Smoothened Receptor Antagonists

Hedgehog Pathway Inhibitor

Leukemia, Myeloid, Acute

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">DAURISMO (glasdegib) is a hedgehog pathway inhibitor. It is formulated with the maleate salt of glasdegib. The molecular formula for glasdegib maleate is C<span class="Sub">25</span>H<span class="Sub">26</span>N<span class="Sub">6</span>O<span class="Sub">5</span>. The molecular weight for glasdegib maleate is 490.51 Daltons. The chemical name of glasdegib maleate is 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate. The molecular structure is shown below:</p><div class="Figure"><a name="id1492"></a><img alt="Chemical Structure" src="daurismo-01.jpg"/></div><p>Glasdegib maleate is a white to pale colored powder with pKa values of 1.7 and 6.1. The aqueous solubility of glasdegib maleate is 1.7 mg/mL.</p><p>DAURISMO (glasdegib) is supplied as a film-coated tablet for oral use containing either 100 mg glasdegib (equivalent to 131.1 mg glasdegib maleate) or 25 mg of glasdegib (equivalent to 32.8 mg glasdegib maleate) together with microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate as inactive ingredients in the tablet. The film-coating consists of Opadry II<span class="Sup">®</span> Beige (33G170003) and Opadry II<span class="Sup">®</span> Yellow (33G120011) containing: hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin, iron oxide yellow, and iron oxide red. </p></section>

Daurismo

glasdegib

glasdegib 100 MG Oral Tablet

glasdegib 100 MG Oral Tablet [Daurismo]

glasdegib 25 MG Oral Tablet

glasdegib 25 MG Oral Tablet [Daurismo]

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