A pilot study to investigate the potential role of atosiban, a selective oxytocin receptor inhibitor, in the management of endometriosis-related pain. Ten patients will be administered atosiban intravenously during 6 hours on a day during their period when they experience (severe) pain

Start Date01 Feb 2022

Sponsor / Collaborator

Radboud University Medical Center

100 Clinical Results associated with Atosiban acetate

100 Translational Medicine associated with Atosiban acetate

100 Patents (Medical) associated with Atosiban acetate

667

Literatures (Medical) associated with Atosiban acetate

01 Mar 2025·BRAIN RESEARCH

Combination of rTMS and oxytocin agonist attenuate depression-like behavior after postpartum depression in mice

Article

Author: Fang, Marong ; Yuan, Xia ; Amin, Nashwa ; Hu, Zhiying ; Abbasi, Irum Naz ; Wu, Fei ; Ye, Qing ; Sundus, Javaria ; Chen, Shijia ; Hussein, Azhar B

The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) categorizes postpartum depression (PPD) as a subtype of Major Depressive Disorder (MDD) with peripartum onset, generally arising within the initial trimester following delivery. This acute psychiatric condition is characterized by feelings of worthlessness, insomnia, extreme anxiety, or maternal neglect. Intranasal oxytocin (OT) and transcranial magnetic stimulation (TMS) have the potential to address impaired social cognition; nonetheless, their neuronal underpinnings, along with their safety and efficacy, are little comprehended. This study examines the effects of rTMS stimulation with an oxytocin agonist or antagonist in a PPD model. We employed the maternal separation with early weaning (MSEW) strategy for 21 days to attain our objective. Oxytocin acetate (agonist) and atosiban (antagonist) were administered by injection twice daily for three consecutive days following the model according to the established protocol. A single session of rTMS involved the application of high-frequency stimulation (20 Hz) one hour following the final injection. Behavioral testing and brain collection were conducted 12 h post-rTMS. The results indicated that treatment with OT followed by rTMS stimulation decreased neuronal cell death and microglial activation, meanwhile enhancing synaptic plasticity through the upregulation of PSD95, Synapsin I, and Synaptophysin. Simultaneously, both OT therapy and repetitive transcranial magnetic stimulation demonstrated a significant capacity to alter autophagy activity and astrocyte function. Nonetheless, OTA therapy followed by rTMS did not exhibit the same pattern of outcomes. Our findings indicate that the combination of rTMS stimulation and an oxytocin agonist in a PPD model may mitigate depression-like behavior.

01 Feb 2025·NEUROCHEMICAL RESEARCH

Oxytocin Protects Against Corticosterone-Induced DA Dysfunction: An Involvement of the PKA/CREB Pathway

Article

Author: Sookkua, Tichaporn ; Chaipunko, Sirinun ; Nopparat, Chutikorn ; Chutabhakdikul, Nuanchan

Abstract:

Chronic stress disrupts dopamine (DA) transmission, adversely affecting mood and contribution to neuropsychiatric disorders like ADHD, autism, schizophrenia, anxiety, depression, and drug addiction. The neuropeptide oxytocin (OXT) plays a key role in social cognition, bonding, attachment, and parenting behaviors. In addition, OXT can modulate the activity of the HPA axis, counteracting the effects of stress, and alleviating fear and anxiety. However, whether OXT can mitigate stress-induced DA dysfunction and the underlying mechanisms remains unclear. This study investigated the neuroprotective effects of OXT on corticosterone (CORT) induced DA dysfunction in the neuroblastoma cell line SH-SY5Y. The results revealed that CORT decreases the levels of intracellular signaling molecules associated with DA function, including phosphorylated tyrosine hydroxylase (pTH), phosphorylated cAMP response element-binding protein (pCREB), and protein kinase A (PKA). Interestingly, pretreatment with OXT mitigated CORT-induced DA dysfunction through its potent PKA activator properties. In addition, the neuroprotective effect of OXT was abolished by atosiban (an OXT receptor antagonist) or H89 (a PKA inhibitor). Our results suggest that OXT protects dopaminergic neuroblastoma cells from CORT-induced DA dysfunction, potentially through the involvement of oxytocin receptors and the PKA/CREB signaling pathway. These findings contribute to the understanding of the neurobiological mechanisms underlying stress resilience and highlight potential pathways for developing targeted treatments that leverage the neuroprotective properties of OXT to address disorders characterized by DA dysregulation and impaired stress responses.

01 Jan 2025·GEBURTSHILFE UND FRAUENHEILKUNDE

Differences between Current Clinical Practice and Evidence-Based Guideline Recommendations Regarding Tocolysis – an Austria-wide Survey

Article

Author: Stroemer, Annika ; Eichinger, Teresa ; Stelzl, Patrick ; Mayr, Andreas ; Oppelt, Peter ; Kehl, Sven ; Enengl, Sabine ; Rath, Werner ; Lastinger, Julia

Abstract:

To evaluate the adherence of Austrian obstetricians to national guideline recommendations by investigating data on the current practice of tocolysis regarding indications, timing and monitoring of tocolysis, choice of tocolytics and serious side effects, maintenance tocolysis, support of decision-making and recommendations at patient’s discharge from the hospital.78 obstetric departments in Austria were invited to participate in a nationwide survey between June 5th and August 31st 2023 by answering a web-based questionnaire about clinical standards. The survey was conducted approximately one year after implementation of the AWMF Guideline “Prevention and Therapy of Preterm Birth” 015‑025. Collected data were analyzed descriptively by performing measures of frequency. Fisher’s exact test was used for group comparison.The response rate was 69.2% (33.3% perinatal centers, 66.7% standard care). The most important indication of tocolysis were ≥ 4 contractions within 20 minutes of CTG tracing, as stated by 26 (48.1%) of the respondents; the AWMF Guideline 015‑025 (2022) was the most important decision-making support for tocolytic treatment (61.1%). 19 (35.2%) of obstetric units started tocolysis earliest at 23 + 0 weeks of gestation. Atosiban was the first-line tocolytic drug used by 43 (79.6%) of obstetric units, followed by nifedipine (n = 7, 13.0%); 49 of 54 obstetric units (90.7%) stated to perform maintenance tocolysis, among these 46 (93.9%) not routinely but on special indications (e.g. placenta previa). Serious side effects were observed by 77.8% of the respondents, mostly associated with the use of hexoprenaline.Our survey revealed considerable discrepancies between evidence-based guideline recommendations and daily clinical practice in Austrian hospitals.

News (Medical) associated with Atosiban acetate

22 Nov 2022

·www.biospace.com

XOMA Acquires Royalty and Milestone License to Ebopiprant, a Preterm Labor Asset, Being Developed by Organon

XOMA assumes the rights to ebopiprant from ObsEva, including the Organon License, Patent Estate, and Merck KGaA, Darmstadt, Germany, license, for a $15 million outlay Potential to earn $475 million in development, regulatory, and sales milestones Low- to mid- teens royalties upon commercialization Expands XOMA’s portfolio into new therapeutic segment – women’s health EMERYVILLE, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), a biotech royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of advancing novel therapeutic candidates aimed at improving human health, announced today it has acquired all rights and title to ebopiprant held by ObsEva for $15 million plus certain earn-out payments. XOMA has assumed the ebopiprant intellectual property (IP) estate and all license agreements, including the 2021 exclusive license agreement from ObsEva to Organon related to the development and commercialization of ebopiprant. “We are very pleased to add ebopiprant to XOMA’s royalty and milestone portfolio. Preterm labor is extremely stressful for expectant parents and their families. The costs to care for premature babies can quickly escalate to hundreds of thousands of dollars, resulting in long-term financial distress for many families,” stated Jim Neal, Chairman and Chief Executive Officer of XOMA. “The economics in the ebopiprant license acquisition have the potential to deliver significant returns to XOMA and our stockholders from the clinical development milestones alone. We wish Organon, a global women’s health company, success in its development activities with ebopiprant.” Under the terms of the agreement, XOMA has acquired all rights to ebopiprant held by ObsEva, including the Organon/ObsEva license agreement and the IP associated with the asset. XOMA will now be entitled to receive up to $475 million in development, regulatory, and sales-based milestone payments under the ObsEva/Organon license agreement. XOMA will pay to ObsEva a portion of the development and regulatory milestones, as well as certain sales milestones, up to $98 million. Upon commercialization, XOMA will receive royalties that range from low- to mid-teens from Organon and will make a mid-single-digit royalty payment to Merck KGaA, Darmstadt, Germany. About Ebopiprant Ebopiprant (OBE022) was licensed by ObsEva from Merck KGaA, Darmstadt, Germany, in 2015. ObsEva previously announced positive results from PROLONG Part B, a 113-patient Phase 2a proof-of-concept, randomized, double-blind, placebo-controlled trial in women experiencing spontaneous preterm labor that compared atosiban (ex-U.S. standard of care) plus ebopiprant versus atosiban plus placebo for 7 days. In the study, ebopiprant plus atosiban reduced delivery in singleton pregnancies at 48 hours after the start of dosing by 55% compared to atosiban plus placebo. Overall, 12.5% of women receiving ebopiprant plus atosiban delivered within 48 hours of starting treatment compared to 21.8% receiving atosiban plus placebo (OR 90% CI: 0.52 (0.22, 1.23)). The incidence of maternal, fetal, and neonatal adverse events were comparable between both the ebopiprant and placebo groups. About XOMA Corporation XOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA acquires the potential future economics associated with pre-commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio with more than 70 assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit Forward-Looking Statements/Explanatory Notes Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA and other developments related to ebopiprant, the potential of XOMA’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time, and XOMA’s cash sufficiency forecast. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will”, “would,” “could” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them; and the impact to the global economy as a result of the COVID-19 pandemic. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, all assets in XOMA’s milestone and royalty portfolio, except Vabysmo®, are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. XOMA Investor Contact XOMA Media Contact Juliane Snowden Kathy Vincent XOMA Corporation KV Consulting & Management +1 646-438-9754 +1 310-403-8951 juliane.snowden@xoma.com kathy@kathyvincent.com

Clinical ResultLicense out/in

30 Jul 2021

·endpts.com

Merck's women's health spinout snags mid-stage candidate for preterm birth; Keytruda nails down TNBC approval after March CRL

Nearly two months after spinning out from Merck, women’s health business Organon has struck its first half-billion-dollar deal. Organon $OGN has promised $25 million upfront and another $475 million in biobucks for worldwide rights to ebopiprant, ObsEva’s investigational treatment for preterm labor. Ebopiprant, a selective prostaglandin F2α (PGF2α) receptor antagonist, was originally licensed from Merck KGaA in 2015. The candidate works by reducing inflammation and uterine contractions. “This development-stage asset is being studied in one of the most crucial unmet needs for women globally,” Organon CEO Kevin Ali said in a statement. There are currently no approved drugs for the acute treatment of preterm labor in the US. Back in November, ObsEva said ebopiprant reduced the delivery of pregnancies (not including twin pregnancies) by 55% at 48 hours when administered with atosiban (the ex-US standard of care), compared to atosiban alone. Overall, 12.5% of women in the treatment arm delivered babies within 48 hours of starting treatment, compared to 21.8% in the placebo arm, ObsEva said of the Phase IIa trial. “The incidence of maternal, fetal and neonatal adverse events were comparable between subjects in the ebopiprant group and the placebo group,” the company said. Organon officially spun out from Merck on June 3 with a portfolio of more than 60 medicines, including Nexplanon, its long-active reversible contraceptive. Nexplanon is one of the top hormonal contraceptives in the country, according to IQVIA data, and grew at an annual compound growth rate of 9% between 2014 and 2019. — Nicole DeFeudis Keytruda nails down TNBC approval after March CRL Merck’s blockbuster checkpoint inhibitor Keytruda has won another FDA approval, this time in a line of triple-negative breast cancer. Regulators handed down the greenlight for the treatment of patients with high-risk early-stage TNBC in combination with chemo, as neoadjuvant and then continued as a single agent as adjuvant treatment after surgery. The thumbs up marks the 30th indication for which the Keytruda is approved in the US, Merck said. Additionally, the FDA converted the Keytruda-chemo combo accelerated approval in locally recurrent unresectable or metastatic TNBC for tumors expressing PD-L1 to full approval. The TNBC approval comes after the FDA handed Merck a rare CRL for Keytruda back in March, after an adcomm unanimously voted to recommend waiting for more data for the study in question. Advisers and regulators pointed toward concerns over the trial’s event-free survival primary endpoint over placebo, saying researchers hadn’t watched patients long enough after treatment to determine EFS and OS. But a few weeks later, Merck claimed a win in the study after claiming it reached the interim analysis checkpoint. The trial, known as KEYNOTE-522, met its dual primary endpoints of event-free survival and pathological complete response. — Max Gelman

CollaborateAccelerated Approval

27 Jul 2021

·www.pharmatimes.com

Organon and ObsEva to collaborate on preterm labour treatment

Women’s health company Organon has signed a license agreement with Swiss biopharma company ObsEva to develop a potential treatment for preterm labour. Under the terms of the agreement, Organon will license the global development, manufacturing and commercial rights to ebopiprant, an investigational selective prostaglandin F2α (PGF2α) receptor antagonist. Ebopiprant is being evaluated for the treatment for preterm labour by reducing inflammation and uterine contraction – if approved, it has the potential to be a first-in-class therapy for the condition in the US. ObsEva will receive tiered double-digit royalties on commercial sales of ebopiprant as well as up to $500m in upfront and milestone payments. This includes $25m to be paid upon signing of the deal, up to a further $90m in development and regulatory milestones and up to $385m in sales-based milestones. Last year, ObsEva announced positive results from a Phase IIa trial of ebopiprant in preterm labour. In this trial, the PGF2α receptor agonist reduced delivery in singleton pregnancies at 48 hours after the start of dosing by 55% compared to atosiban, the ex-US standard of care treatment for preterm labour. Overall, 12.5% of women receiving ebopiprant delivered within 48 hours of starting treatment compared to 21.8% on placebo. In singleton pregnancies, 12.5% of women receiving ebopiprant treatment delivered with 48 jours compared to 26.8% in the placebo group. “This development-stage asset is being studied in one of the most crucial unmet needs for women globally. As we build Organon’s women’s health research and development portfolio, the agreement strengthens our path to long term growth,” said Kevin Ali, chief executive officer of Organon. “Organon and ObsEva share a commitment to improve the lives of women around the world. Through Organon’s strong development, scientific and medical capabilities, our goal is to change the future for millions of mothers and babies,” he added.

CollaborateFirst in Class

100 Deals associated with Atosiban acetate

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-	Atosiban acetate	G02CX01	DB09059

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Obstetric Labor, Premature	European Union	Ferring Pharmaceuticals A/S	20 Jan 2000
Obstetric Labor, Premature	Iceland	Ferring Pharmaceuticals A/S	20 Jan 2000
Obstetric Labor, Premature	Liechtenstein	Ferring Pharmaceuticals A/S	20 Jan 2000
Obstetric Labor, Premature	Norway	Ferring Pharmaceuticals A/S	20 Jan 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ventricular Fibrillation, Paroxysmal Familial, 1	Phase 2	Belgium	Ferring Pharmaceuticals A/S	01 Nov 2007
Ventricular Fibrillation, Paroxysmal Familial, 1	Phase 2	Czechia	Ferring Pharmaceuticals A/S	01 Nov 2007
Ventricular Fibrillation, Paroxysmal Familial, 1	Phase 2	Spain	Ferring Pharmaceuticals A/S	01 Nov 2007

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02893722 (Pubmed \| Reprod Biol Endocrinol)	Phase 1	-	194	Atosiban	wrxrbafszn(qxqzbtbnua) = scjyifbggx xrkgsllvvr (ilvkpvdshv )	-	19 Aug 2022
				Placebo	wrxrbafszn(qxqzbtbnua) = dvfcupywjl xrkgsllvvr (ilvkpvdshv )
NCT03570294 (Pubmed \| Oxid Med Cell Longev)	Not Applicable	Obstetric Labor, Premature	56	Atosiban	ocagppuqhh(ulkuwrwwkp) = ufhcxqlkzv siknswlclt (pljdsfkbox ) View more	-	01 Jan 2018
ChiCTR-IOQ-14005715 (Pubmed \| Fertil Steril)	Phase 1	Endometriosis	-	Atosiban treatment	njvxbcasuz(gopialpqje) = bguhfktadd edlqnhbzon (xhxmwcbmte ) View more	-	01 Aug 2016
				atosiban (Control group)	njvxbcasuz(gopialpqje) = ngvnqruupk edlqnhbzon (xhxmwcbmte ) View more
NCT01501214 (Pubmed \| Hum Reprod)	Phase 4	Ventricular Fibrillation, Paroxysmal Familial, 1	800	Atosiban	xhpbkzfzdy(koybmbcsio) = cciqntemmy fnbwkehqlz (gxyaymrsnf )	-	01 Dec 2014
				Placebo	xhpbkzfzdy(koybmbcsio) = bkcocqglpf fnbwkehqlz (gxyaymrsnf )
NCT02893722 (Pubmed \| Reprod Biomed Online)	Phase 1	-	71	Atosiban	ngzajsuojc(zjkncxuhdh) = bnxmtoxhjf wblqxyrpra (jkofwtdvmj ) View more	-	01 Sep 2012

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