merotocin (FE 202767) / Ferring - LARVOL DELTA

First-in-Human Study of Merotocin, a Short-Acting Peptidic Oxytocin Receptor Agonist for Lactation Support. (PubMed, Clin Pharmacol Drug Dev) - "A maximum tolerated intranasal dose was not identified in this study. Intranasal administration of merotocin at doses up to 400 µg was tolerated by healthy women, and the pharmacokinetic and safety profiles support frequent repeated administration expected in lactation clinical practice."

Journal • P1 data • Pain

No Measurable Transfer of Oxytocin-Receptor Agonist Merotocin Detected in Human Breast Milk. (PubMed, Breastfeed Med) - "There was one moderate event, whereas all the other events were considered mild. Merotocin was undetectable in breast milk after single iv administration of up to 20 μg in early postpartum women and women with established lactation."

Journal

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 (ACOG 2023) - P2 | "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)."

Clinical

Mermaid: Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: Ferring Pharmaceuticals | N=100 ➔ 4 | Trial completion date: Oct 2023 ➔ Nov 2022 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2023 ➔ Nov 2022; Trial was prematurely terminated due to slow recruitment.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

Mermaid: Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Ferring Pharmaceuticals | Trial completion date: Oct 2022 ➔ Sep 2023 | Trial primary completion date: Oct 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date

Mermaid: Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely (clinicaltrials.gov) - P2; N=100; Not yet recruiting; Sponsor: Ferring Pharmaceuticals; Trial completion date: Jun 2022 ➔ Sep 2022; Trial primary completion date: Jun 2022 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date

Mermaid: Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Ferring Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Mermaid: Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely (clinicaltrials.gov) - P2; N=100; Not yet recruiting; Sponsor: Ferring Pharmaceuticals; Trial completion date: Dec 2021 ➔ May 2022; Trial primary completion date: Dec 2021 ➔ May 2022

Clinical • Trial completion date • Trial primary completion date

Mermaid: Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely (clinicaltrials.gov) - P2; N=100; Not yet recruiting; Sponsor: Ferring Pharmaceuticals; Trial completion date: Apr 2021 ➔ Dec 2021; Trial primary completion date: Apr 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date