ulipristal
Trade name: ella
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
Earliest trial started Sep 1, 1999 (NCT00271583)
Timeline
1990s
- Jan 1, 1999
Earliest Phase 2 Sponsor(trial)
2000s
- Jan 1, 2002
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2006
HRA Pharma — Earliest Phase 3 Sponsor(trial)
2010s
- Aug 13, 2010
HRA Pharma — Earliest FDA Approval
- Aug 13, 2010
HRA Pharma — NDA Secondary Org
- Aug 13, 2010
HRA Pharma — NDA Organization
- Feb 13, 2017
Teva — Marketing Organization
Indications
Approved for
Studied for
- Abortion, Induced · Phase 4
- Abortion, Missed · Phase 2
- Abortion, Spontaneous · Phase 2
- Adenomyosis · Phase 4
- Breast Neoplasms · Phase 2
- Charcot-Marie-Tooth Disease · Phase 2
- Contraception · Phase 4
- Contraception Behavior · Phase 4
- Contraception, Postcoital · Phase 4
- Contraceptive Agents · Phase 2
- Depression · Phase 2
- Dysmenorrhea · Phase 4
- Endometriosis · Phase 4
- Fertilization in Vitro · Phase 4
- Fibroins · Phase 3
- Genital Diseases, Female · Phase 2
- Healthy Volunteers · Phase 2
- Hemorrhage · Phase 4
- Infertility · Phase 4
- Kidney Diseases · Phase 1
- Leiomyoma · Phase 4
- Menorrhagia · Phase 4
- Obesity · Phase 4
- Ovulation Inhibition · Phase 1/Phase 2
- Postmenopause · Phase 2
- Pregnancy Complications · Phase 2
- Premenstrual Dysphoric Disorder · Phase 2
- Premenstrual Syndrome · Phase 2
- Prostheses and Implants · Phase 4
- Urogenital Abnormalities · Early Phase 1
- Uterine Diseases · Phase 4
- Uterine Hemorrhage · Phase 3
Mechanism of action
- Progesterone receptorMODULATOR
PGR modulator
Approval history
- approvedAug 13, 2010
Chemistry & pharmacology
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
- WikipediaUlipristal acetate ↗
- NCATS6J5J15Q2X8 ↗
- ChEMBLCHEMBL260538 ↗
- ChEMBLCHEMBL2103846 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06727734 | Phase 3 | Dec 31, 2024 | The Family Planning Association of Hong Kong, The University of Hong Kong |
| NCT05674513 | Phase 4 | Jan 9, 2023 | National Institutes of Health (NIH), Oregon Health and Science University |
| NCT05216952 | Phase 2 | May 11, 2022 | University of North Carolina at Chapel Hill |
| NCT04291001 | Early Phase 1 (Phase 1) | Mar 4, 2020 | Merck, University of Utah |
| NCT03829696 | Phase 4 | Jan 31, 2020 | University of California, San Francisco |
| NCT04132349 | Phase 4 | Oct 30, 2019 | My Duc Phu Nhuan Hospital |
| NCT03802149 | Early Phase 1 (Phase 1) | Apr 16, 2019 | Stanford University |
| NCT04832906 | Phase 4 | Mar 13, 2019 | Ain Shams University |
| NCT04989400 | Phase 4 | Jan 1, 2019 | Ain Shams University |
| NCT03296098 | Phase 2 | Dec 31, 2018 | Health Decisions, National Institutes of Health (NIH) |
| NCT03537768 | Phase 4 | Jul 12, 2018 | Health Decisions, National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) |
| NCT03354117 | Phase 1 | Mar 15, 2018 | Stanford University |
| NCT03325868 | Phase 4 | Feb 28, 2018 | Vanderbilt University |
| NCT03421639 | Phase 4 | Dec 1, 2017 | University of Milan |
| NCT03342859 | Phase 1 | Nov 16, 2017 | Bayer |
| NCT02859337 | Phase 4 | Oct 1, 2017 | National Institutes of Health (NIH), Oregon Health and Science University |
| NCT03186586 | Phase 4 | Jul 1, 2017 | University of Campinas |
| NCT03208985 | Phase 3 | May 23, 2017 | HRA Pharma, Pegus Research, Inc. |
| NCT03230539 | Phase 1 | May 1, 2017 | Population Council |
| NCT03156127 | Phase 1 | May 1, 2017 | Boryung Pharmaceutical Company |
Organizations
Research & Development (50)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Institutes of Health (NIH) | Government | 11 | 5 | 4 | 1999 |
| Gedeon Richter Ltd. | For profit | 7 | 6 | 2 | 2008 |
| HRA Pharma | For profit | 7 | 6 | 3 | 2004 |
| Magna Graecia University | Academic/Hospital | 4 | 4 | 1 | 2015 |
| Health Decisions | For profit | 3 | 3 | 2 | 2014 |
| Oregon Health and Science University | Academic/Hospital | 3 | 3 | 1 | 2015 |
| Population Council | Academic/Hospital | 3 | 3 | 2 | 2008 |
| Watson Pharmaceuticals | For profit | 3 | 3 | 1 | 2012 |
| Ain Shams University | Academic/Hospital | 2 | 2 | 1 | 2019 |
| Allergan | For profit | 2 | 0 | 2 | 2014 |
| Bayer | For profit | 2 | 2 | 2 | 2015 |
| Columbia University | Academic/Hospital | 2 | 2 | 2 | 2015 |
| Forest Laboratories | For profit | 2 | 1 | 2 | 2014 |
| National Institute of Child Health and Human Development (NICHD) | Government | 2 | 0 | 2 | 2006 |
| Planned Parenthood | Academic/Hospital | 2 | 0 | 2 | 2006 |
| Stanford University | Academic/Hospital | 2 | 2 | 1 | 2018 |
| The University of Hong Kong | Academic/Hospital | 2 | 2 | 2 | 2015 |
| University of Paris | Academic/Hospital | 2 | 1 | 1 | 2004 |
| Washington University in St. Louis | Academic/Hospital | 2 | 2 | 2 | 2012 |
| Boryung Pharmaceutical Company | For profit | 1 | 1 | 1 | 2017 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| HRA Pharma | For profit | NDA2 | Aug 13, 2010 |
| HRA Pharma | For profit | NDA | Aug 13, 2010 |
| Teva | For profit | MKTG | Feb 13, 2017 |