Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Infacort · 5 trials · 2 indications
The primary endpoint was the nature and occurrence of serious adverse events (SAEs) and adverse events (AEs) observed throughout the study. AEs were recorded from the time of the first intake of Infacort until the final visit.
The primary endpoint will be the maximum levels of serum cortisol concentration up to 240 minutes after intake of study drug as determined by the central laboratory.
Comparing the maximum serum cortisol concentration (Cmax) of Infacort® compared to Cortef® immediate release hydrocortisone tablets.This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Comparing the total drug exposure over time for Infacort® compared to Cortef®. This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Comparing the total drug exposure over time for Infacort® compared to Cortef® extrapolated to infinity from dosing time, based on the last observed concentration. This This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
The pharmacokinetic parameter AUC0-inf of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
The pharmacokinetic parameter AUC0-inf of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
The pharmacokinetic parameter Cmax of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
To compare the Cmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.
To compare the Tmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.
To compare the AUC0-t of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg. AUC0-t represents the total exposure to drug over time, hence the reporting of a single value below.
| Arm | Type | Description |
|---|---|---|
| Infacort | EXPERIMENTAL | Infacort® granules |
| Cortef® Tablets - fasted | ACTIVE_COMPARATOR | Single dose of 20mg Cortef® Tablets - fasted arm |
| Infacort® - fasted | EXPERIMENTAL | Single dose of 20mg Infacort® - fasted arm |
| Cortef® Tablets - fed | ACTIVE_COMPARATOR | Single dose of 20mg Cortef® Tablets - fed arm |
| Infacort® - fed | EXPERIMENTAL | Single dose of 20mg Infacort® - fed arm |
| Infacort - Yoghurt | EXPERIMENTAL | One single 5mg dose of Infacort will be sprinkled onto 5mL of yoghurt and swallowed within three minutes. This will be taken with 240mL of water. |
| Infacort - Soft Food | EXPERIMENTAL | One single 5mg dose of Infacort will be sprinkled onto 5mL of soft food (such as applesauce) and swallowed within three minutes. This will be taken with 240mL of water. |
| Infacort - Dry Granules | ACTIVE_COMPARATOR | One single 5mg dose of Infacort will be administered as dry granules to the back of the tongue and swallowed. This will be taken with 240mL of water. |
| Infacort 0.5 mg | EXPERIMENTAL | Multi-particulate granules from 1 (0.5 mg) capsule |
| Infacort 2 mg | EXPERIMENTAL | Multi-particulate granules from 1 (2 mg) capsule |
| Infacort 5 mg | EXPERIMENTAL | Multi-particulate granules from 1 (5 mg) capsule |
| Infacort 10 mg | EXPERIMENTAL | Multi-particulate granules from 1 (10 mg) capsule |
| Hydrocortisone | ACTIVE_COMPARATOR | 1 (10 mg) tablet |
| Name | Type | Description |
|---|---|---|
| Infacort® | DRUG | Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). |
| Cortef® | DRUG | Immediate release hydrocortisone tablets |
| Infacort | DRUG | Immediate-release multiparticulate formulation of hydrocortisone. |
| Hydrocortisone | DRUG | Tablet |
Inclusion Criteria: Subjects successfully completing study Infacort 003, whose inclusion criteria were: 1. Male and female children less than 6 years of age. 2. A diagnosis of adrenal insufficiency (AI) as confirmed by an inappropriately low cortisol usually with other supporting tests. 3. Receivi...
Infacort is an investigational small molecule being developed for the treatment of adrenal insufficiency. It is being studied in children as young as one week old and in adults. The drug is currently in Phase 3 clinical development.
Infacort is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker NBIX. The company is conducting clinical trials of Infacort for adrenal insufficiency.
Infacort is in Phase 3 clinical development for adrenal insufficiency. It has completed Phase 3 trials in children and is not yet approved by regulatory authorities. The drug remains investigational.
Infacort has completed four clinical trials. These include two Phase 3 studies in children with adrenal insufficiency in Germany (NCT02720952 and NCT02733367), and two Phase 1 studies in healthy adults in the United Kingdom (NCT03178214 and NCT03311932).
Infacort is not the same as Cortef, but a Phase 1 study (NCT03311932) directly compared Infacort to Cortef in healthy adult subjects. Both are being studied for adrenal insufficiency, but they are distinct drug products.
Infacort is a small molecule designed to treat adrenal insufficiency. The specific molecular target of Infacort has not been disclosed in the available clinical trial information, so its precise mechanism of action is not described here.