Drugs / arzoxifene
arzoxifene
also known as
LY353381 · Arzoxifene hcl · arzoxifene hydrochloride · Arzoxifeno · LY-353381.HCL · SERM 3
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00005886 | Jul 2000 → Aug 2002 | breast cancer | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT00767299 | Dec 2008 → Oct 2009 | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00253539 | Jan 2002 → Apr 2005 | breast cancer, hereditary breast ovarian cancer syndrome | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 2 | NCT00005879 | Aug 2000 → Jul 2008 | breast cancer | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00003669 | Nov 1998 → Apr 2001 | endometrial cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00003670 | Oct 1998 → Jan 2001 | ovarian cancer, primary peritoneal carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00003428 | May 1998 → Jun 2001 | breast cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT00383422 | Oct 2006 → Jul 2008 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00088010 | Jun 2004 → Jun 2009 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00085956 | Apr 2004 → Feb 2007 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00034125 | — | breast cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00190697 | Jan 2001 → Apr 2007 | breast cancer, endometrial cancer, ovarian cancer | Eli Lilly and Company | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2009-08-18 | Eli Lilly and Company | Results Lilly Reports on Outcome of Phase III Study of Arzoxifene lilly.com ↗
While arzoxifene met its primary efficacy objectives in this study, we are disappointed that the GENERATIONS data did not convincingly demonstrate that arzoxifene would represent a meaningful advancement in the treatment of osteoporosis. |
| 2009-04-08 | Eli Lilly and Company | Results Newly Published Phase III Study Shows Arzoxifene Significantly Increased Bone Mineral Density lilly.com ↗
In addition, arzoxifene, dosed at 20 mg/day, decreased biochemical markers of bone turnover, and showed a neutral effect on the uterus and endometrium. |
| 2009-03-23 | Eli Lilly and Company | Results Phase III Trial Showed Investigational Compound Arzoxifene Was Superior to Evista® (raloxifene HCl) in Increasing BMD in Postmenopausal Women with Osteoporosis lilly.com ↗
Arzoxifene significantly increased BMD at all sites to a greater extent than raloxifene, respectively (p<0.05 for all comparisons) |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2009-08-18 | Eli Lilly and Company | Lilly Reports on Outcome of Phase III Study of Arzoxifene lilly.com ↗ |
| 2009-04-08 | Eli Lilly and Company | Newly Published Phase III Study Shows Arzoxifene Significantly Increased Bone Mineral Density lilly.com ↗ |
| 2009-03-23 | Eli Lilly and Company | Phase III Trial Showed Investigational Compound Arzoxifene Was Superior to Evista® (raloxifene HCl) in Increasing BMD in Postmenopausal Women with Osteoporosis lilly.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | arzoxifene | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00253539 ↗ |
| Known as | Arzoxifene hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL226267 ↗ |
| Known as | arzoxifene hydrochloride | “Hormone therapy using arzoxifene hydrochloride may fight the endometrial cancer by blocking the use of estrogen by the tumor cells” NCT00003669 ↗ |
| Known as | Arzoxifeno | ChEMBL registry synonym — accepted as the source's own label CHEMBL226267 ↗ |
| Known as | LY-353381.HCL | ChEMBL registry synonym — accepted as the source's own label CHEMBL226267 ↗ |
| Known as | LY353381 | “A Study of LY353381 (Arzoxifene) for Patients Who Benefitted From This Drug in Other Oncology Trials and Wished to Continue Treatment” NCT00190697 ↗ |
| Known as | SERM 3 | ChEMBL registry synonym — accepted as the source's own label CHEMBL226267 ↗ |
| Action | Inhibit | “Hormone therapy using arzoxifene hydrochloride may fight breast cancer by blocking the use of estrogen by the tumor cells.” NCT00003428 ↗ |
| Modality | Other / unclassified | “Selective Estrogen Receptor Modulator (LY353381*HCl)” NCT00005879 ↗ |
| Route | Oral | “Patients receive arzoxifene hydrochloride orally once daily for 12 weeks.” NCT00003428 ↗ |