{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T12:11:38Z","timestamp":1771503098457,"version":"3.50.1"},"reference-count":37,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T00:00:00Z","timestamp":1746057600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T00:00:00Z","timestamp":1746057600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,3,7]],"date-time":"2025-03-07T00:00:00Z","timestamp":1741305600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100011944","name":"School of Public Health, University of California Berkeley","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011944","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100011110","name":"UCB","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011110","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Reproductive Toxicology"],"published-print":{"date-parts":[[2025,5]]},"DOI":"10.1016\/j.reprotox.2025.108877","type":"journal-article","created":{"date-parts":[[2025,3,4]],"date-time":"2025-03-04T17:03:24Z","timestamp":1741107804000},"page":"108877","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":3,"special_numbering":"C","title":["Subcutaneous zilucoplan: Evaluation of reproductive toxicology"],"prefix":"10.1016","volume":"134","author":[{"given":"Marie","family":"Lemper","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C. Marc","family":"Luetjens","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antje","family":"Fuchs","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Hall","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fran\u00e7ois-Xavier","family":"Mathy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeff","family":"Long","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joy","family":"Cavagnaro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sucharita","family":"Roy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Evan A.","family":"Thackaberry","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Petra","family":"Duda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.reprotox.2025.108877_bib1","unstructured":"Zilbrysq U.S.P.I., 2023. \u3008https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/216834s000lbl.pdf\u3009, (accessed December 2024)."},{"issue":"1","key":"10.1016\/j.reprotox.2025.108877_bib2","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1111\/nyas.13522","article-title":"Myasthenia gravis: the role of complement at the neuromuscular junction","volume":"1412","author":"Howard","year":"2018","journal-title":"Ann. N. Y Acad. Sci."},{"issue":"7","key":"10.1016\/j.reprotox.2025.108877_bib3","doi-asserted-by":"crossref","first-page":"3329","DOI":"10.1007\/s00415-023-11733-y","article-title":"Myasthenia gravis, respiratory function, and respiratory tract disease","volume":"270","author":"Gilhus","year":"2023","journal-title":"J. Neurol."},{"issue":"4","key":"10.1016\/j.reprotox.2025.108877_bib4","doi-asserted-by":"crossref","first-page":"472","DOI":"10.4103\/aian.AIAN_472_19","article-title":"Myasthenic crisis \u2013 comorbidities, complications, long-term outcomes: the challenges","volume":"22","author":"Murthy","year":"2019","journal-title":"Ann. Indian Acad. Neurol."},{"key":"10.1016\/j.reprotox.2025.108877_bib5","doi-asserted-by":"crossref","first-page":"1213920","DOI":"10.3389\/fimmu.2023.1213920","article-title":"Zilucoplan, a macrocyclic peptide inhibitor of human complement component 5, uses a dual mode of action to prevent terminal complement pathway activation","volume":"14","author":"Tang","year":"2023","journal-title":"Front Immunol."},{"issue":"5","key":"10.1016\/j.reprotox.2025.108877_bib6","doi-asserted-by":"crossref","first-page":"483","DOI":"10.1080\/13543784.2021.1897567","article-title":"Zilucoplan: an investigational complement C5 inhibitor for the treatment of acetylcholine receptor autoantibody-positive generalized myasthenia gravis","volume":"30","author":"Howard","year":"2021","journal-title":"Expert Opin. Invest. Drugs"},{"issue":"5","key":"10.1016\/j.reprotox.2025.108877_bib7","doi-asserted-by":"crossref","first-page":"395","DOI":"10.1016\/S1474-4422(23)00080-7","article-title":"Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, Phase 3 study","volume":"22","author":"Howard","year":"2023","journal-title":"Lancet Neurol."},{"key":"10.1016\/j.reprotox.2025.108877_bib8","doi-asserted-by":"crossref","first-page":"23","DOI":"10.3389\/fnins.2020.00023","article-title":"Complement system in brain architecture and neurodevelopmental disorders","volume":"14","author":"Magdalon","year":"2020","journal-title":"Front Neurosci."},{"issue":"1","key":"10.1016\/j.reprotox.2025.108877_bib9","doi-asserted-by":"crossref","first-page":"170","DOI":"10.1016\/j.molimm.2014.11.010","article-title":"A complement C5 gene mutation, c.754G>A:p.A252T, is common in the Western Cape, South Africa and found to be homozygous in seven percent of Black African meningococcal disease cases","volume":"64","author":"Owen","year":"2015","journal-title":"Mol. Immunol."},{"issue":"4","key":"10.1016\/j.reprotox.2025.108877_bib10","doi-asserted-by":"crossref","first-page":"871","DOI":"10.1007\/s10875-013-9872-7","article-title":"C5 complement deficiency in a Saudi family, molecular characterization of mutation and literature review","volume":"33","author":"Arnaout","year":"2013","journal-title":"J. Clin. Immunol."},{"issue":"10","key":"10.1016\/j.reprotox.2025.108877_bib11","doi-asserted-by":"crossref","first-page":"2116","DOI":"10.1016\/j.molimm.2008.10.035","article-title":"Skipping of exon 30 in C5 gene results in complete human C5 deficiency and demonstrates the importance of C5d and CUB domains for stability","volume":"46","author":"Aguilar-Ramirez","year":"2009","journal-title":"Mol. Immunol."},{"issue":"1","key":"10.1016\/j.reprotox.2025.108877_bib12","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1016\/j.molimm.2004.06.036","article-title":"C5 complement deficiency in a Spanish family. Molecular characterization of the double mutation responsible for the defect","volume":"42","author":"Delgado-Cervi\u00f1o","year":"2005","journal-title":"Mol. Immunol."},{"issue":"10","key":"10.1016\/j.reprotox.2025.108877_bib13","doi-asserted-by":"crossref","first-page":"1304","DOI":"10.1016\/j.imbio.2013.04.021","article-title":"Primary complement C5 deficiencies \u2013 molecular characterization and clinical review of two families","volume":"218","author":"Schejbel","year":"2013","journal-title":"Immunobiology"},{"issue":"11","key":"10.1016\/j.reprotox.2025.108877_bib14","doi-asserted-by":"crossref","first-page":"87","DOI":"10.1007\/s11906-017-0784-4","article-title":"The complement system and preeclampsia","volume":"19","author":"Regal","year":"2017","journal-title":"Curr. Hypertens. Rep."},{"issue":"1","key":"10.1016\/j.reprotox.2025.108877_bib15","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1293\/tox.25.63","article-title":"Histopathology of incidental findings in cynomolgus monkeys (Macaca fascicularis) used in toxicity studies","volume":"25","author":"Sato","year":"2012","journal-title":"J. Toxicol. Pathol."},{"issue":"1","key":"10.1016\/j.reprotox.2025.108877_bib16","doi-asserted-by":"crossref","first-page":"5519","DOI":"10.1038\/s41467-022-33003-7","article-title":"Insight into mode-of-action and structural determinants of the compstatin family of clinical complement inhibitors","volume":"13","author":"Lamers","year":"2022","journal-title":"Nat. Commun."},{"issue":"17","key":"10.1016\/j.reprotox.2025.108877_bib17","doi-asserted-by":"crossref","first-page":"10241","DOI":"10.1021\/acs.chemrev.9b00008","article-title":"Understanding cell penetration of cyclic peptides","volume":"119","author":"Dougherty","year":"2019","journal-title":"Chem. Rev."},{"issue":"3","key":"10.1016\/j.reprotox.2025.108877_bib18","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1002\/bdrb.20234","article-title":"The cynomolgus monkey as a model for developmental toxicity studies: variability of pregnancy losses, statistical power estimates, and group size considerations","volume":"89","author":"Jarvis","year":"2010","journal-title":"Birth Defects Res B Dev. Reprod. Toxicol."},{"key":"10.1016\/j.reprotox.2025.108877_bib19","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1016\/j.reprotox.2020.04.074","article-title":"Enhanced normograms and pregnancy outcome analysis in nonhuman primate developmental toxicity studies","volume":"95","author":"Grossmann","year":"2020","journal-title":"Reprod. Toxicol."},{"issue":"5","key":"10.1016\/j.reprotox.2025.108877_bib20","doi-asserted-by":"crossref","first-page":"409","DOI":"10.3109\/14767050903168424","article-title":"Transplacental transfer and metabolism of bupropion","volume":"23","author":"Earhart","year":"2010","journal-title":"J. Matern Fetal Neonatal Med"},{"issue":"4","key":"10.1016\/j.reprotox.2025.108877_bib21","doi-asserted-by":"crossref","DOI":"10.1016\/j.ajog.2012.06.064","article-title":"Transplacental transfer of vancomycin and telavancin","volume":"207","author":"Nanovskaya","year":"2012","journal-title":"Am. J. Obstet. Gynecol."},{"issue":"4","key":"10.1016\/j.reprotox.2025.108877_bib22","doi-asserted-by":"crossref","DOI":"10.1016\/j.ajog.2013.05.038","article-title":"Transplacental transfer and distribution of pravastatin","volume":"209","author":"Nanovskaya","year":"2013","journal-title":"Am. J. Obstet. Gynecol."},{"issue":"6","key":"10.1016\/j.reprotox.2025.108877_bib23","doi-asserted-by":"crossref","first-page":"446","DOI":"10.1002\/bdrb.20216","article-title":"Developmental and reproductive toxicology studies in nonhuman primates","volume":"86","author":"Chellman","year":"2009","journal-title":"Birth Defects Res B Dev. Reprod. Toxicol."},{"issue":"1","key":"10.1016\/j.reprotox.2025.108877_bib24","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1002\/(SICI)1098-2345(1996)40:1<41::AID-AJP3>3.0.CO;2-0","article-title":"Frequency of prenatal loss in a macaque breeding colony","volume":"40","author":"Hendrie","year":"1996","journal-title":"Am. J. Prima"},{"issue":"4","key":"10.1016\/j.reprotox.2025.108877_bib25","doi-asserted-by":"crossref","first-page":"169","DOI":"10.1111\/j.1600-0684.2007.00275.x","article-title":"Stillbirths in Macaca fascicularis","volume":"37","author":"Sesbuppha","year":"2008","journal-title":"J. Med Prima"},{"issue":"1","key":"10.1016\/j.reprotox.2025.108877_bib26","doi-asserted-by":"crossref","first-page":"1","DOI":"10.5194\/pb-7-1-2020","article-title":"Group size experiences with enhanced pre- and postnatal development studies in the long-tailed macaque (Macaca fascicularis)","volume":"7","author":"Luetjens","year":"2020","journal-title":"Primate Biol."},{"issue":"5","key":"10.1016\/j.reprotox.2025.108877_bib27","doi-asserted-by":"crossref","first-page":"660","DOI":"10.1177\/01926233221082302","article-title":"Spontaneous findings in the reproductive system of sexually mature male cynomolgus macaques","volume":"50","author":"Vidal","year":"2022","journal-title":"Toxicol. Pathol."},{"issue":"4","key":"10.1016\/j.reprotox.2025.108877_bib28","doi-asserted-by":"crossref","first-page":"536","DOI":"10.1177\/0192623317709539","article-title":"Testicular fibrous hypoplasia in cynomolgus monkeys (Macaca fascicularis): an incidental, congenital lesion","volume":"45","author":"Pereira Bacares","year":"2017","journal-title":"Toxicol. Pathol."},{"issue":"2","key":"10.1016\/j.reprotox.2025.108877_bib29","first-page":"282","article-title":"Toward implementing virtual control groups in nonclinical safety studies","volume":"41","author":"Golden","year":"2024","journal-title":"ALTEX"},{"key":"10.1016\/j.reprotox.2025.108877_bib30","doi-asserted-by":"crossref","DOI":"10.1016\/j.yrtph.2024.105632","article-title":"Points to consider regarding the use and implementation of virtual controls in nonclinical general toxicology studies","volume":"150","author":"Palazzi","year":"2024","journal-title":"Regul. Toxicol. Pharm."},{"key":"10.1016\/j.reprotox.2025.108877_bib31","unstructured":"Soliris EU SmPC. \u3008https:\/\/www.medicines.org.uk\/emc\/product\/362\/smpc\u3009, (accessed December 2024)."},{"key":"10.1016\/j.reprotox.2025.108877_bib32","unstructured":"Ultomiris EU SmPC. \u3008https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/ultomiris-epar-product-information_en.pdf\u3009, (accessed December 2024)."},{"issue":"2\u20133","key":"10.1016\/j.reprotox.2025.108877_bib33","doi-asserted-by":"crossref","first-page":"367","DOI":"10.1387\/ijdb.082773hs","article-title":"Receptor-mediated uptake and transport of macromolecules in the human placenta","volume":"54","author":"Schneider","year":"2010","journal-title":"Int J. Dev. Biol."},{"issue":"2","key":"10.1016\/j.reprotox.2025.108877_bib34","doi-asserted-by":"crossref","first-page":"280","DOI":"10.1093\/humupd\/dmaa049","article-title":"Nanoparticles in pregnancy: the next frontier in reproductive therapeutics","volume":"27","author":"Pritchard","year":"2021","journal-title":"Hum. Reprod. Update"},{"issue":"4","key":"10.1016\/j.reprotox.2025.108877_bib35","doi-asserted-by":"crossref","first-page":"328","DOI":"10.1002\/bdrb.20201","article-title":"An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies","volume":"86","author":"Pentsuk","year":"2009","journal-title":"Birth Defects Res B Dev. Reprod. Toxicol."},{"issue":"24","key":"10.1016\/j.reprotox.2025.108877_bib36","doi-asserted-by":"crossref","first-page":"3365","DOI":"10.1016\/S0264-410X(03)00334-7","article-title":"Placental transport of immunoglobulin G","volume":"21","author":"Simister","year":"2003","journal-title":"Vaccine"},{"issue":"3","key":"10.1016\/j.reprotox.2025.108877_bib37","first-page":"e533","article-title":"Prediction of placental drug transfer using the human placental perfusion model","volume":"18","author":"Hutson","year":"2011","journal-title":"J. Popul Ther. Clin. Pharm."}],"container-title":["Reproductive Toxicology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0890623825000486?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0890623825000486?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,4,17]],"date-time":"2025-04-17T19:16:23Z","timestamp":1744917383000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0890623825000486"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5]]},"references-count":37,"alternative-id":["S0890623825000486"],"URL":"https:\/\/doi.org\/10.1016\/j.reprotox.2025.108877","relation":{},"ISSN":["0890-6238"],"issn-type":[{"value":"0890-6238","type":"print"}],"subject":[],"published":{"date-parts":[[2025,5]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Subcutaneous zilucoplan: Evaluation of reproductive toxicology","name":"articletitle","label":"Article Title"},{"value":"Reproductive Toxicology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.reprotox.2025.108877","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 The Authors. Published by Elsevier Inc.","name":"copyright","label":"Copyright"}],"article-number":"108877"}}