CRENESSITY Capsule / Oral solution Ref.[115529] Active ingredients: Crinecerfont

Source: FDA, National Drug Code (US)  Revision Year: 2024 

Product description

CRENESSITY contains crinecerfont, a selective corticotropin-releasing factor type 1 receptor antagonist, present as crinecerfont free base, with the chemical name, 2-thiazolamine, 4-(2-chloro-4-methoxy-5-methylphenyl)-N[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methylN-2-propyn-1-yl. Crinecerfont free base is the S-enantiomer with an enantiomeric excess of at least 99.7%. Its molecular formula is C27H28ClFN2OS, and its molecular weight is 483.04 g/mol with the following structure:

CRENESSITY Capsules:

CRENESSITY capsules are intended for oral administration only. Each capsule contains 25 mg, 50 mg, or 100 mg of crinecerfont free base. Inactive ingredients include lauroyl polyoxyl-32 glycerides, medium chain triglycerides, propylene glycol dicaprylate/dicaprate, and Vitamin E polyethylene glycol succinate. The capsule shell contains gelatin, glycerin, red iron oxide, Sorbitol glycerin blend, titanium dioxide, and yellow iron oxide.

CRENESSITY Oral Solution:

The oral solution formulation contains 50 mg/mL of crinecerfont free base. Inactive ingredients include butylated hydroxytoluene, medium-chain triglycerides, oleoyl polyoxyl glycerides, orange flavor, and saccharin.

Dosage Forms and Strengths

CRENESSITY is available as:

  • Capsules
    • 25 mg oval, orange soft gelatin capsule printed with 'WWV 25' in black ink
    • 50 mg oval, two-toned orange and gold soft gelatin capsule printed with 'WWV 50' in black ink
    • 100 mg oblong, gold soft gelatin capsule printed with 'WWV 100' in black ink
  • Oral Solution: 50 mg/mL in light yellow to orange, clear to slightly opalescent oral solution
How Supplied

CRENESSITY Capsules:

CRENESSITY (crinecerfont) capsules are available in the doses shown in Table 11.

Table 11. CRENESSITY Capsule Information:

Capsule StrengthCapsule Color/ShapeCapsule MarkingQuantity in bottleNDC Number
25 mgOval, orange soft gelatin capsulesPrinted with 'WWV 25' in black ink6070370-5025-1
50 mgOval, two-toned orange and gold soft gelatin capsulesPrinted with 'WWV 50' in black ink6070370-5050-1
100 mgOblong, gold soft gelatin capsulesPrinted with 'WWV 100' in black ink3070370-5100-1

CRENESSITY Oral Solution:

50 mg/mL is a light yellow to orange, orange-flavored liquid. The amber polyethylene terephthalate (PET) bottle contains 30 mL oral solution (NBC 70370-5250-1).

Distributed by: Neurocrine Biosciences, Inc., San Diego, CA 92130, U.S.A.

Drugs

Drug Countries
CRENESSITY United States
 
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