Drugs / Etidronate
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | DIDRONEL | — | 1979-01-23 – 1980-08-25 | fda.gov ↗ |
| Approved | US (FDA) | DIDRONEL | — | 1977-09-01 | fda.gov ↗ |
Trials 4 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01585402 | Aug 2012 → Aug 2021 | calcinosis | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05832580 | Apr 2023 → Mar 2027 expected | pseudoxanthoma elasticum (inherited or acquired) | UMC Utrecht | Recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00376662 | Aug 1992 → Oct 2000 | osteoporosis | British Thoracic Society | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04035330 | Sep 2019 → Mar 2021 | dental pulp necrosis | Cairo University | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05662111 Comparator | Apr 2023 → Dec 2027 expected | basal ganglia calcification, idiopathic, 1 | UMC Utrecht | Recruiting | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Etidronate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05662111 ↗ |
| Modality | Small molecule | “Etidronate is a bisphosphonate that interferes with bone metabolism.” NCT01585402 ↗ |
| Route | Oral | “Etidronate will be administered orally at total dose of 20mg/kg daily x 14 days” NCT01585402 ↗ |