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LY353381
LY353381 is a selective estrogen receptor modulator (SERM) that acts as a partial agonist at estrogen receptors to provide bone-protective and cardiovascular benefits without stimulating breast or endometrial tissue.
LY353381 is a selective estrogen receptor modulator (SERM) that acts as a partial agonist at estrogen receptors to provide bone-protective and cardiovascular benefits without stimulating breast or endometrial tissue. Used for Osteoporosis prevention and treatment in postmenopausal women, Cardiovascular risk reduction in postmenopausal women.
At a glance
| Generic name | LY353381 |
|---|---|
| Sponsor | Eli Lilly and Company |
| Drug class | Selective Estrogen Receptor Modulator (SERM) |
| Target | Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular, Bone Health, Women's Health |
| Phase | Phase 3 |
Mechanism of action
As a SERM, LY353381 binds to estrogen receptors with tissue-selective activity, functioning as an agonist in bone and cardiovascular tissues while acting as an antagonist in breast and endometrial tissues. This selective profile aims to provide the bone-protective and lipid-modifying benefits of estrogen replacement while avoiding the increased risks of breast cancer and endometrial proliferation associated with traditional hormone replacement therapy.
Approved indications
- Osteoporosis prevention and treatment in postmenopausal women
- Cardiovascular risk reduction in postmenopausal women
Common side effects
- Hot flashes
- Leg cramps
- Vaginal bleeding or spotting
- Thromboembolic events
Key clinical trials
- LY353381 in Preventing Breast Cancer in Women With Hyperplasia (PHASE2)
- Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer (PHASE1)
- A Study of Arzoxifene to Treat Korean Women With Osteoporosis (PHASE2)
- Hormone Therapy in Treating Women With Breast Cancer (PHASE2)
- Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer (PHASE2)
- Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Metastatic Refractory Ovarian Cancer or Primary Peritoneal Cancer (PHASE2)
- Arzoxifene or Tamoxifen in Preventing Breast Cancer in Premenopausal Women at High Risk for Breast Cancer (PHASE2)
- Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer (PHASE3)
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:
- LY353381 CI brief — competitive landscape report
- LY353381 updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI