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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 a small molecule being developed by Tempest Therapeutics for the treatment of adrenocortical carcinoma and congenital adrenal hyperplasia. It is an investigational drug that has been studied in clinical trials for these conditions.
ATR-101 is being developed by Tempest Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol TPST.
ATR-101 has completed a Phase 1 clinical trial in advanced adrenocortical carcinoma and a Phase 2 clinical trial in congenital adrenal hyperplasia. It is an investigational drug and has not been approved by the FDA.
ATR-101 has been studied in two completed clinical trials. NCT01898715 was a Phase 1 study in advanced adrenocortical carcinoma with 63 participants in the United States and Germany. NCT02804178 was a Phase 2 study in congenital adrenal hyperplasia with 10 participants in the United States.
ATR-101 is the primary name used for this investigational small molecule. No alternative names have been reported for this drug in clinical trial records.