TheraRadar
Data updated: May 26, 2026

RECLAST (zoledronic acid)

Trial Activity: Declining 10 active trials
Musculoskeletal Approved 2007-04-16

RECLAST is indicated for the treatment of Postmenopausal Osteoporosis; Osteoporosis; Glucocorticoid-Induced Osteoporosis; Paget's Disease of Bone.

Source: FDA Label • Novartis
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How RECLAST Works

Zoledronic acid is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. It exhibits a high affinity for mineralized bone, localizing preferentially at sites of high bone turnover. The primary molecular target within the osteoclast is the enzyme farnesyl pyrophosphate (FPP) synthase. By inhibiting FPP synthase, zoledronic acid disrupts the mevalonate pathway, preventing the prenylation of small GTP-binding proteins essential for osteoclast function and survival. Its long duration of action is attributed to its high binding affinity to the bone mineral matrix.

Source: FDA Label

Development Insights

Novartis Pharmaceuticals conducting 9 trials (11%)
112 indications explored (Broad Platform)
→ osteoporosis (14 trials)
→ multiple myeloma (5 trials)
→ breast cancer (5 trials)
6
Indications
--
Phase 3 Trials
1
Priority Reviews
19
Years on Market

Details

Status
Prescription
First Approved
2007-04-16
Patent Cliff
2028

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAVENOUS, INJECTION
Dosage Forms
INJECTABLE

Companies

Novartis
Active Ingredient: ZOLEDRONIC ACID

RECLAST Approval History

2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
22 FDA actions from 2007 to 2026 · 4 indication expansions
Feb 2026 SUPPL
Label · Labeling
FDA Letter Label
Apr 2020 SUPPL
Label · Labeling
FDA Letter Label
Jul 2017 SUPPL
Label · Labeling
FDA Letter Label

What RECLAST Treats

4 indications

RECLAST is approved for 4 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Postmenopausal Osteoporosis
  • Osteoporosis
  • Glucocorticoid-Induced Osteoporosis
  • Paget's Disease of Bone
Source: FDA Label

RECLAST Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

BONCRESA
AMNEAL PHARMS
2025 3 indic.
CONJUGATED ESTROGENS
NOVAST LABS
2025 6 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to RECLAST

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALENDRONATE SODIUM
ALENDRONATE SODIUM
3 shared
WATSON LABS
Shared indications:
Postmenopausal osteoporosisGlucocorticoid-induced osteoporosisPaget's disease of bone
BILDYOS
DENOSUMAB-NXXP
2 shared
SHANGHAI HENLIUS BIOTECH
Shared indications:
OsteoporosisGlucocorticoid-Induced Osteoporosis
BONCRESA
DENOSUMAB-MOBZ
2 shared
AMNEAL PHARMS LLC
Shared indications:
OsteoporosisGlucocorticoid-Induced Osteoporosis
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Clinical Trial Registry

80 trials
Trial Sponsor ID Phase Status Title
NCT06533865 2024P000273 Ph 3 recruiting Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea
NCT03295981 28229 Ph 3 recruiting Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
NCT06374459 202406065 BC200714 Ph 1, Ph 2 recruiting Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis
NCT07471516 IIT2025152 Ph 1, Ph 2 recruiting Zoledronic Acid Treatment in Patients With Congenital Dyserythropoietic Anemia
NCT06625190 UF-PED-006 IRB202500132 Ph 1, Ph 2 recruiting Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors
NCT05058976 RUBI STUDY20060028 5R01AG066825-02 Ph 4 active not recruiting Romosozumab Use to Build Skeletal Integrity
NCT06135298 2023/1702 Ph 4 completed FARE Augmentation of Proximal Femoral Fractures With CaS/HA and Systemic ZA
NCT05666310 MITO STUDY22080139 P30AG024827 Ph 4 active not recruiting Muscle Impact of Treating Osteoporosis
NCT02325414 results posted STU00098239 CDMRP-130125 Ph 2 completed Prevention of Bone Loss After Acute SCI by Zoledronic Acid
NCT03173976 201610743 Ph 1 active not recruiting Anti-Osteoclast Therapy as Neoadjuvant in Treatment of Chondrosarcoma - Phase 1b Trial
NCT04087096 results posted 20187525 20187525 Ph 4 completed Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
NCT03735537 TOPaZ AC16092 2016-003228-22 Ph 4 completed Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid
NCT03073785 0552-16-FB NCI-2016-01360, P30CA036727 Ph 2 active not recruiting Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer
NCT01671774 PILOT GM-IMAB-001-04 2011-005509-64 Ph 1 completed Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer
NCT03336983 BonEnza ASCB-ONCO-2336-2017 2017-000305-21 Ph 2 completed Luteinizing Hormone-releasing Hormone Analogue and Enzalutamide +/- Zoledronic Acid in Prostate Cancer Patients
NCT03396315 results posted AAAR5220 Ph 2 completed Bisphosphonates for Prevention of Post-Denosumab Bone Loss
NCT03868033 DST 201811067MIPC Ph 4 completed Denosumab Sequential Therapy
NCT06221072 JMT103-012 Ph 3 not yet recruiting A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid
NCT03862833 HILDEGAZ RC18_0419 Ph 1 completed Zoledronic Acid in Combination With Interleukin-2 to Expand Vγ9Vδ2 T Cells After T-replete Haplo-identical Allotransplant
NCT02589600 ZEST II results posted STUDY19040149 (ZEST II) 1R01AG050302-01A1 Ph 4 completed Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)
NCT01642901 results posted 11F.612 Ph 3 completed Zoledronic Acid in Acute Spinal Cord Injury
NCT00885326 CDR0000638257 P01CA081403 Ph 1 completed N2007-02:Bevacizumab,Cyclophosphamide,& Zoledronic Acid in Patients W/ Recurrent or Refractory High-Risk Neuroblastoma
NCT02286830 Magnolia NMSG 22/14 2014-001121-32 Ph 4 completed Prolonged Protection From Bone Disease in Multiple Myeloma
NCT01345019 results posted 20090482 2010-020454-34 Ph 3 completed Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
NCT00896532 results posted 20060326 2008-005991-28 Ph 2 completed Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density
NCT01951586 results posted 20120249 2013-001662-42 Ph 2 completed Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer
NCT01679080 TreatOI Ph 2 terminated The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
NCT00740129 results posted CZOL446K2418 2008-002898-12 Ph 4 completed Re-treatment of Participants With Paget's Disease Using Zoledronic Acid
NCT03424239 results posted 2017P002081 Ph 4 completed Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery
NCT03087851 ZOLARMAB results posted 2015-005529-37 Ph 4 completed Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis
NCT02176382 DATA-HD results posted 2014P000853 Ph 4 completed Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
NCT00799266 results posted CZOL446H2337 2008-001252-52 Ph 3 completed An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
NCT02632916 DZA9DEC2015 Ph 2 completed Denosumab for the Treatment of Osteoporosis in Children: A Pilot Study
NCT01087008 AZABACHE AZABACHE: 2009-017440-13 Ph 4 completed Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse
NCT01732770 results posted 20110153 2012-001821-28 Ph 4 completed Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
NCT00795483 VIH-ZOL Ph 4 completed Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort
NCT01099436 NEO-ZOTAC BOOG-2010-01 CDR0000669246, BOOG-NEO-ZOTAC Ph 3 completed Neo-Adjuvant Chemotherapy (TAC) With or Without Zoledronic Acid in Treating HER2-negative Breast Cancer Patients
NCT00987636 EWING2008 108128 2008-003658-13 Ph 3 completed Study in Localized and Disseminated Ewing Sarcoma
NCT01197300 results posted CZOL446H2337E1 2010-020399-41 Ph 3 completed 1 Year Open-label Extension to CZOL446H2337 Safety and Efficacy Trial of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
NCT03289338 ZoleMethCNO Ph 2, Ph 3 completed Zoledronic Acid or Methylprednisolone for Active Charcot's Neuroarthropathy of Foot in Patients With Diabetes Mellitus
NCT01006395 MG2009_01 Ph 2, Ph 3 completed Prevention of Micro-architectural Bone Decay in Males With Non-metastatic Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)
NCT00879034 results posted 09-02-0074 P06087 Ph 2 completed A Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria
NCT02499237 AfterDmab AfterDmab Ph 4 completed Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation
NCT02123264 AZAR CGV222 Ph 3 terminated Zoledronic Acid in Rheumatoid Arthritis
NCT00869206 results posted CALGB-70604 CDR0000637947, NCI-2009-01102 Ph 3 completed Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
NCT01194440 results posted J1022 SKCCC J1022 Ph 2 completed Zoledronic Acid in Aromatase Inhibitor Induced Musculoskeletal Symptoms
NCT02632903 ZA8DEC2015 Ph 2 withdrawn Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
NCT00807963 HZ2-08-02 Ph 1 completed Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone
NCT01228318 BLIR-HIV results posted IRB00038739 BLIR-HIV Ph 2 completed Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV)
NCT01802658 DBMZol BRD/11/06-P 2012-001778-27 Ph 3 terminated Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled (DBMZol)

Showing 50 of 80 trials

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Key Completed Trials

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

RECLAST FDA Label Details

Indications & Usage

FDA Label (PDF)

RECLAST is indicated for the treatment of Postmenopausal Osteoporosis; Osteoporosis; Glucocorticoid-Induced Osteoporosis; Paget's Disease of Bone.

View full patent landscape →
2 OB patents · 1 families · 32 international docs across 23 countries

RECLAST Patents & Exclusivity

Latest Patent: Aug 2028

Patents (2 active)

US7932241*PED Expires Aug 5, 2028
US7932241 Expires Feb 5, 2028
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for RECLAST

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2028
  • • 2 active patents

Trial Analysis

  • • 81 total trials
  • • Stage: Declining

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA021817 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment