Odanacatib Clinical Trials

Size	Price	Qty
5mg	USD 270
100mg	USD 1,670

Clinical Trials

Numerous clinical trials, primarily sponsored by Merck Sharp & Dohme LLC, evaluate odanacatib (MK-0822) across Phase 1 through Phase 3. These studies investigate conditions including postmenopausal osteoporosis, bone mineral density loss, metastatic bone disease, breast cancer, and prostate cancer, alongside pharmacokinetic evaluations in hepatic and renal insufficiency. Trial recruitment statuses range from completed investigations to those that were terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01630616	TERMINATED	Osteoporosis	Merck Sharp & Dohme LLC	2013-03-12	PHASE1
NCT01552122	WITHDRAWN	Osteoporosis; Postmenopausal Osteoporosis	Merck Sharp & Dohme LLC	2012-05	PHASE3
NCT01803607	TERMINATED	Osteoporosis	Merck Sharp & Dohme LLC	2013-03-14	PHASE3
NCT01120600	COMPLETED	Osteoporosis	Merck Sharp & Dohme LLC	2010-06-09	PHASE3
NCT01803607	Terminated	Osteoporosis	Merck Sharp & Dohme LLC	2013-03-14	Phase 3
NCT01630616	Terminated	Osteoporosis	Merck Sharp & Dohme LLC	2013-03-12	Phase 1
NCT00529373	TERMINATED	Postmenopausal Osteoporosis	Merck Sharp & Dohme LLC	2007-09-13	PHASE3
NCT01512667	COMPLETED	Renal Insufficiency	Merck Sharp & Dohme LLC	2012-01-17	PHASE1
NCT01512693	COMPLETED	Hepatic Insufficiency	Merck Sharp & Dohme LLC	2012-02-23	PHASE1
NCT01512693	Completed	Hepatic Insufficiency	Merck Sharp & Dohme LLC	2012-02-23	Phase 1
NCT01512667	Completed	Renal Insufficiency	Merck Sharp & Dohme LLC	2012-01-17	Phase 1
NCT00885170	COMPLETED	Osteoporosis	Merck Sharp & Dohme LLC	2009-04-13	PHASE2
NCT01068262	COMPLETED	Osteoporosis	Merck Sharp & Dohme LLC	2009-12-08	PHASE1
NCT00729183	COMPLETED	Osteoporosis	Merck Sharp & Dohme LLC	2008-10-02	PHASE3
NCT01068262	Completed	Osteoporosis	Merck Sharp & Dohme LLC	2009-12-08	Phase 1
NCT00620113	COMPLETED	Osteoporosis Postmenopausal	Merck Sharp & Dohme LLC	2007-12-03	PHASE2
NCT00691899	Withdrawn	Prostate Cancer	Merck Sharp & Dohme LLC	2008-09	Phase 3
NCT00692458	WITHDRAWN	Breast Cancer	Merck Sharp & Dohme LLC	2008-09	PHASE3
NCT00691899	WITHDRAWN	Prostate Cancer	Merck Sharp & Dohme LLC	2008-09	PHASE3
NCT00112437	COMPLETED	Osteoporosis	Merck Sharp & Dohme LLC	2005-06-24	PHASE2
NCT00399802	COMPLETED	Breast Cancer; Metastatic Bone Disease	Merck Sharp & Dohme LLC	2006-11-16	PHASE2
NCT00770159	COMPLETED	Osteoporosis	Merck Sharp & Dohme LLC	2004-11	PHASE1
NCT00863590	COMPLETED	Osteoporosis	Merck Sharp & Dohme LLC	2004-06	PHASE1
NCT00769418	COMPLETED	Osteoporosis	Merck Sharp & Dohme LLC	2004-09	PHASE1
NCT00863525	COMPLETED	Osteoporosis	Merck Sharp & Dohme LLC	2004-11	PHASE1

(data from https://clinicaltrials.gov, updated on 2018-08-28)

Check the Odanacatib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Odanacatib selectively binds to and potently inhibits human cathepsin K, a cysteine protease crucial for degrading type I collagen within the bone matrix, thereby preventing osteoclast-mediated bone breakdown. This inhibition reduces bone resorption and restores bone mineral density, offering targeted therapeutic potential for clinical conditions such as postmenopausal osteoporosis and metastatic bone disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).