Recent Updates
Recently added Catalysts

Raloxifene

Phase 4FDA approved 2007

Cardiovascular Diseases | Small molecule | Oncology |Eli Lilly and Company|Trials Updated: May 1, 2008

Raloxifene development status

FDA approval Sep 13, 2007 as Evista
Approval holderLilly
ApplicationNDA022042
Highest phase Phase 4 (NCT00532428)
Phase scored for LLYPhase 3
Registered trials 18 across 11 sponsors since Sep 2002

Raloxifene target and mechanism

Molecular targetESR2, ESR1
Target classModulator
ModalitySmall molecule
ChEMBLCHEMBL81

Also known as Raloxifene HCL, Evista, LY139481

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment17,855

FDA Designations

No designations recorded

Raloxifene clinical trials

Raloxifene · 3 trials · 5 indications

Phase 3 2Phase 2 1
NCT00190593Raloxifene Use for The HeartCardiovascular Diseases
COMPLETED10,000 Analytics
NCT00670319Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With OsteoporosisOsteoporosis, Postmenopausal
COMPLETED7,705 Analytics
PHASE3COMPLETED
Raloxifene Use for The Heart
Cardiovascular DiseasesUnlock trial analytics
PHASE3COMPLETED
Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis
Osteoporosis, PostmenopausalUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up.
Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.
To establish the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without prevalent vertebral fractures by spinal x-ray.
Screening, 24, 36, and 72 months
To establish the effect of long-term treatment with raloxifene, compared with placebo, on lumbar spine and femoral neck bone mineral density (BMD) in postmenopausal women with osteoporosis.
Screening, baseline, 12, 24, 36, 48, 60 and 72 months
To establish the safety of chronic administration of raloxifene in postmenopausal women with osteoporosis. Adverse events (AEs), physical exam (PE), EKG, mammograms and laboratory tests will be used to assess safety in the patients.
AEs: throughout the trial. PEs: Randomization, 12, 24, 36, 48, 60, 72 months. ECG: Randomization, 24, 48, 72 months. Mammograms: Randomization, 12, 24, 36, 48, 60, 72 months. Labs: Randomization, baseline, 6, 12, 18, 24, 30, 36, 48, 60, 72 months.
Compare the number of vasomotor symptoms at 12 weeks between those women taking the combination of raloxifene with oral estradiol versus those taking raloxifene alone.

Secondary Endpoints

After an expected 5 to 7.5 years of follow-up:
Cardiovascular death, non-fatal MI, hospitalized acute coronary syndrome other than MI, myocardial revascularization, and stroke (individually and combined)
All-cause hospitalization and mortality
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRaloxifene HCL 60 mg orally once a day
2EXPERIMENTALRaloxifene HCL 120 mg orally once a day
3PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
raloxifeneDRUG -
placeboDRUG -
Raloxifene HCLDRUGRaloxifene HCL 60 mg orally once daily
medroxyprogesterone acetateDRUG -
estrogenDRUG -
17 beta estradiolDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range55 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Postmenopausal women with established coronary heart disease or at risk for a major coronary event. Exclusion Criteria: * Postmenopausal symptoms that required estrogen replacement therapy. * Suspected or known history of breast or endometrial carcinoma. * Known or probable ...

Countries:United StatesArgentinaAustraliaAustriaBelgiumCanadaCzechiaDenmarkFinlandFranceGermanyHungaryIsraelItalyMexicoNetherlandsNew ZealandNorwayPolandSingaporeSlovakiaSloveniaSpainSwedenUnited Kingdom
Unlock Eligibility Criteria

Competitive Landscape -General Cardiovascular Diseases 67 trials (matched to "Cardiovascular Diseases")

Unlock Competitive Intelligence

Frequently asked questions about Raloxifene

What is Raloxifene used for?

Raloxifene is used to treat postmenopausal osteoporosis. It has also been studied in postmenopausal women for cardiovascular disease, vasomotor symptoms such as hot flashes and night sweats, and breast neoplasms. It is a small molecule modulator of the estrogen receptors ESR1 and ESR2.

What does Raloxifene target?

Raloxifene targets the estrogen receptors ESR1 and ESR2. It acts as a modulator of these receptors, which is why it is classified as a selective estrogen receptor modulator. This receptor activity underlies its use in postmenopausal osteoporosis and its study in cardiovascular and vasomotor conditions.

Who makes Raloxifene?

Raloxifene is developed by Eli Lilly and Company, which trades under the ticker LLY. Eli Lilly is the sponsor associated with the clinical development program for raloxifene, including the Phase 3 osteoporosis and cardiovascular outcomes trials.

What phase is Raloxifene in?

Raloxifene has been studied in Phase 3 clinical development, including a Phase 3 osteoporosis trial and a Phase 3 cardiovascular outcomes trial. It is also listed as having completed Phase 2 work in vasomotor symptoms. The completed trials include NCT00670319, NCT00332553, and NCT00190593.

What clinical trials is Raloxifene in?

Raloxifene has been studied in NCT00670319, a Phase 3 comparison of raloxifene hydrochloride and placebo in postmenopausal women with osteoporosis enrolling 7,705 participants, NCT00190593, the Phase 3 Raloxifene Use for The Heart trial enrolling 10,000 women, and NCT00332553, a Phase 2 study of hot flashes and night sweats.

Is Raloxifene the same as Raloxifene HCL?

Yes, Raloxifene HCL refers to the hydrochloride salt form of raloxifene, the same active drug. The two names are used interchangeably, and the Phase 3 osteoporosis trial NCT00670319 is titled as a comparison of raloxifene hydrochloride and placebo.