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danazol

Trade name: danocrine

Small moleculeapproved

Approved

Jun 1, 1976

Danazol is a synthetic derivative of ethisterone which is approved by FDA for the treatment of endometriosis, fibrocystic breast disease and for preventing hereditary angioedema. It is believed that the in vivo therapeutic effect is achieved through activating androgen receptors. Danazol has teratogenic effects. — NCATS

Clinical trial activity

36 trials · 40 clinical orgs · 4 marketing orgs

Phase 1
6
Phase 2
32
Phase 3
5
Phase 4
1

Earliest trial started Aug 1, 1999 (NCT00003946)

Timeline

1970s

  1. Jun 1, 1976

    Earliest FDA Approval

  2. Jun 21, 1976

    Sanofi-Aventis — First NDA Organization

  3. Jun 21, 1976

    Sanofi-Aventis — NDA Secondary Org

  4. Jun 21, 1976

    Sanofi-Aventis — NDA Organization

1990s

  1. Aug 9, 1996

    Barr Laboratories — Marketing Organization

  2. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Apr 19, 2007

    Lannett Company, Inc. — Marketing Organization

  2. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 1, 1976

Chemistry & pharmacology

Loading structure…

SMILES

C[C@]12CC[C@H]3[C@@H](CCC4=CC5=C(C[C@]34C)C=NO5)[C@@H]1CC[C@@]2(O)C#C
Mol. weight
337.4553 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

  • chronogyn
  • cyclomen
  • cyclomen
  • danatrol
  • danazol
  • danazol
  • danazol
  • danazol
  • danazol
  • danazol
  • danazol
  • danazol
  • danazol
  • danazol
  • danazol
  • danazolum
  • danazolum
  • danazolum
  • danocrine
  • danocrine
  • danocrine
  • danocrine
  • danovaol
  • danzol
  • win-17757
  • win-17757
  • winobanin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06176911Phase 2Dec 5, 2023Capital Medical University, Government of China, Peking University, People's Liberation Army of China, Tsinghua University
NCT05852847Phase 2May 16, 2023Capital Medical University, Government of China, Peking University, People's Liberation Army of China, Tsinghua University
NCT05697471Phase 3Feb 25, 2023Far Eastern Memorial Hospital
NCT05494307Phase 2Sep 1, 2022Peking University
NCT05471050Phase 2Mar 2, 2022Peking University
NCT04997811Phase 2Dec 31, 2021Blood Cancer UK, The Dudley Group NHS Foundation Trust, University of Birmingham, University of London, University of Manchester, University of Warwick
NCT05281068Phase 2Sep 1, 2021Capital Medical University, Chongqing Medical University, Peking University, Shanxi Bethune Hospital, Zhengzhou University
NCT04807309Phase 1/Phase 2 (Phase 2)Jul 31, 2021Harvard University
NCT05353673Phase 2Jun 1, 2021Peking University
NCT04873102Phase 2May 1, 2021University of Southern California
NCT04638517Phase 2Jan 31, 2021University of Queensland
NCT04757532Phase 1Dec 3, 2020Institut Hospital del Mar d'Investigacions Mèdiques
NCT04481282Phase 2Jul 8, 2020Peking University
NCT04324060Phase 2/Phase 3 (Phase 3)Mar 1, 2020Chinese Academy of Medical Sciences
NCT04289207Phase 2Mar 1, 2020Kyowa Kirin, Seoul National University
NCT04173494Phase 3Nov 30, 2019Sierra Oncology, Inc., University of Texas at Houston
NCT04058678N/AOct 31, 2019IVI Madrid
NCT07183787Phase 2Apr 10, 2019Sharif Medical And Dental College, Lahore
NCT03710356Phase 1/Phase 2 (Phase 2)Oct 20, 2018Assistance Publique - Hôpitaux de Paris
NCT03460808Phase 1/Phase 2 (Phase 2)Mar 10, 2018Peking University
Showing 20 of 36 trials
Page 1 / 2

Organizations

Research & Development (40)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Peking UniversityAcademic/Hospital101012012
Capital Medical UniversityAcademic/Hospital4012012
Government of ChinaGovernment3012012
Harvard UniversityAcademic/Hospital3312008
FemmePharma Global Healthcare, Inc.For profit2212007
National Cancer Institute (NCI)Government2011999
National Heart, Lung, and Blood Institute (NHLBI)Government2212011
People's Liberation Army of ChinaGovernment2012023
Tsinghua UniversityAcademic/Hospital2012023
University of TorontoAcademic/Hospital2111999
Ain Shams UniversityAcademic/Hospital1112015
Ampio Pharmaceuticals. Inc.For profit1112013
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112018
Blood Cancer UKAcademic/Hospital1012021
Chinese Academy of Medical SciencesAcademic/Hospital1112020
Chongqing Medical UniversityAcademic/Hospital1012021
Far Eastern Memorial HospitalAcademic/Hospital1112023
Gynecologic Oncology GroupAcademic/Hospital1111999
Icahn School of Medicine at Mount SinaiAcademic/Hospital1012008
Institut Hospital del Mar d'Investigacions MèdiquesAcademic/Hospital1112020
40 organizations
Page 1 / 2

Marketing (6)

OrganizationOrg typeRelationshipDate
Am TherapFor profitMKTG—
Barr LaboratoriesFor profitMKTGAug 9, 1996
Lannett Company, Inc.For profitMKTGApr 19, 2007
Lannett Company, Inc.For profitSYNSep 28, 2005
Sanofi-AventisFor profitNDA2Jun 21, 1976
Sanofi-AventisFor profitNDAJun 21, 1976