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hydroxyprogesterone

Trade name: Delalutin

Small moleculeapproved

Approved

Jun 1, 1956

17α-Hydroxyprogesterone (17α-OHP), or hydroxyprogesterone (OHP), also known as 17α-hydroxypregn-4-ene-3, 20-dione is used under the brand name Gestageno, and has been marketed for clinical use in Argentina. It was indicated for female infertility, hypertrichosis, menstrual disorders, premature labour, threatened or recurrent miscarriage. It is used to properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle. 17α-OHP is an agonist of the progesterone receptor (PR) similarly to progesterone. In addition, it is an antagonist of the mineralocorticoid receptor (MR) as well as a partial agonist of the glucocorticoid receptor (GR), albeit with very low potency (EC50 >100-fold less relative to cortisol) at the latter site, also similarly to progesterone. — NCATS

Clinical trial activity

31 trials · 29 clinical orgs · 14 marketing orgs

Phase 1
3
Phase 2
17
Phase 3
15
Phase 4
3

Earliest trial started Oct 1, 1997 (NCT00123669)

Timeline

1950s

  1. Jun 1, 1956

    Earliest FDA Approval

1970s

  1. Dec 26, 1974

    Allergan — NDA Secondary Org

  2. Dec 26, 1974

    Allergan — Marketing Organization

1990s

  1. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Feb 3, 2011

    Covis — Marketing Organization

  3. Feb 3, 2011

    AMAG Pharmaceuticals, Inc. — NDA Secondary Org

  4. Aug 24, 2015

    Aspen Pharmaceuticals — Marketing Organization

  5. Jun 21, 2018

    Lutipold — Marketing Organization

  6. Jun 21, 2018

    Sankyo — Marketing Organization

  7. Jun 21, 2018

    Daiichi Sankyo — Marketing Organization

  8. Dec 28, 2018

    Slayback Pharma Llc — Marketing Organization

  9. Apr 9, 2019

    Sun Pharmaceuticals — Marketing Organization

  10. Apr 16, 2019

    Eugia Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 1, 1956

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)[C@@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3CC[C@]12C
Mol. weight
330.4611 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 17-((1-oxohexyl)oxy)pregn-4-ene-3,20-dione
  • 17a-hydroxyprogesterone caproate
  • 17 alfa hydroxyprogesterone caproate
  • 17alpha-caproyloxypregn-4-ene-3,20-dione
  • 17alpha-caproyloxypregn-4-ene-3,20-dione
  • 17alpha-hydroxyprogesterone
  • 17 alpha-hydroxy progesterone caproate
  • 17 alpha-hydroxy progesterone caproate
  • 17 alpha-hydroxyprogesterone caproate
  • 17 alpha-hydroxyprogesterone caproate
  • 17 alpha-hydroxyprogesterone caproate
  • 17-alpha-hydroxy-progesterone caproate
  • 17-alpha-hydroxy-progesterone caproate
  • 17alpha hydroxy progesterone caproate
  • 17 alpha-hydroxyprogesterone capronate
  • 17alpha-hydroxyprogesterone hexanoate
  • 17 alpha-oxyprogesterone capronate
  • 17-hydroxyporgesterone caproate
  • 17-hydroxyprogesterone caproate
  • 17-hydroxyprogesterone caproate
  • 17-hydroxyprogesterone capronate
  • 17α hydroxy progesterone caproate
  • alpha hydroxyprogesterone caproate
  • delalutin
  • delalutin
  • delalutin
  • delalutin
  • delalutin
  • delalutin
  • dihydroxyprogesterone caproate
  • gestageno
  • gestapuran
  • gestapuran
  • hydroxyprogesterone
  • hydroxyprogesterone
  • hydroxyprogesterone
  • hydroxyprogesterone
  • hydroxy-progesterone
  • hydroxyprogesterone caproate
  • hydroxyprogesterone caproate
  • hydroxyprogesterone caproate
  • hydroxyprogesterone caproate
  • hydroxyprogesterone caproate
  • hydroxyprogesterone caproate
  • hydroxyprogesterone caproate
  • hydroxyprogesterone caproate
  • hydroxyprogesterone caproate
  • hydroxyprogesterone caproate
  • hydroxyprogesterone hexanoate
  • hydroxyprogesterone hexanoate
  • makena
  • makena
  • makena
  • makena
  • neolutin
  • oxiprogesterone caproate
  • oxiprogesterone caproate
  • oxiprogesterone caproate
  • oxyprogesterone caproate
  • oxyprogesterone caproate
  • oxyprogesterone caproate
  • oxyprogesterone caproate
  • oxyprogesterone caproate
  • oxyprogesterone caproate
  • primolut depot
  • primolut depot
  • progesterone caproate
  • prolutin depot
  • proluton depot
  • proluton depot
  • proluton depot

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04077853Phase 4Dec 31, 2019Assiut University
NCT03779451N/AJan 1, 2019Aswan University
NCT03779438N/AJan 1, 2019Aswan University
NCT03292731Phase 2/Phase 3 (Phase 3)Feb 12, 2018National Institutes of Health (NIH), University of Pittsburgh
NCT04807543Phase 2Jan 10, 2018Ain Shams University
NCT04797338Phase 4Dec 29, 2017Hebrew University, Tel Aviv University
NCT03433040Phase 3Aug 23, 2017University of South Florida, Washington University in St. Louis
NCT02989025Phase 3May 22, 2017University of Mississippi
NCT03130504Phase 2Apr 1, 2017Assiut University
NCT02937766Phase 3Oct 1, 2016AMAG Pharmaceuticals, Inc., Lotus Clinical Research
NCT02940522Phase 1Sep 1, 2016AMAG Pharmaceuticals, Inc.
NCT03537287Phase 2Jul 31, 2016Ain Shams University
NCT01899846Phase 1Jul 1, 2013Lumara Health
NCT01501890N/AJan 1, 2012Ben Gurion University
NCT01119963Phase 2/Phase 3 (Phase 3)Oct 1, 2011Obstetrix Medical Group
NCT01317225Phase 3Jun 1, 2011Saint Thomas Hospital, Panama
NCT00809939Phase 3Dec 1, 2010Tel Aviv University
NCT01178788Phase 3Feb 1, 2010University of Modena and Reggio Emilia
NCT01050647Phase 1/Phase 2 (Phase 2)Feb 1, 2010Stanford University
NCT01004029Phase 3Oct 1, 2009AMAG Pharmaceuticals, Inc., Lumara Health, ResearchPoint Global
Showing 20 of 31 trials
Page 1 / 2

Organizations

Research & Development (29)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institutes of Health (NIH)Government5122004
AMAG Pharmaceuticals, Inc.For profit3222009
University of PittsburghAcademic/Hospital3222004
Ain Shams UniversityAcademic/Hospital2212016
Assiut UniversityAcademic/Hospital2222017
Aswan UniversityAcademic/Hospital2212019
George Washington UniversityAcademic/Hospital2212004
Lumara HealthFor profit2222009
Obstetrix Medical GroupAcademic/Hospital2212004
Tel Aviv UniversityAcademic/Hospital2122010
University of South FloridaAcademic/Hospital2222003
American University of BeirutAcademic/Hospital1112006
Ben Gurion UniversityAcademic/Hospital1112012
Government of IndiaGovernment1011997
Hebrew UniversityAcademic/Hospital1112017
Karolinska InstituteAcademic/Hospital1112003
Lotus Clinical ResearchFor profit1012016
Northwestern UniversityAcademic/Hospital1012007
ResearchPoint GlobalFor profit1012009
Saint Thomas Hospital, PanamaAcademic/Hospital1112011
29 organizations
Page 1 / 2

Marketing (16)

OrganizationOrg typeRelationshipDate
AMAG Pharmaceuticals, Inc.For profitNDA2Feb 3, 2011
Akorn, Inc.For profitNDA2—
AllerganFor profitNDA2Dec 26, 1974
AllerganFor profitMKTGDec 26, 1974
Aspen PharmaceuticalsFor profitMKTGAug 24, 2015
Aspen PharmaceuticalsFor profitSYNAug 8, 2019
Athenex, Inc.For profitMKTG—
Bristol-Myers SquibbFor profitNDA2—
CovisFor profitMKTGFeb 3, 2011
Daiichi SankyoFor profitMKTGJun 21, 2018
Eugia PharmaFor profitMKTGApr 16, 2019
LutipoldFor profitMKTGJun 21, 2018
SankyoFor profitMKTGJun 21, 2018
Slayback Pharma LlcFor profitMKTGDec 28, 2018
SquibbFor profitNDA—
Sun PharmaceuticalsFor profitMKTGApr 9, 2019