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cyclosporine

Trade name: sandimmune

Small moleculeapproved

Approved

Nov 14, 1983

Cyclosporins are cyclic polypeptide macrolides that were originally derived from the soil fungus Tolypocladium inflatum. Cyclosporine (also known as cyclosporine A) was discovered by Sandoz and developed for the tretment of immune disorders. The drug was approved by FDA for such diseases as Rheumatoid Arthritis, Psoriasis (Neoral), Keratoconjunctivitis sicca (Restasis) and prevention of transplant rejections (Neoral and Sandimmune). Cyclosporine’s primary immunosuppressive mechanism of action is inhibition of T-lymphocyte function. Upon administration cyclosporine binds to cyclophilin A and thus inhibits calcineurin, leading to immune system suppression. — NCATS

Clinical trial activity

864 trials · 519 clinical orgs · 23 marketing orgs

Phase 1
164
Phase 2
486
Phase 3
180
Phase 4
160

Earliest trial started May 1, 1986 (NCT00002456)

Timeline

1980s

  1. Nov 14, 1983

    Novartis — Earliest FDA Approval

  2. Nov 14, 1983

    Novartis — NDA Organization

  3. Nov 14, 1983

    Novartis — NDA Secondary Org

  4. Jan 1, 1986

    Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 1986

    Earliest Phase 3 Sponsor(trial)

1990s

  1. Jan 1, 1992

    Earliest Phase 1 Sponsor(trial)

  2. Oct 29, 1999

    Hikma — Marketing Organization

  3. Oct 29, 1999

    West-Ward Pharmaceutical — Marketing Organization

2000s

  1. Jan 13, 2000

    Sandoz — Marketing Organization

  2. Jan 13, 2000

    Novartis — Marketing Organization

  3. Mar 3, 2000

    AbbVie — Marketing Organization

  4. Dec 20, 2000

    Dr. Reddy's Laboratories — Marketing Organization

  5. Dec 20, 2000

    Mayne Pharma — Marketing Organization

  6. May 9, 2002

    Apotex — Marketing Organization

  7. Dec 23, 2002

    Allergan — NDA Secondary Org

  8. Dec 23, 2002

    AbbVie — NDA Secondary Org

  9. Oct 7, 2003

    Lutipold — Marketing Organization

  10. Oct 7, 2003

    Sankyo — Marketing Organization

  11. Oct 7, 2003

    Paddock Laboratories — Marketing Organization

  12. Oct 7, 2003

    Padagis Us — Marketing Organization

  13. Oct 10, 2003

    GlaxoSmithKline — NDA Secondary Org

  14. Sep 17, 2004

    Xttrium Laboratories — Marketing Organization

  15. Sep 17, 2004

    Wockhardt — Marketing Organization

  16. Jan 5, 2005

    Pharmaceutical Associates — Marketing Organization

  17. Mar 25, 2005

    Teva — Marketing Organization

2010s

  1. Aug 14, 2018

    Sun Pharmaceuticals — Marketing Organization

  2. Aug 14, 2018

    Sun Pharmaceuticals — NDA Secondary Org

2020s

  1. Jun 23, 2021

    Santen Inc. — Marketing Organization

  2. Jun 23, 2021

    Santen Inc. — NDA Secondary Org

  3. Feb 2, 2022

    Mylan — Marketing Organization

  4. Aug 2, 2022

    Strides Pharma Science — Marketing Organization

  5. May 30, 2023

    Novaliq GmbH — Marketing Organization

  6. May 30, 2023

    Novaliq GmbH — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewNov 14, 1983

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C
Mol. weight
1202.6112 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 27-400
  • 27-400
  • 3'-keto-bmt(1)-val(2)-cyclosporin a
  • amdray
  • amdray
  • amdray
  • capimune
  • capsorin
  • ciclosporin
  • ciclosporin
  • ciclosporin
  • ciclosporin
  • ciclosporin
  • ciclosporin
  • ciclosporin
  • ciclosporin
  • ciclosporin
  • ciclosporina
  • ciclosporina
  • ciclosporine
  • ciclosporine
  • ciclosporine
  • ciclosporinum
  • ciclosporinum
  • csa
  • csa
  • csa
  • cya
  • cya
  • cyclosporin
  • cyclosporin
  • cyclosporin
  • cyclosporin
  • cyclosporin a
  • cyclosporin a
  • cyclosporin a
  • cyclosporin a
  • cyclosporin a
  • cyclosporine
  • cyclosporine
  • cyclosporine
  • cyclosporine
  • cyclosporine
  • cyclosporine
  • cyclosporine
  • cyclosporine
  • cyclosporine a
  • cyclosporine a
  • cyclosporine-a
  • cyclosporine-a
  • cycosporine a
  • deximune
  • gengraf
  • gengraf
  • gengraf
  • he 10
  • ikervis
  • ikervis
  • iminoral
  • lx201
  • lx201
  • neoral
  • neoral
  • neoral
  • optimmune
  • optimmune
  • otx-101
  • psc833
  • psc 833
  • psc 833
  • psc 833
  • psc-833
  • restasis
  • restasis
  • restasis
  • sandimmun
  • sandimmun
  • sandimmun
  • sandimmune
  • sandimmune
  • sandimmune
  • sandimmune
  • sangcya
  • sangcya
  • sangcya
  • sdz psc 833
  • sdz-psc-833
  • valspodar
  • valspodar
  • valspodar
  • valspodar
  • valspodar
  • vanquoral

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07169695Phase 2Mar 2, 2026Laboratoires Thea
NCT07224529Phase 4Feb 1, 2026Harrow Health, University of Alabama, Birmingham
NCT06903884Phase 3Dec 30, 2025The University of Hong Kong
NCT07138898Phase 2Sep 30, 2025New York University
NCT07029204Early Phase 1 (Phase 1)Aug 19, 2025University of California, Davis
NCT07025811Phase 4Jul 9, 2025Roche
NCT07029139Phase 2Jun 30, 2025Shanghai JMT-Bio Inc.
NCT06942793Phase 3May 20, 2025Zhaoke (Guangzhou) Pharmaceutical Limited
NCT07196449Phase 1May 14, 2025Seoul National University
NCT06898853N/AMay 1, 2025University of Melbourne, University of New South Wales
NCT06790095Phase 2Apr 30, 2025United States Army, University of California, San Francisco
NCT06766357Phase 3Apr 3, 2025Xiamen University, Zhaoke (Guangzhou) Pharmaceutical Limited
NCT06837259Phase 1Mar 21, 2025Pfizer
NCT06892756Phase 1Mar 18, 2025Chiesi, Comac Medical
NCT07089511N/AMar 11, 2025A.O. Ospedale Maggiore di Lodi
NCT06752694Phase 2Mar 10, 2025Incyte, University of Washington
NCT06809608Phase 1Feb 13, 2025Roche
NCT06802055Phase 2Jan 25, 2025Chinese Academy of Medical Sciences
NCT06658002Phase 3Jan 1, 2025Aravind Eye Hospital, University of California, San Francisco
NCT06541678Phase 1Dec 16, 2024Pfizer
Showing 20 of 864 trials
Page 1 / 44

Organizations

Research & Development (519)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government1602741987
University of WashingtonAcademic/Hospital828041986
NovartisFor profit634852001
National Heart, Lung, and Blood Institute (NHLBI)Government482141986
University of MinnesotaAcademic/Hospital292751996
RocheFor profit241351999
PfizerFor profit232241998
Chinese Academy of Medical SciencesAcademic/Hospital181632012
Harvard UniversityAcademic/Hospital18951999
AllerganFor profit17852004
National Institutes of Health (NIH)Government16441998
WyethFor profit16031998
Stanford UniversityAcademic/Hospital141151997
University of LyonAcademic/Hospital141332004
University of Texas at HoustonAcademic/Hospital131031994
National Institute of Allergy and Infectious Diseases (NIAID)Government12941999
University of LondonAcademic/Hospital12732004
Peking UniversityAcademic/Hospital10722014
People's Liberation Army of ChinaGovernment10542004
Sun Yat-Sen UniversityAcademic/Hospital10332009
519 organizations
Page 1 / 26

Marketing (30)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGMar 3, 2000
AbbVieFor profitNDA2Dec 23, 2002
AllerganFor profitNDA2Dec 23, 2002
ApotexFor profitMKTGMay 9, 2002
ApotexFor profitSYNJan 5, 2005
Dr. Reddy's LaboratoriesFor profitMKTGDec 20, 2000
GlaxoSmithKlineFor profitNDA2Oct 10, 2003
HikmaFor profitMKTGOct 29, 1999
LutipoldFor profitMKTGOct 7, 2003
Mayne PharmaFor profitMKTGDec 20, 2000
MylanFor profitMKTGFeb 2, 2022
Novaliq GmbHFor profitMKTGMay 30, 2023
Novaliq GmbHFor profitNDA2May 30, 2023
NovartisFor profitNDANov 14, 1983
NovartisFor profitNDA2Nov 14, 1983
NovartisFor profitMKTGJan 13, 2000
Padagis UsFor profitMKTGOct 7, 2003
Paddock LaboratoriesFor profitMKTGOct 7, 2003
Pharmaceutical AssociatesFor profitMKTGJan 5, 2005
SandozFor profitMKTGJan 13, 2000
SankyoFor profitMKTGOct 7, 2003
Santen Inc.For profitMKTGJun 23, 2021
Santen Inc.For profitNDA2Jun 23, 2021
Strides Pharma ScienceFor profitMKTGAug 2, 2022
Sun PharmaceuticalsFor profitMKTGAug 14, 2018
Sun PharmaceuticalsFor profitNDA2Aug 14, 2018
TevaFor profitMKTGMar 25, 2005
West-Ward PharmaceuticalFor profitMKTGOct 29, 1999
WockhardtFor profitMKTGSep 17, 2004
Xttrium LaboratoriesFor profitMKTGSep 17, 2004