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prasterone

Trade name: intrarosa

Small moleculeapproved

Approved

Nov 16, 2016

Dehydroepiandrosterone (INTRAROSA™, prasterone) is a major C19 steroid produced from cholesterol by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Dehydroepiandrosterone (INTRAROSA, prasterone) is structurally similar to, and is a precursor of, androstenedione, testosterone, estradiol, estrone and estrogen. It indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. The mechanism of action of dehydroepiandrosterone (INTRAROSA, prasterone) in postmenopausal women with vulvar and vaginal atrophy is not fully established. — NCATS

Clinical trial activity

23 trials · 25 clinical orgs · 4 marketing orgs

Phase 1
1
Phase 2
16
Phase 3
18
Phase 4
2

Earliest trial started Mar 1, 1998 (NCT00037128)

Timeline

1990s

  1. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Nov 16, 2016

    EndoCeutics Inc. — Earliest FDA Approval

  3. Nov 16, 2016

    AMAG Pharmaceuticals, Inc. — NDA Secondary Org

  4. Nov 16, 2016

    EndoCeutics Inc. — NDA Organization

  5. Nov 16, 2016

    Galen — Marketing Organization

  6. Nov 16, 2016

    Allergan PLC (2015) — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedNov 16, 2016

Chemistry & pharmacology

Loading structure…

SMILES

C[C@]12CC[C@H]3[C@@H](CC=C4C[C@@H](O)CC[C@]34C)[C@@H]1CCC2=O
Mol. weight
288.4244 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

  • 3-beta-hydroxy-5-androsten-17-one
  • 3-beta-hydroxy-5-androsten-17-one
  • 3beta-hydroxyandrost-5-en-17-one
  • 3beta-hydroxyandrost-5-en-17-one
  • 3β-hydroxyandrost-5-en-17-one
  • 3β-hydroxyandrost-5-en-17-one
  • androstenolone acetate
  • dehydroandrosterone
  • dehydroandrosterone
  • dehydroandrosterone
  • dehydroandrosterone
  • dehydroandrosterone
  • dehydroandrosterone
  • dehydroandrosterone sulfate
  • dehydroepiandrosterone
  • dehydroepiandrosterone
  • dehydroepiandrosterone acetate
  • dehydroepiandrosterone acetate
  • dehydroepiandrosterone acetate
  • dehydroepiandrosterone monosulfate
  • dehydroepiandrosterone sulfate
  • dehydroepiandrosterone sulphate
  • dehydroisoandosterone 3-acetate
  • dehydroisoandrosterone
  • dehydroisoandrosterone
  • dehydroisoandrosterone
  • dehydroisoandrosterone acetate
  • dehydroisoandrosterone sulfate
  • dhea
  • dhea
  • dhea
  • em-760
  • em-760
  • enzymatic therapy
  • gl701
  • gl701
  • natrol dhea
  • prasterone
  • prasterone
  • prasterone
  • prasterone
  • prasterone
  • prasterone
  • prasterone
  • prasterone
  • prasterone acetate
  • prasterone acetate
  • prasterone sulfate
  • prasterone sulfate
  • prasterone sulfate
  • prasterone sulfate
  • prasterone sulfate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06611514Phase 3Oct 1, 2024University of Milan
NCT04982692Phase 3Jul 31, 2021Lee's Pharmaceutical
NCT04898556Phase 3Dec 22, 2020Instituto Palacios
NCT04705883Phase 4Sep 1, 2020University of Barcelona
NCT03740945Phase 3Jul 31, 2019AMAG Pharmaceuticals, Inc., EndoCeutics Inc., MacDonald Women's Hospital, Cleveland, The Jones Institute
NCT03854396Phase 3Jun 30, 2019AMAG Pharmaceuticals, Inc., University of Louisville
NCT03782480Phase 3Mar 2, 2019Center for Vulvovaginal Disorders, EndoCeutics Inc.
NCT03619005Phase 3Sep 30, 2018AMAG Pharmaceuticals, Inc., EndoCeutics Inc.
NCT03568604Phase 4Aug 7, 2018San Diego Sexual Medicine
NCT03287232Phase 3Oct 16, 2017EndoCeutics Inc., Maryland Center for Sexual Health
NCT02013544Phase 3Feb 1, 2014Eastern Virginia Medical School, EndoCeutics Inc.
NCT01535872Phase 3Feb 1, 2012KK Women's and Children's Hospital
NCT01376349Phase 3Jul 1, 2011Mayo Clinic, National Cancer Institute (NCI), University of Michigan
NCT01129830Early Phase 1 (Phase 1)Jan 1, 2010Virginia Center for Reproductive Medicine
NCT00948857Phase 2/Phase 3 (Phase 3)Jun 1, 2009Center for Human Reproduction
NCT00650754Phase 2/Phase 3 (Phase 3)Mar 1, 2008Center for Human Reproduction
NCT00549081N/AJan 1, 2008Hebrew University, Tel Aviv University
NCT00419913Phase 2/Phase 3 (Phase 3)Jan 1, 2007Center for Human Reproduction, Foundation for Reproductive Medicine
NCT00082511Phase 3Jul 1, 2003Genelabs Technologies
NCT00053560Phase 3Dec 1, 2002Genelabs Technologies
Showing 20 of 23 trials
Page 1 / 2

Organizations

Research & Development (25)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
EndoCeutics Inc.For profit5412014
AMAG Pharmaceuticals, Inc.For profit3012018
Center for Human ReproductionAcademic/Hospital3312007
Genelabs TechnologiesFor profit3311998
Mayo ClinicAcademic/Hospital2122000
National Cancer Institute (NCI)Government2122000
BayerFor profit1112002
Center for Vulvovaginal DisordersAcademic/Hospital1112019
Eastern Virginia Medical SchoolAcademic/Hospital1012014
Foundation for Reproductive MedicineAcademic/Hospital1012007
Hebrew UniversityAcademic/Hospital1112008
Instituto PalaciosAcademic/Hospital1112020
KK Women's and Children's HospitalAcademic/Hospital1112012
Lee's PharmaceuticalFor profit1112021
MacDonald Women's Hospital, ClevelandAcademic/Hospital1012019
Maryland Center for Sexual HealthAcademic/Hospital1012017
Navitas PharmaFor profit1012002
San Diego Sexual MedicineAcademic/Hospital1112018
Tel Aviv UniversityAcademic/Hospital1012008
The Jones InstituteAcademic/Hospital1012019
25 organizations
Page 1 / 2

Marketing (4)

OrganizationOrg typeRelationshipDate
AMAG Pharmaceuticals, Inc.For profitNDA2Nov 16, 2016
Allergan PLC (2015)For profitNDA2Nov 16, 2016
EndoCeutics Inc.For profitNDANov 16, 2016
GalenFor profitMKTGNov 16, 2016