<?xml version="1.0"?>
<ownershipDocument>

    <schemaVersion>X0609</schemaVersion>

    <documentType>4</documentType>

    <periodOfReport>2026-09-22</periodOfReport>

    <notSubjectToSection16>0</notSubjectToSection16>

    <issuer>
        <issuerCik>0001933414</issuerCik>
        <issuerName>Mineralys Therapeutics, Inc.</issuerName>
        <issuerTradingSymbol>MLYS</issuerTradingSymbol>
        <issuerForeignTradingSymbol></issuerForeignTradingSymbol>
    </issuer>

    <reportingOwner>
        <reportingOwnerId>
            <rptOwnerCik>0001963901</rptOwnerCik>
            <rptOwnerName>Slingsby Brian Taylor</rptOwnerName>
        </reportingOwnerId>
        <reportingOwnerAddress>
            <rptOwnerNonUSAddressFlag>false</rptOwnerNonUSAddressFlag>
            <rptOwnerStreet1>1700 WESTLAKE AVE. N, SUITE 200</rptOwnerStreet1>
            <rptOwnerStreet2>THINKSPACE</rptOwnerStreet2>
            <rptOwnerCity>SEATTLE</rptOwnerCity>
            <rptOwnerState>WA</rptOwnerState>
            <rptOwnerZipCode>98109</rptOwnerZipCode>
            <rptOwnerStateDescription></rptOwnerStateDescription>
        </reportingOwnerAddress>
        <reportingOwnerRelationship>
            <isDirector>1</isDirector>
            <isOfficer>0</isOfficer>
            <isTenPercentOwner>0</isTenPercentOwner>
            <isOther>0</isOther>
        </reportingOwnerRelationship>
    </reportingOwner>

    <aff10b5One>0</aff10b5One>

    <nonDerivativeTable>
        <nonDerivativeTransaction>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <transactionDate>
                <value>2026-09-22</value>
            </transactionDate>
            <transactionCoding>
                <transactionFormType>4</transactionFormType>
                <transactionCode>S</transactionCode>
                <equitySwapInvolved>0</equitySwapInvolved>
                <footnoteId id="F1"/>
            </transactionCoding>
            <transactionAmounts>
                <transactionShares>
                    <value>104320</value>
                </transactionShares>
                <transactionPricePerShare>
                    <value>28.8085</value>
                    <footnoteId id="F2"/>
                </transactionPricePerShare>
                <transactionAcquiredDisposedCode>
                    <value>D</value>
                </transactionAcquiredDisposedCode>
            </transactionAmounts>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>7805718</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>I</value>
                </directOrIndirectOwnership>
                <natureOfOwnership>
                    <value>See footnote</value>
                    <footnoteId id="F3"/>
                </natureOfOwnership>
            </ownershipNature>
        </nonDerivativeTransaction>
    </nonDerivativeTable>

    <derivativeTable></derivativeTable>

    <footnotes>
        <footnote id="F1">Represents shares of common stock sold by Catalys Pacific Fund, LP. See footnote (3).</footnote>
        <footnote id="F2">The price reported in Column 4 is a weighted-average price. These shares were sold in multiple transactions at prices ranging from $28.700 to $28.905. The Reporting Person undertakes to provide to the Issuer, any security holder of the Issuer, or the staff of the Securities and Exchange Commission, upon request, full information regarding the number of shares sold at each separate price within the range set forth in this footnote.</footnote>
        <footnote id="F3">Represents shares of common stock held of record by Catalys Pacific Fund, LP. Catalys Pacific Fund GP, LP is the general partner of Catalys Pacific Fund, LP. Catalys Pacific, LLC is the general partner of Catalys Pacific Fund GP, LP, and Mr. Slingsby is the managing partner of Catalys Pacific, LLC. Accordingly,  Mr. Slingsby may be deemed to share voting and investment power over the shares held of record by Catalys Pacific Fund, LP. Mr. Slingsby disclaims beneficial ownership of such shares, except to the extent of his pecuniary interest therein.</footnote>
    </footnotes>

    <remarks></remarks>

    <ownerSignature>
        <signatureName>/s/ Adam Levy, Attorney-in-fact</signatureName>
        <signatureDate>2026-09-24</signatureDate>
    </ownerSignature>
</ownershipDocument>
