A Randomized, Double-blind, Placebo-controlled, Multicenter Trial Exploring the Efficacy and Safety of Intra-nasal Administration of Merotocin in Increasing Milk Production in Maternal Subjects With Preterm Delivery and Inadequate Milk Production

Induction and support of lactation in women with preterm delivery and inadequate milk production.

开始日期2021-05-28

申办/合作机构

Ferring Pharmaceuticals A/S

100 项与 Merotocin 相关的临床结果

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100 项与 Merotocin 相关的转化医学

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100 项与 Merotocin 相关的专利（医药）

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项与 Merotocin 相关的文献（医药）

2024-06-01·Breastfeeding Medicine

No Measurable Transfer of Oxytocin-Receptor Agonist Merotocin Detected in Human Breast Milk

Article

作者: Holmqvist, Carina ; Bagger, Yu ; Urban, Lorien E ; Hale, Thomas W ; Lorch, Ulrike ; Jonker, Daniël M ; Baker, Teresa

Objective: The study aimed to assess the transfer of merotocin from systemic circulation to breast milk in early postpartum women and women with established lactation. Methods: This was a two-part, multicenter, open-label, parallel-group study. Merotocin was administered as a single 90-minute intravenous (iv) infusion mimicking the intranasal pharmacokinetic profile. In Part A, 12 early postpartum women received doses of either 4 μg (n = 6) or 16 μg (n = 6) of merotocin within 4 days of delivery. In Part B, six women with established lactation received 20 μg of merotocin. The total concentration of merotocin in plasma and breast milk and its metabolites excreted in breast milk were measured at various time points. Adverse events (AEs) were also assessed for both parts of the study. Results: In both early postpartum and established lactation groups (mean age, 26.3 years; 83.3% Caucasian), merotocin and its metabolites in breast milk were below the limit of quantification (25.0 pg/mL) at all time points. Sixteen treatment-emergent AEs occurred in early postpartum women only, including seven events of uterine spasm and three of breast engorgement. There was one moderate event, whereas all the other events were considered mild. Conclusion: Merotocin was undetectable in breast milk after single iv administration of up to 20 μg in early postpartum women and women with established lactation.

2023-05-01·Obstetrics & Gynecology

No Transfer of Merotocin (FE 202767) to Breast Milk in Postpartum Women: A Novel Short-Acting Oxytocin Receptor Agonist for the Induction and Support of Lactation [ID: 1370662]

作者: Urban, Lorien ; Baker, Teresa ; Bagger, Yu ; Holmqvist, Carina ; Jonker, Daniel ; Hale, Thomas

INTRODUCTION:Establishing lactation after preterm birth is challenging, and there are no approved therapies. Merotocin (FE 202767) is a potent, short-acting, selective oxytocin-receptor agonist in clinical development for induction and support of lactation. This phase 1, open-label, parallel-group study of early postpartum women and women with established lactation investigated possible transfer of merotocin from plasma to breast milk.METHODS:Merotocin was administered as a single 90-minute intravenous (IV) infusion mimicking the intranasal pharmacokinetic profile. In part A, 12 early postpartum women received doses of 5 micrograms (n=6) or 20 micrograms (n=6) merotocin within 4 days of delivery. In part B, 6 women with established lactation received 20 micrograms of merotocin. The total amount of merotocin excreted in breast milk was determined, as well as the presence of metabolites of merotocin in breast milk, and adverse events. The IV route was chosen to minimize the variability in bioavailability often observed with nasal sprays. Institutional review board approval was obtained for the study.RESULTS:In all women (mean age, 26.3 years; 83.3% Caucasian) and at all time points, merotocin in breast milk was below the limit of quantification (25 pg/mL). Merotocin metabolites were not detected in any milk samples. Sixteen treatment-emergent adverse events occurred in early postpartum women only: including seven uterine spasms, and three breast engorgements. All events were mild except one moderate.CONCLUSION:Merotocin is not transferred into breast milk at quantifiable amounts, and is well tolerated. This study supports the evaluation of merotocin in an ongoing phase 2 study in women with preterm delivery (NCT02545127).

2019-04-11·Journal of Medicinal Chemistry1区 · 医学

Development of a Highly Potent Analogue and a Long-Acting Analogue of Oxytocin for the Treatment of Social Impairment-Like Behaviors

1区 · 医学

Article

作者: Junpei Terakawa ; Hiroaki Yamaguchi ; Hiroshi Okamoto ; Teruko Yuhi ; Shinichi Horike ; Ayu Watanabe ; Anna A. Shabalova ; Stanislav M. Cherepanov ; Haruhiro Higashida ; Satoshi Shuto ; Wataru Ichinose ; Shigeru Yokoyama ; Mizuki Watanabe ; Yasuhiko Yamamoto ; Takiko Daikoku ; Nariyasu Mano

The nonapeptide hormone oxytocin (OT) has pivotal brain roles in social recognition and interaction and is thus a promising therapeutic drug for social deficits. Because of its peptide structure, however, OT is rapidly eliminated from the bloodstream, which decreases its potential therapeutic effects in the brain. We found that newly synthesized OT analogues in which the Pro⁷ of OT was replaced with N-( p-fluorobenzyl)glycine (2) or N-(3-hydroxypropyl)glycine (5) exhibited highly potent binding affinities for OT receptors and Ca²⁺ mobilization effects by selectively activating OT receptors over vasopressin receptors in HEK cells, where 2 was identified as a superagonist ( E_Max = 131%) for OT receptors. Furthermore, the two OT analogues had a remarkably long-acting effect, up to 16-24 h, on recovery from impaired social behaviors in two strains of CD38 knockout mice that exhibit autism spectrum disorder-like social behavioral deficits, whereas the effect of OT itself rapidly diminished.

100 项与 Merotocin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Merotocin	-	DB12932

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适应症	最高研发状态	国家/地区	公司	日期
非产褥期溢乳	临床2期	美国	Ferring Pharmaceuticals A/S	2021-05-28
早产	临床2期	美国	Ferring Pharmaceuticals A/S	2021-05-28
泌乳障碍	临床2期	-	Ferring BV	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02545127 (MERMAID, CTgov)	临床2期	非产褥期溢乳 \| 早产	4	Merotocin (Merotocin (a Selective Oxytocin-receptor Agonist))	鹹糧繭製顧繭顧餘顧憲(淵觸獵艱廠遞膚鹽構壓) = 夢衊膚窪鑰齋簾夢淵顧夢鏇憲蓋鹽鑰觸構範鹽 (窪簾襯夢憲積積製衊廠, 繭鑰遞淵蓋艱齋憲餘積 ~ 顧鏇範繭範餘淵憲範繭) 更多	-	2024-02-07
				Placebo (Placebo)	鹹糧繭製顧繭顧餘顧憲(淵觸獵艱廠遞膚鹽構壓) = 糧願願範壓範艱窪鬱蓋夢鏇憲蓋鹽鑰觸構範鹽 (窪簾襯夢憲積積製衊廠, 糧築膚蓋願顧鏇鹽簾範 ~ 築淵糧壓願餘膚淵網鑰) 更多