Granted Patent
B2
US 12,673,056 · App. 18/000,945 · Granted Jul 7, 2026
Oral formulation comprising a crystalline form of rabeximod
Assignee:
Gulch Pharma AB
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Abstract
The present invention relates to a solid oral composition comprising a crystalline form of Rabeximod or a pharmaceutically acceptable salt thereof and optionally a pharmaceutically acceptable additive.
Claims (11)
1 . A solid composition comprising a crystalline form of 9-chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo-[2,3-b]quinoxaline (rabeximod) and optionally a pharmaceutically acceptable additive, wherein the crystalline form of rabeximod exhibits at least X-ray lines (2-theta values) in a powder diffraction pattern when measured using Cu Kα radiation at 5.0±0.2, 8.7±0.2, and 21.5±0.2.
2 . The composition of claim 1 , wherein rabeximod is a crystalline free base having a melting point of 259-261° C.
3 . The composition of claim 1 , wherein the rabeximod is in the form of a dry powder.
4 . The composition of claim 3 , wherein the dry powder is characterized by a D10 within the range of 0.5-1.0 μm, a D50 within the range of 1.5-3.5 μm, and/or a D90 within the range of 5.5-9.9 μm, when measured using laser light diffractometry.
5 . The composition of claim 1 , which is an immediate release composition.
6 . The composition of claim 5 , wherein at least 70% of the rabeximod, is dissolved within 45 minutes in a standardized in vitro dissolution test.
7 . The composition of claim 5 , wherein at least 90% of the rabeximod is dissolved within 15 minutes in a standardized in vitro dissolution test.
8 . The composition of claim 1 , wherein the composition is a capsule or tablet.
9 . The composition of claim 1 , wherein the composition is a solid oral unit dosage form comprising the crystalline form of rabeximod in an amount of 6-50 mg per unit dosage.
10 . The composition of claim 9 , wherein the solid oral dosage form comprises the crystalline form of rabeximod in an amount of 6.25 mg, 12.5 mg, 15 mg, 25 mg, 37.5 mg, or 50 mg per unit dosage.
11 . The composition of claim 1 , where in wherein the crystalline form of rabeximod further exhibits one or more X-ray lines (2-theta values) in a powder diffraction pattern when measured using Cu K α radiation selected from the group consisting of 12.3±0.2, 16.0±0.2, 17.4±0.2, 19.0±0.2, 21.8±0.2, 24.3±0.2, 24.9±0.2, 26.0±0.2, and 27.8±0.2.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 15, 2026
From: CYXONE AB
To: GULCH PHARMA AB
Reel/Frame 075405/0760 →
Priority Claims (4)
EP 20179239
· Jun 10, 2020
· regional
EP 20179277
· Jun 10, 2020
· regional
EP 20179279
· Jun 10, 2020
· regional
EP 20180706
· Jun 18, 2020
· regional
Continuity (1)
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