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norgestimate

Small moleculeapproved

Approved

Dec 29, 1989

Norgestimate is a steroidal progestin of the 19-nortestosterone group that is used in combination with ethinylestradiol as an oral contraceptive and for treatment of acne. and in combination with estradiol in menopausal hormone replacement therapy. Norgestimate shows high selectivity for the progesterone receptor and low androgenic activity. — NCATS

Clinical trial activity

51 trials · 39 clinical orgs · 14 marketing orgs

Phase 1
29
Phase 2
8
Phase 3
6
Phase 4
8

Earliest trial started Apr 1, 2003 (NCT00554632)

Timeline

1980s

  1. Dec 29, 1989

    Johnson and Johnson — Earliest FDA Approval

  2. Dec 29, 1989

    Johnson and Johnson — NDA Secondary Org

  3. Dec 29, 1989

    Johnson and Johnson — NDA Organization

1990s

  1. Oct 22, 1999

    Teva — NDA Secondary Org

2000s

  1. Sep 25, 2002

    Barr Laboratories — Marketing Organization

  2. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  4. Jan 9, 2004

    Vintage — Marketing Organization

  5. Jan 9, 2004

    Endo Pharmaceuticals — Marketing Organization

  6. Jan 1, 2005

    Johnson and Johnson — Earliest Phase 1 Sponsor(trial)

  7. Aug 17, 2006

    Watson Pharmaceuticals — Marketing Organization

  8. Jun 29, 2009

    Teva — Marketing Organization

2010s

  1. Jun 17, 2011

    Glenmark Pharmaceuticals — Marketing Organization

  2. May 23, 2012

    Novast Labs — Marketing Organization

  3. Jan 30, 2013

    Exeltis — Marketing Organization

  4. Apr 7, 2015

    Naari Pte Ltd — Marketing Organization

  5. Sep 9, 2015

    Mylan — Marketing Organization

  6. Oct 27, 2015

    Amneal Pharmaceuticals — Marketing Organization

  7. Apr 26, 2016

    Lupin — Marketing Organization

  8. Jul 6, 2016

    Aurobindo Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • ortho cyclen

    with ethinyl estradiol

    Also known as estarylla, mili, mono-linyah, ortho tri-cyclen, ortho tri-cyclen lo, previfem, sprintec, tri-estarylla, tri-linyah, tri-lo-estarylla, tri-lo-linyah, tri-lo-mili, tri lo sprintec, tri-mili, tri-previfem, tri-sprintec

  • prefest

    with estradiol

Approval history

  • approvedDec 29, 1989

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@]12CC[C@H]3[C@@H](CCC4=C\C(CC[C@H]34)=N\O)[C@@H]1CC[C@@]2(OC(C)=O)C#C
Mol. weight
369.4971 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • (+)-13-ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one oxime acetate (ester)
  • (+)-13-ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one oxime acetate (ester)
  • (17alpha)-17-(acetyloxy)-13-ethyl-18,19-dinorpregn-4-en-20-yn-3-one 3-oxime
  • (17alpha)-17-(acetyloxy)-13-ethyl-18,19-dinorpregn-4-en-20-yn-3-one 3-oxime
  • d-13beta-ethyl-17alpha-ethynyl-17beta-acetoxygon-4-en-3-one oxime
  • d-13beta-ethyl-17alpha-ethynyl-17beta-acetoxygon-4-en-3-one oxime
  • dexnorgestrel acetime
  • dexnorgestrel acetime
  • dexnorgestrel acetime
  • dexnorgestrel acetime
  • norgestimate
  • norgestimate
  • norgestimate
  • norgestimate
  • norgestimate
  • norgestimate
  • norgestimate
  • norgestimate
  • norgestimato
  • norgestimato
  • norgestimatum
  • norgestimatum
  • norgestrel oxime acetate
  • norgestrel oxime acetate
  • norgestrel oxime acetate
  • norgestrel oxime acetate
  • norgestrel oxime acetate
  • norgestrel oxime acetate
  • orf-10131
  • orf-10131
  • rwj-10131
  • rwj-10131

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07074327Phase 1Jul 11, 2025Vertex
NCT06820307Phase 1Feb 25, 2025Vertex
NCT04828824Phase 4Jun 18, 2021University of Colorado, Denver
NCT04423068Early Phase 1 (Phase 1)Jan 1, 2021University of Kansas
NCT04718636Phase 1Sep 30, 2020Bristol-Myers Squibb, Celgene
NCT04172987Phase 1Feb 7, 2020Eli Lilly
NCT03357640Phase 2/Phase 3 (Phase 3)May 1, 2017Benha University
NCT02533427Phase 1Oct 1, 2015Gilead Sciences
NCT02480881Phase 1Jul 1, 2015Bristol-Myers Squibb
NCT02494609Phase 1Jul 1, 2015Lexicon Pharmaceuticals
NCT02213029Phase 1Aug 28, 2014GlaxoSmithKline
NCT02157467Phase 1Jun 1, 2014Bristol-Myers Squibb, MRA Clinical Research
NCT02144246Phase 1May 1, 2014Society of Family Planning, University of Pennsylvania
NCT02080468Phase 1Feb 1, 2014Covance, Novelion Therapeutics
NCT02127593Phase 1Jun 1, 2013Johnson and Johnson
NCT01746732Phase 1Dec 1, 2012Eli Lilly
NCT01798875Phase 4Apr 1, 2012Medical University of Gdansk
NCT02257671N/AFeb 1, 2012Karolinska Institute
NCT01498861Phase 1Dec 1, 2011GlaxoSmithKline, Shionogi, ViiV Healthcare
NCT01475513Phase 4Nov 1, 2011American Heart Association, Virginia Commonwealth University
Showing 20 of 51 trials
Page 1 / 3

Organizations

Research & Development (39)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Johnson and JohnsonFor profit111042004
Bristol-Myers SquibbFor profit7612006
Eli LillyFor profit4412011
Agile TherapeuticsFor profit2222009
GlaxoSmithKlineFor profit2112011
McNeilFor profit2212003
VertexFor profit2212025
Virginia Commonwealth UniversityAcademic/Hospital2212005
American Heart AssociationAcademic/Hospital1012011
AstraZenecaFor profit1112009
BayerFor profit1112008
Benha UniversityAcademic/Hospital1112017
CelgeneFor profit1112020
CovanceFor profit1012014
Gilead SciencesFor profit1112015
Harvard UniversityAcademic/Hospital1012004
IQVIAFor profit1012009
Karolinska InstituteAcademic/Hospital1112012
Lexicon PharmaceuticalsFor profit1112015
Medical University of GdanskAcademic/Hospital1112012
39 organizations
Page 1 / 2

Marketing (25)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitMKTGOct 27, 2015
Aurobindo PharmaFor profitSYNNov 4, 2016
Aurobindo PharmaFor profitMKTGJul 6, 2016
Barr LaboratoriesFor profitMKTGSep 25, 2002
Barr LaboratoriesFor profitSYNJun 29, 2009
Endo PharmaceuticalsFor profitMKTGJan 9, 2004
ExeltisFor profitMKTGJan 30, 2013
Glenmark PharmaceuticalsFor profitMKTGJun 17, 2011
Glenmark PharmaceuticalsFor profitSYNFeb 23, 2016
Glenmark PharmaceuticalsFor profitSYNJun 17, 2011
Glenmark PharmaceuticalsFor profitSYNFeb 23, 2016
Johnson and JohnsonFor profitNDA2Dec 29, 1989
Johnson and JohnsonFor profitSYNMay 13, 2005
Johnson and JohnsonFor profitNDADec 29, 1989
LupinFor profitMKTGApr 26, 2016
LupinFor profitSYNJun 25, 2012
MylanFor profitSYNJan 27, 2016
MylanFor profitMKTGSep 9, 2015
Naari Pte LtdFor profitMKTGApr 7, 2015
Novast LabsFor profitSYNSep 2, 2022
Novast LabsFor profitMKTGMay 23, 2012
TevaFor profitNDA2Oct 22, 1999
TevaFor profitMKTGJun 29, 2009
VintageFor profitMKTGJan 9, 2004
Watson PharmaceuticalsFor profitMKTGAug 17, 2006