US2021361664A1PendingUtilityA1
Corticotropin releasing factor receptor antagonists
Est. expiryAug 14, 2037(~11.1 yrs left)· nominal 20-yr term from priority
A61P 5/08A61K 9/2077A61P 3/00A61P 15/00A61P 5/00A61P 5/38A61P 5/24A61P 15/08A61K 31/5377A61K 9/14A61K 2300/00C07D 487/04A61K 9/48A61K 31/573A61K 9/4825
66
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Claims
Abstract
The present invention provides novel pharmaceutical compositions comprising -(4-Chloro-2-(morpholin-4-yl)thiazol-5-yl)-7-(1-ethylpropyl)-2,5-dimethylpyrazolo(1,5-a)pyrimidine and methods of using the same for the treatment of Congenital adrenal hyperplasia (CAH).
Claims
exact text as granted — not AI-modifiedWhat is claimed is:
1 . A method of treating congenital adrenal hyperplasia (CAH) in a subject in need thereof, comprising administering a pharmaceutical composition comprising Compound 1:
or a pharmaceutically acceptable salt or solvate thereof, wherein Compound 1 is administered at a dose between about 50 mg/day and about 1600 mg/day.
2 . The method of claim 1 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 50 mg/day and about 1200 mg/day.
3 . The method of claim 1 or 2 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 50 mg/day and about 1000 mg/day.
4 . The method of any one of claims 1 to 3 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 50 mg/day and about 800 mg/day.
5 . The method of any one of claims 1 to 4 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 100 mg/day and about 600 mg/day.
6 . The method of any one of claims 1 to 5 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 200 mg/day and 400 mg/day.
7 . The method of any one of claims 1 to 6 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose of about 200 mg/day.
8 . The method of any one of claims 1 to 7 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is in the form of microparticles.
9 . The method of claim 8 , wherein the average size of the microparticles is between about 1 μm and about 20 μm.
10 . The method of claim 8 or 9 , wherein the average size of the microparticles is between about 5 μm and about 15 μm.
11 . The method of any one of claims 8 to 10 , wherein the average size of the microparticles is less than about 10 μm.
12 . The method of any one of claims 1 to 11 , wherein the pharmaceutical composition is in the form of a capsule or a tablet.
13 . The method of any one of claims 1 to 12 , wherein the pharmaceutical composition is in the form of a capsule.
14 . The method of claim 13 , wherein the capsule is a hard gelatin capsule.
15 . The method of claim 13 , wherein the capsule is a soft gelatin capsule.
16 . The method of any one of claims 13 to 15 , wherein the capsule is formed using materials selected from the group consisting of natural gelatin, synthetic gelatin, pectin, casein, collagen, protein, modified starch, polyvinylpyrrolidone, acrylic polymers, cellulose derivatives, and any combinations thereof.
17 . The method of any one of claims 13 to 16 , wherein the pharmaceutical composition is free of additional excipients.
18 . The method of any one of claims 13 to 16 , wherein the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients.
19 . The method of any one of claims 1 to 12 , wherein the pharmaceutical composition is in the form of a tablet.
20 . The method of claim 19 , wherein the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients.
21 . The method of any one of claims 1 to 20 , wherein the pharmaceutical composition comprises between about 1 mg and about 500 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
22 . The method of any one of claims 1 to 21 , wherein the pharmaceutical composition comprises between about 5 mg and about 500 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
23 . The method of any one of claims 1 to 22 , wherein the pharmaceutical composition comprises between about 10 mg and about 500 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
24 . The method of any one of claims 1 to 23 , wherein the pharmaceutical composition comprises between about 10 mg and about 300 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
25 . The method of any one of claims 1 to 24 , wherein the pharmaceutical composition comprises between about 10 mg and about 100 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
26 . The method of any one of claims 1 to 23 , wherein the pharmaceutical composition comprises between about 50 mg and about 500 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
27 . The method of any one of claims 1 to 23 , wherein the pharmaceutical composition comprises between about 100 mg and about 400 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
28 . The method of any one of claims 1 to 24 , wherein the pharmaceutical composition comprises between about 100 mg and about 300 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
29 . The method of any one of claims 1 to 24 , wherein the pharmaceutical composition comprises between about 150 mg and about 250 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
30 . The method of any one of claims 1 to 23 , wherein the pharmaceutical composition comprises about 400 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
31 . The method of any one of claims 1 to 24 , wherein the pharmaceutical composition comprises about 300 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
32 . The method of any one of claims 1 to 24 , wherein the pharmaceutical composition comprises about 250 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
33 . The method of any one of claims 1 to 24 , wherein the pharmaceutical composition comprises about 200 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
34 . The method of any one of claims 1 to 24 , wherein the pharmaceutical composition comprises about 150 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
35 . The method of any one of claims 1 to 25 , wherein the pharmaceutical composition comprises about 100 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
36 . The method of any one of claims 1 to 25 , wherein the pharmaceutical composition comprises about 80 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
37 . The method of any one of claims 1 to 25 , wherein the pharmaceutical composition comprises about 60 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
38 . The method of any one of claims 1 to 25 , wherein the pharmaceutical composition comprises about 50 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
39 . The method of any one of claims 1 to 25 , wherein the pharmaceutical composition comprises about 30 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
40 . The method of any one of claims 1 to 39 , wherein the pharmaceutical composition provides a Compound 1 T max of about 2 to about 6 hours in a subject.
41 . The method of any one of claims 1 to 40 , wherein the pharmaceutical composition provides a Compound 1 T max of about 3 to about 5 hours in a subject.
42 . The method of any one of claims 1 to 40 , wherein the pharmaceutical composition provides a Compound 1 T max of about 6 hours in a subject.
43 . The method of any one of claims 1 to 41 , wherein the pharmaceutical composition provides a Compound 1 T max of about 5 hours in a subject.
44 . The method of any one of claims 1 to 41 , wherein the pharmaceutical composition provides a Compound 1 T max of about 4 hours in a subject.
45 . The method of any one of claims 1 to 41 , wherein the pharmaceutical composition provides a Compound 1 T max of about 3 hours in a subject.
46 . The method of any one of claims 1 to 45 , wherein the pharmaceutical composition is administered in the fed state.
47 . The method of any one of claims 1 to 45 , wherein the pharmaceutical composition is administered in the fasted state.
48 . The method of any one of claims 1 to 47 , wherein the pharmaceutical composition is administered once a day.
49 . The method of any one of claims 1 to 47 , wherein the pharmaceutical composition is administered twice a day.
50 . The method of any one of claims 1 to 47 , wherein the pharmaceutical composition is administered three times a day.
51 . The method of any of claims 1 to 50 , further comprising administering a glucocorticoid.
52 . The method of claim 51 , wherein the amount of glucocorticoid administered is reduced as compared to a method not comprising administering Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
53 . The method of claim 52 , wherein the amount of glucocorticoid used is reduced from a supraphysiologic amount to a physiologic amount.
54 . The method of claim 52 , wherein the amount of glucocorticoid is reduced by about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%.
55 . The method of any one of claims 52 to 54 , wherein the symptoms associated with high-dose glucocorticoid therapy are reduced.
56 . The method of claim 55 , wherein the symptoms associated with high-dose glucocorticoid therapy are obesity, insulin resistance, metabolic abnormalities, hypertension, cardiovascular diseases, or osteoporosis.
57 . The method of any one of claims 51 to 56 , wherein the glucocorticoid is beclomethasone, betamethasone, budesonide, cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, or triamcinolone.
58 . The method of any one of claims 51 to 57 , wherein the glucocorticoid is hydrocortisone.
59 . The method of claim 58 , wherein the hydrocortisone is administered at a dose less than about 15 mg/day.
60 . The method of claim 58 or 59 , wherein the hydrocortisone is administered at a dose less than about 10 mg/day.
61 . The method of any one of claims 58 to 60 , wherein the hydrocortisone is administered at a dose less than about 5 mg/day.
62 . The method of any one of claims 51 to 61 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered concurrently.
63 . The method of any one of claims 51 to 62 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered sequentially.
64 . The method of any one of claims 51 to 62 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered sequentially within 24 hours.
65 . The method of any one of claims 51 to 62 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered sequentially within 8 hours.
66 . The method of any one of claims 51 to 62 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered sequentially within 2 hours.
67 . The method of any one of claims 51 to 62 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered sequentially within 30 minutes.
68 . The method of any one of claims 1 to 67 , further comprising administering a mineralocorticoid.
69 . The method of claim 68 , wherein the mineralocorticoid is fludrocortisone.
70 . The method of any one of claims 1 to 69 , wherein the pharmaceutical composition is administered at bedtime.
71 . The method of any one of claims 1 to 70 , wherein the pharmaceutical composition is administered less than about 4 hours before sleep.
72 . The method of any one of claims 1 to 70 , wherein the pharmaceutical composition is administered less than about 2 hours before sleep.
73 . The method of any one of claims 1 to 70 , wherein the pharmaceutical composition is administered less than about 30 mins before sleep.
74 . The method of any one of claims 1 to 70 , wherein the pharmaceutical composition is administered in the evening.
75 . The method of any one of claims 1 to 70 , wherein the pharmaceutical composition is administered at about 10 pm at night.
76 . The method of any one of claims 1 to 70 , wherein the pharmaceutical composition is administered at or before the expected circadian release of adrenocorticotropic hormone (ACTH).
77 . The method of any one of claims 1 to 70 , wherein the pharmaceutical composition is administered about 3-4 hours before the expected circadian release of adrenocorticotropic hormone (ACTH).
78 . The method of any one of claims 1 to 77 , wherein CAH is classic CAH.
79 . The method of any one of claims 1 to 77 , wherein CAH is non-classic CAH.
80 . A method of treating congenital adrenal hyperplasia (CAH) in a subject in need thereof, the method comprising:
(iv) measuring a hormone level in the subject in need thereof; (v) administering Compound 1:
or a pharmaceutically acceptable salt or solvate thereof;
(vi) repeating steps (i) and (ii) until the hormone level reaches a pre-determined range followed by a maintenance therapy of a daily dosing of compound 1.
81 . The method of claim 80 , wherein the hormone is 17α-Hydroxyprogesterone (17-OHP), adrenocorticotropic hormone (ACTH), testosterone, or androstenedione.
82 . The method of claim 81 , wherein the hormone is 17-OHP, and the pre-determined range is from about 200 ng/dL to about 400 ng/dL.
83 . The method of claim 81 , wherein the hormone is ACTH, and the pre-determined range is below about 100 pg/mL.
84 . The method of claim 81 , wherein the hormone is testosterone and the pre-determined range is from about 14 ng/dL to about 76 ng/dL.
85 . The method of claim 81 , wherein the hormone is androstenedione and the pre-determined range is from about 30 ng/dL to about 150 ng/dL in males.
86 . The method of claim 81 , wherein the hormone is androstenedione and the pre-determined range is from about 40 ng/dL to about 200 ng/dL in females.
87 . The method of any one of claims 80 to 86 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 200 mg/day and about 1600 mg/day.
88 . The method of any one of claims 80 to 87 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 200 mg/day and about 1200 mg/day.
89 . The method of any one of claims 80 to 88 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 200 mg/day and about 1000 mg/day.
90 . The method of any one of claims 80 to 89 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 200 mg/day and about 800 mg/day.
91 . The method of any one of claims 80 to 90 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 200 mg/day and about 600 mg/day.
92 . The method of any one of claims 80 to 91 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 200 mg/day and 400 mg/day.
93 . The method of any one of claims 80 to 92 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose of about 200 mg/day.
94 . The method of any one of claims 80 to 86 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 50 mg/day and about 1600 mg/day.
95 . The method of claim 94 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 50 mg/day and about 1200 mg/day.
96 . The method of claim 94 or 95 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 50 mg/day and about 1000 mg/day.
97 . The method of any one of claims 94 to 96 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 50 mg/day and about 800 mg/day.
98 . The method of any one of claims 94 to 97 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 50 mg/day and about 600 mg/day.
99 . The method of any one of claims 94 to 98 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between about 50 mg/day and 400 mg/day.
100 . The method of any one of claims 94 to 99 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose between 50 mg/day and 200 mg/day.
101 . The method of any one of claims 94 to 99 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose of about 50 mg/day.
102 . The method of any one of claims 80 to 101 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is in the form of microparticles.
103 . The method of claim 102 , wherein the average size of the microparticles is between about 1 μm and about 20 μm.
104 . The method of claim 102 or 103 , wherein the average size of the microparticles is between about 5 μm and about 15 μm.
105 . The method of any one of claims 102 to 104 , wherein the average size of the microparticles is less than about 10 μm.
106 . The method of any one of claims 80 to 105 , wherein Compound 1 is formulated in a pharmaceutical composition in the form of a capsule or a tablet.
107 . The method of claim 106 , wherein the pharmaceutical composition is in the form of a capsule.
108 . The method of claim 107 , wherein the capsule is a hard gelatin capsule.
109 . The method of claim 107 , wherein the capsule is a soft gelatin capsule.
110 . The method of any one of claims 106 to 109 , wherein the capsule is formed using materials selected from the group consisting of natural gelatin, synthetic gelatin, pectin, casein, collagen, protein, modified starch, polyvinylpyrrolidone, acrylic polymers, cellulose derivatives, and any combinations thereof.
111 . The method of any one of claims 106 to 110 , wherein the pharmaceutical composition is free of additional excipients.
112 . The method of any one of claims 106 to 110 , wherein the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients.
113 . The method of claim 106 , wherein the pharmaceutical composition is in the form of a tablet.
114 . The method of claim 113 , wherein the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients.
115 . The method of any one of claims 106 to 114 , wherein the pharmaceutical composition comprises between about 1 mg and about 500 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
116 . The method of any one of claims 106 to 115 , wherein the pharmaceutical composition comprises between about 5 mg and about 500 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
117 . The method of any one of claims 106 to 116 , wherein the pharmaceutical composition comprises between about 10 mg and about 500 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
118 . The method of any one of claims 106 to 117 , wherein the pharmaceutical composition comprises between about 10 mg and about 300 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
119 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition comprises between about 10 mg and about 100 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
120 . The method of any one of claims 106 to 117 , wherein the pharmaceutical composition comprises between about 50 mg and about 500 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
121 . The method of any one of claims 106 to 117 , wherein the pharmaceutical composition comprises between about 100 mg and about 400 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
122 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition comprises between about 100 mg and about 300 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
123 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition comprises between about 150 mg and about 250 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
124 . The method of any one of claims 106 to 117 , wherein the pharmaceutical composition comprises about 400 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
125 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition comprises about 300 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
126 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition comprises about 250 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
127 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition comprises about 200 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
128 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition comprises about 150 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
129 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition comprises about 100 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
130 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition comprises about 80 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
131 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition comprises about 60 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
132 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition comprises about 50 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
133 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition comprises about 30 mg of Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
134 . The method of any one of claims 106 to 133 , wherein the pharmaceutical composition provides a Compound 1 T max of about 2 to about 6 hours in a subject.
135 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition provides a Compound 1 T max of about 3 to about 5 hours in a subject.
136 . The method of any one of claims 106 to 118 , wherein the pharmaceutical composition provides a Compound 1 T max of about 6 hours in a subject.
137 . The method of any one of claims 106 to 135 , wherein the pharmaceutical composition provides a Compound 1 T max of about 5 hours in a subject.
138 . The method of any one of claims 106 to 135 , wherein the pharmaceutical composition provides a Compound 1 T max of about 4 hours in a subject.
139 . The method of any one of claims 106 to 135 , wherein the pharmaceutical composition provides a Compound 1 T max of about 3 hours in a subject.
140 . The method of any one of claims 106 to 139 , wherein the pharmaceutical composition is administered in the fed state.
141 . The method of any one of claims 106 to 140 , wherein the pharmaceutical composition is administered in the fasted state.
142 . The method of any one of claims 106 to 141 , wherein the pharmaceutical composition is administered once a day.
143 . The method of any one of claims 106 to 141 , wherein the pharmaceutical composition is administered twice a day.
144 . The method of any one of claims 106 to 141 , wherein the pharmaceutical composition is administered three times a day.
145 . The method of any of claims 80 to 144 , further comprising administering a glucocorticoid.
146 . The method of claim 145 , wherein the amount of glucocorticoid administered is reduced as compared to a method not comprising administering Compound 1, or a pharmaceutically acceptable salt or solvate thereof.
147 . The method of claim 145 , wherein the amount of glucocorticoid used is reduced from a supraphysiologic amount to a physiologic amount.
148 . The method of claim 145 , wherein the amount of glucocorticoid is reduced by about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%.
149 . The method of any one of claims 145 to 148 , wherein the symptoms associated with high-dose glucocorticoid therapy are reduced.
150 . The method of claim 149 , wherein the symptoms associated with high-dose glucocorticoid therapy are obesity, insulin resistance, metabolic abnormalities, hypertension, cardiovascular diseases, or osteoporosis.
151 . The method of any one of claims 145 to 150 , wherein the glucocorticoid is beclomethasone, betamethasone, budesonide, cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, or triamcinolone.
152 . The method of any one of claims 145 to 151 , wherein the glucocorticoid is hydrocortisone.
153 . The method of claim 152 , wherein the hydrocortisone is administered at a dose less than about 15 mg/day.
154 . The method of claim 152 or 153 , wherein the hydrocortisone is administered at a dose less than about 10 mg/day.
155 . The method of any one of claims 152 to 154 , wherein the hydrocortisone is administered at a dose less than about 5 mg/day.
156 . The method of any one of claims 152 to 155 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered concurrently.
157 . The method of any one of claims 152 to 155 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered sequentially.
158 . The method of any one of claims 152 to 155 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered sequentially within 24 hours.
159 . The method of any one of claims 152 to 155 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered sequentially within 8 hours.
160 . The method of any one of claims 152 to 155 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered sequentially within 2 hours.
161 . The method of any one of claims 152 to 155 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, and the glucocorticoid are administered sequentially within 30 minutes.
162 . The method of any one of claims 80 to 161 , further comprising administering a mineralocorticoid.
163 . The method of claim 162 , wherein the mineralocorticoid is fludrocortisone.
164 . The method of any one of claims 80 to 163 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at bedtime.
165 . The method of any one of claims 80 to 163 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered less than about 4 hours before sleeping.
166 . The method of any one of claims 80 to 163 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered less than about 2 hours before sleeping.
167 . The method of any one of claims 80 to 163 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered less than about 30 mins before sleeping.
168 . The method of any one of claims 80 to 163 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered in the evening.
169 . The method of any one of claims 80 to 163 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at 10 pm at night.
170 . The method of any one of claims 80 to 163 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered at or before the expected circadian release of adrenocorticotropic hormone (ACTH).
171 . The method of any one of claims 80 to 163 , wherein Compound 1, or a pharmaceutically acceptable salt or solvate thereof, is administered about 3-4 hours before the expected circadian release of adrenocorticotropic hormone (ACTH).
172 . The method of any one of claims 80 to 171 , wherein CAH is classic CAH.
173 . The method of any one of claims 80 to 171 , wherein CAH is non-classic CAH.
174 . A method of any one of claims 1 to 173 , wherein the subject in need thereof is from about 12 years of age to about 20 years of age.
175 . A method of improving hyperandrogenic symptoms in a subject in need thereof, comprising administering a pharmaceutical composition comprising Compound 1:
or a pharmaceutically acceptable salt or solvate thereof, wherein Compound 1 is administered at a dose between about 50 mg/day and about 1600 mg/day.
176 . A method of claim 175 , wherein the hyperandrogenic symptoms are selected from the group consisting of acne, hirsutism and alopecia.
177 . A method of treating menstrual irregularity, ovulatory dysfunction or infertility, in a subject in need thereof, comprising administering a pharmaceutical composition comprising Compound 1:
or a pharmaceutically acceptable salt or solvate thereof, wherein Compound 1 is administered at a dose between about 50 mg/day and about 1600 mg/day.
178 . A method of improving metabolic symptoms in a subject in need thereof, comprising administering a pharmaceutical composition comprising Compound 1:
or a pharmaceutically acceptable salt or solvate thereof, wherein Compound 1 is administered at a dose between about 50 mg/day and about 1600 mg/day.
179 . A method of claim 178 , wherein the metabolic symptoms are selected from the group consisting of body weight, BMI, waist circumference, blood pressure and glycemic control.
180 . A method of improving quality of life in a subject in need thereof, comprising administering a pharmaceutical composition comprising Compound 1:
or a pharmaceutically acceptable salt or solvate thereof, wherein Compound 1 is administered at a dose between about 50 mg/day and about 1600 mg/day, wherein treatment results in an improved quality of life.Cited by (0)
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