ulipristal

Trade name: ella

Small moleculeapproved

Approved

Aug 13, 2010

Ulipristal acetate (also known as CDB-2914 and PGL4001 and trade name Ella in the U.S) is a novel oral emergency contraceptive designed and developed by HRA Pharma. It is a selective progesterone receptor modulator, which reversibly blocks the progesterone receptors in target tissues it was approved in May 2009 by the European Commission and in August 2010 by the FDA as safe and effective in preventing unintended pregnancy for up to 120 hours – or five days – post- unprotected intercourse or contraceptive failure. Ella is not intended for routine use as a contraceptive. When taken immediately before ovulation is to occur, ella postpones follicular rupture. The likely primary mechanism of action of ulipristal acetate for emergency contraception is therefore inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also contribute to efficacy. The most common side effects are: headache, nausea, stomach (abdominal) pain, menstrual pain. Some women taking ella may have their next period earlier or later than expected. If your period is more than a week late, you should get a pregnancy test. — NCATS

Clinical trial activity

66 trials · 50 clinical orgs · 2 marketing orgs

Phase 1
12
Phase 2
30
Phase 3
16
Phase 4
22

Earliest trial started Sep 1, 1999 (NCT00271583)

Timeline

1990s

  1. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2006

    HRA Pharma — Earliest Phase 3 Sponsor(trial)

2010s

  1. Aug 13, 2010

    HRA Pharma — Earliest FDA Approval

  2. Aug 13, 2010

    HRA Pharma — NDA Secondary Org

  3. Aug 13, 2010

    HRA Pharma — NDA Organization

  4. Feb 13, 2017

    Teva — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedAug 13, 2010

Chemistry & pharmacology

Loading structure…

SMILES

CN(C)C1=CC=C(C=C1)[C@H]2C[C@@]3(C)[C@@H](CC[C@]3(O)C(C)=O)[C@@H]4CCC5=CC(=O)CCC5=C24
Mol. weight
433.5824 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

  • 17alpha-acetoxy-11beta-(4-n,n-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione
  • cdb 2914
  • cdb-2914
  • cdb-2914
  • cdb-2914
  • ella
  • ella
  • ella
  • ella
  • ella norpregnadiene
  • ellaone
  • ellaone
  • ellaone
  • esmya
  • esmya
  • esmya
  • esmya
  • hrp 2000
  • hrp-2000
  • rti-3021-012
  • rti-3021-022
  • ulipristal
  • ulipristal
  • ulipristal
  • ulipristal
  • ulipristal
  • ulipristal
  • ulipristal
  • ulipristal
  • ulipristal
  • ulipristal
  • ulipristal acet
  • ulipristal acet
  • ulipristal acetate
  • ulipristal acetate
  • ulipristal acetate
  • ulipristal acetate
  • ulipristal acetate
  • ulipristal acetate
  • ulipristal acetate
  • ulipristal acetate
  • ulipristal acetate
  • va2914
  • va2914
  • va2914
  • va2914
  • va-2914

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06727734Phase 3Dec 31, 2024The Family Planning Association of Hong Kong, The University of Hong Kong
NCT05674513Phase 4Jan 9, 2023National Institutes of Health (NIH), Oregon Health and Science University
NCT05216952Phase 2May 11, 2022University of North Carolina at Chapel Hill
NCT04291001Early Phase 1 (Phase 1)Mar 4, 2020Merck, University of Utah
NCT03829696Phase 4Jan 31, 2020University of California, San Francisco
NCT04132349Phase 4Oct 30, 2019My Duc Phu Nhuan Hospital
NCT03802149Early Phase 1 (Phase 1)Apr 16, 2019Stanford University
NCT04832906Phase 4Mar 13, 2019Ain Shams University
NCT04989400Phase 4Jan 1, 2019Ain Shams University
NCT03296098Phase 2Dec 31, 2018Health Decisions, National Institutes of Health (NIH)
NCT03537768Phase 4Jul 12, 2018Health Decisions, National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)
NCT03354117Phase 1Mar 15, 2018Stanford University
NCT03325868Phase 4Feb 28, 2018Vanderbilt University
NCT03421639Phase 4Dec 1, 2017University of Milan
NCT03342859Phase 1Nov 16, 2017Bayer
NCT02859337Phase 4Oct 1, 2017National Institutes of Health (NIH), Oregon Health and Science University
NCT03186586Phase 4Jul 1, 2017University of Campinas
NCT03208985Phase 3May 23, 2017HRA Pharma, Pegus Research, Inc.
NCT03230539Phase 1May 1, 2017Population Council
NCT03156127Phase 1May 1, 2017Boryung Pharmaceutical Company
Showing 20 of 66 trials
Page 1 / 4

Organizations

Research & Development (50)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institutes of Health (NIH)Government11541999
Gedeon Richter Ltd.For profit7622008
HRA PharmaFor profit7632004
Magna Graecia UniversityAcademic/Hospital4412015
Health DecisionsFor profit3322014
Oregon Health and Science UniversityAcademic/Hospital3312015
Population CouncilAcademic/Hospital3322008
Watson PharmaceuticalsFor profit3312012
Ain Shams UniversityAcademic/Hospital2212019
AllerganFor profit2022014
BayerFor profit2222015
Columbia UniversityAcademic/Hospital2222015
Forest LaboratoriesFor profit2122014
National Institute of Child Health and Human Development (NICHD)Government2022006
Planned ParenthoodAcademic/Hospital2022006
Stanford UniversityAcademic/Hospital2212018
The University of Hong KongAcademic/Hospital2222015
University of ParisAcademic/Hospital2112004
Washington University in St. LouisAcademic/Hospital2222012
Boryung Pharmaceutical CompanyFor profit1112017
50 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
HRA PharmaFor profitNDA2Aug 13, 2010
HRA PharmaFor profitNDAAug 13, 2010
TevaFor profitMKTGFeb 13, 2017