Claims for Patent: 12,364,699

Summary for Patent: 12,364,699

Title:	Method of treating hair loss disorders
Abstract:	The disclosure relates to treatment of Alopecia Areata comprising the administration of Compound (I) or a pharmaceutically acceptable salt thereof.
Inventor(s):	Christopher L. Brummel, James V. Cassella, Meghan A. HOLDEN
Assignee:	Sun Pharmaceutical Industries Inc
Application Number:	US18/905,898
Patent Claims:	1. A method of treating alopecia areata in a subject in need thereof, the method comprising, orally administering to the subject 16 mg/day or 24 mg/day of Compound (I) or a pharmaceutically acceptable salt thereof, wherein Compound (I) is represented by the following structural formula: wherein each position designated specifically as deuterium has at least 95% incorporation of deuterium, and wherein the subject has an estimated glomerular filtration rate (eGFR) of ≥30 mL/min, MDRD. 2. The method of claim 1, wherein the subject has mild to moderate renal impairment as evidenced by an eGFR of 30-89 mL/min. 3. The method of claim 1, wherein the subject has moderate renal impairment as evidenced by an eGFR of 30-59 mL/min, MDRD. 4. The method of claim 1, wherein the eGFR of the subject is between ≥60 mL/min and <90 mL/min, MDRD. 5. The method of claim 1, wherein the subject has an absolute SALT score of ≥50 at the onset of treatment. 6. The method of claim 1, wherein the subject has severe alopecia areata at the onset of treatment. 7. The method of claim 1, wherein after 8 weeks of treating the subject has an absolute SALT score of ≤20. 8. The method of claim 1, wherein after 12 weeks of treating the subject has an absolute SALT score of ≤20. 9. The method of claim 1, wherein after 24 weeks of treating the subject has an absolute SALT score of ≤20. 10. The method of claim 1, wherein after 24 weeks of treating the subject has an absolute SALT score of ≤10. 11. The method of claim 1, wherein after 52 weeks of treating the subject has an absolute SALT score of ≤20. 12. The method of claim 1, wherein after 24 weeks of treating the subject i) reports a response of “satisfied” or “very satisfied” on the Hair Satisfaction Patient Reported Outcome (SPRO) scale, ii) reports a response of “much improved” or “very much improved” using the Patient Global Impression of Improvement (PGI-I), or iii) reports a response of “much improved” or “very much improved” using the Clinical Global Impression of Improvement (CGI-I). 13. The method of claim 1, wherein after 12 weeks of treating i) a reduction in score at least 1.5 points from baseline is reported by the subject on the Hair Satisfaction Patient Reported Outcome (SPRO) scale, ii) a reduction in score of at least 1.5 points from baseline is reported by the subject on the Patient Global Impression of Improvement (PGI-I), iii) a reduction in score of at least 1.0 point from baseline is reported by the subject on the Clinical Global Impression of Severity (CGI-S), or iv) an increase in score of at least 0.5 points from baseline is achieved by the subject on the Brigham Eyelash Tool for Alopecia (BELA) or the Brigham Eyebrow Tool for Alopecia (BETA). 14. The method of claim 1, wherein the subject is a human. 15. The method of claim 1, wherein 16 mg/day of Compound (I) or a pharmaceutically acceptable salt thereof is administered. 16. The method of claim 15, wherein the 16 mg/day of Compound (I) or a pharmaceutically acceptable salt thereof is administered as 8 mg twice per day. 17. A method of treating alopecia areata in a subject in need thereof, the method comprising: determining an estimated glomerular filtration rate (eGFR) of the subject; and orally administering 16 mg/day or 24 mg/day of Compound (I) or a pharmaceutically acceptable salt thereof to the subject, if the subject has an eGFR of ≥30 mL/min, MDRD, wherein Compound (I) is represented by the following structural formula: wherein each position designated specifically as deuterium has at least 95% incorporation of deuterium. 18. The method of claim 17, wherein the subject has mild to moderate renal impairment as evidenced by an eGFR of 30-89 mL/min. 19. The method of claim 17, wherein the subject has moderate renal impairment as evidenced by an eGFR of 30-59 mL/min, MDRD. 20. A method of treating alopecia areata, the method comprising: a) determining an estimated glomerular filtration rate (eGFR) of a population of subjects suffering from alopecia areata; and b) orally administering 16 mg/day or 24 mg/day of Compound (I) or a pharmaceutically acceptable salt thereof to a sub-group of the population of subjects having an eGFR of ≥30 mL/min, MDRD, wherein Compound (I) is represented by the following structural formula: wherein each position designated specifically as deuterium has at least 95% incorporation of deuterium. 21. The method of claim 20, wherein the subject has mild to moderate renal impairment as evidenced by an eGFR of 30-89 mL/min. 22. The method of claim 20, wherein the subject has moderate renal impairment as evidenced by an eGFR of 30-59 mL/min, MDRD. 23. The method of claim 20, wherein the eGFR of the sub-group of the population of subjects is between ≥30 mL/min, MDRD and <60 mL/min, MDRD. 24. The method of claim 20, wherein the eGFR of the sub-group of the population of subjects is between ≥60 mL/min, MDRD and <90 mL/min, MDRD. 25. The method of claim 20, wherein the sub-group of the population of subjects has an absolute SALT score of ≥50 at the onset of treatment. 26. The method of claim 20, wherein the sub-group of the population of subjects has moderate to severe alopecia areata at the onset of treatment. 27. The method of claim 20, wherein after 12 weeks of treating at least 5% of the sub-group of the population of subjects has an absolute SALT score of ≤20. 28. The method of claim 20, wherein after 24 weeks of treating at least 25% of the sub-group of the population of subjects has an absolute SALT score of ≤20. 29. The method of claim 20, wherein after 24 weeks of treating at least 15% of the sub-group of the population of subjects has an absolute SALT score of ≤10. 30. A method of treating alopecia areata in a population of subjects in need thereof, the method comprising orally administering 16 mg/day or 24 mg/day of Compound (I) or a pharmaceutically acceptable salt thereof to a sub-group of the population of subjects having an eGFR of ≥30 mL/min, MDRD, wherein Compound (I) is represented by the following structural formula: wherein each position designated specifically as deuterium has at least 95% incorporation of deuterium.