Overview
Ergocalciferol is an inactivated vitamin D analog. It is synthesized by some plants in the presence of UVB light. The production of ergocalciferol was prompted by the identification of dietary deficiency, more specifically vitamin D, as the main causative factor for the development of rickets. Ergocalciferol was isolated for the first time from yeast in 1931 and its structure was elucidated in 1932. Ergocalciferol is considered the first vitamin D analog and is differentiated from cholecalciferol by the presence of a double bond between C22 and C23 and the presence of a methyl group at C24. These modifications reduce the affinity of ergocalciferol for the vitamin D binding protein resulting in faster clearance, limits its activation, and alters its catabolism. The first approved product containing ergocalciferol under the FDA records was developed by US Pharm Holdings and was FDA approved in 1941.
Indication
Ergocalciferol is indicated for the treatment of hypoparathyroidism, refractory rickets, and familial hypophosphatemia. Hypoparathyroidism is the result of inadequate parathyroid hormone production that occurs due to the presence of damage or removal of the parathyroid glands. This condition produces decreased calcium and increased phosphorus levels. Rickets is a condition produced due to a deficiency in vitamin D, calcium or phosphorus. However, this condition can also be related to renal diseases. It is characterized to present weak or soft bones. Familial hypophosphatemia is characterized by the impaired transport of phosphate and an altered vitamin D metabolism in the kidneys. The presence of this condition can derive in the presence of osteomalacia, bone softening and rickets.
Associated Conditions
- Deficiency, Vitamin A
- Deficiency, Vitamin D
- Hypoparathyroidism
- Hypophosphatemia, Familial
- Vitamin D Resistant Rickets
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/01/06 | Not Applicable | Recruiting | |||
2022/11/16 | Phase 2 | Recruiting | |||
2022/07/14 | Phase 2 | Completed | |||
2022/04/06 | Phase 4 | Completed | |||
2022/02/28 | Phase 2 | Recruiting | |||
2021/10/19 | Phase 4 | Recruiting | |||
2021/06/02 | Not Applicable | Completed | |||
2021/04/02 | Not Applicable | UNKNOWN | |||
2020/10/19 | Phase 3 | Completed | |||
2020/07/15 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Proficient Rx LP | 71205-676 | ORAL | 1.25 mg in 1 1 | 7/1/2022 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-552 | ORAL | 1.25 mg in 1 1 | 8/28/2023 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-712 | ORAL | 1.25 mg in 1 1 | 8/18/2023 | |
| Bionpharma Inc. | 69452-151 | ORAL | 1.25 mg in 1 1 | 12/27/2023 | |
| Dispensing Solutions, Inc. | 66336-907 | ORAL | 1.25 mg in 1 1 | 2/6/2012 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-219 | ORAL | 1.25 mg in 1 1 | 5/26/2017 | |
| NuCare Pharmaceuticals,Inc. | 68071-2352 | ORAL | 1.25 mg in 1 1 | 12/22/2022 | |
| Validus Pharmaceuticals LLC | 30698-493 | ORAL | 1.25 mg in 1 1 | 5/8/2023 | |
| SigmaPharm Laboratories, LLC | 42794-006 | ORAL | 1.25 mg in 1 1 | 1/25/2012 | |
| Epic Pharma LLC | 42806-547 | ORAL | 1.25 mg in 1 1 | 10/31/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VITALIPID N INFANT INJECTION | SIN05207P | INJECTION | 40 iu/ml | 11/14/1990 | |
| VITALIPID N ADULT INJECTION | SIN05208P | INJECTION | 20 iu/ml | 11/14/1990 | |
| TAMIPOOL FOR INJECTION | SIN11849P | INJECTION, POWDER, FOR SOLUTION | 200 iu/vial | 3/15/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Vitamin D2 Pills | 国药准字H35021558 | 化学药品 | 丸剂（糖丸） | 4/7/2020 | |
| Vitamin D2 Pills | 国药准字H23023402 | 化学药品 | 丸剂(糖丸) | 7/27/2020 | |
| Vitamin D2 Pills | 国药准字H23023025 | 化学药品 | 丸剂(糖丸) | 7/28/2020 | |
| Vitamin D2 Soft Capsules | 国药准字H36021226 | 化学药品 | 胶囊剂(软胶囊) | 1/6/2021 | |
| Vitamin D2 Soft Capsules | 国药准字H19983062 | 化学药品 | 软胶囊剂 | 1/9/2020 | |
| Vitamin D2 Soft Capsules | 国药准字H19983063 | 化学药品 | 软胶囊剂 | 1/9/2020 | |
| Vitamin D2 Soft Capsules | 国药准字H35020238 | 化学药品 | 胶囊剂(软胶囊) | 2/25/2020 | |
| Vitamin D2 Soft Capsules | 国药准字H35020237 | 化学药品 | 胶囊剂(软胶囊) | 2/25/2020 | |
| Vitamin D2 Soft Capsules | 国药准字H31020845 | 化学药品 | 软胶囊剂 | 4/22/2021 | |
| Vitamin D2 Soft Capsules | 国药准字H11020642 | 化学药品 | 胶囊剂 | 6/12/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FOREST PHARMA WITH AMINO ACIDS capsule carton | 51067 | Forest Pharmatech Pty Limited | Medicine | A | 12/7/1994 |
| Vital Kids | 206084 | Medicine | A | 2/13/2013 | |
| Bio-Enhanced Liquid Calcium plus Vitamin D | 91955 | Medicine | A | 11/20/2002 | |
| Fitline Heart Duo Microsolve+ | 496608 | Medicine | A | 7/3/2025 | |
| VITALIPID N INFANT 10mL injection emulsion ampoule | 40253 | Medicine | A | 8/21/1992 | |
| HYDRODOL Before | 320523 | Medicine | A | 7/22/2019 | |
| Hydrodol Before Powder | 345274 | Medicine | A | 9/30/2020 | |
| Skin Vitality | 395171 | Medicine | A | 8/31/2022 | |
| VITALIPID N ADULT 10mL injection ampoule | 40252 | Medicine | A | 8/21/1992 | |
| HYDRODOL REHYDRATION + IMMUNITY POWDER HONEY LEMON FLAVOUR | 427925 | Medicine | A | 11/15/2023 |
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