ergocalciferol
Trade name: drisdol
Approved
Jan 11, 1941
Ergoalcifediol (Vitamin D2) is a fat soluble steroid hormone precursor of vitamin D. The principal biologic function of vitamin D is the maintenance of normal levels of serum calcium and phosphorus in the bloodstream by enhancing the efficacy of the small intestine to absorb these minerals from the diet. Cholecalciferol is synthesized within our bodies naturally, but if UV exposure is inadequate or the metabolism of cholecalciferol is abnormal, then an exogenous source is required. Vitamin D2 is converted to 25-hydroxyvitamin D (25OHD) in the liver, and then to the active form, 1,25-dihydroxyvitamin D (1,25(OH)2D), in the kidney. Once transformed, it binds to the vitamin D receptor, which leads to a variety of regulatory roles. Vitamin D plays an important role in maintaining calcium balance and in the regulation of parathyroid hormone (PTH). It promotes renal reabsorption of calcium, increases intestinal absorption of calcium and phosphorus, and increases calcium and phosphorus mobilization from bone to plasma. Very few foods naturally contain vitamin D. Sources that contain the vitamin include fatty fish, the liver and fat of aquatic mammals (e.g., seals, polar bears), and eggs from chickens fed vitamin D-fortified feed. As such, many countries have instituted policies to fortify certain foods with vitamin D to compensate for the potentially low exposures of skin to sunlight. Vitamin D deficiency results in inadequate mineralization of bone or compensatory skeletal demineralization and causes decreased ionized calcium concentrations in blood and a resultant increase in the production and secretion of PTH. Increase in PTH stimulates the mobilization of skeletal calcium, inhibits renal excretion of calcium, and stimulates renal excretion of phosphorus. This results in normal fasting serum calcium concentrations and low or near-normal serum phosphorus. The enhanced mobilization of skeletal calcium induced by this secondary hyperparathyroidism leads porotic bone. Ergoalcifediol is used for use in the management of hypocalcemia and its clinical manifestations in patients with hypoparathyroidism, as well as for the treatment of familial hypophosphatemia (vitamin D resistant rickets). This drug has also been used in the treatment of nutritional rickets or osteomalacia, vitamin D dependent rickets, rickets or osteomalacia secondary to long-term high dose anticonvulsant therapy, early renal osteodystrophy, osteoporosis (in conjunction with calcium), and hypophosphatemia associated with Fanconi syndrome (with treatment of acidosis). Ergocalciferol is manufactured and marketed under various names, including Deltalin (Eli Lilly and Company), Drisdol (Sanofi-Synthelabo) and Calcidol (Patrin Pharma). — NCATS
Clinical trial activity
94 trials · 109 clinical orgs · 24 marketing orgs
Earliest trial started Dec 1, 2002 (NCT00157066)
Timeline
1940s
- Jan 11, 1941
Sterling Drug — Earliest FDA Approval
- Jan 11, 1941
Validus Pharmaceuticals — NDA Secondary Org
- Jan 11, 1941
Validus Pharmaceuticals — Marketing Organization
- Jan 11, 1941
Sterling Drug — NDA Organization
- Jan 11, 1941
ESJAY PHARMA — Marketing Organization
- Jul 28, 1947
Roche — Marketing Organization
- Jul 28, 1947
Roche — NDA Secondary Org
1970s
- Mar 26, 1973
West-Ward Pharmaceutical — Marketing Organization
- Jun 12, 1973
Eli Lilly — Marketing Organization
- Jul 13, 1973
Impax Laboratories — Marketing Organization
- Sep 26, 1974
Chartwell Pharmaceuticals — Marketing Organization
- Sep 26, 1974
Lannett Company, Inc. — Marketing Organization
- Oct 16, 1978
Bionpharma Inc — Marketing Organization
1980s
- Nov 6, 1981
Abraxis — Marketing Organization
- Nov 6, 1981
Abraxis — NDA Secondary Org
- Jul 13, 1982
Watson Pharmaceuticals — Marketing Organization
- Jul 13, 1982
Watson Pharmaceuticals — NDA Secondary Org
2000s
- Jan 1, 2003
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2009
Earliest Phase 3 Sponsor(trial)
- May 20, 2009
Orit Labs Llc — Marketing Organization
- May 20, 2009
Alembic — Marketing Organization
- Dec 29, 2009
Sun Pharmaceuticals — Marketing Organization
2010s
- Jan 1, 2010
Earliest Phase 2 Sponsor(trial)
- Jul 14, 2010
Sigmapharm Laboratories — Marketing Organization
- Aug 3, 2010
Strides Pharma Science — Marketing Organization
- Aug 3, 2010
ONESOURCE SPECIALTY — Marketing Organization
- Dec 7, 2018
Puracap Pharmaceutical — Marketing Organization
Indications
Approved for
Studied for
- Anemia · Phase 4
- Arthritis, Rheumatoid · Phase 4
- Back Pain · Phase 3
- Bariatric Surgery · Phase 2
- Bone Diseases · Phase 4
- Breast Neoplasms · Phase 3
- Burns · Phase 2
- Cardiovascular Diseases · Phase 2
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Chronic Pain · Phase 2
- COVID-19 · Phase 3
- Cystic Fibrosis · Phase 2
- Death, Sudden, Cardiac · Phase 2
- Dental Caries · Phase 4
- Dermatology · Phase 4
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 1 · Phase 2/Phase 3
- Diabetes Mellitus, Type 2 · Phase 3
- Ergocalciferols · Phase 4
- General Surgery · Phase 2
- Healthy Volunteers · Phase 3
- Hepcidins · Phase 4
- Hip Fractures · Phase 4
- Hypercalciuria · Phase 4
- Hyperparathyroidism, Secondary · Phase 4
- Inflammation · Phase 1
- Insulin Resistance · Phase 1
- Iron Deficiencies · Phase 4
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 4
- Malabsorption Syndromes · Early Phase 1
- Malnutrition · Phase 4
- Multiple Trauma · Phase 1/Phase 2
- Musculoskeletal Diseases · Phase 1/Phase 2
- Musculoskeletal Pain · Phase 2
- Nephrolithiasis · Phase 4
- Non-alcoholic Fatty Liver Disease · Phase 3
- Obesity · Phase 4
- Overweight · Phase 4
- Penile Induration · Phase 1
- Pregnancy Complications · Phase 3
- Pruritus · Phase 4
- Renal Insufficiency, Chronic · Phase 4
- Sarcoidosis · Phase 4
- Signs and Symptoms · Phase 4
- Urolithiasis · Phase 4
- Vitamin D · Phase 4
- Vitamin D Deficiency · Phase 4
Mechanism of action
- Vitamin D receptorAGONIST
VDR agonist
Combination products
berocca pn
with vitamin e, folic acid, cyanocobalamin, vitamin c, nicotinamide, thiamine, biotin, panthenol, pyridoxine, riboflavin, vitamin a
Also known as m.v.c, mvc plus
m.v.i. adult (pharmacy bulk package)
with vitamin e, folic acid, cyanocobalamin, vitamin c, nicotinamide, thiamine, vitamin k, biotin, panthenol, pyridoxine, riboflavin, vitamin a
m.v.i. pediatric
with vitamin e, folic acid, cyanocobalamin, vitamin c, nicotinamide, thiamine, biotin, panthenol, pyridoxine, riboflavin, vitamin a, phytonadione
vitape
with vitamin e, folic acid, cyanocobalamin, vitamin c, nicotinamide, thiamine, pantothenic acid, biotin, pyridoxine, riboflavin, vitamin a, phytonadione
Approval history
- approvedJan 11, 1941
Chemistry & pharmacology
SMILES
CC(C)[C@@H](C)\C=C\[C@@H](C)[C@H]1CC[C@@H]2[C@]1(C)CCC\C2=C/C=C3/C[C@@H](O)CCC3=C- Mol. weight
- 396.6484 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
No
Sources
- WikipediaErgocalciferol ↗
- NCATSVS041H42XC ↗
- ChEMBLCHEMBL1536 ↗
Also known as
- (3β,5z,7e,22e)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
- (3β,5z,7e,22e)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
- (5z,7e,22e)-(3s)-9,10-seco-5,7,10(19),22-ergostatetraen-3-ol
- (5z,7e,22e)-(3s)-9,10-seco-5,7,10(19),22-ergostatetraen-3-ol
- (5z,7e,22e)-(3s)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
- (5z,7e,22e)-(3s)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
- activated ergosterol
- activated ergosterol
- calciferol
- calciferol
- calciferol
- calciferol
- calciferol
- calciferol in arach oil
- caltrate
- caltrate
- caltrate
- deltalin
- deltalin
- d-forte
- drisdol
- drisdol
- drisdol
- eciferol d2
- ercalciol
- ercalciol
- ercalciol
- ergocalciferol
- ergocalciferol
- ergocalciferol
- ergocalciferol
- ergocalciferol
- ergocalciferol
- ergocalciferol
- ergocalciferol
- ergocalciferol
- ergocalciferol
- ergocalciférol
- ergocalciférol
- ergocalciferolum
- ergocalciferolum
- ergo-d2
- ergoral d2
- ergorone
- lanes
- oleovitamin d
- oleovitamin d
- oleovitamin d2
- oleovitamin d2
- oleovitamin d, synthetic
- oleovitamin d, synthetic
- osto-d2
- sterogyl
- sterogyl
- sterogyl-15
- sterogyl 15h
- uvesterol d
- uvesterol d
- vitamina d2
- vitamina d2
- vitamin d2
- vitamin d2
- vitamin d2
- vitamin d2
- vitamin d2
- vitamin d2
- vitamin d 2
- vitamin d 2
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06791044 | N/A | Jun 1, 2025 | Dionyssiotis, Yannis, M.D. |
| NCT06642441 | N/A | Oct 18, 2024 | Qinghai University |
| NCT06642428 | N/A | Oct 15, 2024 | Qinghai University |
| NCT07310329 | N/A | Apr 27, 2024 | Wroclaw University of Health and Sport Sciences |
| NCT06516094 | Phase 3 | Apr 11, 2024 | Consultorio Médico "Dr. Rodrigo Suárez Otero", Imacen S.A. de C.V., Laboratorios Silanes S.A. de C.V. |
| NCT06176157 | Phase 4 | Dec 31, 2023 | Ain Shams University |
| NCT06172764 | Phase 4 | Dec 12, 2023 | Dow University of Health Sciences, Duke University, University of Karachi |
| NCT06158932 | N/A | Sep 8, 2023 | Citruslabs, Optify |
| NCT06148545 | N/A | Mar 30, 2023 | University of Hasanuddin |
| NCT05673980 | N/A | Dec 18, 2022 | Peking University |
| NCT05458024 | Phase 2 | Dec 8, 2022 | National Institutes of Health (NIH), University of North Carolina at Chapel Hill |
| NCT05619289 | Phase 2 | Nov 30, 2022 | National Center for Complementary and Integrative Health (NCCIH), University of North Carolina at Chapel Hill |
| NCT05549154 | N/A | Oct 1, 2022 | Jiao Tong University |
| NCT05434377 | N/A | Aug 31, 2022 | Chulalongkorn University |
| NCT04909931 | N/A | Jun 15, 2021 | Rajavithi Hospital, Bangkok |
| NCT06142136 | N/A | Mar 28, 2021 | Pauls Stradins Clinical University Hospital |
| NCT04591847 | Phase 3 | Oct 19, 2020 | Rajavithi Hospital, Bangkok |
| NCT04450199 | Early Phase 1 (Phase 1) | Jul 24, 2020 | Allegheny Health Network, The Podiatry Foundation, West Penn Hospital |
| NCT04385940 | Phase 3 | May 31, 2020 | University of Alberta |
| NCT04472481 | Phase 4 | Sep 6, 2019 | Loughborough University, Tanta University |
Organizations
Research & Development (109)
Marketing (31)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Abraxis | For profit | MKTG | Nov 6, 1981 |
| Abraxis | For profit | NDA2 | Nov 6, 1981 |
| Alembic | For profit | MKTG | May 20, 2009 |
| Bionpharma Inc | For profit | MKTG | Oct 16, 1978 |
| Bionpharma Inc | For profit | SYN | Oct 16, 1978 |
| Chartwell Pharmaceuticals | For profit | MKTG | Sep 26, 1974 |
| Chartwell Pharmaceuticals | For profit | SYN | May 20, 2009 |
| Chase Pharmaceuticals Corporation | For profit | MKTG | — |
| ESJAY PHARMA | For profit | MKTG | Jan 11, 1941 |
| Eli Lilly | For profit | MKTG | Jun 12, 1973 |
| Everylife Foundation for Rare Diseases | Academic/Hospital | MKTG | — |
| Hospira | For profit | MKTG | Feb 20, 1953 |
| Hospira | For profit | NDA2 | Feb 20, 1953 |
| Impax Laboratories | For profit | MKTG | Jul 13, 1973 |
| Lannett Company, Inc. | For profit | MKTG | Sep 26, 1974 |
| ONESOURCE SPECIALTY | For profit | MKTG | Aug 3, 2010 |
| Orit Labs Llc | For profit | MKTG | May 20, 2009 |
| Puracap Pharmaceutical | For profit | MKTG | Dec 7, 2018 |
| Roche | For profit | MKTG | Jul 28, 1947 |
| Roche | For profit | NDA2 | Jul 28, 1947 |
| Sigmapharm Laboratories | For profit | MKTG | Jul 14, 2010 |
| Sterling Drug | For profit | NDA | Jan 11, 1941 |
| Strides Pharma Science | For profit | MKTG | Aug 3, 2010 |
| Sun Pharmaceuticals | For profit | MKTG | Dec 29, 2009 |
| Teligent Pharmaceuticals | For profit | NDA2 | — |
| Validus Pharmaceuticals | For profit | NDA2 | Jan 11, 1941 |
| Validus Pharmaceuticals | For profit | MKTG | Jan 11, 1941 |
| Vitarine | For profit | MKTG | — |
| Watson Pharmaceuticals | For profit | MKTG | Jul 13, 1982 |
| Watson Pharmaceuticals | For profit | NDA2 | Jul 13, 1982 |
| West-Ward Pharmaceutical | For profit | MKTG | Mar 26, 1973 |