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Actonel

(Risedronate)

ApprovedSmall molecule

VVitae Pharmaceuticals Inc., an Allergan affiliate

Risedronate is a medication that strengthens bones by slowing down bone loss and increasing bone density. It's used to prevent and treat osteoporosis (weak, brittle bones), particularly in postmenopausal women, and to treat Paget's disease of bone, a condition where bones become soft and deformed.[2] Actonel is currently approved and in use across 13 indications[4].[1]

Actonel is one of 337 small molecule programs targeting Hip Fracture. It is currently in Approved.

13

Indications

61

Total Trials

2

Active Trials

336

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

3

Patents

Pipeline

Status by Indication[4][1]

Indication

Hip FractureActive, not recruiting

Bone DensityActive, not recruiting

Esophageal CancerActive, not recruiting

Anorexia NervosaActive, not recruiting

Hearing LossActive, not recruiting

Postmenopausal OsteoporosisActive, not recruiting

Metastatic Prostate CancerActive, not recruiting

Total Hip ArthroplastyActive, not recruiting

Fibrous DysplasiaActive, not recruiting

Breast CancerActive, not recruiting

Hip FractureApproved

Active, not recruiting

Bone DensityPhase 2

Active, not recruiting

Esophageal CancerPreclinical

Active, not recruiting

Anorexia NervosaPreclinical

Active, not recruiting

Hearing LossApproved

Active, not recruiting

Postmenopausal OsteoporosisPhase 3

Active, not recruiting

Metastatic Prostate CancerPhase 3

Active, not recruiting

Total Hip ArthroplastyApproved

Active, not recruiting

Fibrous DysplasiaPhase 2/Phase 3

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Actonel

VVitae Pharmaceuticals Inc., an Allergan affiliate

Tecentriq

Avastin

BBio-Thera Solutions

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Megace

Bristol-Myers Squibb

MS Contin

Voltaren

Zolymbus

Lupron

EEastern Cooperative Oncology Group

MS Contin

HHikma Pharmaceuticals LLC

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

Timeline

Expected Milestones

Q2 2028

Phase 3Recruiting

Bariatric Surgery

NCT04922333

Clinical

Trials by Indication[1]

Osteoporosis16 trials

A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

Completed·WWarner Chilcott·Phase 3·NCT00541658·923 enrolled

Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis

Completed·HHanlim Pharm. Co., Ltd.·Phase 4·NCT01675297·1,053 enrolled

Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use

Completed·UUniversity of California, Davis·Phase 4·NCT00221299·60 enrolled

Show 13 more trials

Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis

Completed·—·Phase 3·NCT01611571·31 enrolled

Post-menopausal Women Osteoporosis(Phase III)

Completed·HHanlim Pharm. Co., Ltd.·Phase 3·NCT01806792·150 enrolled

Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00503399·92 enrolled

Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00343252·712 enrolled

A Study of Monthly Risedronate for Osteoporosis

Completed·WWarner Chilcott·Phase 3·NCT00247273·1,294 enrolled

Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)

Completed· Takeda logo

Takeda·Phase 3·NCT00365456·407 enrolled

Heartland Osteoporosis Prevention Study

Completed·UUniversity of Nebraska·Phase 3·NCT02186600·276 enrolled

A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

Completed· Roche logo

Roche·Phase 4·NCT00377234·356 enrolled

Replication of the VERO Osteoporosis Trial in Healthcare Claims Data

Completed·—··NCT04879420·12,757 enrolled

Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis

Completed·WWarner Chilcott·Phase 3·NCT00619957·285 enrolled

Risedronate in the Prevention of Osteoporosis in Postmenopausal Women

Completed· Sanofi logo

Sanofi·Phase 4·NCT00402441·260 enrolled

Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

Completed· Sanofi logo

Sanofi·Phase 3·NCT00353080·171 enrolled

Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women

Completed· Sanofi logo

Sanofi·Phase 3·NCT00358176·1,231 enrolled

Treatment5 trials

Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO

Completed·WWarner Chilcott·Phase 3·NCT00577421·32 enrolled

Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients

Completed·HHospital Regional 1o de Octubre·N/A·NCT05346419·33 enrolled

VERtebral Fracture Treatment Comparisons in Osteoporotic Women

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT01709110·1,366 enrolled

Show 2 more trials

Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover

Completed·WWarner Chilcott·Phase 3·NCT01249261·61 enrolled

IMPACT Study (Improving Measurements of Persistence on "ACtonel" Treatment)

Completed· Sanofi logo

Sanofi·Phase 3·NCT00268632

Postmenopausal Women3 trials

Risedronate in Osteopenic Postmenopausal Women

Completed· Sanofi logo

Sanofi·Phase 3·NCT00345644·156 enrolled

Bone Microarchitecture in Osteopenic Postmenopausal Women

Terminated·WWarner Chilcott·Phase 4·NCT00577395·13 enrolled

Effect of Actonel on Periodontal Health of Postmenopausal Women

Withdrawn·UUniversity Hospitals Cleveland Medical Center·Phase 4·NCT00594334

Efficacy3 trials

Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate

Completed·WWarner Chilcott·Phase 2·NCT00577720·181 enrolled

Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD

Completed·WWarner Chilcott·Phase 2·NCT00577837·370 enrolled

Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis

Terminated·UUniversity Hospital, Limoges·Phase 3·NCT02744482·3 enrolled

Spinal Cord Injury2 trials

Risedronate for the Treatment of Osteoporosis for People With Spinal Cord Injury

Completed·TToronto Rehabilitation Institute·Phase 3·NCT00138866·46 enrolled

Risedronate for the Prevention of Osteoporosis in People With Spinal Cord Injury.

Completed·TToronto Rehabilitation Institute·Phase 3·NCT00150696·38 enrolled

25 more indications

Prevention2 trials

Antiepileptic Drugs and Osteoporotic Prevention Trial

Completed·—·Phase 4·NCT00869622·80 enrolled

The Efficacy of Risedronate in Prevention of Bone Loss in Patients Receiving High Dose Corticosteroid Treatment

Completed·TTuen Mun Hospital·Phase 4·NCT00372372·120 enrolled

Breast Cancer2 trials

Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy

Completed·SSusan L. Greenspan·Phase 4·NCT00485953·109 enrolled

Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer

Completed·HHospices Civils de Lyon·Phase 3·NCT00859703·20 enrolled

ESS2 trials

Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects

Completed·WWarner Chilcott·Phase 1·NCT00699777·96 enrolled

Assess the Influence of a High-fat Meal on the Relative Bioavailability Of Two Formulations of Risedronate

Completed·WWarner Chilcott·Phase 1·NCT00755872·76 enrolled

Prostate Cancer2 trials

Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer

Completed·UUConn Health·Phase 4·NCT00859027·50 enrolled

Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer

Completed·CCMX Research·Phase 3·NCT00426777·160 enrolled

Hip Fracture2 trials

Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

Completed·KKarolinska Institutet·N/A·NCT01950169·79 enrolled

A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00887354·224 enrolled

Paget's Disease of Bone2 trials

Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

Completed· Novartis logo

Novartis·Phase 3·NCT00051636·172 enrolled

Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

Completed· Novartis logo

Novartis·Phase 3·NCT00103740·185 enrolled

Renal Transplant Recipients1 trial

Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients.

Completed·MMontefiore Medical Center·Phase 1/2·NCT00266708·60 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

Age1 trial

Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

Completed·WWarner Chilcott·Phase 1·NCT00717145·94 enrolled

Oral1 trial

Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose

Completed·WWarner Chilcott·Phase 1·NCT00577850·32 enrolled

TIA1 trial

Bisphosphonate Action on the Appendicular Skeleton: Evidence for Differential Effects

Completed·SSheffield Teaching Hospitals NHS Foundation Trust·Phase 2·NCT00666627·410 enrolled

Bariatric Surgery1 trial

Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

Recruiting·WWake Forest University Health Sciences·Phase 3·NCT04922333·200 enrolled

Bone Density1 trial

Risedronate in Postmenopausal Women With Low Bone Density

Completed· Sanofi logo

Sanofi·Phase 2·NCT00351091·150 enrolled

Anorexia Nervosa1 trial

IGF-1 and Bone Loss in Women With Anorexia Nervosa

Completed·MMassachusetts General Hospital·N/A·NCT01406444·148 enrolled

Metastatic Prostate Cancer1 trial

Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy

Terminated·—·Phase 3·NCT00216060·63 enrolled

Fibrous Dysplasia1 trial

Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

Completed·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 2/3·NCT00445575·80 enrolled

Hormone Replacement Therapy1 trial

Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation

Terminated· Sanofi logo

Sanofi·Phase 4·NCT00790101·6 enrolled

Low Bone Mineral Density1 trial

Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease

Completed·UUniversity of Alberta·Phase 4·NCT01215890

Arthroplasty1 trial

Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty

Unknown status·MMahidol University·Phase 4·NCT02148848·86 enrolled

Tumors1 trial

Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT

Completed·WWake Forest University Health Sciences·Phase 2·NCT03861091·84 enrolled

Satisfaction1 trial

ROSPA - Record on Satisfaction of Patients With Actonel 35 mg Once a Week

Terminated· Sanofi logo

Sanofi·Phase 4·NCT00544180·7 enrolled

Total Hip Arthroplasty1 trial

Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty

Completed·—·Phase 4·NCT00772395·78 enrolled

Postmenopausal Osteoporosis1 trial

A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)

Completed·OOrganon and Co·Phase 3·NCT00092014·1,053 enrolled

Hearing Loss1 trial

Effects of Bisphosphonates on OI-Related Hearing Loss

Recruiting·HHospital for Special Surgery, New York·Phase 4·NCT04152551·100 enrolled

Unspecified2 trials

Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate

Completed·WWarner Chilcott··NCT00837746·29 enrolled

Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method

Completed·WWarner Chilcott·Phase 3·NCT00386360·161 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 14, 2000

ACTONEL

NDA NDA020835

Oct 8, 2010

ATELVIA

NDA NDA022560

Sources

References

[1]
ClinicalTrials.gov — 61 trial records for Risedronate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Actonel drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Risedronate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Risedronate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022560). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Actonel. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Vitae Pharmaceuticals Inc., an Allergan affiliate company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: VVitae Pharmaceuticals Inc., an Allergan affiliate

Patent Landscape[6]

Patent Cliff

Jan 9, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8246989Jan 16, 2026

7645460Jan 9, 2028

7645459Jan 9, 2028

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