Available EU DMF/CEP
EU DMF
CEP
API Status
Commercial
Pipeline
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
Opthalmological preparations
Respiratory system
Available US DMF
US DMF
Available Japanese/Chinese DMF
Japanese DMF
Chinese DMF
Korean DMF

Zoledronic acid

CAS No.

165800-06-6

Innovator/marketer

Zometa

Polymorphic form

Monohydrate

Therapeutic Area

Musculo-skeletal system

Status

Commercial

EU DMF readiness

US DMF readiness

024306

Other documentation

Japanese DMF

Available also in injectable form

Drug description:

Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates that acts primarily on bones.

It is indicated for the treatment of osteoporosis in adult men and post-menopausal osteoporosis in women - at increased risk of fracture, including those with a recent low-trauma hip fracture, for the treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and adult men, as well as the treatment of Paget’s disease of the bone in adults.
It is formulated as injection solution, powder for solution and concentrate solution for intravenous route of administration.

Mechanism of action:

Zoledronic acid is farnesyl diphosphate synthase inhibitor. It binds to hydroxyapatite crystals in the bone matrix and inhibits farnesyl pyrophosphate (diphosphate) synthase, thereby preventing protein prenylation within the mevalonate pathway. This leads to the loss of downstream metabolites essential for osteoclast function, leading to the induction of apoptosis and eventually, osteoclast-cell death. By preventing osteoclast-mediated bone resorption, zoledronic acid decreases bone turnover and stabilizes the bone matrix.

DISCLAIMER
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).

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