Product Description
Alendronic Acid is a second generation bisphosphonate and synthetic analog of pyrophosphate with anti-bone-resorption activity. Alendronic acid binds to and inhibits the activity of farnesyl pyrophosphatesynthetase, an enzyme involved in terpenoid biosynthesis. Inhibition of this enzyme prevents the biosynthesis of isoprenoid lipids, donor substrates of farnesylation and geranylgeranylation during the post-translational modification of small GTPase signalling proteins, which are important in the process of osteoclast turnover. As a result, bone resorption and turnover are reduced. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Alendronic-acid)
Mechanisms of Action: Bone Resorption Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Osteoporosis | Osteoporosis, Postmenopausal
Known Adverse Events: Abdominal Pain | Pain Unspecified | Musculoskeletal Pain | Constipation | Diarrhea | Dyspepsia
Company: Organon
Company Location: JERSEY CITY NJ 07302
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Belgium, United States
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Healthy Volunteers
Phase 2: Osteoarthritis|Osteoporosis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| AAAR5220 | P2 |
Completed |
Osteoporosis |
2023-06-09 |
|
| 2021-005511-32 | P3 |
Active, not recruiting |
Healthy Volunteers |
2022-12-06 |
|
| 2019-003570-11 | P2 |
Completed |
Osteoarthritis |
2022-03-09 |
|
| BC-6072 | P2 |
Completed |
Osteoarthritis |
2022-03-09 |