Actonel
(Risedronate)ApprovedSmall molecule
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 6 indications[4].[1]
Actonel is one of 142 small molecule programs targeting Bariatric Surgery. It is currently in Approved.
6
Indications
61
Total Trials
2
Active Trials
141
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
3
Patents
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
99 competitors in Esophageal Cancer
#DrugCompanyPhaseTrials
1Taxol
TevaPhase 3
Eloxatin
TevaPhase 3
Platinol
MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Phase 3
Opdivo
Bristol-Myers SquibbPhase 3
Paraplatin
AAvyxa
Phase 3
Keytruda
Merck & Co.Phase 3
Actonel
VVitae Pharmaceuticals Inc., an Allergan affiliate
Approved
Taxotere
AAvyxa
Phase 3
Xeloda
EEngelhard Arzneimittel GmbH & Co.KG
Phase 3
Herceptin
OOrganon and Co
Phase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Osteoporosis16 trials
Show 13 more trials
Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis
Completed·—·Phase 3·NCT01611571·31 enrolled
Replication of the VERO Osteoporosis Trial in Healthcare Claims Data
Completed·—··NCT04879420·12,757 enrolled
Treatment5 trials
Postmenopausal Women3 trials
Efficacy3 trials
25 more indications
Hip Fracture2 trials
Prostate Cancer2 trials
Paget's Disease of Bone2 trials
ESS2 trials
Spinal Cord Injury2 trials
Prevention2 trials
Antiepileptic Drugs and Osteoporotic Prevention Trial
Completed·—·Phase 4·NCT00869622·80 enrolled
Hormone Replacement Therapy1 trial
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
Total Hip Arthroplasty1 trial
Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty
Completed·—·Phase 4·NCT00772395·78 enrolled
Postmenopausal Osteoporosis1 trial
Oral1 trial
Renal Transplant Recipients1 trial
Esophageal Cancer1 trial
Low Bone Mineral Density1 trial
Arthroplasty1 trial
Lung Neoplasm1 trial
Regulatory
FDA Approval Timeline[5]
Apr 14, 2000
ACTONEL
NDA NDA020835
Oct 8, 2010
ATELVIA
NDA NDA022560
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Actonel drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Risedronate. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]