{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T15:40:48Z","timestamp":1789659648494,"version":"4.0.1"},"reference-count":29,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,8,9]],"date-time":"2025-08-09T00:00:00Z","timestamp":1754697600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Endogenous oxytocin plays an important role in lactation, but its effectiveness as an exogenous galactagogue has been modest due to dose\u2010limiting side effects related to off\u2010target effects at the vasopressin V2 receptor. Merotocin (FE 202767) is a short\u2010acting peptidic oxytocin receptor agonist with the potential to aid mothers experiencing preterm delivery and inadequate milk production by increasing their milk volume. A first\u2010in\u2010human, single\u2010center, randomized, placebo\u2010controlled study investigated single and repeated intranasal administrations (every 3 hours) at doses from 5 to 400\u00a0\u00b5g and intravenous administration at 20\u00a0\u00b5g in healthy, nonpuerperal women. Pharmacokinetic parameters were determined after all doses. Bioavailability was determined after crossover intranasal and intravenous administrations. Merotocin was rapidly absorbed and eliminated after intranasal administration, median time to maximum plasma concentration was approximately 15\u00a0minutes, and the terminal half\u2010life was approximately 30\u00a0minutes. No accumulation was seen. Merotocin was not detected in urine, and metabolites were not detected in either plasma or urine, indicating elimination independent of the kidneys. Systemic bioavailability of merotocin after intranasal administration is low. All doses were tolerated, with few adverse events (mostly headache), all mild intensity. A maximum tolerated intranasal dose was not identified in this study. Intranasal administration of merotocin at doses up to 400\u00a0\u00b5g was tolerated by healthy women, and the pharmacokinetic and safety profiles support frequent repeated administration expected in lactation clinical practice.<\/jats:p>","DOI":"10.1002\/cpdd.1581","type":"journal-article","created":{"date-parts":[[2025,8,9]],"date-time":"2025-08-09T11:09:55Z","timestamp":1754737795000},"page":"879-888","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["First\u2010in\u2010Human Study of Merotocin, a Short\u2010Acting Peptidic Oxytocin Receptor Agonist for Lactation Support"],"prefix":"10.1002","volume":"14","author":[{"given":"Yu","family":"Bagger","sequence":"first","affiliation":[{"name":"Ferring Pharmaceuticals A\/S  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carina","family":"Holmqvist","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals A\/S  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dani\u00ebl M.","family":"Jonker","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals A\/S  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bjarke M.","family":"Klein","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals A\/S  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorien E.","family":"Urban","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals A\/S  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,8,9]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000004253"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)01024-7"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.3390\/nu11050974"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1089\/bfm.2019.0247"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamapediatrics.2019.2645"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.3390\/nu10050600"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2393-6-17"},{"issue":"10","key":"e_1_2_9_9_1","first-page":"3661","article-title":"Relation of plasma oxytocin and prolactin concentrations to milk production in mothers of preterm infants: influence of stress","volume":"85","author":"Chatterton RT","year":"2000","journal-title":"J Clin Endocrinol Metabol"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1089\/bfm.2020.0234"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.78.4.614"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/0897190011431636"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000002033"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.292.3.322"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.283.6287.340"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2005.081265"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2007010029"},{"key":"e_1_2_9_18_1","first-page":"F78","article-title":"Oxytocin as an antidiuretic hormone II. 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