{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T01:47:41Z","timestamp":1793238461213,"version":"4.5.0"},"reference-count":165,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T00:00:00Z","timestamp":1628553600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000025","name":"National Institute of Mental Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000025","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Psychiatry"],"abstract":"<jats:p><jats:bold>Background:<\/jats:bold><jats:sc>D-<\/jats:sc>Serine, a direct, full agonist at the<jats:sc>D-<\/jats:sc>serine\/glycine modulatory site of the N-methyl-D-aspartate-type glutamate receptors (NMDAR), has been assessed as a treatment for multiple psychiatric and neurological conditions. Based on studies in rats, concerns of nephrotoxicity have limited<jats:sc>D-<\/jats:sc>serine research in humans, particularly using high doses. A review of<jats:sc>D-<\/jats:sc>serine's safety is timely and pertinent, as<jats:sc>D-<\/jats:sc>serine remains under active study for schizophrenia, both directly (R61 MH116093) and indirectly through<jats:sc>D-<\/jats:sc>amino acid oxidase (<jats:sc>D<\/jats:sc>AAO) inhibitors. The principal focus is on nephrotoxicity, but safety in other physiologic and pathophysiologic systems are also reviewed.<\/jats:p><jats:p><jats:bold>Methods:<\/jats:bold>Using the search terms \u201c<jats:sc>D-<\/jats:sc>serine,\u201d \u201c<jats:sc>D-<\/jats:sc>serine and schizophrenia,\u201d \u201c<jats:sc>D-<\/jats:sc>serine and safety,\u201d \u201c<jats:sc>D-<\/jats:sc>serine and nephrotoxicity\u201d in PubMed, we conducted a systematic review on<jats:sc>D-<\/jats:sc>serine safety.<jats:sc>D-<\/jats:sc>serine physiology, dose-response and efficacy in clinical studies and<jats:sc>d<\/jats:sc>AAO inhibitor safety is also discussed.<\/jats:p><jats:p><jats:bold>Results:<\/jats:bold>When<jats:sc>D-<\/jats:sc>serine doses &amp;gt;500 mg\/kg are used in rats, nephrotoxicity, manifesting as an acute tubular necrosis syndrome, seen within hours of administration is highly common, if not universal. In other species, however,<jats:sc>D<\/jats:sc>-serine induced nephrotoxicity has not been reported, even in other rodent species such as mice and rabbits. Even in rats,<jats:sc>D-<\/jats:sc>-serine related toxicity is dose dependent and reversible; and does not appear to be present in rats at doses producing an acute Cmax of &amp;lt;2,000 nmol\/mL. For comparison, the Cmax of<jats:sc>D-<\/jats:sc>serine 120 mg\/kg, the highest dose tested in humans, is ~500 nmol\/mL in acute dosing. Across all published human studies, only one subject has been reported to have abnormal renal values related to<jats:sc>D-<\/jats:sc>serine treatment. This abnormality did not clearly map on to the acute tubular necrosis syndrome seen in rats, and fully resolved within a few days of stopping treatment.<jats:sc>D<\/jats:sc>AAO inhibitors may be nephroprotective.<jats:sc>D-<\/jats:sc>Serine may have a physiologic role in metabolic, extra-pyramidal, cardiac and other systems, but no other clinically significant safety concerns are revealed in the literature.<\/jats:p><jats:p><jats:bold>Conclusions:<\/jats:bold>Even before considering human to rat differences in renal physiology, using current FDA guided monitoring paradigms,<jats:sc>D-<\/jats:sc>serine appears safe at currently studied maximal doses, with potential safety in combination with<jats:sc>D<\/jats:sc>AAO inhibitors.<\/jats:p>","DOI":"10.3389\/fpsyt.2021.726365","type":"journal-article","created":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T04:57:59Z","timestamp":1628571479000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":35,"title":["D-Serine: A Cross Species Review of Safety"],"prefix":"10.3389","volume":"12","author":[{"given":"Amir","family":"Meftah","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Hasegawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua T.","family":"Kantrowitz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2021,8,10]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"1842","DOI":"10.1038\/s41386-020-0706-z","article-title":"Proof of mechanism and 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