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norelgestromin

Trade name: Evra

Small moleculeapproved

Approved

Nov 20, 2001

Norelgestromin, the progestin, is the active metabolite of norgestimate and is structurally related to 19-nortestosterone. Norgestimate and norelgestromin mimic the physiologic effects of progesterone at the progesterone receptor. Johnson & Johnson developed an adhesive female contraceptive patch that contains ethinylestradiol (0.75mg) and the progestogen norelgestromin (6mg). his product is a combination contraceptive acting via the inhibition gonadotropins. Its primary mechanism of action involves the suppression of ovulation, including changes in the cervical mucus and endometrium. The patch delivers a continuous flow of hormones through the skin and into the bloodstream. The contraceptive patch is available in countries worldwide. — NCATS

Clinical trial activity

28 trials · 22 clinical orgs · 5 marketing orgs

Phase 1
7
Phase 2
9
Phase 3
6
Phase 4
8

Earliest trial started Jan 1, 1997 (NCT00236795)

Timeline

1990s

  1. Jan 1, 1997

    Johnson and Johnson — Earliest Phase 3 Sponsor(trial)

2000s

  1. Nov 20, 2001

    Johnson and Johnson — Earliest FDA Approval

  2. Nov 20, 2001

    Johnson and Johnson — NDA Organization

  3. Nov 20, 2001

    Johnson and Johnson — NDA Secondary Org

  4. Jan 1, 2002

    Johnson and Johnson — Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Apr 16, 2014

    Mylan — Marketing Organization

2020s

  1. Feb 25, 2021

    Amneal Pharmaceuticals — Marketing Organization

  2. Aug 25, 2021

    Teva — Marketing Organization

  3. Sep 14, 2023

    Zydus Discovery DMCC — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedNov 20, 2001

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@]12CC[C@H]3[C@@H](CCC4=CC(CC[C@H]34)=NO)[C@@H]1CC[C@@]2(O)C#C
Mol. weight
327.4605 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 17-deacetylnorgestimate
  • 17-deacetylnorgestimate
  • 17-deacetylnorgestimate
  • 17-deacetylnorgestimate
  • 17-deacylnorgestimate
  • 17-deacylnorgestimate
  • 18-methylnorethindrone oxime
  • 18-methylnorethindrone oxime
  • 18-methylnorethindrone oxime
  • brn 4202099
  • deacetylnorgestimate
  • deacetylnorgestimate
  • d-norgestrel 3-oxime
  • d-norgestrel 3-oxime
  • evra
  • evra
  • evra
  • levonorgestrel 3-oxime
  • levonorgestrel 3-oxime
  • levonorgestrel oxime
  • levonorgestrel oxime
  • levonorgestrel oxime
  • levonorgestrel oxime
  • levonorgestrel oxime, (3e,17alpha)-isomer
  • levonorgestrel oxime, (3z,17alpha)-isomer
  • lngo
  • norelgestromin
  • norelgestromin
  • norelgestromin
  • norelgestromin
  • norelgestromin
  • norelgestromin
  • norelgestromin / ethinyl estradiol
  • norelgestromin-ethinyl estradiol combination patch
  • norplant 3-oxime
  • norplant 3-oxime
  • ortho evra
  • ortho evra
  • ortho evra
  • progestin norelgestromin
  • progestin norelgestromin
  • progestin norelgestromin
  • progestin norelgestromin
  • progestin norelgestromin
  • progestin norelgestromin
  • rwj-10553
  • rwj-10553

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05139121Phase 3Oct 26, 2021Mylan
NCT05753098Phase 4Jan 15, 2021Beni Suef University
NCT04423068Early Phase 1 (Phase 1)Jan 1, 2021University of Kansas
NCT04539626N/AOct 1, 2020CMN "20 de Noviembre"
NCT04017195Phase 1Jul 10, 2019Janssen Pharmaceutica NV
NCT03274297Phase 4Sep 20, 2017Johnson and Johnson
NCT02585999N/AOct 1, 2015Boston University
NCT02367833Phase 4Jan 1, 2015Harvard University, Pennsylvania State University, Purdue University
NCT01535820Phase 1Mar 1, 2011Johnson and Johnson
NCT00984789Phase 3May 1, 2009Bayer, Parexel
NCT01087879N/AOct 1, 2007University of Oulu
NCT00439972Phase 2Feb 1, 2007Johnson and Johnson, University of Washington
NCT00357981N/AJul 26, 2006Johnson and Johnson, University of California, San Francisco
NCT00320580Phase 2Apr 28, 2006McNeil
NCT00125983Phase 2Jul 29, 2005AIDS Clinical Trials Group, National Institute of Allergy and Infectious Diseases (NIAID), University of Hawaii
NCT00269620Phase 4Jun 1, 2005Organon, University of Pittsburgh
NCT00185354Phase 3Nov 1, 2004Bayer
NCT00775086Phase 1May 1, 2004Johnson and Johnson
NCT00258063Phase 1May 1, 2004Johnson and Johnson
NCT00258076Phase 1Apr 1, 2004Johnson and Johnson
Showing 20 of 28 trials
Page 1 / 2

Organizations

Research & Development (22)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Johnson and JohnsonFor profit141251997
Janssen Pharmaceutica NVFor profit3122002
BayerFor profit2212004
AIDS Clinical Trials GroupAcademic/Hospital1012005
Beni Suef UniversityAcademic/Hospital1112021
Boston UniversityAcademic/Hospital1112015
CMN "20 de Noviembre"Academic/Hospital1112020
Harvard UniversityAcademic/Hospital1012015
McNeilFor profit1112006
MerckFor profit1112004
MylanFor profit1112021
National Institute of Allergy and Infectious Diseases (NIAID)Government1112005
OrganonFor profit1012005
ParexelFor profit1012009
Pennsylvania State UniversityAcademic/Hospital1112015
Purdue UniversityAcademic/Hospital1012015
University of California, San FranciscoAcademic/Hospital1112006
University of HawaiiAcademic/Hospital1012005
University of KansasAcademic/Hospital1112021
University of OuluAcademic/Hospital1112007
22 organizations
Page 1 / 2

Marketing (7)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitMKTGFeb 25, 2021
Johnson and JohnsonFor profitNDANov 20, 2001
Johnson and JohnsonFor profitNDA2Nov 20, 2001
MylanFor profitMKTGApr 16, 2014
TevaFor profitMKTGAug 25, 2021
Zydus Discovery DMCCFor profitMKTGSep 14, 2023
Zydus Discovery DMCCFor profitSYNSep 14, 2023