Falecalcitriol
Falecalcitriol was first approved by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on Apr 4, 2001. It was co-developed by Taisho, Dainippon Sumitomo and Kissei, then marketed as Hornel® by Taisho and Taisho Toyama or as Fulstan® by Dainippon Sumitomo Pharma and Kissei in JP.
Falecalcitriol is an analog of calcitriol. It has a higher potency both in vivo and in vitro systems, and longer duration of action in vivo. This medicine improves bone disease and symptoms caused by shortage of vitamin D, etc. It also prompts calcium absorption to supply lacked calcium and prevents bone-thinning. It is usually used to treat secondary hyperparathyroidism under maintenance dialysis, hypoparathyroidism, rickets or osteomalacia.
Hornel®/Fulstan® is available as tablet for oral use, containing 0.15 μg or 0.3 μg of free Falecalcitriol. The recommended dose is 0.3 μg once daily for secondary hyperparathyroidism and 0.3-0.9 μg once daily for hypoparathyroidism, rickets or osteomalacia.
Update Date：2016-05-16
- Drug Name：
- Falecalcitriol
- Research Code：
- ST-630; Ro-23-4194
- Trade Name：
- Hornel® / Fulstan®
- MOA：
- Active vitamin D3 derivative
- Indication：
- Hyperparathyroidism; Maintenance dialysis; Rickets; Osteomalacia
- Status：
- Approved
- Company：
- Taisho Toyama (Originator) , Dainippon Sumitomo,Kissei
- Sales：
-
$5.6 Million (Y2015);
$5.2 Million (Y2014);
$6.4 Million (Y2013);
$6.8 Million (Y2012);
$7.6 Million (Y2011); - ATC Code：
- M05
Update Date：2015-07-29
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2001-04-04 | Marketing approval | Hornel | Hyperparathyroidism,Rickets,Osteomalacia,Maintenance dialysis | Tablet | 0.15 μg/0.3 μg | Taisho, Taisho Toyama | |
| 2001-04-04 | Marketing approval | Fulstan | Hyperparathyroidism,Rickets,Osteomalacia,Maintenance dialysis | Tablet | 0.15 μg/0.3 μg | Dainippon Sumitomo, Kissei |
Update Date：2015-08-27
|
Molecular Weight | 524.59 | ||||||||||||
| Formula | C27H38F6O3 | |||||||||||||
| CAS No. | 83805-11-2 (Falecalcitriol); | |||||||||||||
| Chemical Name | (+)-(5Z,7E)-26,26,26,27,27,27-hexafluoro-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol | |||||||||||||
| Falecalcitriol （Free Acid/Base）Parameters： | ||||||||||||||
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| *：Calculated by ACD/Labs software V11.02. | ||||||||||||||
Update Date：2016-06-22
