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ATR-101 · 2 trials · 4 indications
17-hydroxyprogesterone was measured predose in the morning at the beginning and end of each dose level.
Adverse events will be recorded and tabulated by grade and system organ class according to CTCAE v 4.03. Laboratory measures and ECGs will be assessed.
| Arm | Type | Description |
|---|---|---|
| ATR-101 | EXPERIMENTAL | Ascending dose levels of ATR-101 beginning with 125 mg by mouth twice per day up to 1000 mg twice per day. |
| Name | Type | Description |
|---|---|---|
| ATR-101 | DRUG | 125-1000 mg twice per week |
Inclusion Criteria: * Documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency based on: Documented genetic mutation in the CYP21A2 enzyme consistent with a diagnosis of classic CAH, or historical documentation of elevated 17-hydroxyprogesterone * Biochemical marker of diseas...
ATR-101 is an investigational small molecule being studied for the treatment of adrenocortical carcinoma and congenital adrenal hyperplasia. It has been evaluated in clinical trials for these conditions, though it is not yet approved and remains in clinical development.
ATR-101 is being developed by Tempest Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol TPST. The company has conducted clinical trials of ATR-101 in the United States and Germany.
ATR-101 has completed a Phase 1 trial for adrenocortical carcinoma and a Phase 2 trial for congenital adrenal hyperplasia. Both trials are completed, and the drug is investigational, meaning it is not yet approved by regulatory authorities.
ATR-101 has been studied in two completed trials: NCT01898715, a Phase 1 study in advanced adrenocortical carcinoma with 63 participants, and NCT02804178, a Phase 2 study in congenital adrenal hyperplasia with 10 participants. Both trials were conducted in the United States, with the first also including Germany.
ATR-101 is the primary name used for this investigational drug in clinical trials. No alternative names have been reported for this compound in the available clinical trial information.