Risedronate sodium

Form A

Therapeutic Area

Musculo-skeletal system

Status

Commercial

EU DMF readiness

US DMF readiness

CEP

Other documentation

Japanese DMF
Korean DMF
Canadian DMF
Brazilian DMF

CAS No.

329003-65-8

Reference Product

Actonel, Benet/ACCORD

Drug description:

Risedronate sodium is a pyridines derivative drug which belongs to the class of bone density conservation agents.
Risedronate sodium is indicated for treatment and prevention of osteoporosis in postmenopausal women, glucocorticoid-induced osteoporosis in men and women and treatment of osteoporosis in men, and also used for treatment of Paget’s disease of bone.
It is formulated as tablets, film-coated tablet for oral route of administration.

Mechanism of action:

Risedronate sodium is a pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption. The bone turnover is reduced while the osteoblast activity and bone mineralization is preserved.