Claims for Patent: 12,533,358

Summary for Patent: 12,533,358

Title:	Methods of treatment with elinzanetant
Abstract:	The present disclosure relates to methods of treating vasomotor symptoms in a female subject in need thereof by administering a therapeutically effective amount of elinzanetant or a pharmaceutically acceptable salt or deuterated thereof, wherein the female subject is concurrently administered with a moderate CYP3A4 inhibitor.
Inventor(s):	Michael Block, Stefan Willmann, Alexander Solms, Annika Ruth Patricia Schneider, Marcus-Hillert SCHULTZE-MOSGAU
Assignee:	Bayer Consumer Care AG , Emerald Lake Safety LLC
Application Number:	US19/208,416
Patent Claims:	1. A method of treating vasomotor symptoms in a female subject in need thereof, comprising administering a daily dose of about 25 mg to about 100 mg of elinzanetant or stereoisomer thereof, or an equivalent dose of a pharmaceutically acceptable salt or deuterated form thereof, wherein the female subject is undergoing concomitant treatment with a moderate CYP3A4 inhibitor. 2. The method of claim 1, wherein about 30 mg of elinzanetant is administered once a day. 3. The method of claim 1, wherein about 60 mg of elinzanetant is administered once a day. 4. The method of claim 1, wherein about 90 mg of elinzanetant is administered once a day. 5. The method of claim 1, further comprising treating sleep disturbances associated with vasomotor symptoms. 6. The method of claim 1, wherein elinzanetant is administered once a day. 7. The method of claim 1, wherein elinzanetant is administered at bedtime (h.s.). 8. The method of claim 1, wherein the female subject has moderate to severe vasomotor symptoms prior to administering elinzanetant. 9. The method of claim 1, wherein the female subject is an adult. 10. The method of claim 1, wherein the female subject is 40-65 years old. 11. The method of claim 1, wherein the female subject is menopausal. 12. The method of claim 11, wherein prior to administering elinzanetant, the female subject experienced: (i) at least 12 months of spontaneous amenorrhea; (ii) at least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels>40 mIU/mL and a serum estradiol concentration of <30 pg/mL; (iii) hysterectomy with serum FSH levels>40 mIU/mL and a serum estradiol concentration of <30 pg/mL; or (iv) surgical bilateral oophorectomy with or without hysterectomy. 13. The method of claim 1, wherein the vasomotor symptoms are caused by adjuvant endocrine therapy. 14. The method of claim 1, wherein the vasomotor symptoms are associated with menopause. 15. The method of claim 1, wherein the moderate CYP3A4 inhibitor is amiodarone, aprepitant, ciprofloxacin, clarithromycin, conivaptan, crizotinib, cyclosporine, diltiazem, dronedarone, erythromycin, fluconazole, grapefruit juice, imatinib, isavuconazole, or verapamil. 16. The method of claim 1, comprising reducing the frequency of the vasomotor symptoms compared to baseline. 17. The method of claim 1, comprising reducing the severity of the vasomotor symptoms compared to baseline. 18. The method of claim 1, comprising reducing the frequency of moderate to severe hot flash (HF) from baseline. 19. The method of claim 1, comprising decreasing a Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) total T-score compared to baseline. 20. The method of claim 1, comprising decreasing a menopause specific quality of life scale (MENQOL) total score compared to baseline. 21. The method of claim 1, comprising decreasing a Beck depression inventory (BDI-II) total score compared to baseline. 22. The method of claim 3, comprising reducing the frequency of the vasomotor symptoms by about 50-70% compared to baseline. 23. The method of claim 3, comprising reducing the severity of the vasomotor symptoms by about 30-40% compared to baseline. 24. The method of claim 3, comprising reducing the frequency of moderate to severe hot flash (HF) from baseline. 25. The method of claim 3, comprising decreasing a Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) total T-score compared to baseline. 26. The method of claim 3, comprising decreasing a menopause specific quality of life scale (MENQOL) total score compared to baseline. 27. The method of claim 3, comprising decreasing a Beck depression inventory (BDI-II) total score compared to baseline.