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Drug

Zoledronic acid

Approved · EMA
ClassFarnesyl diphosphate synthase inhibitorEmerging researchLate-stage developmentRising momentum
Also known as (1-hydroxy-2-(1H-imidazol-1-yl)ethylidene)bisphosphonic acid, (1-hydroxy-2-imidazol-1-ylethylidene)diphosphonic acid, Reclast, Zometa+1 more

(1-hydroxy-2-(1H-imidazol-1-yl)ethylidene)bisphosphonic acid, (1-hydroxy-2-imidazol-1-ylethylidene)diphosphonic acid, Reclast, Zometa, ácido zoledrónico.

7
Research papers
12
Active clinical trials
Farnesyl pyrophosphate synthase
Primary target
8
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Program of Continuous Passive Motion Exercises Against Heterotopic Ossification

Clinical trial2026-04-25Primary completion · ClinicalTrials.gov

Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis: A 2-Year Randomized Study.

Research2021-04-20Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research

A Single-dose Zoledronic Acid Infusion Prevents Antiretroviral Therapy-induced Bone Loss in Treatment-naive HIV-infected Patients: A Phase IIb Trial.

Research2016-05-18Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Bone Marker-Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Multiple Myeloma: Results of the Z-MARK Study.

Research2015-12-07Clinical cancer research : an official journal of the American Association for Cancer Research

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Zoledronic acid
Aliases & brands
(1-hydroxy-2-(1H-imidazol-1-yl)ethylidene)bisphosphonic acid(1-hydroxy-2-imidazol-1-ylethylidene)diphosphonic acidReclastZometaácido zoledrónico
RxNorm CUI
77655
ChEMBL ID
CHEMBL4303669
ATC codes
M05BA08
UNII
6XC1PAD3KF
Primary mechanism
Farnesyl diphosphate synthase inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORFarnesyl diphosphate synthase inhibitor

Regulatory timeline

8 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2001-03-20
Latest approval
2014-01-16
Authorities
EMA
Total events
8
emaEuropean Medicines Agency· 8 events
2026-03-13Market withdrawalMarket
Market withdrawal: Zoledronic acid medac (EMA)
Indication: Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advancedShow full indication

Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH).

Evidence ↗
2024-03-01Market withdrawalMarket
Market withdrawal: Zoledronic acid Actavis (EMA)
Indication: Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advancedShow full indication

Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia.

Evidence ↗
2024-02-22Market withdrawalMarket
Market withdrawal: Zoledronic Acid Hospira (EMA)
Indication: 4 mg / 5 ml and 4 mg / 100 ml: Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia)Show full indication

4 mg / 5 ml and 4 mg / 100 ml: Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH). 5 mg / 100 ml: Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: in post-menopausal women; in men; at increased risk of fracture. Treatment of Paget's disease of the bone in adults.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

192 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
192
registered trials across all phases
LATEST COMPLETION 2026
12
Active studies
6
Recruiting
135
Late-stage (III+)
130
Completed
50
Discontinued
PHASE DISTRIBUTIONn = 192
Phase 111Phase 1 / 25Phase 241Phase 2 / 310Phase 365Phase 447Phase N / A13

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

7 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20022021
Most influential

Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis: A 2-Year Randomized Study.

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2021 · 69 cites

A Single-dose Zoledronic Acid Infusion Prevents Antiretroviral Therapy-induced Bone Loss in Treatment-naive HIV-infected Patients: A Phase IIb Trial.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016 · 41 cites

Bone Marker-Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Multiple Myeloma: Results of the Z-MARK Study.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2016 · 36 cites
Recent papers

Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis: A 2-Year Randomized Study.

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2021 · 69 cites

A Single-dose Zoledronic Acid Infusion Prevents Antiretroviral Therapy-induced Bone Loss in Treatment-naive HIV-infected Patients: A Phase IIb Trial.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016 · 41 cites

Bone Marker-Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Multiple Myeloma: Results of the Z-MARK Study.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2016 · 36 cites
Major research themes3
Bone Density Conservation Agents1Osteoporosis1Osteoporosis, Postmenopausal1
Journals, researchers & institutions
Top journals
  • BoneKEy reports1
  • Breast (Edinburgh, Scotland)1
  • Clinical cancer research : an official journal of the American Association for Cancer Research1
  • Clinical infectious diseases : an official publication of the Infectious Diseases Society of America1
  • Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research1
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Aftring RP1
  • Anderson KC1
  • Antunez-Flores O1
  • Argonza-Aviles E1
  • Atherton PJ1
  • Bachiller-Corral J1
  • Badros A1
  • Brown JP1
Leading institutions
free-text, unnormalised
  • Aarhus University Hospital1
  • Atlanta Department of Veterans Affairs Medical Center1
  • Cedars-Sinai Samuel Oschin Comprehensive Cancer Center1
  • Dana-Farber/Partners Cancer Care Institute1
  • Emory University School of Medicine.1
  • Hospital Ramon Y Cajal1

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.