PALSONIFY Film-coated tablet Ref.[116079] Active ingredients: Paltusotine

Source: FDA, National Drug Code (US)  Revision Year: 2025 

Product description

PALSONIFY tablets contain paltusotine hydrochloride, a somatostatin receptor agonist. Paltusotine is known chemically as 3-[4-(4-Amino-1-piperidinyl)-3-(3,5-difluorophenyl)-6-quinolinyl]-2-hydroxybenzonitrile hydrochloride. The molecular weight of paltusotine hydrochloride is 492.95 g/mol (C27H22F2N4O·HCl).

PALSONIFY tablets for oral administration contain 20 mg of paltusotine (equivalent to 21.6 mg of paltusotine hydrochloride) or 30 mg of paltusotine (equivalent to 32.4 mg of paltusotine hydrochloride). Each tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone, crospovidone, magnesium stearate, mannitol, and microcrystalline cellulose. Additionally, the 20 mg tablets contain Opadry pink coating (hypromellose, iron oxide red, iron oxide yellow, titanium dioxide, and triacetin) and the 30 mg tablets contain Opadry yellow coating (hypromellose, iron oxide yellow, titanium dioxide, and triacetin).

Dosage Forms and Strengths

PALSONIFY Tablets:

  • 20 mg: pink, biconvex oval tablets, debossed with "PAL" on one side and "20" on the other side; contains 20 mg paltusotine free base.
  • 30 mg: yellow, biconvex oval tablets, debossed with "PAL" on one side and "30" on the other side; contains 30 mg paltusotine free base.
How Supplied

PALSONIFY is provided in two strengths: 20 mg and 30 mg.

Table 8. PALSONIFY Configurations and NDC Numbers:

StrengthTablet Color/ShapeImprintNDCPackage Size
20 mgPink; biconvex oval shape"PAL" on one side; "20" on other side84015-920-60Bottle of 60 tablets
30 mgYellow; biconvex oval shape"PAL" on one side; "30" on other side84015-930-60Bottle of 60 tablets

Manufactured for: Crinetics Pharmaceuticals, Inc., San Diego, CA 92121 USA

Drugs

Drug Countries
PALSONIFY United States

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