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Also known as atumelnant (CRN04894), CRN04894
Atumelnant · 6 trials · 6 indications
A4 is the principal biochemical measure of disease activity in adult CAH. Blood samples were collected for the measurement of serum concentration of A4 prior to glucocorticoid administration. Baseline is defined as the last non-missing morning window value prior to or on the same day as the first dose date of atumelnant. Change from baseline was obtained by subtracting post-baseline visit value minus baseline value.
A4 is the principal biochemical measure of disease activity in adult CAH. Blood samples were collected for the measurement of serum concentration of A4 prior to glucocorticoid administration. Baseline is defined as the last non-missing morning window value prior to or on the same day as the first dose date of atumelnant. Change from baseline was obtained by subtracting post-baseline visit value minus baseline value.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. TEAEs were collected in the full analysis set which consisted of all participants who received at least one dose of study drug. A serious AE is defined by its severe clinical consequences: it is any event that results in death, is life-threatening, requires inpatient hospitalization, results in persistent disability, or requires medical intervention to prevent these outcomes.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Atumelnant tablet, administered orally, once daily for 32 weeks. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, administered orally, once daily for 32 weeks. |
| Treatment (Part A) | EXPERIMENTAL | Open-label, semi-sequential cohorts. |
| Active Treatment (Part B) | EXPERIMENTAL | Randomized, Parallel Arms, Double-Blind |
| Placebo (Part B) | PLACEBO_COMPARATOR | Randomized, Parallel Arms, Double-Blind |
| Open-Label Treatment (Part C) | EXPERIMENTAL | Open-label treatment period for participants entering Part C from Part A and B. |
| Sequential Dose | EXPERIMENTAL | Sequential, open-label, 12-week fixed-dose cohorts. |
| Multiple Ascending Doses | EXPERIMENTAL | Sequential, open-label, 10-day or 14-day fixed-dose cohorts. |
| Single Ascending Dose (Part 1) | EXPERIMENTAL | - |
| Multiple Ascending Dose (Part 2) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Atumelnant | DRUG | Atumelnant, tablets, once daily by mouth |
| Placebo | DRUG | Placebo, tablets, once daily by mouth |
| atumelnant (CRN04894) | DRUG | Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) receptor antagonist. |
| CRN04894 Oral Solution | DRUG | CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist. |
| Placebo Oral Solution | DRUG | Placebo |
Inclusion Criteria: 1. Male or female, between ≥18 to \<75 years of age at the time of signing the ICF. 2. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment. 3. Have classic CAH due to 21-OHD confirmed by the Investiga...
Atumelnant is an investigational oral small molecule developed by Crinetics Pharmaceuticals for congenital adrenal hyperplasia and Cushing syndrome. It is in Phase 3 clinical development and holds Orphan Drug and Rare Pediatric Disease designations from the FDA. Atumelnant is also known by the code CRN04894.
Atumelnant is being developed for classic congenital adrenal hyperplasia, a condition in which the body cannot produce cortisol normally. Clinical studies are enrolling adults and pediatric participants with the condition, including a Phase 3 study in adults and a Phase 2 study in children as young as 1 year. It is also in development for Cushing syndrome.
Atumelnant targets MC2R, the melanocortin 2 receptor, which is the receptor for adrenocorticotropic hormone (ACTH) on the adrenal gland. By acting at MC2R, the small molecule is designed to modulate ACTH-driven signaling in the adrenal cortex, the pathway relevant to cortisol production in congenital adrenal hyperplasia.
Atumelnant is being developed by Crinetics Pharmaceuticals, Inc., a company traded on Nasdaq under the ticker CRNX. Crinetics is the sponsor of the atumelnant clinical program in congenital adrenal hyperplasia, which includes Phase 2 and Phase 3 studies across North America, South America, Europe, Asia, and Australia.
Atumelnant is in Phase 3 clinical development. A Phase 3 study in adults with congenital adrenal hyperplasia (NCT07144163) is recruiting, alongside a Phase 2 pediatric study (NCT07159841) and a Phase 2 extension study (NCT06712823). Atumelnant is investigational and has not been approved by the FDA.
Atumelnant has four registered clinical trials in congenital adrenal hyperplasia. The recruiting studies are the Phase 3 adult trial NCT07144163, the Phase 2 pediatric Balance-CAH trial NCT07159841, and the Phase 2 extension study NCT06712823. The completed Phase 2 TouCAHn trial, NCT05907291, enrolled 38 participants.
Yes, atumelnant and CRN04894 refer to the same drug. CRN04894 is the earlier code name used for the compound, and it appears in the identifier of the completed Phase 2 TouCAHn study (NCT05907291). Atumelnant is the name now used for the Crinetics Pharmaceuticals development program in congenital adrenal hyperplasia and Cushing syndrome.