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norgestrel

Trade name: Ovral

Small moleculeapproved

Approved

Apr 16, 1968

Norgestrel is synthetic steroidal progestin that is used in combination with ethinyl estradiol for oral contraception. Norgestrel is composed of a racemic mixture of two stereoisomers, dextronorgestrel and levonorgestrel. However, only the levorotary enantiomer (levonorgestrel) is biologically active. Norgestrel (and more specifically the active stereoisomer levonorgestrel) binds to the progesterone and estrogen receptors within the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary. Once bound to the receptor, progestins like levonorgestrel will slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH (luteinizing hormone) surge. Loss of the LH surge inhibits ovulation and thereby prevents pregnancy. Norgestrel in combination with ethinyl estradiol is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. — NCATS

Clinical trial activity

197 trials · 142 clinical orgs · 39 marketing orgs

Phase 1
48
Phase 2
87
Phase 3
57
Phase 4
43

Earliest trial started Oct 1, 1994 (NCT00966264)

Timeline

1960s

  1. Apr 16, 1968

    Earliest FDA Approval

  2. Apr 16, 1968

    Wyeth — Marketing Organization

1970s

  1. Oct 23, 1973

    HRA Pharma — NDA Secondary Org

  2. Mar 17, 1975

    Cadence Pharmaceuticals — Marketing Organization

  3. Mar 17, 1975

    Cadence Pharmaceuticals — NDA Secondary Org

1980s

  1. May 10, 1982

    Teva — Marketing Organization

  2. May 10, 1982

    Teva — NDA Secondary Org

  3. Nov 1, 1984

    Wyeth — NDA Secondary Org

1990s

  1. Dec 10, 1990

    Population Council — NDA Secondary Org

  2. Dec 13, 1993

    Watson Pharmaceuticals — Marketing Organization

  3. Dec 13, 1993

    Dr. Reddy's Laboratories — Marketing Organization

  4. Jan 1, 1994

    Earliest Phase 3 Sponsor(trial)

  5. Jul 13, 1998

    Bayer — NDA Secondary Org

  6. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

  7. Jul 28, 1999

    Consumer Health Foundation — NDA Secondary Org

2000s

  1. Apr 30, 2001

    Duramed Research — Marketing Organization

  2. Mar 20, 2002

    Barr Laboratories — Marketing Organization

  3. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  4. Dec 27, 2005

    Schering AG — Marketing Organization

  5. Dec 27, 2005

    Schering AG — NDA Secondary Org

  6. Aug 28, 2009

    Consumer Health Foundation — Marketing Organization

2010s

  1. Aug 3, 2010

    Leon Pharma — Marketing Organization

  2. Aug 3, 2010

    Exeltis — Marketing Organization

  3. Dec 29, 2010

    Novast Labs — Marketing Organization

  4. Dec 30, 2010

    Perrigo — Marketing Organization

  5. May 11, 2011

    Endo Pharmaceuticals — Marketing Organization

  6. May 11, 2011

    Vintage — Marketing Organization

  7. May 11, 2011

    Apax Partners — Marketing Organization

  8. Oct 26, 2011

    Lupin — Marketing Organization

  9. Dec 21, 2012

    Mylan — Marketing Organization

  10. Feb 22, 2013

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  11. Feb 5, 2014

    Amneal Pharmaceuticals — Marketing Organization

  12. Sep 11, 2014

    Sun Pharmaceuticals — Marketing Organization

  13. Feb 26, 2015

    Medicines360 — NDA Secondary Org

  14. May 29, 2015

    Oc Pharma — Marketing Organization

  15. May 29, 2015

    Naari Pte Ltd — Marketing Organization

  16. Jun 5, 2015

    Reckitt Benckiser Pharmaceutical — Marketing Organization

  17. Jun 5, 2015

    Alvogen — Marketing Organization

  18. Jun 12, 2015

    Glenmark Pharmaceuticals — Marketing Organization

  19. Dec 8, 2015

    Aurobindo Pharma — Marketing Organization

  20. Sep 2, 2016

    Lotus Pharmaceutical — Marketing Organization

  21. Apr 28, 2017

    Mayne Pharma — Marketing Organization

  22. Jan 9, 2018

    Avion Pharmaceuticals — Marketing Organization

  23. Jan 9, 2018

    Avion Pharmaceuticals — NDA Secondary Org

  24. Jul 3, 2018

    HRA Pharma — Marketing Organization

  25. Sep 18, 2018

    Apotex — Marketing Organization

  26. May 2, 2019

    Accord Research — Marketing Organization

2020s

  1. Feb 14, 2020

    Agile Therapeutics — NDA Secondary Org

  2. Mar 30, 2020

    Exeltis — NDA Secondary Org

  3. Feb 13, 2023

    Hetero Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • climara pro

    with estradiol

  • lo/ovral fe

    with ferrous fumarate, ethinyl estradiol

  • ovral

    with ethinyl estradiol

    Also known as afirmelle, alesse, altavera, ashlyna, aviane, ayuna, balcoltra, cerinta, cryselle, daysee, elifemme, elinest, enpresse, falmina, fayosim, iclevia, introvale, jaimiess, kurvelo, lessina, levlite, levonest, levonorgestrel and ethinyl estradiol and ethinyl estradiol, levora, lo/ovral, loseasonique, lo simpesse, low-ogestrel, lybrel, marlissa, myzilra, nordette, ogestrel, orsythia, portia, preven emergency contraceptive, quartette, quasense, seasonale, seasonique, setlakin, simpesse, sylevia, triphasil, trivora, vienva

Approval history

  • approvedPriority reviewApr 16, 1968

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@]12CC[C@H]3[C@@H](CCC4=CC(=O)CC[C@H]34)[C@@H]1CC[C@@]2(O)C#C
Mol. weight
312.4458 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral, Topical
Availability
Over the Counter

Oral

Yes

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • 13-beta-ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one
  • 13-beta-ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one
  • 13-ethyl-17-alpha-ethynyl-17-beta-hydroxy-4-gonen-3-one
  • 13-ethyl-17-alpha-ethynyl-17-beta-hydroxy-4-gonen-3-one
  • 13-ethyl-17-alpha-ethynylgon-4-en-17-beta-ol-3-one
  • 13-ethyl-17-alpha-ethynylgon-4-en-17-beta-ol-3-one
  • (-)-13-ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one
  • (-)-13-ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one
  • 17-alpha-ethinyl-13-beta-ethyl-17-beta-hydroxy-4-estren-3-one
  • 17-alpha-ethinyl-13-beta-ethyl-17-beta-hydroxy-4-estren-3-one
  • 17alpha-ethynyl-13beta-ethyl-3-oxo-4-estren-17beta-ol
  • 17alpha-ethynyl-13beta-ethyl-3-oxo-4-estren-17beta-ol
  • 17-alpha-ethynyl-13-ethyl-19-nortestosterone
  • 17-alpha-ethynyl-13-ethyl-19-nortestosterone
  • 17alpha-ethynyl-17-hydroxy-18-methylestr-4-en-3-one
  • 17alpha-ethynyl-17-hydroxy-18-methylestr-4-en-3-one
  • 17alpha-ethynyl-18-homo-19-nortestosterone
  • 17alpha-ethynyl-18-homo-19-nortestosterone
  • 17-ethynyl-17-hydroxy-18a-homoestr-4-en-3-one
  • 17-ethynyl-17-hydroxy-18a-homoestr-4-en-3-one
  • 17-ethynyl-18-methyl-19-nortestosterone
  • 17-ethynyl-18-methyl-19-nortestosterone
  • 18-methyl-17-alpha-ethynyl-19-nortestosterone
  • 18-methyl-17-alpha-ethynyl-19-nortestosterone
  • 18-methylnorethindrone
  • 18-methylnorethisterone
  • 18-methylnorethisterone
  • (8r,9s,10r,13s,14s,17r)-13-ethyl-17-ethynyl-17-hydroxy- 1,2,6,7,8,9,10,11,12,13,14,15,16, 17- tetradecahydrocyclopenta[a] phenanthren-3-one
  • (8r,9s,10r,13s,14s,17r)-13-ethyl-17-ethynyl-17-hydroxy- 1,2,6,7,8,9,10,11,12,13,14,15,16, 17- tetradecahydrocyclopenta[a] phenanthren-3-one
  • dexnorgestrel
  • d-norgestrel
  • d(-)-norgestrel
  • d(-)-norgestrel
  • emerres
  • emerres una
  • ezinelle
  • isteranda
  • jadelle
  • jadelle
  • jaydess
  • ld norgestrel
  • ld norgestrel
  • levonelle
  • levonelle
  • levonelle
  • levonelle-2
  • levonelle one step
  • levongestrel
  • levonorgestrel
  • levonorgestrel
  • levonorgestrel
  • levonorgestrel
  • levonorgestrel
  • levonorgestrel
  • levonorgestrel
  • levonorgestrel
  • levonorgestrel
  • levonorgestrel
  • levonorgestrel
  • lévonorgestrel
  • lévonorgestrel
  • levonorgestrelum
  • levonorgestrelum
  • levonova
  • levonova
  • levosert
  • levosert
  • methylnorethindrone
  • methylnorethindrone
  • microlut
  • microlut
  • microluton
  • microluton
  • microval
  • microval
  • microval
  • mirena
  • mirena
  • nordette
  • nordette
  • norgeston
  • norgeston
  • norgestrel
  • norgestrel
  • norgestrel
  • norgestrel
  • norgestrel
  • norgestrel
  • norgestrel
  • norgestrel
  • norlevo
  • norlevo
  • norplant
  • norplant
  • norplant ii
  • norplant ii
  • norplant system
  • ovral
  • ovral
  • ovrette
  • ovrette
  • plan b
  • plan b
  • plan b one-step
  • plan b one-step
  • postinor
  • postinor
  • postinor-2
  • postinor-2
  • prefest
  • prefest
  • previfem
  • sh d593b
  • skyla
  • skyla
  • sprintec
  • sprintec
  • tri-previfem
  • tri-sprintec
  • tri-sprintec
  • upostelle
  • wy-3707
  • wy-3707
  • wy-5104
  • wy-5104

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06073184Phase 2Jan 31, 2024University of Toronto
NCT06306131Phase 2Dec 10, 2023InnovaGyn, Inc., National Institutes of Health (NIH)
NCT04537078Phase 3Sep 30, 2020Elshatby University hospital, El Shatby University Hospital for Obstetrics and Gynecology
NCT05492487Phase 2Jan 3, 2020KK Women's and Children's Hospital
NCT04112095Phase 3Sep 6, 2019HRA Pharma, Pegus Research, Inc.
NCT03657602Early Phase 1 (Phase 1)Sep 30, 2018University of Oklahoma
NCT03585712Phase 2Jul 24, 2018Health Decisions, HRA Pharma, Oregon Health and Science University, University of California, Davis
NCT03559010Phase 3Apr 27, 2018HRA Pharma, Pegus Research, Inc.
NCT03463252Phase 2/Phase 3 (Phase 3)Apr 1, 2018Sichuan University
NCT03043924N/ASep 1, 2017National Research Agency, France, University of Lille
NCT02669238Phase 2/Phase 3 (Phase 3)Jun 1, 2017Centre Hospitalier Universitaire de la Réunion
NCT02855346Phase 1May 3, 2017International Partnership for Microbicides, Inc., National Institutes of Health (NIH)
NCT02722421Phase 2Apr 6, 2017Infectious Disease Institute, Kampala, Uganda, National Institutes of Health (NIH), Northwestern University, University of Liverpool, University of Nebraska
NCT03074045Phase 3Mar 13, 2017Bayer
NCT02985541Phase 3Dec 22, 2016Bayer
NCT02922127Phase 1Dec 16, 2016Columbia University, Cornell University
NCT02943655Phase 3Nov 1, 2016Assiut University
NCT02863445Phase 4Oct 1, 2016National Institutes of Health (NIH), Oregon Health and Science University
NCT02957630Phase 1/Phase 2 (Phase 2)Sep 1, 2016Dinox BV, Estetra
NCT02175030Phase 4Aug 1, 2016University of Utah
Showing 20 of 197 trials
Page 1 / 10

Organizations

Research & Development (142)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BayerFor profit353252000
National Institutes of Health (NIH)Government14251999
Duramed ResearchFor profit121122003
PfizerFor profit101032002
Oregon Health and Science UniversityAcademic/Hospital9832006
Agile TherapeuticsFor profit8832007
WyethFor profit8032002
Society of Family PlanningAcademic/Hospital6012012
TevaFor profit6532007
Boehringer IngelheimFor profit5512008
Columbia UniversityAcademic/Hospital5432006
FHI 360Academic/Hospital5532007
HRA PharmaFor profit5532007
AstraZenecaFor profit4412005
MerckFor profit4422004
University of Colorado, DenverAcademic/Hospital4332007
University of North Carolina at Chapel HillAcademic/Hospital4322009
University of UtahAcademic/Hospital4422005
University of WashingtonAcademic/Hospital4222004
Harvard UniversityAcademic/Hospital3322004
142 organizations
Page 1 / 8

Marketing (54)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGMay 2, 2019
Agile TherapeuticsFor profitNDA2Feb 14, 2020
AlvogenFor profitMKTGJun 5, 2015
American Home ProductsFor profitNDA—
Amneal PharmaceuticalsFor profitMKTGFeb 5, 2014
Apax PartnersFor profitMKTGMay 11, 2011
ApotexFor profitMKTGSep 18, 2018
ApotexFor profitSYNSep 18, 2018
Aurobindo PharmaFor profitMKTGDec 8, 2015
Aurobindo PharmaFor profitSYNDec 8, 2015
Avion PharmaceuticalsFor profitMKTGJan 9, 2018
Avion PharmaceuticalsFor profitNDA2Jan 9, 2018
Barr LaboratoriesFor profitMKTGMar 20, 2002
BayerFor profitNDA2Jul 13, 1998
Cadence PharmaceuticalsFor profitMKTGMar 17, 1975
Cadence PharmaceuticalsFor profitNDA2Mar 17, 1975
Consumer Health FoundationAcademic/HospitalNDA2Jul 28, 1999
Consumer Health FoundationAcademic/HospitalMKTGAug 28, 2009
Dr. Reddy's LaboratoriesFor profitMKTGDec 13, 1993
Duramed ResearchFor profitMKTGApr 30, 2001
Endo PharmaceuticalsFor profitMKTGMay 11, 2011
ExeltisFor profitNDA2Mar 30, 2020
ExeltisFor profitMKTGAug 3, 2010
Glenmark PharmaceuticalsFor profitSYNFeb 29, 2012
Glenmark PharmaceuticalsFor profitMKTGJun 12, 2015
HRA PharmaFor profitNDA2Oct 23, 1973
HRA PharmaFor profitMKTGJul 3, 2018
Hetero Labs LtdFor profitMKTGFeb 13, 2023
Leon PharmaFor profitMKTGAug 3, 2010
Lotus PharmaceuticalFor profitMKTGSep 2, 2016
LupinFor profitMKTGOct 26, 2011
Mayne PharmaFor profitSYNDec 13, 1993
Mayne PharmaFor profitMKTGApr 28, 2017
Medicines360Academic/HospitalNDA2Feb 26, 2015
MylanFor profitMKTGDec 21, 2012
Naari Pte LtdFor profitMKTGMay 29, 2015
Novast LabsFor profitSYNSep 15, 2014
Novast LabsFor profitMKTGDec 29, 2010
Novel Anti-Infective Technologies, LLCFor profitMKTGFeb 22, 2013
Oc PharmaFor profitMKTGMay 29, 2015
PerrigoFor profitMKTGDec 30, 2010
PerrigoFor profitSYNDec 30, 2010
Population CouncilAcademic/HospitalNDA2Dec 10, 1990
Reckitt Benckiser PharmaceuticalFor profitMKTGJun 5, 2015
Schering AGFor profitMKTGDec 27, 2005
Schering AGFor profitNDA2Dec 27, 2005
Sun PharmaceuticalsFor profitMKTGSep 11, 2014
Sun PharmaceuticalsFor profitSYNSep 11, 2014
TevaFor profitMKTGMay 10, 1982
TevaFor profitNDA2May 10, 1982
VintageFor profitMKTGMay 11, 2011
Watson PharmaceuticalsFor profitMKTGDec 13, 1993
WyethFor profitNDA2Nov 1, 1984
WyethFor profitMKTGApr 16, 1968