IBANDRONATE SODIUM

Post-LOE

ibandronate sodium

Entera Bio

ANDAINTRAVENOUSINJECTABLE

Approved

Oct 2015

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

IBANDRONATE SODIUM (ibandronate sodium) by Entera Bio is hydroxyapatite, which is part of the mineral matrix of bone. Approved for osteoporosis in postmenopausal women. First approved in 2015.

Drug data last refreshed 20h ago

Mechanism of Action

hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.

Indications (1)

osteoporosis in postmenopausal women

Clinical Trials (1)

NCT01627886Phase 1Completed

Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition

Started Sep 2008

100 enrolled

Healthy

Company

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.