Claims for Patent: 12,285,432

Summary for Patent: 12,285,432

Title:	Treatment of hair loss disorders with deuterated JAK inhibitors
Abstract:	A method of treating a JAK-inhibition-responsive condition (such as a hair loss disorder) in a human subject in need thereof, the method comprising administering to the human subject a therapeutically effective amount of Compound (I) or a pharmaceutically acceptable salt thereof, wherein each position designated specifically as deuterium has at least 95% incorporation of deuterium; and wherein: the subject is receiving a concomitant administration of a CYP3A4 inhibitor; and the therapeutically effective amount of Compound (I), or a pharmaceutically acceptable salt thereof, is not reduced compared to the therapeutically effective amount of Compound (I), or pharmaceutically acceptable salt thereof, that would be administered to the subject in the absence of concomitant administration of a CYP3A4 inhibitor.
Inventor(s):	James V. Cassella, Christopher L. Brummel
Assignee:	Sun Pharmaceutical Industries Inc
Application Number:	US18/382,307
Patent Claims:	1. A method of treating a hair loss disorder in a human subject in need thereof, the method comprising orally administering to the human subject about 4 mg to about 50 mg of Compound (I) represented by the following structural formula: or a pharmaceutically acceptable salt thereof, wherein each position designated specifically as deuterium has at least 95% incorporation of deuterium; and wherein: (i) about 0.1 mg to about 200 mg of a CYP3A4 inhibitor is being co-administered to the human subject; and (ii) no adjustment of the dosage of Compound (I), or a pharmaceutically acceptable salt thereof, is required due to the co-administering of the CYP3A4 inhibitor, wherein the hair loss disorder is alopecia areata, alopecia totalis or alopecia universalis. 2. The method of claim 1, wherein the hair loss disorder is alopecia areata. 3. The method of claim 1, wherein Compound (I), or a pharmaceutically acceptable salt thereof, is administered at about 16 mg/day, or about 24 mg/day, wherein the about 16 mg/day of Compound (I) or pharmaceutically acceptable salt thereof is administered as about 8 mg twice per day and the about 24 mg/day of the compound or pharmaceutically acceptable salt thereof is administered as about 12 mg twice per day. 4. The method of claim 1, wherein Compound (I), or a pharmaceutically acceptable salt thereof, is administered in a pharmaceutical formulation which is a tablet. 5. The method of claim 1, wherein the human subject's SALT score is less than or equal to 20 after treatment. 6. The method of claim 1, wherein the CYP3A4 inhibitor is a strong CYP3A4 inhibitor. 7. The method of claim 1, wherein no interruption of the administration of the CYP3A4 inhibitor is required. 8. A method of treating a hair loss disorder in a human subject in need thereof, the method comprising orally administering to the human subject about 4 mg to about 50 mg of Compound (I) represented by the following structural formula: or a pharmaceutically acceptable salt thereof, wherein each position designated specifically as deuterium has at least 95% incorporation of deuterium; and wherein: (ii) the subject is receiving a concomitant administration of about 0.1 mg to about 200 mg of a CYP3A4 inhibitor; and (ii) the amount of Compound (I), or a pharmaceutically acceptable salt thereof, is not reduced compared to the amount of Compound (I), or pharmaceutically acceptable salt thereof, that would be administered to the subject in the absence of concomitant administration of a CYP3A4 inhibitor, wherein the hair loss disorder is alopecia areata, alopecia totalis or alopecia universalis. 9. The method of claim 8, wherein the hair loss disorder is alopecia areata. 10. The method of claim 8, wherein Compound (I), or a pharmaceutically acceptable salt thereof, is administered at about 16 mg/day, or about 24 mg/day, wherein the about 16 mg/day of Compound (I) or pharmaceutically acceptable salt thereof is administered as about 8 mg twice per day and the about 24 mg/day of the compound or pharmaceutically acceptable salt thereof is administered as about 12 mg twice per day. 11. The method of claim 8, wherein Compound (I), or a pharmaceutically acceptable salt thereof, is administered in a pharmaceutical formulation which is a tablet. 12. The method of claim 8, wherein the human subject's SALT score is less than or equal to 20 after treatment. 13. The method of claim 8, wherein the CYP3A4 inhibitor is a strong CYP3A4 inhibitor. 14. The method of claim 8, wherein no interruption of the administration of the CYP3A4 inhibitor is required. 15. A method of treating a hair loss disorder in a human subject in need thereof, the method comprising orally administering to the human subject about 4 mg to about 50 mg of Compound (I) represented by the following structural formula: or a pharmaceutically acceptable salt thereof, wherein each position designated specifically as deuterium has at least 95% incorporation of deuterium; and wherein: (i) the subject has been determined to be receiving a concomitant administration of about 0.1 mg to about 200 mg of a CYP3A4 inhibitor; and (ii) the amount of Compound (I), or a pharmaceutically acceptable salt thereof, is not reduced compared to the amount of Compound (I), or pharmaceutically acceptable salt thereof, that would be administered to the subject in the absence of concomitant administration of a CYP3A4 inhibitor, wherein the hair loss disorder is alopecia areata, alopecia totalis or alopecia universalis. 16. The method of claim 15, wherein the hair loss disorder is alopecia areata. 17. The method of claim 15, wherein Compound (I), or a pharmaceutically acceptable salt thereof, is administered at about 16 mg/day, or about 24 mg/day, wherein the about 16 mg/day of Compound (I) or pharmaceutically acceptable salt thereof is administered as about 8 mg twice per day and the about 24 mg/day of the compound or pharmaceutically acceptable salt thereof is administered as about 12 mg twice per day. 18. The method of claim 15, wherein Compound (I), or a pharmaceutically acceptable salt thereof, is administered in a pharmaceutical formulation which is a tablet. 19. The method of claim 15, wherein the human subject's SALT score is less than or equal to 20 after treatment. 20. The method of claim 15, wherein the CYP3A4 inhibitor is a strong CYP3A4 inhibitor. 21. The method of claim 15, wherein no interruption of the administration of the CYP3A4 inhibitor is required. 22. A method of treating a hair loss disorder in a human subject in need thereof, the method comprising: (iii) determining if the human subject is receiving a concomitant administration of a CYP3A4 inhibitor; and (iv) orally administering to the human subject about 4 mg to about 50 mg of Compound (I) if the subject is receiving concomitant administration of about 0.1 mg to about 200 mg of a CYP3A4 inhibitor, wherein Compound (I) is represented by the following structural formula: or a pharmaceutically acceptable salt thereof, wherein each position designated specifically as deuterium has at least 95% incorporation of deuterium; and wherein, the amount of Compound (I), or a pharmaceutically acceptable salt thereof, is not reduced compared to the amount of Compound (I), or pharmaceutically acceptable salt thereof, that would be administered to the subject in the absence of concomitant administration of a CYP3A4 inhibitor, wherein the hair loss disorder is alopecia areata, alopecia totalis or alopecia universalis. 23. The method of claim 22, wherein the hair loss disorder is alopecia areata. 24. The method of claim 22, wherein Compound (I), or a pharmaceutically acceptable salt thereof, is administered at about 16 mg/day, or about 24 mg/day, wherein the about 16 mg/day of Compound (I) or pharmaceutically acceptable salt thereof is administered as about 8 mg twice per day and the about 24 mg/day of the compound or pharmaceutically acceptable salt thereof is administered as about 12 mg twice per day. 25. The method of claim 22, wherein Compound (I), or a pharmaceutically acceptable salt thereof, is administered in a pharmaceutical formulation which is a tablet. 26. The method of claim 22, wherein the human subject's SALT score is less than or equal to 20 after treatment. 27. The method of claim 22, wherein the CYP3A4 inhibitor is a strong CYP3A4 inhibitor. 28. The method of claim 22, wherein no interruption of the administration of the CYP3A4 inhibitor is required.