Drugs / Doxercalciferol
Doxercalciferol
also known as
Hectorol · 1-.alpha.-hydroxyergocalciferol · 1-hydroxyergocalciferol · 1.alpha.-hydroxyvitamin d2 · 1alpha OH vitamin D2 · GZ427397 · Hectorol (the other name for Doxercalciferol) · TSA-840
Small molecule targets VDR via activation
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | HECTOROL | — | 2004-04-23 – 2025-06-11 | fda.gov ↗ |
| Approved | US (FDA) | HECTOROL | — | 1999-06-09 | fda.gov ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00511017 | Aug 2007 → Sep 2010 | cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT00601107 | Apr 2008 → Feb 2009 | psoriasis | Genzyme, a Sanofi Company | Completed | Missed primary |
| Phase 2 | NCT00582582 | Apr 2002 → Apr 2007 | prostate cancer | University of Wisconsin, Madison | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07660536 | Nov 1989 → Apr 1992 | osteoporosis | Creighton University | Completed | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT02859896 | Jan 2017 → Jun 2025 | secondary hyperparathyroidism of renal origin | Sanofi | Terminated | Missed primary |
| Phase 3 | NCT02282813 | Apr 2013 → May 2015 | chronic kidney disease, secondary hyperparathyroidism of renal origin, vitamin D deficiency | OPKO Health, Inc. | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT00889629 | Nov 2008 → Jan 2010 | chronic kidney disease | Mariana Markell | Completed | No outcome recorded |
| Phase 4 | NCT00646282 | Apr 2008 → Jan 2010 | secondary hyperparathyroidism | Emory University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00528788 | Sep 2007 → Aug 2012 | chronic renal failure syndrome, secondary hyperparathyroidism of renal origin | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT00463021 | Apr → Dec 2007 | secondary hyperparathyroidism of renal origin | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT00454350 | Feb → Jul 2007 | secondary hyperparathyroidism of renal origin | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT00418600 | Nov 2006 → Jun 2007 | secondary hyperparathyroidism of renal origin | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT00135304 | Aug 2005 → Oct 2006 | secondary hyperparathyroidism of renal origin | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00123461 | Jul 2005 → Oct 2007 | chronic kidney disease, kidney failure, secondary hyperparathyroidism of renal origin | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07640347 | Jul 2026 → May 2027 expected | secondary hyperparathyroidism of renal origin | Chittagong Medical College | Not yet recruiting | No outcome recorded |
| — | NCT00285467 | Jan 2006 → Dec 2009 | renal osteodystrophy | Indiana University | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT00792857 Comparator | Nov 2008 → Sep 2009 | chronic renal failure syndrome, secondary hyperparathyroidism of renal origin | OPKO IP Holdings II, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01181531 Comparator | Oct 2010 → Jul 2012 | secondary hyperparathyroidism | Amgen | Completed | Missed primary |
| Phase 4 | NCT00502268 Comparator | Feb 2008 → Feb 2009 | calcinosis, end stage renal failure, secondary hyperparathyroidism | Southeast Renal Research Institute | Withdrawn | No outcome recorded |
| Phase 4 | NCT00257920 Comparator | Jun 2006 → Jan 2008 | end stage renal failure, secondary hyperparathyroidism of renal origin | Abbott | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-07-01 | Alembic Pharmaceuticals Ltd. | Regulatory APL-PR-USFDA-Products-Approval-Qtr-Ended-30062023.pdf alembicpharmaceuticals.com ↗ |
| 2018-11-05 | Lupin Limited | Regulatory Lupin receives FDA approval for Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multi-dose Vials lupin.com ↗
Pharma major Lupin announced that it has received approval for its Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multi-dose Vials from the United States Food and Drug Administration (FDA) to market a generic version of Sanofi Genzyme’s Hectorol Injection. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-07-01 | Alembic Pharmaceuticals Ltd. | APL-PR-USFDA-Products-Approval-Qtr-Ended-30062023.pdf alembicpharmaceuticals.com ↗ |
| 2019-12-18 | Lupin Limited | Lupin launches Doxercalciferol Injection lupin.com ↗ |
| 2018-11-05 | Lupin Limited | Lupin receives FDA approval for Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multi-dose Vials lupin.com ↗ |
| 2014-03-11 | Prasco LLC | Prasco® Markets Authorized Generic of Hectorol® (doxercalciferol) 0.5, 1.0 & 2.5 mcg capsules prasco.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Doxercalciferol | “Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT)” NCT01181531 ↗ |
| Known as | 1-.alpha.-hydroxyergocalciferol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200810 ↗ |
| Known as | 1-hydroxyergocalciferol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200810 ↗ |
| Known as | 1.alpha.-hydroxyvitamin d2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200810 ↗ |
| Known as | 1alpha OH vitamin D2 | “Patients randomized to group 1 will have the administration of 1alpha OH vitamin D2 (Hectorol) targeted to achieve serum PTH levels between 150-300 ng/ml using a Bayer Centaur...” NCT00502268 ↗ |
| Known as | GZ427397 | “Drug: Doxercalciferol (GZ427397)” NCT02859896 ↗ |
| Known as | Hectorol | “The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney...” NCT00123461 ↗6“Patients randomized to group 1 will have the administration of 1alpha OH vitamin D2 (Hectorol) targeted to achieve serum PTH levels between 150-300 ng/ml using a Bayer Centaur...” NCT00502268 ↗ “Hectorol® (doxercalciferol capsules)” NCT00418600 ↗ “Hectorol (doxercalciferol injection)” NCT00454350 ↗ “doxercalciferol capsules, Hectorol®” NCT07660536 ↗ “Hectorol (doxercalciferol capsules)” NCT00463021 ↗ |
| Known as | Hectorol (the other name for Doxercalciferol) | “Hectorol (the other name for Doxercalciferol)” NCT00889629 ↗ |
| Known as | TSA-840 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200810 ↗ |
| Action | Activate | “Vitamin D receptor agonist” CHEMBL1200810 ↗ |
| Modality | Small molecule | — CHEMBL1200810 ↗ |
| Route | Intravenous | “Vitamin D administered IV” NCT00135304 ↗ |
| Target | VDR | “Vitamin D receptor agonist” CHEMBL1200810 ↗ |