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ASC-01
ASC-01 is a selective androgen receptor modulator (SARM) that activates androgen signaling in a tissue-selective manner.
ASC-01 is a selective androgen receptor modulator (SARM) that activates androgen signaling in a tissue-selective manner. Used for Muscle wasting and weakness in older adults, Age-related decline in muscle mass and function.
At a glance
| Generic name | ASC-01 |
|---|---|
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Drug class | Selective androgen receptor modulator (SARM) |
| Target | Androgen receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Musculoskeletal |
| Phase | Phase 3 |
Mechanism of action
ASC-01 binds to the androgen receptor with high selectivity, promoting anabolic effects in muscle and bone while minimizing androgenic side effects in other tissues. This tissue-selective activation aims to provide the therapeutic benefits of androgens without the adverse effects associated with traditional androgen replacement therapy or non-selective androgens.
Approved indications
- Muscle wasting and weakness in older adults
- Age-related decline in muscle mass and function
Common side effects
- Acne
- Hair loss
- Elevated liver enzymes
- Mood changes
Key clinical trials
- A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects (PHASE1)
- Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults (PHASE1)
- Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |