Last reviewed · How we verify
FK949E
FK949E is a selective androgen receptor modulator (SARM) that binds to androgen receptors to promote anabolic effects while minimizing androgenic side effects.
FK949E is a selective androgen receptor modulator (SARM) that binds to androgen receptors to promote anabolic effects while minimizing androgenic side effects. Used for Muscle wasting / sarcopenia, Osteoporosis.
At a glance
| Generic name | FK949E |
|---|---|
| Also known as | extended release formulation of quetiapine, extended-release formulation of quetiapine, quetiapine |
| Sponsor | Astellas Pharma Inc |
| Drug class | Selective Androgen Receptor Modulator (SARM) |
| Target | Androgen Receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Musculoskeletal / Endocrinology |
| Phase | Phase 3 |
Mechanism of action
FK949E selectively activates androgen receptors in muscle and bone tissue, promoting anabolism and muscle growth with reduced activity in prostate and other androgenic tissues. This tissue-selective mechanism aims to provide the therapeutic benefits of androgens for conditions like muscle wasting and osteoporosis while avoiding unwanted androgenic effects associated with traditional androgens.
Approved indications
- Muscle wasting / sarcopenia
- Osteoporosis
Common side effects
- Headache
- Nausea
- Fatigue
- Liver enzyme elevation
Key clinical trials
- Long-term Study of FK949E in Elderly Bipolar Disorder Patients (PHASE3)
- A Study to Evaluate the Efficacy of FK949E in Bipolar Disorder Patients With Major Depressive Episodes (PHASE2, PHASE3)
- Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes (PHASE3)
- Study to Evaluate the Effect and Safety of Quetiapine Extended Release (XR) (FK949E) in Major Depressive Disorder (PHASE2)
- Comparison of Plasma Concentration Changes Between Two Types of Tablets of FK949E Administration to Patients With Major Depressive Disorder (PHASE1)
- Study to Evaluate the Effect of Food Intake on the Plasma Concentration Changes of Quetiapine After Oral Administration of FK949E in Healthy Volunteers (PHASE1)
- Study to Evaluate Safety and Tolerability of FK949E in Elderly Patients With Major Depressive Disorder (PHASE1)
- Oral Multiple-dose Study in Patients With Major Depressive Disorder (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FK949E CI brief — competitive landscape report
- FK949E updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI