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.

Start Date28 May 2021

Sponsor / Collaborator

Ferring Pharmaceuticals A/S

100 Clinical Results associated with Merotocin

100 Translational Medicine associated with Merotocin

100 Patents (Medical) associated with Merotocin

Literatures (Medical) associated with Merotocin

01 Jun 2024·Breastfeeding Medicine

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

Article

Author: 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.

01 May 2023·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]

Author: 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).

11 Apr 2019·Journal of Medicinal ChemistryQ1 · MEDICINE

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

Q1 · MEDICINE

Article

Author: 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 Deals associated with Merotocin

External Link

KEGG	Wiki	ATC	Drug Bank
-	Merotocin	-	DB12932

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Nonpuerperal Galactorrhea	Phase 2	United States	Ferring Pharmaceuticals A/S	28 May 2021
Obstetric Labor, Premature	Phase 2	United States	Ferring Pharmaceuticals A/S	28 May 2021
Lactation Disorders	Phase 2	-	Ferring BV	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02545127 (MERMAID, CTgov)	Phase 2	Nonpuerperal Galactorrhea \| Obstetric Labor, Premature	4	Merotocin (Merotocin (a Selective Oxytocin-receptor Agonist))	qsdfdaclxi(nzuvottuhi) = styknvgmat drzpnfhtuv (xibkfneemo, gragkkysmw - qtszqzltlb) View more	-	07 Feb 2024
				Placebo (Placebo)	qsdfdaclxi(nzuvottuhi) = myiwxghleq drzpnfhtuv (xibkfneemo, gyyprbrrol - ddtiixgcab) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis