Wednesday, July 8, 2026

Drug profile · INN

zoledronic acid

zoledronic acid (ACLASTA) is a farnesyl diphosphate synthase inhibitor. Associated with Apotex Pty Ltd. Route of administration: iv (infusion). Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Musculo-skeletal system (M05) M05BA08
US status approved
Patents linked 0
Pipeline programs 10
News articles 0
Drug details — zoledronic acid
US status
approved
Class
Musculo-skeletal system (M05)
Route
IV (INFUSION)
Patents
0
Programs
10
Data quality
0.89

Quick answer

zoledronic acid (ACLASTA) is a farnesyl diphosphate synthase inhibitor. Associated with Apotex Pty Ltd. Route of administration: iv (infusion). Current US regulatory status: approved.

Key facts

INN zoledronic acid
Brand ACLASTA
Mechanism Farnesyl diphosphate synthase inhibitor
Target Farnesyl pyrophosphate synthase
Therapeutic class Musculo-skeletal system (M05)
Route IV (INFUSION)
Formulation INJECTABLE
ATC code M05BA08
Originator Apotex Pty Ltd

Mechanism of action

Farnesyl diphosphate synthase inhibitor

Primary target: Farnesyl pyrophosphate synthase

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. ZOSTER ICO-N-2018-14 Phase 3 · CERo Therapeutics · Patients, men or women over 18 old, with inoperable vertebra
  2. Zoledronic acid Phase 3 · Novartis India · Osteoporosis
  3. Zoledronic acid Phase 3 · Novartis India · Breast Cancer
  4. Zoledronic acid Phase 3 · United Therapeutics Europe · Osteoporosis
  5. Zometa 4 mg/100 ml solution for infusion Phase 3 · Ningbo Cancer Hospital · High grade osteosarcoma
  6. zoledronic acid Phase 3 · Novartis India · Paget's Disease of Bone
  7. zoledronic acid Phase 2 · Chinese Academy of · Congenital Dyserythropoietic Anemia (CDA)
  8. Zoledronate Approved · United Therapeutics Europe · Hip Fractures

Related & competitor drugs

  1. alendronate sodium Farnesyl diphosphate synthase inhibitor
  2. allopurinol Musculo-skeletal system (M04)
  3. colchicine Musculo-skeletal system (M04)
  4. denosumab Musculo-skeletal system (M05)
  5. eteplirsen Musculo-skeletal system (M09)
  6. febuxostat Musculo-skeletal system (M04)

Frequently asked questions

What is zoledronic acid?

zoledronic acid (ACLASTA) is a farnesyl diphosphate synthase inhibitor. Associated with Apotex Pty Ltd. Route of administration: iv (infusion). Current US regulatory status: approved.

What is the brand name for zoledronic acid?

ACLASTA is a marketed brand name for zoledronic acid. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of zoledronic acid?

zoledronic acid has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.