Drugs / Odanacatib
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials · 1 missed | ||||||
| Phase 1 | NCT01630616 | Mar 2013 → Jul 2016 | osteoporosis | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 1 | NCT01512693 | Feb → Apr 2012 | liver disorder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01512667 | Jan → Aug 2012 | impaired renal function disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01068262 | Dec 2009 → Apr 2010 | osteoporosis | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 1 | NCT00863525 | Nov → Dec 2004 | osteoporosis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00770159 | Nov 2004 → Jun 2005 | osteoporosis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00769418 | Sep → Dec 2004 | osteoporosis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00863590 | Jun 2004 → Feb 2005 | osteoporosis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 25 trials · 3 met primary | ||||||
| Phase 2 | NCT00885170 | Apr 2009 → Sep 2011 | osteoporosis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2 | NCT00620113 | Dec 2007 → May 2009 | postmenopausal osteoporosis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2 | NCT00399802 | Nov 2006 → Dec 2007 | breast cancer, metastatic carcinoma in the bone | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00397683 | Oct 2006 → Apr 2007 | osteoarthritis | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 2 | NCT00112437 | Jun 2005 → Dec 2007 | osteoporosis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 37 trials · 3 met primary | ||||||
| Phase 3 | NCT01803607 | Mar 2013 → Nov 2014 | osteoporosis | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01552122 | May 2012 → Feb 2015 | postmenopausal osteoporosis | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 3 | NCT01120600 | Jun 2010 → Jul 2013 | osteoporosis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00729183 | Oct 2008 → Mar 2010 | osteoporosis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00691899 | Sep 2008 | prostate cancer | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 3 | NCT00692458 | Sep 2008 | breast cancer | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 3 | NCT00529373 | Sep 2007 → Nov 2012 | postmenopausal osteoporosis | Merck Sharp & Dohme LLC | Terminated | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2016-09-02 | Merck Sharp & Dohme LLC | Results Merck Provides Update on Odanacatib Development Program merck.com ↗
The company has decided to discontinue development after an independent adjudication and analysis of major adverse cardiovascular events confirmed an increased risk of stroke. |
| 2014-09-15 | Merck Sharp & Dohme LLC | Results Merck Announces Data from Pivotal Phase 3 Fracture Outcomes Study for Odanacatib, an Investigational Oral, Once-Weekly Treatment for Osteoporosis merck.com ↗
In the Long-Term Odanacatib Fracture Trial (LOFT), odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo. |
| 2012-10-13 | Merck Sharp & Dohme LLC | Results Merck Researchers Present BMD Data from a Phase II Study of Odanacatib, Merck’s Investigational Cat-K Inhibitor for Post-Menopausal Osteoporosis merck.com ↗
In the study, treatment with odanacatib (compared to placebo) significantly increased Bone Mineral Density (BMD) over a two-year period in post-menopausal osteoporotic women who previously had three or more years of treatment with alendronate. |
| 2012-07-11 | Merck Sharp & Dohme LLC | Results Update on Phase III Trial for Odanacatib, Merck’s Investigational Cat-K Inhibitor for Osteoporosis merck.com ↗
The Data Monitoring Committee (DMC) for the study recently completed its first planned interim analysis for efficacy and recommended that the study be closed early due to robust efficacy and a favorable benefit-risk profile. |
| 2011-09-19 | Merck Sharp & Dohme LLC | Results New Data on Odanacatib, Merck’s Phase III Investigational Cat-K Inhibitor for Osteoporosis, Presented at the Annual Meeting of The American Society for Bone and Mineral Research merck.com ↗
In a Phase IIb clinical study extending to five years, odanacatib continued to increase bone mineral density (BMD) and reduce bone resorption markers in postmenopausal women with low BMD (N=141). |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2016-09-02 | Merck Sharp & Dohme LLC | Merck Provides Update on Odanacatib Development Program merck.com ↗ |
| 2014-09-15 | Merck Sharp & Dohme LLC | Merck Announces Data from Pivotal Phase 3 Fracture Outcomes Study for Odanacatib, an Investigational Oral, Once-Weekly Treatment for Osteoporosis merck.com ↗ |
| 2012-10-13 | Merck Sharp & Dohme LLC | Merck Researchers Present BMD Data from a Phase II Study of Odanacatib, Merck’s Investigational Cat-K Inhibitor for Post-Menopausal Osteoporosis merck.com ↗ |
| 2012-07-11 | Merck Sharp & Dohme LLC | Update on Phase III Trial for Odanacatib, Merck’s Investigational Cat-K Inhibitor for Osteoporosis merck.com ↗ |
| 2011-09-19 | Merck Sharp & Dohme LLC | New Data on Odanacatib, Merck’s Phase III Investigational Cat-K Inhibitor for Osteoporosis, Presented at the Annual Meeting of The American Society for Bone and Mineral Research merck.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | odanacatib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00691899 ↗ |
| Known as | L-001037536 | ChEMBL registry synonym — accepted as the source's own label CHEMBL481611 ↗ |
| Known as | L-1037536 | ChEMBL registry synonym — accepted as the source's own label CHEMBL481611 ↗ |
| Known as | MK0822 | “This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).” NCT00769418 ↗5“A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers” NCT00863590 ↗ “Odanacatib (MK0822)” NCT00770159 ↗ |
| Known as | ODN | “Odanacatib (ODN) is a selective cathepsin K inhibitor being developed to treat osteoporosis.” PMID 24064689 ↗ Sep 20132“Odanacatib (ODN) was investigated as an osteoporosis treatment in 292 men.” PMID 33200257 ↗ Nov 2020 “odanacatib (ODN), a cathepsin K inhibitor, in humans.” PMID 23013236 ↗ May 2013 |
| Action | Inhibit | “Odanacatib selectively and reversibly inhibited cathepsin K” PMID 19874198 ↗ May 2010 |
| Modality | Small molecule | — CHEMBL481611 ↗ |
| Route | Oral | “The efficacy and safety of weekly oral odanacatib (ODN) 50 mg for up to 8 years were assessed” PMID 26879200 ↗ Feb 2016 |
| Target | CTSK | “Odanacatib (ODN) is a selective cathepsin K inhibitor being developed to treat osteoporosis.” PMID 24064689 ↗ Sep 2013 |