Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as atumelnant (CRN04894)
atumelnant · 7 trials · 6 indications
Assessment of the maximum observed plasma concentration of atumelnant
Assessment of time to maximal atumelnant concentration (Tmax)
Assessment of the plasma area under the curve of Atumelnant
| 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. |
| Cohort 1 | EXPERIMENTAL | atumelnant, carbamazepine (CYP3A4 Inducer) |
| Cohort 2 | EXPERIMENTAL | atumelnant, midazolam (CYP3A4 substrate), digoxin (P-gp substrate), metformin (MATE1/2-K substrate) |
| Treatment (Cohort 1) | EXPERIMENTAL | Fixed-sequence cohort for Japanese participants. |
| Placebo (Cohort 1) | ACTIVE_COMPARATOR | Fixed-sequence cohort for Japanese participants. |
| Treatment (Cohort 2) | EXPERIMENTAL | Fixed-sequence cohort for Caucasian participants. |
| Placebo (Cohort 2) | ACTIVE_COMPARATOR | Fixed-sequence cohort for Caucasian participants. |
| Multiple Ascending Doses | EXPERIMENTAL | Sequential, open-label, 10-day or 14-day fixed-dose cohorts. |
| 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. |
| Carbamazepine | DRUG | CYP3A4 inducer |
| Midazolam | DRUG | CYP3A4 substrate |
| Digoxin | DRUG | P-gp substrate |
| Metformin | DRUG | MATE1/2-K substrate |
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 small molecule being developed for the treatment of congenital adrenal hyperplasia (CAH), including classic congenital adrenal hyperplasia. It is also being studied in healthy volunteers and for Cushing syndrome. The drug is currently in Phase 1 clinical development.
Atumelnant is being developed by Crinetics Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CRNX. The company is conducting clinical trials to evaluate the safety and efficacy of Atumelnant in patients with congenital adrenal hyperplasia.
Atumelnant is in Phase 1 clinical development. It has received orphan drug designation and rare pediatric disease designation from the FDA. The drug is investigational and has not been approved by regulatory authorities for any indication.
Atumelnant is being studied in four clinical trials, including NCT05907291 (completed Phase 2 in congenital adrenal hyperplasia), NCT06712823 (recruiting Phase 2 extension study), NCT07144163 (recruiting Phase 3 in adults with CAH), and NCT07159841 (recruiting Phase 2 pediatric study).
Yes, Atumelnant is also known as CRN04894. The drug is referred to by both names in clinical research and development documentation. Crinetics Pharmaceuticals is developing this compound under the brand name Atumelnant.