Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACE-536 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ACE-536 | EXPERIMENTAL | Subjects assigned to 1 of 5 possible dosing groups. |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ACE-536 | BIOLOGICAL | Subjects receive a total of 2 subcutaneous doses of ACE-536 on Day 1 and Day 15. |
| Placebo | OTHER | Subjects receive a total of 2 subcutaneous doses of placebo on Day 1 and Day 15. |
Key Inclusion Criteria: * Postmenopausal women * Body Mass Index (BMI) of 20 - 32 kg/m2. Key Exclusion Criteria: * History of hypertension * Subject has received any erythropoiesis stimulating agents (e.g., Epogen, Procrit, Aranesp, etc.) within 6 months prior to Day 1 * History of clinically sig...
ACE-536 is an investigational monoclonal antibody being developed for the treatment of anemia. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being studied in the therapeutic area of hematology.
ACE-536 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for the treatment of anemia.
ACE-536 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of anemia, and its Phase 1 trial has been completed.
ACE-536 has one completed Phase 1 clinical trial with the identifier NCT01432717, titled 'Study of ACE-536 in Healthy Postmenopausal Women.' This trial enrolled 40 participants in the United States and was a randomized, double-blind, placebo-controlled study.
ACE-536 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of anemia. The drug has completed one Phase 1 trial, but it has not yet received regulatory approval.