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drospirenone

Trade name: Yasmin

Small moleculeapproved

Approved

May 11, 2001

Drospirenone (INN, USAN), also known as 1,2-dihydrospirorenone, is a steroidal progestin of the spirolactone group. Drospirenone binds strongly to the progesterone receptor (PR) and mineralocorticoid receptor (MR), with lower affinity, to the androgen receptor (AR), and very low affinity for the glucocorticoid receptor (GR). Drospirenone is an ingredient in some birth control pills and hormone replacement therapy. In combination with ethinylestradiol it is used as contraception, and for women who want contraception it is also approved by the U.S. Food and Drug Administration (FDA) to treat vasomotor symptoms due to menopause.It is sold as a combined oral contraceptive under the brand names Yasmin (US, EU, Latin America), Jasmine (France), Yarina (Russia) in a dosage containing drospirenone 3 mg/ethinylestradiol 30 µg. In the United States, Bayer Schering released a pill based on Yasmin with the B vitamin folate (B9), which is marketed under the names Safyral and Beyaz. — NCATS

Clinical trial activity

127 trials · 76 clinical orgs · 22 marketing orgs

Phase 1
27
Phase 2
59
Phase 3
48
Phase 4
27

Earliest trial started Aug 1, 2002 (NCT00714233)

Timeline

2000s

  1. May 11, 2001

    Earliest FDA Approval

  2. May 11, 2001

    Bayer — NDA Secondary Org

  3. Jan 1, 2002

    Earliest Phase 3 Sponsor(trial)

  4. Jan 1, 2004

    Bayer — Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 2006

    Teva — Earliest Phase 1 Sponsor(trial)

  6. May 9, 2008

    Barr Laboratories — Marketing Organization

  7. Mar 30, 2009

    Teva — Marketing Organization

2010s

  1. Sep 7, 2010

    Mayne Pharma — Marketing Organization

  2. Sep 7, 2010

    Dr. Reddy's Laboratories — Marketing Organization

  3. Mar 28, 2011

    Exeltis — Marketing Organization

  4. Dec 18, 2012

    Lupin — Marketing Organization

  5. Nov 19, 2014

    Novast Labs — Marketing Organization

  6. May 4, 2015

    Mylan — Marketing Organization

  7. Aug 17, 2015

    Glenmark Pharmaceuticals — Marketing Organization

  8. Sep 21, 2016

    Apotex — Marketing Organization

  9. Oct 11, 2016

    Watson Pharmaceuticals — Marketing Organization

  10. Oct 11, 2016

    Allergan PLC (2015) — Marketing Organization

  11. Nov 22, 2016

    Accord Research — Marketing Organization

  12. Nov 22, 2016

    Naari Pte Ltd — Marketing Organization

  13. Jul 18, 2017

    Allied Pharmaceutical Services — Marketing Organization

  14. Jul 18, 2017

    Healthcare Discoveries Inc. — Marketing Organization

  15. Jul 18, 2017

    ANDA Repository — Marketing Organization

  16. Dec 22, 2017

    Jubilant Innovation Ltd. — Marketing Organization

  17. Feb 27, 2018

    Aurobindo Pharma — Marketing Organization

  18. Mar 13, 2019

    Sun Pharmaceuticals — Marketing Organization

  19. Mar 22, 2019

    Hetero Labs Ltd — Marketing Organization

  20. May 23, 2019

    Exeltis — NDA Secondary Org

2020s

  1. Apr 15, 2021

    Mayne Pharma — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • angeliq

    with estradiol

  • beyaz

    with ethinyl estradiol, levomefolate

    Also known as safyral, tydemy

  • nextstellis

    with estetrol

    Also known as drospirenone and estetrol, e4/drsp 15/3 mg combined tablet

  • yasmin

    with ethinyl estradiol

    Also known as kemeya, kyra, loryna, lo-zumandimine, melamisa, nikki, syeda, yaela, yaz, zumandimine

Approval history

  • approvedMay 11, 2001

Chemistry & pharmacology

Loading structure…

SMILES

C[C@]12CC[C@H]3[C@@H]([C@H]4C[C@H]4C5=CC(=O)CC[C@]35C)[C@@H]1[C@@H]6C[C@@H]6[C@@]27CCC(=O)O7
Mol. weight
366.4932 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

Sources

Also known as

  • 1,2-dihydrospirorenone
  • 1,2-dihydrospirorenone
  • 1,2-dihydrospirorenone
  • 1,2-dihydro-spirorenone
  • 6beta,7beta,15beta,16beta-dimethylen-3-oxo-17alpha-pregn-4-en-21,17-carbolacton
  • 6beta,7beta;15beta,16beta-dimethylene-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone
  • 6beta,7beta;15beta,16beta-dimethylene-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone
  • 6β,7β,15β,16β-dimethylene-3-oxo-17α-pregn-4-ene-21,17 carbolactone
  • 6β,7β,15β,16β-dimethylene-3-oxo-17α-pregn-4-ene-21,17 carbolactone
  • angeliq
  • angeliq
  • angeliq
  • dehydrospirorenone
  • dehydrospirorenone
  • dihydrospirorenone
  • dihydrospirorenone
  • drospirenon
  • drospirenona
  • drospirenona
  • drospirenona
  • drospirenone
  • drospirenone
  • drospirenone
  • drospirenone
  • drospirenone
  • drospirenone
  • drospirenone
  • drospirenone
  • drospirenone
  • drospirenone
  • drospirenonum
  • drospirenonum
  • drsp
  • drsp
  • estradiol-drospirenone combination
  • spiro(17h-dicyclopropa(6,7:15,16)cyclopenta(a)phenanthrene-17,2'(5'h)-furan)-3,5'(2h)-dione, 1,3',4',6,7,8,9,10,11,12,13,14,15,16,20,21-hexadecahydro-10,13-dimethyl-, (6r-(6alpha,7alpha,8beta,9alpha,10beta,13beta,14alpha,15alpha,16alpha,17beta))-
  • yasmin
  • yasmin
  • yasmin
  • zk30595
  • zk 30595
  • zk-30595
  • zk-30595

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07293728Phase 4Jul 31, 2026Oregon Health and Science University
NCT07242131N/ADec 1, 2025Ege University
NCT07235774Phase 1Nov 5, 2025Servier
NCT07074327Phase 1Jul 11, 2025Vertex
NCT06820307Phase 1Feb 25, 2025Vertex
NCT06608186Phase 1/Phase 2 (Phase 2)Oct 1, 2024Benha University
NCT06396221N/AMay 1, 2024Chulalongkorn University
NCT06345586N/AApr 18, 2024Chulalongkorn University
NCT06345560Phase 1/Phase 2 (Phase 2)Apr 18, 2024Chulalongkorn University
NCT06233058Phase 1Mar 5, 2024Bio-innova Co., Ltd
NCT05837624Phase 4Feb 29, 2024McGill University
NCT06233071Phase 1Feb 13, 2024Bio-innova Co., Ltd
NCT05934942Phase 1Sep 8, 2023Boehringer Ingelheim
NCT05985590Phase 1Aug 18, 2023Bristol-Myers Squibb
NCT06689150N/AAug 10, 2023Al Azhar University
NCT05675644Phase 2Feb 28, 2023University of Colorado, Denver
NCT05706753Phase 1Jan 25, 2023Bristol-Myers Squibb, Janssen Pharmaceutica NV
NCT06316180Phase 4Jan 1, 2023University of Palermo, University of Roma La Sapienza
NCT05461573Phase 3Aug 2, 2022Exeltis, Insud Pharma
NCT05303636Phase 4Mar 28, 2022Exeltis, Insud Pharma
Showing 20 of 127 trials
Page 1 / 7

Organizations

Research & Development (76)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BayerFor profit464052002
EstetraFor profit8832015
Cairo UniversityAcademic/Hospital5332014
Chulalongkorn UniversityAcademic/Hospital4432011
Harvard UniversityAcademic/Hospital4442008
MerckFor profit4412006
University of Sao PauloAcademic/Hospital4232008
Catholic University of Sacred Heart, RomeAcademic/Hospital3332008
Insud PharmaFor profit3322014
Johnson and JohnsonFor profit3312016
Pharmaceutical Research Associates, Inc. (PRA)For profit3022016
TevaFor profit3312006
Bio-innova Co., LtdFor profit2212024
Bristol-Myers SquibbFor profit2112023
Conselho Nacional de Desenvolvimento Científico e TecnológicoGovernment2022007
Dinox BVFor profit2012016
ExeltisFor profit2022022
National Institute of Mental Health (NIMH)Government2122004
National Institutes of Health (NIH)Government2012003
PRACSFor profit2012006
76 organizations
Page 1 / 4

Marketing (28)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGJul 18, 2017
Accord ResearchFor profitMKTGNov 22, 2016
Allergan PLC (2015)For profitMKTGOct 11, 2016
Allied Pharmaceutical ServicesFor profitMKTGJul 18, 2017
ApotexFor profitMKTGSep 21, 2016
Aurobindo PharmaFor profitMKTGFeb 27, 2018
Barr LaboratoriesFor profitMKTGMay 9, 2008
BayerFor profitNDA—
BayerFor profitNDA2May 11, 2001
Dr. Reddy's LaboratoriesFor profitMKTGSep 7, 2010
ExeltisFor profitMKTGMar 28, 2011
ExeltisFor profitSYNMay 23, 2019
ExeltisFor profitNDA2May 23, 2019
Glenmark PharmaceuticalsFor profitMKTGAug 17, 2015
Healthcare Discoveries Inc.For profitMKTGJul 18, 2017
Hetero Labs LtdFor profitMKTGMar 22, 2019
Hetero Labs LtdFor profitSYNMar 22, 2019
Jubilant Innovation Ltd.For profitMKTGDec 22, 2017
LupinFor profitMKTGDec 18, 2012
Mayne PharmaFor profitMKTGSep 7, 2010
Mayne PharmaFor profitNDA2Apr 15, 2021
MylanFor profitMKTGMay 4, 2015
Naari Pte LtdFor profitMKTGNov 22, 2016
Novast LabsFor profitMKTGNov 19, 2014
Sun PharmaceuticalsFor profitMKTGMar 13, 2019
TevaFor profitMKTGMar 30, 2009
Watson PharmaceuticalsFor profitMKTGOct 11, 2016
Watson PharmaceuticalsFor profitSYNNov 28, 2011