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

    <schemaVersion>X0306</schemaVersion>

    <documentType>4</documentType>

    <periodOfReport>2012-12-31</periodOfReport>

    <notSubjectToSection16>0</notSubjectToSection16>

    <issuer>
        <issuerCik>0001069308</issuerCik>
        <issuerName>Opexa Therapeutics, Inc.</issuerName>
        <issuerTradingSymbol>OPXA</issuerTradingSymbol>
    </issuer>

    <reportingOwner>
        <reportingOwnerId>
            <rptOwnerCik>0001359850</rptOwnerCik>
            <rptOwnerName>Seaman Scott B</rptOwnerName>
        </reportingOwnerId>
        <reportingOwnerAddress>
            <rptOwnerStreet1>C/O OPEXA THERAPEUTICS, INC.</rptOwnerStreet1>
            <rptOwnerStreet2>2635 TECHNOLOGY FOREST BLVD.</rptOwnerStreet2>
            <rptOwnerCity>THE WOODLANDS</rptOwnerCity>
            <rptOwnerState>TX</rptOwnerState>
            <rptOwnerZipCode>77381</rptOwnerZipCode>
            <rptOwnerStateDescription></rptOwnerStateDescription>
        </reportingOwnerAddress>
        <reportingOwnerRelationship>
            <isDirector>1</isDirector>
            <isOfficer>0</isOfficer>
            <isTenPercentOwner>0</isTenPercentOwner>
            <isOther>0</isOther>
            <officerTitle></officerTitle>
            <otherText></otherText>
        </reportingOwnerRelationship>
    </reportingOwner>

    <nonDerivativeTable>
        <nonDerivativeTransaction>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <transactionDate>
                <value>2012-12-31</value>
            </transactionDate>
            <deemedExecutionDate></deemedExecutionDate>
            <transactionCoding>
                <transactionFormType>4</transactionFormType>
                <transactionCode>A</transactionCode>
                <equitySwapInvolved>0</equitySwapInvolved>
            </transactionCoding>
            <transactionAmounts>
                <transactionShares>
                    <value>19978</value>
                    <footnoteId id="F1"/>
                </transactionShares>
                <transactionPricePerShare>
                    <value>1.33</value>
                    <footnoteId id="F1"/>
                </transactionPricePerShare>
                <transactionAcquiredDisposedCode>
                    <value>A</value>
                </transactionAcquiredDisposedCode>
            </transactionAmounts>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>230181</value>
                    <footnoteId id="F1"/>
                    <footnoteId id="F2"/>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>I</value>
                </directOrIndirectOwnership>
                <natureOfOwnership>
                    <value>See footnote</value>
                    <footnoteId id="F3"/>
                </natureOfOwnership>
            </ownershipNature>
        </nonDerivativeTransaction>
        <nonDerivativeHolding>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>10913</value>
                    <footnoteId id="F4"/>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>D</value>
                </directOrIndirectOwnership>
            </ownershipNature>
        </nonDerivativeHolding>
    </nonDerivativeTable>

    <derivativeTable></derivativeTable>

    <footnotes>
        <footnote id="F1">On December 31, 2012, 19,978 shares of Common Stock were issued to Alkek &amp; Williams Ventures Ltd (&quot;Ventures&quot;) as payment-in-kind for interest accrued as of December 31, 2012 on a 12% Convertible Secured Promissory Note held by Ventures in the principal amount of $500,000. The shares issued in payment of accrued interest payable on the interest payment date were deemed to have a value equal to the volume weighted average price for the Common Stock for the five trading days ending three trading days prior to the payment date.</footnote>
        <footnote id="F2">Adjusted to reflect the issuer's 1-for-4 reverse stock split that was implemented December 14, 2012, resulting in Ventures owning 210,203 shares of common stock prior to the transaction reported herein.</footnote>
        <footnote id="F3">Held by Ventures. Chaswil, Ltd. (&quot;Chaswil&quot;) is the investment manager of Ventures and holds voting power and investment power with respect to the Issuer securities held by Ventures. Mr. Seaman is a registered principal of Chaswil and has shared voting power and/or investment power with respect to the Issuer securities held by Ventures.</footnote>
        <footnote id="F4">Adjusted to reflect the issuer's 1-for-4 reverse stock split that was implemented December 14, 2012</footnote>
    </footnotes>

    <remarks></remarks>

    <ownerSignature>
        <signatureName>/s/ John Ginzler, by Power of Attorney</signatureName>
        <signatureDate>2013-01-24</signatureDate>
    </ownerSignature>
</ownershipDocument>
