dydrogesterone

Trade name: gynorest

Small moleculeapproved

Dydrogesterone is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum. Furthermore, dydrogesterone is non-androgenic, non-estrogenic, non-corticoid, non-anabolic and is not excreted as pregnanediol. Dydrogesterone helps to regulate the healthy growth and normal shedding of the uterus lining. Therefore, it may be useful in the treatment of menstrual disorders such as absent, irregular or painful menstrual periods, infertility, premenstrual syndrome and endometriosis. Dydrogesterone works by regulating the healthy growth and normal shedding of the womb lining by acting on progesterone receptors in the uterus. Used to treat irregular duration of cycles and irregular occurrence and duration of periods caused by progesterone deficiency. Also used to prevent natural abortion in patients who have a history of habitual abortions. Dydrogesterone was first introduced to the market in 1961, and is currently approved in over 100 countries world-wide. Banned in the USA and wthdrawn from the UK, but still used in other countries. — NCATS

Clinical trial activity

71 trials · 59 clinical orgs · 1 marketing orgs

Phase 1
6
Phase 2
17
Phase 3
18
Phase 4
18

Earliest trial started Oct 1, 2002 (NCT00206557)

Timeline

1960s

  1. Jun 1, 1962

    Solvay — First NDA Organization

  2. Jun 1, 1962

    Solvay — NDA Organization

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2016

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approved

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)[C@H]1CC[C@H]2[C@@H]3C=CC4=CC(=O)CC[C@@]4(C)[C@@H]3CC[C@]12C
Mol. weight
312.4458 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 10alpha-isopregnenone
  • 10alpha-isopregnenone
  • 6-dehydro-retro-progesterone
  • 6-dehydro-retro-progesterone
  • (9β,10α)-pregna-4,6-diene-3,20-dione
  • (9β,10α)-pregna-4,6-diene-3,20-dione
  • 9β,10α-pregna-4,6-diene-3,20-dione
  • 9β,10α-pregna-4,6-diene-3,20-dione
  • delta(6)-retroprogesterone
  • delta(6)-retroprogesterone
  • delta(sup 6)-retroprogesterone
  • delta(sup 6)-retroprogesterone
  • didrogesterona
  • didrogesterona
  • didrogesterone
  • didrogesterone
  • dihydrogesterone
  • dihydrogesterone
  • duphaston
  • duphaston
  • duphaston-hrt
  • dydrogesterona
  • dydrogesterona
  • dydrogesterone
  • dydrogesterone
  • dydrogesterone
  • dydrogesterone
  • dydrogesterone
  • dydrogesterone
  • dydrogesterone
  • dydrogesterone
  • dydrogesterone
  • dydrogesterone
  • dydrogesterone
  • dydrogestérone
  • dydrogestérone
  • dydrogesteronum
  • dydrogesteronum
  • gestatron
  • gestatron
  • gynorest
  • gynorest
  • gynorest
  • hydrogesterone
  • hydrogesterone
  • hydrogesterone
  • hydrogestrone
  • hydrogestrone
  • isopregnenone
  • isopregnenone
  • isopregnenone
  • isopregnenone
  • retro-6-dehydroprogesterone
  • retro-6-dehydroprogesterone

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07242131N/ADec 1, 2025Ege University
NCT06546397Phase 1May 9, 2024Zhejiang University
NCT06378268N/AApr 24, 2024Ho Chi Minh City University of Medicine and Pharmacy, My Duc Phu Nhuan Hospital
NCT05951400Phase 2/Phase 3 (Phase 3)Aug 20, 2023Beni Suef University
NCT06143696N/AAug 1, 2023Nanjing Medical University
NCT05972902Phase 3Jul 15, 2023Beni Suef University
NCT05847660N/AJun 1, 2023Fayoum University
NCT06358014N/AMay 12, 2023Capital Medical University
NCT05767086N/AMar 15, 2023Bezmialem University
NCT05751681N/AFeb 20, 2023Zagazig University
NCT06868576Phase 3Jan 3, 2023Cairo University
NCT05758064Phase 2/Phase 3 (Phase 3)Jan 1, 2023Alexandria University, El Shatby University Hospital for Obstetrics and Gynecology
NCT05467852Phase 3Dec 10, 2022First People's Hospital of Foshan, Shantou University, Shenzhen University, Sun Yat-Sen University
NCT05521828N/ADec 1, 2022Free University of Brussels
NCT05542797Phase 4Oct 31, 2022Konya Meram State Hospital
NCT05226494Phase 1Jun 23, 2022NanoPharmaceuticals LLC, Yale University
NCT05300841Early Phase 1 (Phase 1)May 1, 2022Sohag University
NCT05112692N/ANov 30, 2021Mansoura University
NCT05156814Phase 4Nov 29, 2021Government of Russia
NCT05021094Phase 4Oct 1, 2021Nantong University
Showing 20 of 71 trials
Page 1 / 4

Organizations

Research & Development (59)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Capital Medical UniversityAcademic/Hospital8832013
Fudan UniversityAcademic/Hospital5522016
AbbottFor profit4322003
Chulalongkorn UniversityAcademic/Hospital3322014
Free University of BrusselsAcademic/Hospital3322019
SolvayFor profit3322005
The University of Hong KongAcademic/Hospital3312016
Assiut UniversityAcademic/Hospital2222017
Beni Suef UniversityAcademic/Hospital2212023
Chinese Academy of Medical SciencesAcademic/Hospital2212014
El Shatby University Hospital for Obstetrics and GynecologyAcademic/Hospital2212020
My Duc Phu Nhuan HospitalAcademic/Hospital2212019
Nanjing Medical UniversityAcademic/Hospital2212017
Sun Yat-Sen UniversityAcademic/Hospital2122021
Zagazig UniversityAcademic/Hospital2212021
Ain Shams UniversityAcademic/Hospital1112016
Alexandria UniversityAcademic/Hospital1012023
Bangladesh Medical UniversityAcademic/Hospital1112020
Bezmialem UniversityAcademic/Hospital1112023
Cairo UniversityAcademic/Hospital1112023
59 organizations
Page 1 / 3

Marketing (1)

OrganizationOrg typeRelationshipDate
SolvayFor profitNDAJun 1, 1962