US 12,220,412 B2
Methods for administering corticosteroids
David A. Katz, Portland, OR (US)
Assigned to Sparrow Pharmaceuticals, Inc., Portland, OR (US)
Appl. No. 17/289,516
Filed by Sparrow Pharmaceuticals, Inc., Portland, OR (US)
PCT Filed Aug. 14, 2019, PCT No. PCT/US2019/046449
§ 371(c)(1), (2) Date Apr. 28, 2021,
PCT Pub. No. WO2020/106337, PCT Pub. Date May 28, 2020.
Claims priority of provisional application 62/769,932, filed on Nov. 20, 2018.
Prior Publication US 2021/0393622 A1, Dec. 23, 2021
Int. Cl. A61K 31/496 (2006.01); A61K 31/4196 (2006.01); A61K 31/573 (2006.01); A61P 39/00 (2006.01)
CPC A61K 31/496 (2013.01) [A61K 31/4196 (2013.01); A61K 31/573 (2013.01); A61P 39/00 (2018.01)] 20 Claims
OG exemplary drawing
 
1. A method for administering a corticosteroid to a patient in need thereof, comprising:
determining a target threshold of 0.2 for the ratio of urinary (tetrahydrocortisol+allotetrahydrocortisol) to urinary tetrahydrocortisone for the patient; and
administering a HSD-1 inhibitor to a patient who is being administered a corticosteroid,
wherein:
the corticosteroid is not prednisone;
the HSD-1 inhibitor is 4-{5-[1-(4-chloro-2,6-difluorophenoxy)-1-methylethyl]-4-methyl-4H-1,2,4-triazol-3-yl-3-fluorobenzamide or a pharmaceutically acceptable salt thereof (Compound A); and
the HSD-1 inhibitor is administered at a first dose for a first time period, such that the administration is effective to maintain or reduce the patient's urinary ratio of urinary (tetrahydrocortisol+allotetrahydrocortisol) to urinary tetrahydrocortisone at a level below the target threshold.