dienogest

Trade name: natazia

Small moleculeapproved

Approved

May 6, 2010

Dienogest (Natazia) is a hybrid progestogen that combines properties of both the 19-nortestosterone derivatives and the progesterone derivatives. It is indicated for use by women to prevent pregnancy and for the treatment of heavy menstrual bleeding in women without organic pathology. Dienogest is also approved in Europe, Australia, Malaysia, Singapore and Japan for the treatment of endometriosis. It is lowers the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation. Dienogest exhibits highly selective binding to the progesterone receptor. It has high progestational and significant antiandrogenic activity, but only moderate antigonadotrophic activity. The most common adverse reactions in clinical trials for Natazia are headache (including migraines), breast pain, menstrual disorders, nausea or vomiting, acne, mood changes and increased weight. — NCATS

Clinical trial activity

59 trials · 41 clinical orgs · 5 marketing orgs

Phase 1
8
Phase 2
28
Phase 3
24
Phase 4
12

Earliest trial started Jul 1, 2002 (NCT00335218)

Timeline

2000s

  1. Jan 1, 2003

    Bayer — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Bayer — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2008

    Bayer — Earliest Phase 1 Sponsor(trial)

2010s

  1. May 6, 2010

    Bayer — Earliest FDA Approval

  2. May 6, 2010

    Bayer — NDA Organization

  3. May 6, 2010

    Bayer — NDA Secondary Org

  4. Mar 18, 2016

    Teva — Marketing Organization

  5. Mar 18, 2016

    Dr. Reddy's Laboratories — Marketing Organization

  6. Mar 9, 2017

    Watson Pharmaceuticals — Marketing Organization

  7. May 9, 2017

    Allergan PLC (2015) — Marketing Organization

Indications

Mechanism of action

  • Unspecified targetOTHER

    Unknown

Combination products

Approval history

  • approvedMay 6, 2010

Chemistry & pharmacology

Loading structure…

SMILES

C[C@]12CCC3=C4CCC(=O)C=C4CC[C@H]3[C@@H]1CC[C@@]2(O)CC#N
Mol. weight
311.418 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

Black box warning

Sources

Also known as

  • 17alpha-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile
  • 17alpha-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile
  • 17 alpha-cyanomethyl-17 beta-hydroxy-13 beta-methylgona-4,9-dien-3-one
  • 17-alpha-cyanomethyl-17-beta-hydroxy-estra-4,9(10)-dien-3-one
  • 17-alpha-cyanomethyl-17-beta-hydroxy-estra-4,9(10)-dien-3-one
  • 17 alpha-cyanomethyl-17 beta-hydroxyestra-4,9(10)-diene-3-one
  • 19-norpregna-4,9-diene-21-nitrile, 17-hydroxy-3-oxo-, (17alpha)-
  • bay 86-5258
  • bay 86-5258
  • dienogest
  • dienogest
  • dienogest
  • dienogest
  • dienogest
  • dienogest
  • dienogest
  • dienogest
  • dienogest
  • dienogestril
  • dienogestril
  • dienogestril
  • dienogestum
  • dienogestum
  • dinagest
  • endometrion
  • endometrion
  • endometrion
  • mjr-35
  • mjr-35
  • natazia
  • natazia
  • sts 557
  • sts 557
  • sts-557
  • sts-557
  • sts-557
  • visanne
  • visanne
  • zk-37659
  • zk-37659

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07164183Phase 3Sep 11, 2025Alcea
NCT06719934Phase 1Jan 1, 2025Al Azhar University
NCT06543550Phase 4Jul 30, 2024
NCT06577974N/AJul 1, 2024Cairo University
NCT06396208N/AMay 1, 2024Chulalongkorn University
NCT06145438Phase 3Sep 4, 2023Diponegoro University
NCT06115408Phase 2/Phase 3 (Phase 3)Jul 1, 2023Ain Shams University
NCT05697471Phase 3Feb 25, 2023Far Eastern Memorial Hospital
NCT06316206Phase 4Jan 1, 2023University of Palermo, University of Roma La Sapienza
NCT05332106Phase 1Mar 12, 2022Azidus, Grunenthal
NCT05476172N/AApr 1, 2021Uludag University
NCT05013242Phase 4Dec 25, 2020Mansoura University
NCT04230083Phase 1Dec 7, 2019Grunenthal
NCT04193852Phase 1Nov 9, 2019Grunenthal
NCT04374006Early Phase 1 (Phase 1)Nov 1, 2019University of Indonesia
NCT03945513Phase 3Aug 31, 2019Exeltis, Insud Pharma
NCT03890042N/AMar 1, 2019Assiut University
NCT03789123Phase 4Jan 1, 2019Bagcilar Research and Training Hospital, Istanbul University, Kocaeli University, Suleymaniye Birth And Women's Health Education And Research Hospital
NCT03654144Phase 4Nov 30, 2018Assiut University
NCT04500743N/AAug 1, 2018National Research Center, Egypt
Showing 20 of 59 trials
Page 1 / 3

Organizations

Research & Development (41)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BayerFor profit252542002
GrunenthalFor profit3312019
Ain Shams UniversityAcademic/Hospital2222014
American University of BeirutAcademic/Hospital2222017
Assiut UniversityAcademic/Hospital2222018
Cairo UniversityAcademic/Hospital2222015
Adana Numune Training and Research HospitalAcademic/Hospital1112015
Ajou UniversityAcademic/Hospital1012016
Al Azhar UniversityAcademic/Hospital1112025
AlceaFor profit1112025
AzidusFor profit1012022
Bagcilar Research and Training HospitalAcademic/Hospital1112019
Chulalongkorn UniversityAcademic/Hospital1112024
Diponegoro UniversityAcademic/Hospital1112023
Ewha Womans UniversityAcademic/Hospital1012016
ExeltisFor profit1012019
Far Eastern Memorial HospitalAcademic/Hospital1112023
Fundación Santa Fe de BogotaAcademic/Hospital1112015
Insud PharmaFor profit1112019
Istanbul UniversityAcademic/Hospital1012019
41 organizations
Page 1 / 3

Marketing (6)

OrganizationOrg typeRelationshipDate
Allergan PLC (2015)For profitMKTGMay 9, 2017
BayerFor profitNDAMay 6, 2010
BayerFor profitNDA2May 6, 2010
Dr. Reddy's LaboratoriesFor profitMKTGMar 18, 2016
TevaFor profitMKTGMar 18, 2016
Watson PharmaceuticalsFor profitMKTGMar 9, 2017