Evista

(Raloxifene)

ApprovedSmall molecule

Raloxifene is used to prevent and treat osteoporosis in postmenopausal women, and it also reduces the risk of breast cancer in women at high risk for the disease.[2] Evista is currently approved and in use across 17 indications[4].[1]

Evista is one of 539 small molecule programs targeting Osteopenia. It is currently in Approved.

Indications

Total Trials

Active Trials

538

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

OsteopeniaApproved

Esophageal CancerActive, not recruiting

Benign Prostatic HyperplasiaActive, not recruiting

Schizoaffective DisorderActive, not recruiting

Severe Acute Respiratory SyndromeApproved

Alzheimer DiseaseApproved

CognitionActive, not recruiting

Postmenopausal OsteoporosisActive, not recruiting

Polycystic Ovary SyndromeApproved

Breast CancerActive, not recruiting

OsteopeniaApproved

Approved

Esophageal CancerPreclinical

Active, not recruiting

Benign Prostatic HyperplasiaPhase 2

Active, not recruiting

Schizoaffective DisorderPhase 3

Active, not recruiting

Severe Acute Respiratory SyndromeApproved

Approved

Alzheimer DiseaseApproved

Approved

CognitionPhase 3

Active, not recruiting

Postmenopausal OsteoporosisApproved

Active, not recruiting

Polycystic Ovary SyndromeApproved

Approved

Breast CancerPhase 3

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Evista

Eli Lilly

Approved

5 2

Avastin

BBio-Thera Solutions

Preclinical

153 3

Gemzar

GGynecologic Oncology Group

Preclinical

22 4

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 5

Voltaren

Novartis

Preclinical

1 6

Zolymbus

AbbVie

Preclinical

1 7

Lexiscan

Astellas

Preclinical

1 8

Adenocard

Astellas

Preclinical

1 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 10

Tricor

JJagotec

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2030

Phase 2Recruiting

Benign Prostatic Hyperplasia

NCT06944145

Q1 2031

Phase 2Not yet recruiting

Radiation Therapy

NCT07470606

Clinical

Trials by Indication[1]

Osteoporosis7 trials

Enhancing Osteoporosis Therapy: Can We Open the Anabolic Window?

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT01166958·26 enrolled

Effects of Teriparatide in Postmenopausal Women With Osteoporosis

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00079924·200 enrolled

Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00383422·320 enrolled

Show 4 more trials

Osteoporosis Treatment in Post-menopausal Women

Unknown status·TTaichung Veterans General Hospital·Phase 4·NCT03006003·500 enrolled

3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women

Completed· Bayer logo

Bayer·Phase 3·NCT00310531·500 enrolled

Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00046137

The Effects of Seasonal Changes in Osteoporosis Treatment

Unknown status·TToshihiko Kono··NCT02977949·200 enrolled

Breast Cancer5 trials

Raloxifene and Goserelin in Preventing Breast Cancer in Women With a Family History of Breast Cancer

Completed·IInstitute of Cancer Research, United Kingdom·N/A·NCT00031850·150 enrolled

Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer

Completed·OOHSU Knight Cancer Institute·N/A·NCT00031811·80 enrolled

Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women

Completed·NNSABP Foundation Inc·Phase 3·NCT00003906·19,747 enrolled

Show 2 more trials

Raloxifene in Preventing Breast Cancer in Premenopausal Women

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00019500

Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention

Completed·MMilton S. Hershey Medical Center·N/A·NCT00723398·266 enrolled

Schizophrenia4 trials

Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder

Completed·IIris Sommer·Phase 3·NCT03043820·110 enrolled

The Use of Selective Estrogen Receptor Modulators in the Treatment of Schizophrenia- a Pilot Study

Completed·TThe Alfred·Phase 2·NCT00206557·60 enrolled

Double Blind, Placebo-controlled Study of Raloxifene for Negative Symptoms of Schizophrenia in Postmenopausal Women

Completed·FFundació Sant Joan de Déu·Phase 4·NCT01041092·34 enrolled

Show 1 more trial

Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women

Completed·FFundació Sant Joan de Déu·Phase 3·NCT01573637·78 enrolled

Polycystic Ovarian Syndrome2 trials

Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome

Terminated·BBruce Lessey·N/A·NCT01607320·3 enrolled

Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome

Completed·HHospital de Clinicas de Porto Alegre·Phase 3·NCT00427700·82 enrolled

Estrogen2 trials

Estrogen Alternatives Study

Completed·UUS Department of Veterans Affairs·Phase 4·NCT00108238

AFTER: Altering Fat Through Estrogen and Raloxifene

Completed·NNational Institute on Aging (NIA)·Phase 2·NCT00149604·108 enrolled

29 more indications

Alzheimer's Disease2 trials

Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

Completed·UUniversity of Wisconsin, Madison·Phase 2/3·NCT00065767·20 enrolled

Raloxifene for Women With Alzheimer's Disease

Completed·SStanford University·Phase 2·NCT00368459·42 enrolled

Tics2 trials

DP-R213 Pharmacokinetics Study

Completed·AAlvogen Korea·Phase 1·NCT02762643·61 enrolled

Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

Completed·AAddpharma Inc.·Phase 1·NCT03764462·52 enrolled

Postmenopausal Osteoporosis2 trials

Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

Completed·UUniversity of Valencia·Phase 4·NCT01544894·80 enrolled

2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or Calcium/Vit D in Severe Postmenopausal Osteoporosis

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00191425·810 enrolled

Esophageal Cancer1 trial

Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)

Completed·OOrganon and Co··NCT01077817·684,815 enrolled

Endometriosis1 trial

The Safety and Effectiveness of Surgery With or Without Raloxifene for the Treatment of Pelvic Pain Caused by Endometriosis

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2·NCT00001848·612 enrolled

Interaction1 trial

A Drug-drug Interaction Study of DP-R213

Completed·AAlvogen Korea·Phase 1·NCT02654093·24 enrolled

COVID-191 trial

Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients.

Completed·DDompé Farmaceutici S.p.A·Phase 2/3·NCT05172050·61 enrolled

Benign Prostatic Hyperplasia1 trial

New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia

Recruiting·—·Phase 2·NCT06944145·242 enrolled

Hot flashes1 trial

Study of Hot Flashes and Night Sweats in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00332553·150 enrolled

Postmenopausal Women1 trial

Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women

Completed· Pfizer logo

Pfizer·Phase 3·NCT00675688·3,544 enrolled

Hormone Replacement Therapy1 trial

Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation

Terminated· Sanofi logo

Sanofi·Phase 4·NCT00790101·6 enrolled

Phase 11 trial

DP-R213 Phase 1 Pharmacokinetics Study

Completed·AAlvogen Korea·Phase 1·NCT03010267·46 enrolled

CAR1 trial

Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene or Placebo

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00532246·147 enrolled

Prostate Cancer1 trial

Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer

Completed·MMayo Clinic·Phase 1·NCT01050842·18 enrolled

Cognition1 trial

Cognition in the Study of Tamoxifen and Raloxifene

Completed·WWake Forest University·Phase 3·NCT00687102·1,498 enrolled

Fracture1 trial

Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data

Completed·—··NCT04736693·18,028 enrolled

Endometrial Cancer1 trial

Raloxifene in Treating Patients With Persistent or Recurrent Endometrial Cancer

Completed·NNorthwestern University·Phase 2·NCT00004915

Menopause1 trial

Raloxifene and Rimostil for Perimenopause-Related Depression

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00030147·65 enrolled

Treatment1 trial

Long Term Effects of Raloxifene Treatment on Bone Quality

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00532428·31 enrolled

Schizoaffective Disorder1 trial

Raloxifene in Treatment of Schizophrenia and Schizoaffective Disorder

Unknown status·SSheba Medical Center·Phase 3·NCT01280305·200 enrolled

Heart1 trial

Raloxifene Use for The Heart

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00190593·10,000 enrolled

Low Bone Mineral Density1 trial

Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density

Completed· Novartis logo

Novartis·Phase 4·NCT00431444·110 enrolled

Prevention1 trial

Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy

Completed·TTuen Mun Hospital·Phase 4·NCT00371956·114 enrolled

Radiation Therapy1 trial

Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the Brain

Not yet recruiting·TThe University of Texas Health Science Center at San Antonio·Phase 2·NCT07470606·108 enrolled

Efficacy1 trial

Comparative Antiresorptive Efficacy Discontinuation of Denosumab

Active, not recruiting·MMassachusetts General Hospital·Phase 4·NCT03623633·51 enrolled

Randomized1 trial

Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss

Completed·LLigand Pharmaceuticals·Phase 3·NCT00163137·540 enrolled

Observational Study1 trial

Observational Study Analyzing RNA Expression Of Endometrial Biopsy Samples From Placebo, Bazedoxifene/Conjugated Estrogens And Raloxifene

Terminated· Pfizer logo

Pfizer··NCT00847821·185 enrolled

Breast1 trial

Study Evaluating Changes In Mammographic Breast Density

Completed· Pfizer logo

Pfizer··NCT00774267·507 enrolled

Unspecified1 trial

Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)

Completed· Pfizer logo

Pfizer··NCT01416194·10,497 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 9, 1997

EVISTA

NDA NDA020815

Sources

References

[1]
ClinicalTrials.gov — 52 trial records for Raloxifene. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Evista drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Raloxifene compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Raloxifene. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020815). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Estrogen Receptor Beta Modulator; Estrogen Receptor Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Eli Lilly

Evista

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2030

Q1 2031

Trials by Indication[1]

Osteoporosis7 trials

Breast Cancer5 trials

Schizophrenia4 trials

Polycystic Ovarian Syndrome2 trials

Estrogen2 trials

Alzheimer's Disease2 trials

Tics2 trials

Postmenopausal Osteoporosis2 trials

Esophageal Cancer1 trial

Endometriosis1 trial

Interaction1 trial

COVID-191 trial

Benign Prostatic Hyperplasia1 trial

Hot flashes1 trial

Postmenopausal Women1 trial

Hormone Replacement Therapy1 trial

Phase 11 trial

CAR1 trial

Prostate Cancer1 trial

Cognition1 trial

Fracture1 trial

Endometrial Cancer1 trial

Menopause1 trial

Treatment1 trial

Schizoaffective Disorder1 trial

Heart1 trial

Low Bone Mineral Density1 trial

Prevention1 trial

Radiation Therapy1 trial

Efficacy1 trial

Randomized1 trial

Observational Study1 trial

Breast1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News