Drugs / Ulipristal Acetate
Ulipristal Acetate
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected submucous uterine fibroid 1 milestone | |||||
| Rejected (CRL) | US (FDA) | — | submucous uterine fibroid | 2018-08-21 | “Complete Response Letter (CRL) from the U.S. Food and Drug Administration ( FDA ) in response to the New Drug Application (NDA) for ulipristal acetate” abbvie.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | ELLA | — | 2021-06-24 | fda.gov ↗ |
| Approved | US (FDA) | ELLA | — | 2010-08-13 | fda.gov ↗ |
| Approved | EU (EMA) | ellaOne | — | 2009-05-15 | europa.eu ↗ |
Trials 47
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT04423068 | Dec 2020 → Apr 2022 | pregnancy disorder | Children's Mercy Hospital Kansas City | Completed | No outcome recorded |
| Phase 0 | NCT03802149 | Apr 2019 → Apr 2020 | — | Stanford University | Completed | No outcome recorded |
| Phase 0 | NCT01493791 | Nov 2011 → Jul 2013 | urogenital tract malformation | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Withdrawn | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT03354117 | Mar 2018 → May 2019 | — | Stanford University | Completed | No outcome recorded |
| Phase 1 | NCT03156127 | May → Jul 2017 | leiomyoma | Boryung Pharmaceutical Co., Ltd | Withdrawn | No outcome recorded |
| Phase 1 | NCT03230539 | May 2017 → Jan 2018 | — | Population Council | Unknown | No outcome recorded |
| Phase 1 | NCT02922127 | Dec 2016 → Oct 2019 | — | Columbia University | Completed | No outcome recorded |
| Phase 1 | NCT02634437 | Dec 2015 → Dec 2016 | impaired renal function disease | Allergan | Completed | No outcome recorded |
| Phase 1 | NCT00041899 | May 2002 → Mar 2005 | — | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT07434128 | Aug 2026 → Dec 2027 expected | breast cancer | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05216952 | May 2022 → Jan 2023 | pregnancy disorder with abortive outcome | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT03296098 | Dec 2020 → Jan 2022 | — | Premier Research | Withdrawn | No outcome recorded |
| Phase 2 | NCT02408770 | Jan 2016 → Mar 2019 | breast cancer | Manchester University NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT02600286 | Oct 2015 → Nov 2017 | Charcot-Marie-Tooth disease type 1A | University Hospital, Strasbourg, France | Terminated | No outcome recorded |
| Phase 2 | NCT00456924 | Jan → Dec 2004 | female reproductive system disorder | HRA Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00044876 | Sep 2002 → Jun 2007 | leiomyoma | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 2 | NCT00009659 | Jan → Dec 2001 | — | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT00271583 | Sep 1999 → Sep 2001 | — | University of Pittsburgh | Completed | Met primary |
| Phase 313 trials · 6 met primary | ||||||
| Phase 3 | NCT03208985 | May 2017 → Jun 2018 | — | HRA Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03118297 | May 2017 → Jan 2018 | hemorrhagic disease | Washington University School of Medicine | Completed | Met primary |
| Phase 3 | NCT02425878 | Oct 2015 → May 2016 | uterus interstitial leiomyoma | Instituto Valenciano de Infertilidad, IVI VALENCIA | Terminated | No outcome recorded |
| Phase 3 | NCT02147197 | Mar 2014 → Mar 2016 | leiomyoma, uterine disorder | Allergan | Completed | Met primary |
| Phase 3 | NCT01642472 | Jul 2012 → Mar 2015 | uterine benign neoplasm | PregLem SA | Completed | No outcome recorded |
| Phase 3 | NCT01629563 | Jun 2012 → Jan 2015 | leiomyoma | PregLem SA | Completed | No outcome recorded |
| Phase 3 | NCT01553123 | Apr 2012 → Nov 2013 | leiomyoma | Watson Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 3 | NCT01252069 | Jan 2011 → Aug 2013 | leiomyoma | PregLem SA | Completed | No outcome recorded |
| Phase 3 | NCT01156857 | Jul 2010 → Nov 2011 | leiomyoma | PregLem SA | Completed | No outcome recorded |
| Phase 3 | NCT00755755 | Oct 2008 → Mar 2010 | leiomyoma | PregLem SA | Completed | Met primary |
| Phase 3 | NCT00740831 | Aug 2008 → Jan 2010 | leiomyoma | PregLem SA | Completed | Met primary |
| Phase 3 | NCT00551616 | Apr 2007 → Apr 2009 | — | HRA Pharma | Completed | Met primary |
| Phase 3 | NCT00411684 | Nov 2006 → Apr 2008 | — | HRA Pharma | Completed | Met primary |
| Phase 415 trials · 1 missed | ||||||
| Phase 4 | NCT04132349 | Oct 2019 → Apr 2020 | leiomyoma | My Duc Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT04989400 | Jan → Oct 2019 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT03325868 | Feb 2018 → May 2019 | adenomyosis, dysmenorrhea | Vanderbilt University Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT03186586 | Jul 2017 → Jul 2018 | hemorrhagic disease | University of Campinas, Brazil | Unknown | Missed primary |
| Phase 4 | NCT02859337 | May 2017 → Jan 2022 | obesity disorder | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 4 | NCT02601196 | Sep 2016 → Jan 2018 | uterus interstitial leiomyoma | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02440750 | Jun 2016 → Apr 2017 | leiomyoma | University of Cagliari | Unknown | No outcome recorded |
| Phase 4 | NCT02825719 | Dec 2015 → Mar 2020 | leiomyoma | Queen Mary Hospital, Hong Kong | Terminated | No outcome recorded |
| Phase 4 | NCT02689804 | Jul → Dec 2015 | — | Columbia University | Completed | No outcome recorded |
| Phase 4 | NCT02357563 | Feb 2015 → Sep 2017 | leiomyoma | University Magna Graecia | Unknown | No outcome recorded |
| Phase 4 | NCT02361905 | Feb 2015 → Sep 2017 | leiomyoma | University Magna Graecia | Unknown | No outcome recorded |
| Phase 4 | NCT02361879 | Feb 2015 → Sep 2017 | leiomyoma | University Magna Graecia | Unknown | No outcome recorded |
| Phase 4 | NCT02213081 | Feb 2015 → Nov 2016 | endometriosis | Northwestern University | Completed | No outcome recorded |
| Phase 4 | NCT02361892 | Feb 2015 → Jun 2017 | infertility disorder | University Magna Graecia | Unknown | No outcome recorded |
| Phase 4 | NCT01569113 | Mar → Aug 2012 | — | HRA Pharma | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01391845 | Jul 2011 → Mar 2012 | infertility disorder | Programa de Asistencia Reproductiva de Rosario | Unknown | No outcome recorded |
| Comparator or background therapy18 trials | ||||||
| Phase 0 | NCT04291001 Comparator | Sep 2020 → Oct 2022 | — | University of Utah | Completed | No outcome recorded |
| Phase 1 | NCT03342859 Comparator | Nov 2017 → Dec 2018 | leiomyoma | Bayer | Terminated | No outcome recorded |
| Phase 1/2 | NCT02451826 Comparator | May 2015 → Nov 2017 | anovulation | Population Council | Unknown | No outcome recorded |
| Phase 2 | NCT02587000 Comparator | Jun 2015 → Feb 2018 | adenomyosis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT02465814 Comparator | Jun 2015 → Oct 2016 | leiomyoma | Bayer | Completed | Met primary |
| Phase 2 | NCT01953679 Comparator | Mar 2014 → Aug 2015 | — | Premier Research | Completed | No outcome recorded |
| Phase 2 | NCT00791297 Comparator | Oct 2008 → Sep 2014 | — | Population Council | Completed | No outcome recorded |
| Phase 2 | NCT01107093 Comparator | May → Dec 2008 | — | HRA Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00290251 Comparator | Feb 2006 → Jul 2009 | leiomyoma | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 2 | NCT00089414 Comparator | Jul 2004 → Jun 2010 | depressive disorder, premenstrual dysphoric disorder | National Institute of Mental Health (NIMH) | Terminated | No outcome recorded |
| Phase 3 | NCT06727734 Comparator | Jan 2025 → Sep 2027 expected | — | The University of Hong Kong | Recruiting | No outcome recorded |
| Phase 4 | NCT05674513 Comparator | Jan 2023 → Dec 2026 expected | — | Oregon Health and Science University | Recruiting | No outcome recorded |
| Phase 4 | NCT03829696 Background | Jan 2020 → Jan 2021 | — | University of California, San Francisco | Withdrawn | No outcome recorded |
| Phase 4 | NCT04832906 Comparator | Mar 2019 → Mar 2021 | uterine benign neoplasm | Ain Shams Maternity Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03537768 Comparator | Jul 2018 → Apr 2022 | — | Kimberly Myer | Terminated | No outcome recorded |
| Phase 4 | NCT02577601 Comparator | Sep 2015 → Jun 2017 | — | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 4 | NCT02288130 Comparator | Dec 2014 → Jul 2017 | leiomyoma | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
| — | NCT01539720 Comparator | Dec 2012 → Nov 2018 | — | Planned Parenthood of the St. Louis Region and Southwest Missouri | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2019-04-08 | Lotus Pharmaceutical | Regulatory Business partners of Lotus obtain first European approvals for generic Ulipristal 5mg lotuspharm.com ↗
This is the first approval of Ulipristal 5mg tablets in Europe. |
| 2019-04-08 | Alvogen Korea | Regulatory Alvogen and business partners obtain first European approvals for generic Ulipristal 5mg alvogen.com ↗
Alvogen and its business partners have received regulatory clearance for its product in multiple European countries. |
| 2018-08-21 | AbbVie | Regulatory Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Ulipristal Acetate New Drug Application abbvie.com ↗
The letter from the FDA indicates it is not able to approve the ulipristal acetate NDA in its current form and is requesting additional information. |
| 2018-02-28 | AbbVie | Regulatory Allergan Announces FDA Has Extended The Ulipristal Acetate NDA Review Period To August 2018 abbvie.com ↗
The PDUFA target action date has been extended to August 2018 to provide time for a full review of the file. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-04-08 | Lotus Pharmaceutical | Business partners of Lotus obtain first European approvals for generic Ulipristal 5mg lotuspharm.com ↗ |
| 2019-04-08 | Alvogen Korea | Alvogen and business partners obtain first European approvals for generic Ulipristal 5mg alvogen.com ↗ |
| 2018-08-21 | AbbVie | Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Ulipristal Acetate New Drug Application abbvie.com ↗ |
| 2018-02-28 | AbbVie | Allergan Announces FDA Has Extended The Ulipristal Acetate NDA Review Period To August 2018 abbvie.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 68 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ulipristal acetate | “Patients within this group will receive oral Ulipristal Acetate (Fibristal ©) 5 mg / day starting from the first day of menstrual bleeding, and for 3 months (period of the study).” NCT04832906 ↗43“A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet” NCT03156127 ↗ “FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg” NCT02689804 ↗ “ella® (ulipristal acetate emergency contraception 30 mg)” NCT03829696 ↗ “Ulipristal acetate 30mg orally x 1 dose” NCT02859337 ↗ “CDB-2914 (ulipristal acetate)” NCT01107093 ↗ |
| Known as | BR-UPS | “A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet” NCT03156127 ↗ |
| Known as | CDB-2914 | “Ulipristal acetate (UPA), previously named CDB-2914, is a selective progesterone-receptor modulator (SPRM).” NCT02825719 ↗ |
| Known as | ella | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03829696 ↗ |
| Known as | ellaOne | “At the conclusion of the enrollment visit, the research coordinator will randomize each woman to receive a single-dose pill of either levonorgestrel 1.5mg (like Plan B...” NCT02689804 ↗3“The long-term safety of anti-progesterone was evaluated for mifepristone (RU486) ulipristal acetate and (EllaOne®).” NCT02600286 ↗ “ellaOne® (Ulipristal Acetate 30 mg)” NCT01569113 ↗ |
| Known as | Esmya | “A selective progesterone receptor modulator (SPRM) is Ulipristal Acetate (UPA) is approved in the European Union as Esmya® as a tretament to reduce the ueterine leiomyomas at...” NCT03186586 ↗ |
| Known as | Inisia | “A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet” NCT03156127 ↗ |
| Known as | PGL4001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01156857 ↗ |
| Known as | ulipristal | “PGL4001 (ulipristal) and iron” NCT00755755 ↗ |
| Known as | Ulipristal acetate (UPA) emergency contraceptive (EC) | “Ulipristal acetate (UPA) emergency contraceptive (EC)” NCT02689804 ↗ |
| Known as | UPA | “Objective: To characterize the effect of ulipristal acetate (UPA) treatment on transforming growth factor (TGF) canonical and noncanonical signaling pathways in uterine...” PMID 30871768 ↗ Mar 201911“A proof-of Concept, Randomized 3-month Study to Evaluate the Effects of Three Contraceptive Intrauterine Systems Delivering Copper and a Daily Dose of 5, 20 or 40 μg of...” NCT03230539 ↗ “OBJECTIVE: To assess the efficacy of ulipristal acetate (UPA) for reducing abnormal bleeding among women using the 52-mg levonorgestrel intrauterine system (LNG-IUS).” PMID 31777949 ↗ Dec 2019 “Efficacy Study of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days” NCT01953679 ↗ “An emergency contraceptive, ulipristal acetate or UPA, normally works by stopping or delaying the ovary from releasing an egg (ovulation).” NCT05674513 ↗ “Ulipristal acetate (UPA) is a selective progesterone receptor modulator (SPRM) prescribed for women with symptomatic leiomyomas.” NCT02601196 ↗ “Ulipristal acetate (UPA), previously named CDB-2914, is a selective progesterone-receptor modulator (SPRM).” NCT02825719 ↗ “Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)” NCT01569113 ↗ “ulipristal acetae (UPA) in women with symptomatic uterine fibroids” NCT04132349 ↗ “continuous daily oral 10 mg of ulipristal acetate (UPA)” NCT03296098 ↗ “ulipristal acetate 30 mg (UPA)” PMID 38663539 ↗ Apr 2024 |
| Known as | UPA-EC | “The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.” NCT02689804 ↗ |
| Known as | VA2914 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00456924 ↗ |
| Action | Inhibit | “Yasmin oral contraceptive; CDB 2914 progesterone antagonist.” NCT00089414 ↗ |
| Route | Oral | “chronic oral administration of CDB-2914” NCT00009659 ↗ |