{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T05:07:32Z","timestamp":1775797652133,"version":"3.50.1"},"reference-count":59,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T00:00:00Z","timestamp":1775779200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100007160","name":"Universidade Presbiteriana Mackenzie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007160","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001807","name":"Funda\u00e7\u00e3o de Amparo \u00e0 Pesquisa do Estado de S\u00e3o Paulo","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001807","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004586","name":"Funda\u00e7\u00e3o Carlos Chagas Filho de Amparo \u00e0 Pesquisa do Estado do Rio de Janeiro","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004586","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003593","name":"Conselho Nacional de Desenvolvimento Cient\u00edfico e Tecnol\u00f3gico","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003593","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      Leishmaniasis remains a major unmet medical need, with limited oral options and persistent constraints related to efficacy, tolerability, and treatment duration. We investigated 18-methoxycoronaridine (18-MC), an iboga-type indole alkaloid, as an oral candidate against\n                      <jats:italic>Leishmania amazonensis,<\/jats:italic>\n                      integrating rodent and non-human primate efficacy, toxicology, and pharmacokinetics to support clinical translation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Antileishmanial activity was first assessed in BALB\/c mice treated orally with 18-MC (20 mg\/kg\/day). Translational efficacy was evaluated in non-human primates receiving oral 18-MC at 30 or 90 mg\/kg\/day for 28 days. Safety was characterized through acute and repeated-dose toxicology to establish the no-observed-adverse-effect level (NOAEL), complemented by pharmacokinetic analyses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A 5-day oral regimen of 18-MC reduced murine tissue parasite burden (expressed as viable parasites per whole organ) by &amp;gt;99%. In\n                      <jats:italic>Chlorocebus aethiops<\/jats:italic>\n                      , 18-MC produced an exposure-dependent reduction in lesion burden, achieving \u223c98% inhibition at 90 mg\/kg\/day, with marked re-epithelialization and no persistent clinical abnormalities. Pharmacokinetic modeling demonstrated a steep exposure\u2013response relationship (EC50 \u2248 209 ng\u22c5h\/mL) and a therapeutic index of approximately 5.4. The NOAEL was 50 mg\/kg\/day across species.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>18-MC demonstrates potent orally bioavailable antileishmanial activity with rodent\u2013primate translational concordance and a safety profile compatible with first-in-human evaluation, supporting Phase I advancement with an estimated human equivalent dose of \u223c16 mg\/kg\/day.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fphar.2026.1780255","type":"journal-article","created":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T04:26:13Z","timestamp":1775795173000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Oral 18-methoxycoronaridine activity in simian and murine Leishmania amazonensis infection"],"prefix":"10.3389","volume":"17","author":[{"given":"J. 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