Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AG10 · 3 trials · 4 indications
Incidence of each treatment-emergent adverse events
Change in Diastolic Blood Pressure from Baseline to Day 28 (Postdose)
Change in Heart Rate from Baseline to Day 28 (Postdose)
Change in Respiratory Rate from Baseline to Day 28 (Postdose)
Change in Temperature from Baseline to Day 28
Change in Systolic Blood Pressure from Baseline to Day 28
To evaluate the safety and tolerability of single and multiple doses of AG10 administered to healthy adult subjects
| Arm | Type | Description |
|---|---|---|
| Open-Label | EXPERIMENTAL | - |
| AG10 Low Dose | ACTIVE_COMPARATOR | AG10 400mg tablets twice daily for 28 days |
| AG10 High Dose | ACTIVE_COMPARATOR | AG10 800mg tablets twice daily for 28 days |
| Placebo | PLACEBO_COMPARATOR | Placebo tablets twice daily for 28 days |
| AG10 single oral dose | EXPERIMENTAL | AG10 oral tablet, administered by mouth, once |
| Placebo single oral dose | PLACEBO_COMPARATOR | Placebo Oral Tablet, administered by mouth, once |
| Name | Type | Description |
|---|---|---|
| AG10 | DRUG | AG10 800mg twice daily, oral administration |
| Placebo Oral Tablet | DRUG | Nonactive control |
| AG10 oral tablet | DRUG | Active single ascending dose |
Inclusion Criteria: 1. Completed participation in study AG10-201. 2. Willing and able to comply with the study medication regimen and all study requirements. 3. The ability to understand and provide informed consent, which must be obtained prior to initiation of study participation. 4. Male patient...
AG10 is an investigational small molecule being developed for the treatment of amyloid cardiomyopathy, including transthyretin-related amyloid cardiomyopathy and familial ATTR-CM (ATTRm-CM, or FAC). It is designed to address the underlying causes of these conditions, which affect the heart's function.
AG10 targets the transthyretin (TTR) protein. By binding to TTR, AG10 aims to stabilize the protein and prevent its misfolding and aggregation, which are key steps in the development of transthyretin-related amyloid cardiomyopathy.
AG10 is being developed by BridgeBio Pharma, Inc., a biopharmaceutical company. BridgeBio is focused on discovering and developing innovative therapies for genetic diseases and cancers. The company's ticker symbol is BBIO.
AG10 is currently in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, and an additional Phase 2 study is active but not recruiting participants. AG10 is not yet approved by regulatory authorities and remains investigational.
AG10 has been studied in several clinical trials. NCT03294707 was a Phase 1 study of safety and tolerability. NCT03458130 was a Phase 2 study in amyloid cardiomyopathy. NCT03536767 is an active Phase 2 open-label study in patients with cardiomyopathy.
AG10 is also known as acoramidis. This alternative name is used in some clinical and scientific contexts. Both names refer to the same investigational drug being developed by BridgeBio Pharma for the treatment of transthyretin-related amyloid cardiomyopathy.