Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AT-001 · 1 trial · 1 indication
Changes in Peak VO2 during cardio-pulmonary exercise test (CPET) from baseline to approximately Month 15 (15-18 months). A CPET may be repeated at approximately Month 27 (27-30 months).
| Arm | Type | Description |
|---|---|---|
| AT-001 High dose | EXPERIMENTAL | The total daily doses will be of 3g. The dose selection and the frequency of dosing was based on the results of the phase 1/2 study demonstrating that 3g/day of AT-001 is capable of producing the maximum inhibition of the production of sorbitol (a pharmacodynamic biomarker of biological activity). |
| AT-001 Low Dose | EXPERIMENTAL | The total daily doses will be of 2g. The dose selection and the frequency of dosing was based on the results of the phase 1/2 study demonstrating that 2g/day of AT-001 is capable of producing a sufficient inhibition of the production of sorbitol (a pharmacodynamic biomarker of biological activity). |
| Placebo Comparator | PLACEBO_COMPARATOR | Placebo capsules will be used as comparator |
| Name | Type | Description |
|---|---|---|
| AT-001 | DRUG | AT-001 will be administered as 3 capsules twice daily, before breakfast and before dinner. At present AT001 is the sole name for the active substance. No INN/genetic name is available to date |
| Placebo | DRUG | Matching placebo will be administered as 3 capsules twice daily, before breakfast and before dinner |
Inclusion Criteria: * Type 2 Diabetes Mellitus * Diabetic cardiomyopathy * Peak VO2 \< 75% of predicted normal value based on age and gender Exclusion Criteria: * Prior diagnosis or signs/symptoms of overt/symptomatic heart failure / stage C heart failure * Prior echocardiogrphic measurement of e...
AT-001 is an investigational small molecule being developed for diabetic cardiomyopathy, a heart muscle disease that occurs in people with diabetes. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
AT-001 targets the enzyme aldose reductase. By inhibiting this enzyme, the drug is intended to address a pathway implicated in diabetic cardiomyopathy. The drug is being studied for its potential to affect the progression of this condition.
AT-001 is being developed by Applied Therapeutics, Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol APLT. The company is conducting clinical trials to evaluate the safety and efficacy of AT-001 in patients with diabetic cardiomyopathy.
AT-001 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is designed to assess its safety and efficacy in patients with diabetic cardiomyopathy.
AT-001 is being studied in a Phase 3 clinical trial registered as NCT04083339, titled "Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy." The trial is active but not recruiting, with an enrollment of 675 participants across multiple countries including the United States, Australia, Canada, and several European nations.
AT-001 is the primary name used for this investigational drug in clinical development. No alternative names have been reported for this compound in the context of its ongoing trials for diabetic cardiomyopathy.