Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACE-031 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| ACE-031 | EXPERIMENTAL | 8 dosing groups |
| Placebo | PLACEBO_COMPARATOR | - |
| single | EXPERIMENTAL | 8 subjects (6 active and 2 placebo) |
| Name | Type | Description |
|---|---|---|
| ACE-031 | BIOLOGICAL | Either 2 or 3 subcutaneous doses of ACE-031 over a period of one month, or 7 subcutaneous doses of ACE-031 over a period of 3 months. |
| Placebo | BIOLOGICAL | Either 2 or 3 subcutaneous doses of placebo over a period of one month, or 7 subcutaneous doses of placebo over a period of 3 months. |
Inclusion Criteria: * Postmenopausal * Body mass index (BMI) of ≥ 18.5 to \< 32. Exclusion Criteria: * History of malignancy, except excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas * History of clinically significant cardiac, endocrinologic, he...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Abbott Laboratories | ABT | 1 | - | Undisclosed |
| CytoSorbents Corporation | CTSO | 1 | - | Undisclosed |
ACE-031 is an investigational monoclonal antibody being studied for muscle loss and muscular atrophy. It is in Phase 1 clinical development for these musculoskeletal conditions. The drug is not approved and remains under investigation.
ACE-031 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and effects in healthy volunteers.
ACE-031 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy postmenopausal women. The drug is investigational and has not been approved for any use.
ACE-031 has completed two Phase 1 trials: NCT00755638 and NCT00952887. Both were conducted in Canada and enrolled healthy postmenopausal women aged 45 years and older to study the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics.
ACE-031 is also known as ActRIIB-IgG1, as reflected in the title of one of its clinical trials. Both names refer to the same investigational monoclonal antibody being developed for muscle loss and muscular atrophy.