrophin
  • alpha(1-24)-corticotrophin
  • atch (1-24)
  • atch (1-24)
  • beta(1-24)-corticotrophin
  • beta(1-24)-corticotrophin
  • corticotrophin
  • corticotrophin
  • corticotrophin
  • corticotrophin
  • corticotrophin zinc hydroxide
  • corticotropin
  • corticotropin
  • corticotropin
  • corticotropin
  • corticotropin
  • corticotropin
  • corticotropin
  • corticotropin
  • corticotropin
  • corticotropin
  • corticotropin (1-24)
  • corticotropin (1-24)
  • corticotropin (1-24)
  • corticotropin (1-24)
  • corticotropin (1-24)
  • corticotropin (1-24)
  • corticotropin-(1-24)
  • corticotropin-(1-24)
  • corticotropin-(1-24) tetracosapeptide
  • corticotropin-(1-24) tetracosapeptide
  • corticotropin, repository
  • corticotropin tetracosapeptide
  • corticotropin tetracosapeptide
  • corticotropin tetracosapeptide
  • corticotropin zinc hydroxide
  • corticotropin zinc hydroxide
  • corticotropin zinc hydroxide
  • corticotropin-zinc hydroxide
  • corticotropin-zinc hydroxide
  • corticotropin-zinc hydroxide
  • corticotropin-zinc hydroxide
  • cortigel
  • cortigel
  • cortrophin
  • cortrophin
  • cortrophin
  • cortrophin-zinc
  • cortrophin-zinc
  • cortrophin-zinc
  • cortrophin zinc acth
  • cortrosyn
  • cortrosyn
  • cortrosyn
  • cortrosyn depot
  • cosyntropin
  • cosyntropin
  • cosyntropin
  • cosyntropin
  • cosyntropin
  • cosyntropin
  • h.p. acthar gel
  • h.p. acthar gel
  • h.p. acthar gel
  • purified cortrophin gel
  • purified cortrophin gel
  • repository corticotropin
  • repository corticotropin
  • seractide
  • seractide
  • seractide
  • seractide
  • seractide
  • seractide
  • seractide acetate
  • seractide acetate
  • seractide acetate
  • seractide acetate hydrate
  • synacthen
  • synacthen
  • synacthen depot
  • synacthen depot
  • synacthen depot
  • synacthen retard
  • tetracosactide
  • tetracosactide
  • tetracosactide
  • tetracosactide
  • tetracosactide
  • tetracosactide
  • tetracosactide acetate
  • tetracosactide acetate
  • tetracosactide acetate
  • tetracosactin
  • tetracosactrin
  • tetracosactrin
  • tetracosactrin
  • tetracosactrin
  • tetracosactrin
  • tetracosactrin depot
  • tetracosactrin zinc
  • tetracosapeptide
  • vicotrope
  • vicotrope
  • zinc corticotropin
  • zn beta(1-24)acth
  • α1-24-corticotrophin
  • α1-24-corticotrophin
  • β1-24-corticotrophin
  • β1-24-corticotrophin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06964269Phase 4Feb 11, 2025Toyos Clinic
NCT06201897Phase 2/Phase 3 (Phase 3)Mar 31, 2024All India Institute of Medical Sciences
NCT06079788Phase 3Nov 1, 2023Huazhong University of Science and Technology, Jiao Tong University, Kunming Medical University, Nanjing Medical University, Ningbo Women & Children's Hospital, Zhejiang University
NCT05696613Phase 3Mar 13, 2023Cerium Pharmaceuticals
NCT05279118Phase 2/Phase 3 (Phase 3)Mar 1, 2022All India Institute of Medical Sciences
NCT04546126Early Phase 1 (Phase 1)Nov 30, 2021University of Michigan
NCT05071781Phase 4May 21, 2021Katholieke Universiteit Leuven
NCT04808856N/AApr 1, 2021Huazhong University of Science and Technology, Tongji University
NCT04461535N/AJul 31, 2020Chongqing Medical University, the Chongqing Primary Aldosteronism Study (CONPASS) Group
NCT04169061Phase 4Sep 30, 2019Mallinckrodt
NCT04080076Phase 4Sep 4, 2019Mallinckrodt, NephroNet Clinical Research Consortium
NCT03905603Early Phase 1 (Phase 1)Aug 31, 2019University of Virginia
NCT03727776Early Phase 1 (Phase 1)Jul 31, 2019Johns Hopkins University, Mallinckrodt
NCT03752190Phase 4Jul 31, 2019Johns Hopkins University
NCT04037605Early Phase 1 (Phase 1)Jul 24, 2019Los Angeles Biomedical Research Institute
NCT05546047Phase 4Mar 14, 2019Mallinckrodt, NephroNet Clinical Research Consortium
NCT04855279N/AJan 7, 2019Istanbul Medipol University
NCT03398018Phase 4Oct 1, 2018University of Alabama, Birmingham
NCT03656692Phase 4Sep 28, 2018Mallinckrodt
NCT03465111Phase 2Sep 15, 2018Colorado Retina Associates, Colorado Retina Institute, Cornell University, Mallinckrodt, Metropolitan Eye Research and Surgery Institute, Ocular Imaging Research and Reading Center, Stanford University, Texas Retina Associates, University of Louisville
Showing 20 of 120 trials
Page 1 / 6

Organizations

Research & Development (111)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MallinckrodtFor profit571452009
University of VirginiaAcademic/Hospital4432006
Johns Hopkins UniversityAcademic/Hospital3332017
Mayo ClinicAcademic/Hospital3322009
University of California, San DiegoAcademic/Hospital3222006
University of RochesterAcademic/Hospital3322015
Albany Medical CollegeAcademic/Hospital2212015
All India Institute of Medical SciencesAcademic/Hospital2212022
Baylor UniversityAcademic/Hospital2122013
Columbia UniversityAcademic/Hospital2212009
Cornell UniversityAcademic/Hospital2122016
Huazhong University of Science and TechnologyAcademic/Hospital2122021
Icahn School of Medicine at Mount SinaiAcademic/Hospital2222013
Jiao Tong UniversityAcademic/Hospital2122016
Los Angeles Biomedical Research InstituteAcademic/Hospital2212017
Michigan State UniversityAcademic/Hospital2212012
National Center for Research Resources (NCRR)Government2221993
National Institutes of Health (NIH)Government2012006
NephroNet Clinical Research ConsortiumAcademic/Hospital2212019
Ohio State UniversityAcademic/Hospital2222013
111 organizations
Page 1 / 6

Marketing (17)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Sep 12, 1957
Amphastar PharmaceuticalsFor profitNDA2Apr 22, 1970
Ani PharmaceuticalsFor profitMKTGJun 16, 1954
Ani PharmaceuticalsFor profitNDA2Jun 16, 1954
MallinckrodtFor profitNDA2Apr 29, 1952
MallinckrodtFor profitMKTGApr 29, 1952
MylanFor profitMKTGDec 17, 2009
NovartisFor profitNDA2Feb 21, 2008
NovartisFor profitMKTGJun 29, 2012
PHARMOBEDIENTFor profitMKTGDec 17, 2009
Parke-DavisFor profitNDA2Mar 14, 1952
Questcor PharmaceuticalsFor profitNDA2Oct 15, 2010
SandozFor profitNDA2Feb 21, 2008
SandozFor profitMKTGJun 29, 2012
Sanofi-AventisFor profitNDA2Jul 3, 1950
Sanofi-AventisFor profitNDAJul 3, 1950
Watson PharmaceuticalsFor profitMKTG—