Drugs / Eldecalcitol
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT00144456 | Sep 2004 → Sep 2008 | osteoporosis | Chugai Pharmaceutical | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT06537115 | Jun 2024 → May 2026 overdue | muscular atrophy | Zhejiang Provincial People's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06385093 | Jun 2024 → Dec 2025 | osteoporosis, rheumatoid arthritis | Chinese SLE Treatment And Research Group | Unknown | No outcome recorded |
| Phase 4 | NCT05902078 | Sep 2023 → Jun 2025 | disease of bone structure, postmenopausal osteoporosis | Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05884372 | Aug 2023 → Jul 2025 | postmenopausal osteoporosis | Xi'an Honghui Hospital | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07063797 | Feb 2026 → Jul 2027 expected | osteoporosis, type 2 diabetes mellitus | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| — | NCT01974167 | Dec 2013 → Feb 2018 | osteoporosis | e-GLORIA trial Protocol Review Committee | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT03755193 Comparator | Nov 2018 → Nov 2024 overdue | osteoporosis | Shinshu University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2022-08-15 | Chugai Pharmaceutical | Regulatory Chugai Obtains Regulatory Approval for Osteoporosis Treatment Edirol Tablet chugai-pharm.co.jp ↗
Chugai obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for an osteoporosis treatment Edirol ® Tablets 0.5 µg/0.75 µg (generic name: eldecalcitol, hereafter, Edirol Tablet). |
| 2021-12-03 | Chugai Pharmaceutical | Regulatory Towa Pharmaceutical Receives Approval for Authorized Generic Version of Chugai’s Osteoporosis Agent Edirol chugai-pharm.co.jp ↗
Towa has obtained regulatory approval from the MHLW for the authorized generic. |
| 2020-12-18 | Chugai Pharmaceutical | Regulatory Chugai's Osteoporosis Agent Edirol Obtains Regulatory Approval in China chugai-pharm.co.jp ↗
Edirol has been approved for the treatment of osteoporosis in China following Japan. |
| 2020-02-17 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approvals for 15 Generic Drugs with 31 Strengths upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) received approvals by the Ministry of Health, Labour and Welfare for 15 generic drugs with 31 strengths. |
| 2018-03-22 | Chugai Pharmaceutical | Regulatory New Drug Application of Eldecalcitol, an Active Vitamin D 3 Derivative, for the Treatment of Osteoporosis Accepted in China chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that the China Food and Drug Administration (CFDA) has accepted for review a New Drug Application (NDA) submitted for eldecalcitol (Japanese brand name: Edirol ® ), a Chugai originated active vitamin D 3 derivative for the treatment of osteoporosis in China. |
| 2017-11-06 | Chugai Pharmaceutical | Results Eldecalcitol, an Active Vitamin D 3 Derivative, Increases Bone Mineral Density of Osteoporosis Patients in Chinese Phase III Study chugai-pharm.co.jp ↗
As a result, patients receiving eldecalcitol showed a statistically significant increase of BMD compared to those receiving alfacalcidol. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-08-15 | Chugai Pharmaceutical | Chugai Obtains Regulatory Approval for Osteoporosis Treatment Edirol Tablet chugai-pharm.co.jp ↗ |
| 2021-12-03 | Chugai Pharmaceutical | Towa Pharmaceutical Receives Approval for Authorized Generic Version of Chugai’s Osteoporosis Agent Edirol chugai-pharm.co.jp ↗ |
| 2020-12-18 | Chugai Pharmaceutical | Chugai's Osteoporosis Agent Edirol Obtains Regulatory Approval in China chugai-pharm.co.jp ↗ |
| 2020-02-17 | Upsher-Smith Laboratories | Sawai Receives Approvals for 15 Generic Drugs with 31 Strengths upsher-smith.com ↗ |
| 2018-03-22 | Chugai Pharmaceutical | New Drug Application of Eldecalcitol, an Active Vitamin D 3 Derivative, for the Treatment of Osteoporosis Accepted in China chugai-pharm.co.jp ↗ |
| 2017-11-06 | Chugai Pharmaceutical | Eldecalcitol, an Active Vitamin D 3 Derivative, Increases Bone Mineral Density of Osteoporosis Patients in Chinese Phase III Study chugai-pharm.co.jp ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | eldecalcitol | “A new active vitamin D3 analog, eldecalcitol, prevents the risk of osteoporotic fractures--a randomized, active comparator, double-blind study.” PMID 21784190 ↗ Jul 20117“Eldecalcitol treatment for 24 months” NCT03755193 ↗ |
| Known as | ED-71 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00144456 ↗ |
| Known as | Gai Sheng Yuan | “Denosumab injection (Mai Lishu), 60 mg subcutaneous injection, once every six months, combined with eldecalcitol soft capsules (Gai Sheng Yuan), 0.75 μg/capsule, take one...” NCT07063797 ↗ |
| Action | Activate | “Vitamin D receptor agonist” CHEMBL4297608 ↗ |
| Modality | Small molecule | “Eldecalcitol is an analog of 1,25-dihydroxyvitamin D(3)” PMID 21784190 ↗ Jul 2011 |
| Route | Oral | “0.75μg/day(p.o.)for 144 weeks” NCT00144456 ↗ |
| Target | VDR | “Vitamin D receptor agonist” CHEMBL4297608 ↗ |