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Label indication ALKINDI SPRINKLE is indicated as replacement therapy in pediatric patients with adrenocortical insufficiency. ALKINDI SPRINKLE is a corticosteroid indicated as replacement therapy in pediatric patients with adrenocortical insufficiency. (1) FDA label
Hydrocortisone · 1 trial · 1 indication
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The data for combined arm 1+2 after multiple doses were reported.
| Arm | Type | Description |
|---|---|---|
| Novel once daily modified release | EXPERIMENTAL | Test drug: hydrocortisone (modified release), oral tablet, available as 20 mg and 5 mg. The modified release hydrocortisone tablet was administered orally o.d. at 8 AM in the fasting state |
| Conventional TID hydrocortisone | ACTIVE_COMPARATOR | Reference drug: hydrocortisone, oral tablet, 10 mg. The reference drug was administered orally thrice daily (at 8 AM, 12 AM and 4 PM)in the same total daily dose as the experimental drug. The morning dose was administered in the fasting state. |
| Name | Type | Description |
|---|---|---|
| hydrocortisone (modified release), oral tablet 20 and 5 mg | DRUG | The modified release hydrocortisone tablet was administered orally o.d. at 8 AM in the fasting state. The dose was the same as patients have had before entering the trial |
| Hydrocortisone, oral tablet, 10 mg | DRUG | The reference drug was administered orally thrice daily (at 8 AM, 12 AM and 4 PM). The morning dose was administered in the fasting state. The total daily dose was the same as in the experimental treatment arm. |
Inclusion Criteria: * Previously diagnosed (e.g. more than 6 months ago) primary adrenal insufficiency with a stable daily glucocorticoid substitution dose for at least 3 months prior to study entry * Signed informed consent to participate in the study. Exclusion Criteria: * Clinical or laborator...
Hydrocortisone is used to treat adrenal insufficiency, a condition in which the adrenal glands do not produce enough cortisol. Takeda Pharmaceutical Company Limited is developing a modified release oral tablet formulation of hydrocortisone in 20 mg and 5 mg strengths for once-daily dosing in adults with adrenal insufficiency.
Hydrocortisone works as an agonist of NR3C1, the glucocorticoid receptor. By binding and activating this receptor, it replaces the cortisol that the adrenal glands fail to produce in adrenal insufficiency. It is a small molecule therapy given as an oral modified release tablet.
Takeda Pharmaceutical Company Limited, which trades under the ticker TAK, is the developer of this modified release oral hydrocortisone tablet for adrenal insufficiency.
This modified release oral hydrocortisone is in Phase 2 development for adrenal insufficiency. It is investigational and has not been approved for this use. The Phase 2 trial has been completed, and no active trials are currently listed for this asset.
The Phase 2 trial NCT00915343, titled Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency, evaluated this formulation. It was a randomized, active-controlled study that enrolled 64 adults aged 18 years and older and has been completed.
Yes. Hydrocortisone modified release, the oral tablet in 20 mg and 5 mg strengths, and hydrocortisone refer to the same Takeda asset. The modified release designation describes the once-daily oral formulation being studied in adrenal insufficiency.