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arzoxifene

Phase 4

Osteoporosis, Postmenopausal | Small molecule | Endocrine |Eli Lilly and Company|Trials Updated: Apr 30, 2015

arzoxifene development status

Highest phase Phase 4 (NCT00190697)
Phase scored for LLYPhase 3
Registered trials 6 across 1 sponsor since Apr 2002

arzoxifene target and mechanism

Molecular targetESR2, ESR1
Target classModulator
ModalitySmall molecule

Also known as arzoxifene hydrochloride, LY353381

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials7
Total Enrollment10,080

FDA Designations

No designations recorded

arzoxifene clinical trials

arzoxifene · 7 trials · 7 indications

Phase 3 4Phase 2 3
NCT00383422Study Comparing Arzoxifene With Raloxifene in Women After Menopause With OsteoporosisOsteoporosis, Postmenopausal
COMPLETED320 Analytics
NCT00088010Effects of Arzoxifene on Bone Fractures and Incidence of Breast CancerOsteoporosis, Postmenopausal
COMPLETED9,369 Analytics
NCT00085956Effects of Arzoxifene on Bone Mass and the UterusPostmenopausal Bone Loss
COMPLETED300 Analytics
NCT00034125Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.Breast Neoplasms
COMPLETED- Analytics
PHASE3COMPLETED
Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis
Osteoporosis, PostmenopausalUnlock trial analytics
PHASE3COMPLETED
Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer
Osteoporosis, PostmenopausalUnlock trial analytics
PHASE3COMPLETED
Effects of Arzoxifene on Bone Mass and the Uterus
Postmenopausal Bone LossUnlock trial analytics
PHASE3COMPLETED
Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.
Breast NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent change in Lumbar Spine BMD
baseline to 12 months
Effects of arzoxifene on bone fractures and bone mass
5 years
Effects of arzoxifene on getting breast cancer
5 years
The safety of arzoxifene and any side effects
5 years
The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women
The effects of arzoxifene on the uterus (womb) in post menopausal women
The safety of arzoxifene and any side effects that might be associated with its use
Lumbar spine bone mineral density (BMD), by dual energy X-ray absorptiometry (DXA) analyses
6 months

Secondary Endpoints

Secondary BMD measures of total hip and femoral neck
at 6 and 12 months
Biochemical markers of bone metabolism assessed
baseline, 3, 6, and 12 months
Assessment of coagulation parameters
baseline, 3, 6, and 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
ArzoxifeneDRUG20 mg, oral, tablet, once a day for 52 weeks
RaloxifeneDRUG60 mg, oral, tablet, once a day for 52 weeks
PlaceboDRUGoral, tablet, once a day for 36 months
LY353381DRUG -
tamoxifenDRUG -
arzoxifene hydrochlorideDRUG -
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Eligibility Criteria

Age Range50 Years to 75 Years
SexFEMALE
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Must have osteoporosis * Must be between 50 and 75 years old and be able to walk * Have at least two of your back bones that can be x-rayed * Have not had a period in at least two years * Be willing to have blood tests Exclusion Criteria: * Have a bone disease other than ost...

Countries:United StatesArgentinaAustraliaCanadaFranceItalySpainTaiwanChileIndiaMexicoSouth Korea
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Frequently asked questions about arzoxifene

What is arzoxifene?

Arzoxifene is an investigational small molecule developed by Eli Lilly and Company. It has been studied in women for osteoporosis, postmenopausal bone loss, and postmenopausal osteoporosis, and it has also been explored in endometrial and ovarian cancer research. It is not an approved medicine and remains in clinical development.

What is arzoxifene used for?

Arzoxifene has been studied for osteoporosis and postmenopausal bone loss, and for postmenopausal osteoporosis. Research has also examined it in endometrial cancer and ovarian cancer. These uses are investigational, meaning arzoxifene is not approved for any indication and remains in clinical development.

What does arzoxifene target?

Arzoxifene targets the estrogen receptors ESR2 and ESR1. It is classified as a modulator, meaning it interacts with these receptors rather than simply blocking or activating them. This receptor activity is the basis for its study in bone loss and in hormone related cancers.

Who makes arzoxifene?

Arzoxifene is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor behind the clinical research program for the drug.

What phase is arzoxifene in?

Arzoxifene is in Phase 2 development and is not FDA approved. It is an investigational small molecule, and no active trials are currently listed. Completed studies include Phase 2 and Phase 3 trials, so the asset has not advanced to regulatory approval.

What clinical trials is arzoxifene in?

Arzoxifene has been studied in completed trials including NCT00767299 in Korean women with osteoporosis, NCT00383422 comparing it with raloxifene in postmenopausal osteoporosis, NCT00088010 on bone fractures and breast cancer incidence, and NCT00085956 on bone mass and the uterus.

Is arzoxifene the same as arzoxifene hydrochloride?

Yes. Arzoxifene hydrochloride is another name for arzoxifene, the same investigational small molecule developed by Eli Lilly and Company. Searches for either name refer to the same drug asset and the same clinical research program.