Delving into the Latest Updates on Ulipristal Acetate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

BR-UPS, Esmya, Fibristal

+ [24]

Target

PR

Action

modulators

Mechanism

PR modulators(Progesterone receptor modulators)

Therapeutic Areas

Urogenital DiseasesOther Diseases

Active Indication

PregnancyContraception

Inactive Indication

Abnormal uterine bleedingAdenomyosisAnemia+ [6]

Originator Organization

HRA Pharma Development SARL

Active Organization

Laboratoire HRA Pharma SAS

Zhejiang Xianju Pharmaceutical Co., Ltd.

Hangzhou Rongli Pharmaceutical Technology Co., Ltd.

+ [1]

Inactive Organization

Gedeon Richter (UK) Ltd.

PregLem SA

HRA Pharma Development SARL

+ [5]

License Organization

Actavis Group ehf

Chemical Works of Gedeon Richter Plc

PregLem SA

+ [3]

Drug Highest PhaseApproved

First Approval Date

European Union (15 May 2009),

Contraception

Regulation-

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Structure/Sequence

Molecular FormulaC30H37NO4

InChIKeyOOLLAFOLCSJHRE-ZHAKMVSLSA-N

CAS Registry126784-99-4

Tumor necrosis factor inhibitors (TNFi) may have insufficient efficacy in 40% of patients with axial spondyloarthritis (axSpA), leading to continued pain. We aimed to compare real-world effectiveness of switching from an initial TNFi to upadacitinib (TNFi-UPA), another TNFi (TNFi-TNFi), or an interleukin-17 inhibitor (TNFi-IL-17i) in patients with axSpA.

METHODS:

Data were drawn from the Adelphi Real World Spondyloarthritis Disease Specific Programme™, a cross-sectional survey of physicians and their patients with axSpA in France, Germany, Italy, Spain, the UK, and the USA from March-November 2021 and June 2023-June 2024. Patients who switched treatment from an initial TNFi were stratified by subsequent therapy: TNFi-UPA, TNFi-TNFi, or TNFi-IL-17i. Physician-reported clinical outcomes including pain (rated 0-10) and number of joints affected by inflammation or stiffness (from 0 to 68) were evaluated ≥ 3 months from treatment switch. Differences in characteristics were adjusted at the point of switch via inverse-probability-weighted regression adjustment to compare outcomes in separate analyses by subsequent class of therapy: TNFi-UPA versus TNFi-TNFi or TNFi-UPA versus TNFi-IL-17i.

RESULTS:

Overall, 310 physicians provided data for 557 patients; 108 were TNFi-UPA, 271 TNFi-TNFi, and 178 TNFi-IL-17i. A higher proportion of patients in the TNFi-UPA group achieved a ≥ 2 point and ≥ 33% reduction in pain than those in the TNFi-IL-17i (97.6% vs 86.4%; p = 0.002) or TNFi-TNFi (100.0% vs 80.1%; p < 0.001) groups. More patients achieved ≥ 50% reduction in pain in the TNFi-UPA group compared to TNFi-IL-17i (90.9% vs 74.0%; p = 0.004) or TNFi-TNFi (96.3% vs 72.3%; p = 0.024). More patients in the TNFi-UPA group had no affected joints than TNFi-IL-17i (93.1% vs 72.6%; p = 0.002) or TNFi-TNFi patients (100.0% vs 79.2%; p < 0.001).

CONCLUSION:

This real-world study demonstrated that more patients who switched from TNFi to UPA had improvements in pain and affected joints compared to those who switched to a second TNFi or IL-17i.

01 Oct 2025·Clinical Pharmacology in Drug Development

Pharmacokinetic and Bioequivalence Evaluation of Ulipristal Acetate in Healthy Chinese Subjects in the Fasting and Postprandial Conditions

Article

Author: Lv, Yuxia ; Li, Weiyong ; He, Ling

Abstract:

Ulipristal acetate (UPA) is indicated for the treatment of moderate to severe uterine fibroids in adult women of reproductive age who are candidates for surgical intervention. A single‐center, randomized, open‐label, 2‐period crossover study was conducted in 46 healthy female subjects under both fasting and postprandial conditions. Blood samples were collected for pharmacokinetic analysis following the oral administration of a 5‐mg dose of UPA. Plasma concentrations were quantified using liquid chromatography‐tandem mass spectrometry. The 90% confidence intervals of the ratio of geometric mean of maximum concentration, area under the plasma concentration‐time curve (AUC) from time 0 to the time of last measurable concentration, AUC from time 0 to infinity of UPA, and monodemethyl‐UPA all fell within the bioequivalence range of 80%‐125% under both fasting and postprandial conditions. In this study, coadministration oral UPA 5 mg with a high‐fat meal resulted in a maximum concentration that was approximately 25% lower, a delayed time to reach maximum concentration (from a median of 0.5‐3 hours) than with the fasting state, and an AUC from time 0 to infinity that increased by a factor of 1.58‐1.85. Similar results were observed for the active metabolite (monodemethyl‐UPA). All adverse events recorded during the study were of mild intensity, and no serious adverse events were observed. Both preparations showed good safety and tolerability. No data are available on the clinical importance of the food effect. Until such data becomes available, treating physicians should be aware of the increase in systemic exposure based on fasting versus postprandial conditions and plan dosage regimens accordingly.

01 Sep 2025·ENVIRONMENTAL TOXICOLOGY AND PHARMACOLOGY

Effect of emergency contraception (ulipristal acetate) on growth, sexual differentiation, and reproduction in Oryzias latipes

Article

Author: Horie, Yoshifumi ; Chihaya, Yuto

Pharmaceuticals used to relieve symptoms of human illnesses may not be completely removed by sewage treatment facilities, resulting in environmental runoff. Pharmaceuticals leaking into the environment can adversely affect wildlife. Ulipristal acetate (UPA), an emergency contraceptive (EC), is used both as EC and to treat uterine fibroids. This study aimed to clarify the effects of UPA on the growth, sexual differentiation, and reproduction of Japanese medaka. No statistically significant difference was observed in the hatching rate, growth, or reproduction between the control and UPA-exposed groups. In addition, investigation of the effect of UPA on sexual differentiation of Japanese medaka revealed no individuals with testis-ova or ovo-testis or individuals with sex change at concentrations of 1, 10, or 100 µg/L. This study is the first to examine the effects of UPA on growth, gonadal sex differentiation, and reproduction in fish. Our results indicate that UPA has no effect on Japanese medaka and is thus an ecosystem-friendly emergency contraceptive.

18

News (Medical) associated with Ulipristal Acetate

24 Jan 2025

·www.drugs.com

Abortion Pill Alternative Found in Morning-After Pill

FRIDAY, Jan. 24, 2025 -- When one abortion pill faces lawsuits, another may be waiting in the wings, a new study suggests. The study, published Jan. 23 in the journal NEJM Evidence , has found a potential alternative to the abortion pill mifepristone , offering yet another option at a time when access to reproductive health care faces increasing legal and political challenges. Researchers tested ulipristal acetate, the active ingredient in the emergency contraceptive pill Ella , as a substitute for mifepristone in the medication abortion regimen. The study found that when ulipristal acetate was used at double the typical dose of Ella followed by misoprostol, the regimen was 97% effective in terminating pregnancies up to nine weeks. No serious complications were reported among the 133 women who participated. All but four completed the termination of their pregnancies without further intervention, researchers reported. The findings dovetail with ongoing lawsuits targeting mifepristone, the only drug specifically approved for abortion in the United States. Typically, it works by blocking progesterone, a hormone necessary for pregnancy, and is followed by misoprostol, which causes contractions to end the pregnancy. Lead author Dr. Beverly Winikoff , president of the reproductive health research organization Gynuity Health Projects, told The New York Times that the U.S. Supreme Court’s 2022 decision to overturn Roe v. Wade increased her interest in exploring alternatives to mifepristone. “I was thinking, there’s maybe something else we can do,” Winikoff said. “Another option. And this one is already on the market.” It's important to note, however, that reproductive health experts warn that the study could fuel political controversy, because Ella is also marketed as a prescription morning-after pill to prevent pregnancy following unprotected sex. Abortion foes have long argued that morning-after pills like Ella can act as abortifacients, substances that cause abortion. These claims have been strongly debunked. Evidence shows that Ella, when taken at its standard 30-milligram dose, works by delaying ovulation, preventing fertilization. This study, which used a 60-milligram dose of ulipristal acetate combined with misoprostol, does not debunk the science of emergency contraception . But it may blur public perceptions of the line between contraception and abortion. “It’s going to put wind in the sails of abortion opponents who have been saying things like contraceptives can be abortifacients,” Mary Ziegler , a law professor and abortion expert at the University of California, Davis, told The Times. “This study being released will be difficult, I think, for abortion rights supporters to manage.” Kristi Hamrick , a spokeswoman for Students for Life of America, said her organization would “absolutely” consider litigation over Ella. “The pro-life movement should be vindicated,” Hamrick told The Times . “We’ve been arguing for years that Ella acts as an abortifacient.” While the results are promising, experts say more research is needed before ulipristal acetate could replace mifepristone. “We can’t change clinical practice based on this study,” Kelly Cleland , executive director of the American Society for Emergency Contraception, told The Times. Dr. Daniel Grossman , a reproductive health researcher at the University of California, San Francisco, called the findings “promising.” But he warned that “if because of this new evidence that at higher doses, ulipristal acetate could cause an abortion, that were to lead to ulipristal acetate being taken off the market for emergency contraception, that would be really, really bad.” The study was conducted in Mexico City and was co-led by researchers there. “The more uses we have for these medications, the harder it will be for people to take them away,” Dr. Paul Blumenthal , an emeritus professor of obstetrics and gynecology at Stanford University who was in an advisory group for the study, concluded. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Drug ApprovalClinical Study

24 Jan 2025

·pharma.economictimes.indiatimes.com

Emergency contraception pill could be an alternative to mifepristone for abortions, study suggests

New Delhi: A new study suggests that a pill used for emergency contraception could be repurposed at a higher dose as an abortion drug, providing a possible alternative to mifepristone, one of the two drugs used in the most common type of abortion in the United States. Mifepristone has been under attack by abortion opponents, with several states seeking in federal court to restrict its use. Now used in two-thirds of U.S. abortions, mifepristone blocks a hormone needed to sustain a pregnancy. It's typically used with misoprostol, which causes contractions and bleeding. In the study, 133 women who were up to nine weeks' pregnant took a 60 milligram dose of ulipristal acetate, the active ingredient in the prescription contraceptive Ella, followed by misoprostol 24 hours later. For 97% of them, that drug combo was effective at inducing an abortion, an effectiveness equal to the mifepristone-misoprostol combination. Four women needed a procedure or an additional medication to complete the abortion. The 60 milligram dose of ulipristal used in the study is twice the dose of Ella, a prescription drug used for emergency contraception. The company that makes Ella says on its website that it won't end an existing pregnancy. It can be taken up to five days after unprotected sex to prevent pregnancy. The findings, published Thursday in the journal NEJM Evidence, may make emergency contraception a target of abortion opponents. "I'm really worried that these results could be misapplied by anti-abortion activists to try to further their assault on contraception," said Dr. Daniel Grossman of the University of California, San Francisco, who wrote an accompanying editorial in the journal. Grossman praised the study but said more research is needed on ulipristal as an abortion drug before doctors would prescribe it routinely for that use. Lead author Dr. Beverly Winikoff, president of Gynuity Health Projects , a not-for-profit research group, said women need information about ulipristal, especially with mifepristone challenged in court. "At least now we would have an alternative," Winikoff said. "I think it's better to have more things that you could use."

Clinical ResultDrug Approval

27 Aug 2024

·www.prnewswire.com

ScaleReady announces the inaugural G-Rex® Grant has been awarded to Stanford Medicine Laboratory for Cell and Gene Medicine

ST. PAUL, Minn., Aug. 27, 2024 /PRNewswire/ -- ScaleReady™, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation (NASDAQ: TECH) and CellReady™, today announced that Dr. Steve Feldman, Scientific Director and Site Head of Stanford Medicine's Laboratory for Cell and Gene Medicine (LCGM), has been awarded the inaugural G-Rex® Grant. Dr. Feldman's $300,000 G-Rex Grant will enable expeditious development of Stanford Medicine's LCGM's G-Rex platform for CAR-T cell therapy manufacturing, which will be offered to internal investigators and external developers who are seeking its development and manufacturing services. "Stanford's LCGM anticipates a need to support a greater number of clinical trials and the G-Rex Grant will be used to help meet that need," said Dr. Feldman. "We are honored to award the inaugural G-Rex Grant to Dr. Feldman and his team at Stanford Medicine LCGM. Stanford University is a world-class institution with faculty who have a reputation for innovative and ground-breaking achievements. Their work aligns with Wilson Wolf's mission of bringing hope to cancer patients, one G-Rex at a time" said John Wilson, CEO of Wilson Wolf and co-inventor of G-Rex. As part of the G-Rex Grant, Stanford Medicine LCGM will deploy their G-Rex-centric manufacturing process in an upcoming Phase 1 trial for GPC2+ pediatric neuroblastoma and medulloblastoma. Previously, the FDA had recommended sponsors develop and implement potency assays earlier in the clinical trial process. With that objective, Stanford Medicine LCGM plans to implement Bio-Techne's leading automated multiplexing immunoassay platform, Ella™, as a potency assay for final drug product release. Furthermore, Stanford Medicine LCGM will collaborate with CellReady, the world's first and only G-Rex based contract development and manufacturing organization (CDMO), to leverage their proven capacity to quickly create G-Rex master batch records that establish manufacturing simplicity, efficiency, and repeatability. Additionally, Stanford Medicine LCGM plans to further develop a novel technology (developed by Wilson Wolf) that enables closed-system T cell purification to be done directly in a G-Rex device, without the need for expensive ancillary equipment. ScaleReady's G-Rex Grant Program is a $20M initiative to advance the state of cell and gene-modified cell therapy (CGT) development and manufacturing by awarding individual Grant Awards worth up to $300,000. G-Rex Grant Recipients also gain access to exclusive support from ScaleReady's growing consortium of G-Rex Grant Partners who bring best-in-class tools and technologies as well as unparalleled knowledge and expertise in the areas of cGMP manufacturing, quality and regulatory affairs, CGT business operations, and more. About ScaleReady ScaleReady provides the field of cell and gene-modfied cell therapy (CGT) with a G-Rex centric manufacturing platform that enables the world's most practical, flexible, scalable, and affordable CGT drug product development and manufacturing. The G-Rex manufacturing platform is currently used by a rapidly growing list of over 800 organizations and is producing drug products for approximately 50% of CGT clinical trials as well as 4 commercially approved CGT drugs. CGT entities relying on the breadth and scope of ScaleReady's expertise can expect to save years of time and millions of dollars on the path to CGT commercialization. For more information about the ScaleReady G-Rex® Grant Program, please contact [email protected]. About Wilson Wolf Manufacturing Wilson Wolf () is dedicated to simplifying cell and gene-modified cell (CGT) therapy research, process development, and manufacturing. This is being accomplished through its scalable G-Rex® technology, which is used throughout the world in CGT applications ranging from basic research to commercial drug production. Wilson Wolf's mission is to create hope for cancer patients, one G-Rex® device at a time. About Bio-Techne Corporation Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne, in partnership with Wilson Wolf, is creating products such as media and cytokines that are specifically tailored to G-Rex® Bioreactors, including right-sized reagent quantities in containers that are tailored to high throughput closed-system manufacturing. For more information on Bio-Techne and its brands, please visit or follow the Company on social media at: Facebook, LinkedIn, Twitter or YouTube. Contact: David Clair, Vice President, Investor Relations & Corporate Development [email protected] 612-656-4416 About CellReady LLC CellReady is the world's first and only G-Rex® centric contract development and manufacturing organization (CDMO) specializing in G-Rex® based cell and gene-modified cell therapy development and manufacturing. The company offers a wide range of services to support the development and commercialization of these therapies. CellReady's mission is to create hope for cancer patients, one G-Rex® process at a time. SOURCE Bio-Techne Corporation

Cell TherapyImmunotherapyGene Therapy

100 Deals associated with Ulipristal Acetate

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External Link

KEGG	Wiki	ATC	Drug Bank
D09687	Ulipristal Acetate	G03XB02 G03AD02	DB08867

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Leiomyoma	European Union	Gedeon Richter (UK) Ltd.	22 Feb 2012
Leiomyoma	Iceland	Gedeon Richter (UK) Ltd.	22 Feb 2012
Leiomyoma	Liechtenstein	Gedeon Richter (UK) Ltd.	22 Feb 2012
Leiomyoma	Norway	Gedeon Richter (UK) Ltd.	22 Feb 2012
Pregnancy	United States	Laboratoire HRA Pharma SAS	13 Aug 2010
Contraception	European Union	Laboratoire HRA Pharma SAS	15 May 2009
Contraception	Iceland	Laboratoire HRA Pharma SAS	15 May 2009
Contraception	Liechtenstein	Laboratoire HRA Pharma SAS	15 May 2009
Contraception	Norway	Laboratoire HRA Pharma SAS	15 May 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Abnormal uterine bleeding	Phase 3	United States	Allergan UC	29 Jan 2014
Abnormal uterine bleeding	Phase 3	Canada	Allergan UC	29 Jan 2014
Anemia	Phase 3	United States	Actavis, Inc.	01 Apr 2012
Uterine Fibroids	Phase 3	Austria	PregLem SA	01 Jul 2010
Uterine Fibroids	Phase 3	Belgium	PregLem SA	01 Jul 2010
Uterine Fibroids	Phase 3	Poland	PregLem SA	01 Jul 2010
Uterine Fibroids	Phase 3	Spain	PregLem SA	01 Jul 2010
Uterine Hemorrhage	Phase 3	Austria	PregLem SA	01 Jul 2010
Uterine Hemorrhage	Phase 3	Belgium	PregLem SA	01 Jul 2010
Uterine Hemorrhage	Phase 3	Poland	PregLem SA	01 Jul 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04291001 (CTgov)	Early Phase 1	Contraception	40	ENG implant (ENG Implant Alone)	wsphqokzbf = kmcrrtzazr qjbygncivf (hiirxeojpn, jbhxftinyx - wjtcaqxmab) View more	-	12 Jul 2024
NCT04291001 (CTgov)	Early Phase 1	Contraception	40	ENG implant+oral ulipristal acetate (ENG Implant Plus Oral UPA)	wsphqokzbf = gcurbsztqo qjbygncivf (hiirxeojpn, gnhgnnlhlf - mfvfdwfyaz) View more	-	12 Jul 2024
NCT02213081 (CTgov)	Phase 4	Endometriosis \| Dysmenorrhea \| Chronic pelvic pain syndrome ... View more	1	Ulipristal	mrijcxnqvb(iswppehouw) = yturgvwdvb lgfyjaiuph (vzwzluvneb, 0.57) View more	-	16 May 2024
NCT02859337 (UPA-Obesity, CTgov)	Phase 4	Contraception \| Obesity	64	UPA (ECx1 BMI>/=30kg/m2)	zzivpawret = urytsmozgq vystrsjavf (uqazflrkri, qsdkjspenb - pojlcbksnw) View more	-	06 Feb 2024
NCT02859337 (UPA-Obesity, CTgov)	Phase 4	Contraception \| Obesity	64	UPA (ECx2 BMI >/=30)	zzivpawret = fglxqxphgm vystrsjavf (uqazflrkri, orrifyneys - eoxjqeeehf)	-	06 Feb 2024
NCT05216952 (CTgov)	Phase 2	Pregnancy \| Abortion \| Abortion, Missed	3	Ulipristal Acetate (UPA)	xmmfynydbh = tjnbttmysy gaontvjwhq (tvidbrjnuw, lwvmivhtpk - jaetfvuuyf) View more	-	28 Jun 2023
NCT03354117 (Pubmed \| BMJ Sex Reprod Health)	Phase 1	Anovulation	9	Ulipristal acetate 30mg plus meloxicam 30mg	zilwpgbfgb(pnwkkjfwlu) = zexogukfhv mypltepgzl (norasudcdf ) View more	-	25 Apr 2022
NCT00551616 (CTgov)	Phase 3	Contraception	2,221	CDB-2914 (CDB-2914)	aedburmzht = nkwqufiaft bhqmxvzezz (msiuidagqc, cedpedpjee - uchjybylpl) View more	-	16 Mar 2022
NCT00551616 (CTgov)	Phase 3	Contraception	2,221	Levonorgestrel (Levonorgestrel)	aedburmzht = ffcgmiobvf bhqmxvzezz (msiuidagqc, etriajcahg - mewrshgajs) View more	-	16 Mar 2022
BC-APPS1 (SABCS2022)	Phase 2	Breast Cancer Ki67+ \| LP markers \| CD49f+/EPCAM+	26	Ulipristal acetate (UA) 5mg daily	fuwxzpuryz(obrsuoojqz) = mqhfwnqgjv aotwjiiyxo (vlmjwoziqk, 1.57 - 3.24) View more	Positive	15 Feb 2022
NCT02922127 (Pubmed \| Breast Cancer Res)	Phase 1	Breast hyperplasia	29	Combination oral contraceptive (COC)	cwpxfjpqyj(jbcbffcual) = Ulipristal would warrant further investigation for breast cancer chemoprevention were it not for concerns about its liver toxicity suvvutjxbn (bticgtvyad )	Positive	11 Jan 2022
NCT00411684 (CTgov)	Phase 3	Contraception	1,623	CDB-2914	rpcroyqwhs = knexlwuzbl gjmqepgtpx (ywhxbkophq, ggzyfjxjxc - gwqmshistt) View more	-	03 May 2021
NCT01629563 (PEARLIV \| PEARL IV, CTgov)	Phase 3	Leiomyoma	451	PGL4001 5 mg (Ulipristal Acetate (PGL4001) 5mg)	woisphgjmt = hyfvbhobfc zmfawxkbsx (szdumuopfn, pvftoolswm - sxqoceqpyt) View more	-	04 Sep 2019
NCT01629563 (PEARLIV \| PEARL IV, CTgov)	Phase 3	Leiomyoma	451	PGL4001 10 mg (Ulipristal Acetate (PGL4001) 10mg)	woisphgjmt = dbornwppcx zmfawxkbsx (szdumuopfn, imhqpqefxt - ckvwggxiqu) View more	-	04 Sep 2019