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segesterone

Trade name: Annovera

Small moleculeapproved

Approved

Aug 10, 2018

Elcometrine (Segesterone acetate, Nestorone) is a steroidal progestin which is used as a hormonal contraceptive and as a treatment of endometriosis. Upon oral administration, Nestorone undergoes rapid metabolism and inactivation. Several clinical trials have been performed with Nestorone administered via subdermal implants. — NCATS

Clinical trial activity

14 trials · 11 clinical orgs · 3 marketing orgs

Phase 1
8
Phase 2
6
Phase 3
2
Phase 4
0

Earliest trial started Mar 1, 2003 (NCT00213096)

Timeline

2000s

  1. Jan 1, 2003

    Population Council — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2005

    Population Council — Earliest Phase 3 Sponsor(trial)

2010s

  1. Aug 10, 2018

    Population Council — Earliest FDA Approval

  2. Aug 10, 2018

    TherapeuticsMD — NDA Secondary Org

  3. Aug 10, 2018

    Population Council — NDA Organization

  4. Aug 10, 2018

    Mayne Pharma — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • annovera

    with ethinyl estradiol

    Also known as segesterone acetate and ethinyl estradiol vaginal system

Approval history

  • approvedAug 10, 2018

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)[C@@]1(O)C(=C)C[C@H]2[C@@H]3CCC4=CC(=O)CC[C@@H]4[C@H]3CC[C@]12C
Mol. weight
328.4452 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

  • 16-methylene-17alpha-acetoxy-19-nor-4-pregnen-3,20-dione
  • elcometrine
  • elcometrine
  • nestorone
  • nestorone
  • nestorone
  • nestorone
  • st 1435
  • st 1435
  • st-1435

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04290390Phase 1Feb 12, 2020TherapeuticsMD
NCT04272008Phase 1Feb 11, 2020TherapeuticsMD
NCT03452111Phase 2Aug 31, 2018Health Decisions, National Institutes of Health (NIH), Population Council
NCT02994602Phase 1Jan 1, 2017Health Decisions, Los Angeles Biomedical Research Institute, National Institutes of Health (NIH), Population Council, University of Washington
NCT02432261Phase 1Apr 1, 2015Health Decisions, National Institutes of Health (NIH)
NCT02236026Phase 1Sep 1, 2014Parexel, Population Council
NCT02215395Phase 1Mar 1, 2014Population Council, QPS
NCT01586000Phase 2Mar 1, 2012Health Decisions, National Institutes of Health (NIH)
NCT00891228Phase 1May 1, 2009National Institutes of Health (NIH), Population Council, University of California, Los Angeles, University of Washington
NCT00796133Phase 2Nov 1, 2008Population Council
NCT00455156Phase 3Dec 1, 2006National Institutes of Health (NIH), Population Council
NCT00263341Phase 3Dec 1, 2005National Institutes of Health (NIH), Population Council, United States Agency for International Development, World Health Organization
NCT00229593Phase 1Sep 1, 2005National Institutes of Health (NIH), University of California, Los Angeles, University of Washington
NCT00213096Phase 2Mar 1, 2003Population Council, United States Agency for International Development
Showing 14 of 14 trials
Page 1 / 1

Organizations

Research & Development (11)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Population CouncilAcademic/Hospital9532003
National Institutes of Health (NIH)Government8232005
Health DecisionsFor profit4422012
University of WashingtonAcademic/Hospital3112005
TherapeuticsMDFor profit2212020
United States Agency for International DevelopmentGovernment2022003
University of California, Los AngelesAcademic/Hospital2012005
Los Angeles Biomedical Research InstituteAcademic/Hospital1012017
ParexelFor profit1012014
QPSFor profit1012014
World Health OrganizationGovernment1012005
11 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Mayne PharmaFor profitNDA2Aug 10, 2018
Population CouncilAcademic/HospitalNDAAug 10, 2018
TherapeuticsMDFor profitNDA2Aug 10, 2018