IP Library Granted Patent US 12,370,188
Granted Patent B2
US 12,370,188 · App. 18/481,549 · Granted Jul 29, 2025

Formulations of dazucorilant, a glucocorticoid receptor modulator

Inventors: Rick Bastin (Menlo Park, CA); Alla Hosny (Nottingham, GB); Dolly Jacob (Nottingham, GB); Wu Lin (Nottingham, GB)
Assignee: Corcept Therapeutics Incorporated
A61K31/4745A61K9/4825A61K9/4858A61K9/4866A61K47/10A61K47/22
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Quick Facts
Patent No.
US 12,370,188
App. No.
18/481,549
Granted
Jul 29, 2025
Kind
B2
Abstract

The present invention provides formulations of (R)-(1-(4-fluorophenyl)-6-((4-(trifluoromethyl)phenyl)sulfonyl)-4,4a,5,6,7,8-hexahydro-1H-pyrazolo[3,4-g]isoquinolin-4a-yl)(pyridin-2-yl)methanone, and methods of making and using the same.

Claims (38)

1. A unit dosage form for oral administration, wherein the unit dosage form comprises a hard gelatin capsule containing a composition, the composition comprising:

Compound I, (R)-(1-(4-fluorophenyl)-6-((4-(trifluoromethyl)phenyl)sulfonyl)-4,4a,5,6,7,8-hexahydro-1H-pyrazolo[3,4-g]isoquinolin-4a-yl)(pyridin-2-yl)methanone:

in an amount of about 18.75% (w/w);

polyethylene glycol having a molecular weight of about 400 Daltons (PEG400), in an amount of about 6.5% (w/w); and

Vitamin E polyethylene glycol succinate (Vitamin E TPGS), in an amount of about 74.75% (w/w).

2. The unit dosage form of claim 1 , wherein Compound I is present in an amount of from about 50 mg to about 150 mg.

3. The unit dosage form of claim 1 , wherein the composition comprises:

Compound I, in an amount of about 50 mg;

PEG400, in an amount of about 17 mg; and

Vitamin E TPGS, in an amount of about 199 mg.

4. The unit dosage form of claim 1 , wherein the composition comprises:

Compound I, in an amount of about 75 mg;

PEG400, in an amount of about 26 mg; and

Vitamin E TPGS, in an amount of about 299 mg.

5. The unit dosage form of claim 1 , wherein the composition comprises:

Compound I, in an amount of about 100 mg;

PEG400, in an amount of about 35 mg; and

Vitamin E TPGS, in an amount of about 399 mg.

6. The unit dosage form of claim 1 , wherein the composition comprises:

Compound I, in an amount of about 150 mg;

PEG400, in an amount of about 52 mg; and

Vitamin E TPGS, in an amount of about 598 mg.

7. The unit dosage form of claim 1 , wherein the composition consists essentially of:

Compound I, in an amount of 50 mg;

PEG400, in an amount of 17 mg; and

Vitamin E TPGS, in an amount of 199 mg.

8. The unit dosage form of claim 1 , wherein the composition consists essentially of:

Compound I, in an amount of 75 mg;

PEG400 in an amount of 26 mg; and

Vitamin E TPGS in an amount of 299 mg.

9. The unit dosage form of claim 1 , wherein the composition consists essentially of:

Compound I, in an amount of 100 mg;

PEG400, in an amount of 35 mg; and

Vitamin E TPGS, in an amount of 399 mg.

10. The unit dosage form of claim 1 , wherein the composition consists essentially of:

Compound I, in an amount of 150 mg;

PEG400, in an amount of 52 mg; and

359, Vitamin E TPGS, in an amount of 598 mg.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 8, 2023
From: BASTIN, RICK
To: CORCEPT THERAPEUTICS INCORPORATED
Reel/Frame 065814/0975 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 8, 2023
From: HOSNY, ALAA; JACOB, DOLLY; LIN, WU
To: QUOTIENT SCIENCES LIMITED
Reel/Frame 065815/0594 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 8, 2023
From: QUOTIENT SCIENCES LIMITED
To: CORCEPT THERAPEUTICS INCORPORATED
Reel/Frame 065815/0679 →
Continuity (2)
Provisional Application 63378578 · Oct 6, 2022
Related Publication 20240131020A1 · Apr 25, 2024
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