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Drug

Ibandronic acid

Approved · EMA
Late-stage development

Also known as Boniva, ácido ibandrónico.

RxNorm115265
6
Regulatory events
Latest activity
beta

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

Market withdrawal: Ibandronic Acid Sandoz (EMA)

Regulatory2024-01-09EMA

A Single--blind, Randomized, Placebo--controlled Phase II Study to Evaluate the Impact of Oral Bisphosphonate Treatment on Bone Mineral Density in Osteopenic Women Receiving Adjuvant Aromatase Inhibitors - BONADIUV Trial

Clinical trial2016-05-01Completed · ClinicalTrials.gov

Approval: Ibandronic acid Accord (EMA)

Regulatory2012-11-18EMA

Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis - Comparative Study With Sodium Risedronate Hydrate(RIS) With Vertebral Fracture as an Index -

Clinical trial2011-12-01Completed · ClinicalTrials.gov

Approval: Iasibon (EMA)

Regulatory2011-01-21EMA

Approval: Ibandronic Acid Teva (EMA)

Regulatory2010-09-17EMA

Phase II Open Label Study to Establish the Safety and Efficacy of Intravenous Loading Dose of Ibandronate 6 mg in 3 Consecutive Days in Breast Cancer Patients With Skeletal Metastases

Clinical trial2006-12-04Status unknown · ClinicalTrials.gov

Approval: Bonviva (EMA)

Regulatory2004-02-23EMA

Approval: Bondronat (EMA)

Regulatory1996-06-25EMA

Profile

Identifiers & mechanism

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

Canonical name
Ibandronic acid
Aliases & brands
Bonivaácido ibandrónico
RxNorm CUI
115265
Regulatory jurisdictions
ema

Regulatory timeline

6 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
1996-06-25
Latest approval
2012-11-18
Authorities
EMA
Total events
6
emaEuropean Medicines Agency· 6 events
2024-01-09Market withdrawalMarket
Market withdrawal: Ibandronic Acid Sandoz (EMA)
Indication: Ibandronic acid Sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast… Show full indication

Ibandronic acid Sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Evidence ↗
2012-11-18Approval
Approval: Ibandronic acid Accord (EMA)
Indication: Ibandronic acid is indicated in adults for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast… Show full indication

Ibandronic acid is indicated in adults for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour induced hypercalcaemia with or without metastases. Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

Evidence ↗
2011-01-21Approval
Approval: Iasibon (EMA)
Indication: Concentrate for solution for infusion Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer… Show full indication

Concentrate for solution for infusion Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour-induced hypercalcaemia with or without metastases. Film-coated Tablets Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Evidence ↗

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

Clinical trials

3 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
3
registered trials across all phases
LATEST COMPLETION 2016
1
Late-stage (III+)
2
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 3
Phase 22Phase 31

Late-stage studies

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

Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis - Comparative Study With Sodium Risedronate Hydrate(RIS) With Vertebral Fracture as an Index -

CompletedPH IIIKey trialChugai Pharmaceuticaln=1,2652011
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.