GOMEKLI Capsule / Tablet Ref.[114757] Active ingredients: Mirdametinib

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

Product description

GOMEKLI capsules and tablets for oral suspension contain mirdametinib, a kinase inhibitor. Mirdametinib is chemically known as (R)N(2,3-dihydroxypropoxy)-3,4-difluoro-2-((2-fluoro-4-iodophenyl)amino) benzamide. The molecular formula is C16H14F3IN2O4 and the molecular weight is 482.20 g/mol. The structural formula for mirdametinib is:

Mirdametinib is a white to tan or pink solid with an aqueous solubility of 0.25 mg/mL and a pH of 7.2 in water at 25°C. The molecule has a pKa of 7.96.

GOMEKLI capsules and tablets for oral suspension are immediate release (IR) dosage forms intended for oral administration.

GOMEKLI (mirdametinib) 1 mg and 2 mg capsules contain 1 mg and 2 mg mirdametinib, respectively, in gelatin capsule and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The gelatin capsule shell contains FD&C blue #1, gelatin, titanium dioxide, and yellow iron oxide. The capsule is imprinted with white ink that contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution, and titanium dioxide.

GOMEKLI (mirdametinib) 1 mg tablets for oral suspension contain 1 mg mirdametinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, grape flavor, and sucralose. The grape flavor includes corn syrup solids, modified corn starch, and triacetin.

Dosage Forms and Strengths

Capsules:

  • 1 mg: light green body and cap with “MIR 1 mg” printed on the cap in white ink.
  • 2 mg: white body and a blue-green cap with “MIR 2 mg” printed on the cap in white ink.

Tablets for Oral Suspension:

  • 1 mg: white to off-white, oval, grape flavored tablet, debossed with “S” on one side.
How Supplied

GOMEKLI Capsules are supplied as follows:

Capsule
Strength		Capsule Description Package
Configuration		NDC
1 mg Light green body and cap with "MIR
1 mg" printed on the cap in white ink.		Bottle of
42 capsules 		82448-130-42
2 mg White body and a blue green cap with
“MIR 2 mg” printed on the cap in white
ink. 		Bottle of
42 capsules 		82448-260-42
Bottle of
84 capsules 		82448-260-84

GOMEKLI Tablets for Oral Suspension are supplied as follows:

Tablet
Strength		Tablet Description Package
Configuration		NDC
1 mg White to off-white, oval, grape flavored
tablet, debossed with “S” on one side.		Bottle of
42 tablets 		82448-134-42
Bottle of
84 tablets 		82448-134-84

Manufactured for: SpringWorks Therapeutics, Inc., Stamford, CT 06902

Drugs

Drug Countries
GOMEKLI United States
 
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