Preparing for Next-Generation Antimalarials in Nigeria: A Pre-Introduction Readiness Assessment with Focus on Infant-Friendly Formulations and Emerging Therapies

Preparing for Next-Generation Antimalarials in Nigeria: A Pre-Introduction Readiness Assessment with Focus on Infant-Friendly Formulations and Emerging Therapies | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Systematic Review Preparing for Next-Generation Antimalarials in Nigeria: A Pre-Introduction Readiness Assessment with Focus on Infant-Friendly Formulations and Emerging Therapies MICHAEL AUDU This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9201692/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Nigeria shoulders the world's highest national malaria burden, accounting for approximately 25.9% of global malaria cases and 30.9% of malaria deaths in 2023, with children under five years of age comprising the most vulnerable group. As the global antimalarial pipeline advances notably with GanLum (ganaplacide-lumefantrine), which completed successful Phase 3 trials in November 2025, and new infant-specific formulations for neonates under 5kg. Nigeria's health system readiness to absorb, deploy, and equitably distribute these innovations is critically under-examined. This paper conducts a secondary data review to assess Nigeria's preparedness across five domains: disease burden, regulatory infrastructure, supply chain capacity, health system readiness, and financing. Findings reveal a nation with enormous need but significant structural gaps in regulatory harmonization, last-mile supply chain reliability, healthcare worker training, and domestic financing. The paper concludes with actionable pre-introduction recommendations to position Nigeria to benefit immediately and equitably when next-generation antimalarials receive regulatory approval. Drug Discovery, Design, & Development Health Economics & Outcomes Research Leadership and Ethics Next-generation antimalarials Nigeria GanLum ganaplacide-lumefantrine infant formulations malaria preparedness NAFDAC supply chain health systems Full Text Additional Declarations The authors declare no competing interests. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9201692","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Systematic Review","associatedPublications":[],"authors":[{"id":610792637,"identity":"4aeb0315-ae90-4009-8b7c-e0d253692d97","order_by":0,"name":"MICHAEL AUDU","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA+ElEQVRIiWNgGAWjYDACZgY2IGkBxAkMBxIMbIAMxsYDRGiRAGlhPPChIA2kpQG/FgaEFuaDMz4cBgvh1aLbzvzswY8KCXmD4zkGh3kMztutbT8MtKXGJhqXFrPDbOaGPWckDDeceQPScjt525lEoJZjabkNOLXwsEnwtkkwbriRA9FidgCohbHhMF4tkn//SdhDtZxLNjv/kLAWad4GiUSQloMzDA7Ymd0gaAubmbTMMYnkmWeeFRz4YJCcYHYDaEsCPr+cP/xM8k2NjW3f8eTNHxL+2NmbnU9/+OBDjQ1OLRggEawygVjlIGBPiuJRMApGwSgYGQAAjS5nzcLrolIAAAAASUVORK5CYII=","orcid":"https://orcid.org/0009-0009-2931-8964","institution":"Independent Researcher","correspondingAuthor":true,"prefix":"","firstName":"MICHAEL","middleName":"","lastName":"AUDU","suffix":""}],"badges":[],"createdAt":"2026-03-23 14:16:20","currentVersionCode":1,"declarations":{"humanSubjects":false,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":false,"humanSubjectConsent":false,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-9201692/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9201692/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":105343121,"identity":"634d300b-cd99-4f64-a104-66194b790dd1","added_by":"auto","created_at":"2026-03-25 03:19:56","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":329404,"visible":true,"origin":"","legend":"","description":"","filename":"nigeriaantimalarialsMichaelAudufinal.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9201692/v1_covered_b66b86a0-eb98-4a24-a9d0-8b205681b138.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cstrong\u003ePreparing for Next-Generation Antimalarials in Nigeria: A Pre-Introduction Readiness Assessment with Focus on Infant-Friendly Formulations and Emerging Therapies\u003c/strong\u003e\u003c/p\u003e","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Next-generation antimalarials, Nigeria, GanLum, ganaplacide-lumefantrine, infant formulations, malaria preparedness, NAFDAC, supply chain, health systems","lastPublishedDoi":"10.21203/rs.3.rs-9201692/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9201692/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003eNigeria shoulders the world's highest national malaria burden, accounting for approximately 25.9% of global malaria cases and 30.9% of malaria deaths in 2023, with children under five years of age comprising the most vulnerable group. 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