Drugs / sodium citrate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ISOLYTE E W/ DEXTROSE 5% IN PLASTIC CONTAINER | — | 1980-10-03 | fda.gov ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT00968565 | Jan 2010 → Jun 2015 | congenital heart disease, respiratory failure | Vanderbilt University | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT05067270 | Oct → Dec 2021 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01421160 | Jul 2011 → Mar 2012 | arthritic joint disease | Texas Tech University Health Sciences Center, El Paso | Withdrawn | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06204432 | Dec 2023 → Dec 2025 overdue | anosmia, long COVID-19, olfactory nerve disorder | University of North Carolina, Chapel Hill | Active not recruiting | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05188339 | Jul → Dec 2022 | venous thromboembolism | Chang Gung Memorial Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT04802785 | Jun → Jul 2021 | — | Dinara Zhumanbayeva | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03106922 | Apr 2016 → Jul 2020 | — | Alfasigma S.p.A. | Unknown | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04756427 | Mar 2022 → Nov 2023 | — | Johns Hopkins University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05191290 | Jan → Dec 2022 | — | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1/2 | NCT02577718 Background | Nov 2015 → Jun 2016 | nosocomial infection, prosthesis-related infectious disease | Novel Anti-Infective Technologies, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04284657 Comparator | Jan 2019 → Aug 2025 | autosomal dominant polycystic kidney disease | University of Southern California | Completed | No outcome recorded |
| Phase 4 | NCT00571259 Comparator | Sep 2003 → Jan 2010 | bacterial infectious disease | Satellite Healthcare | Completed | No outcome recorded |
| — | NCT06994312 Comparator | Jul 2025 → May 2028 expected | blood coagulation disease | The First Hospital of Jilin University | Not yet recruiting | No outcome recorded |
| — | NCT02751320 Comparator | Feb → Jul 2016 | dental caries | GlaxoSmithKline | Completed | Missed primary |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sodium Citrate | “Sachet B: sodium citrate 1.863 g, anhydrous citric acid 0.813 g, sodium chloride 0.730 g, potassium chloride 0.370 g;” NCT03106922 ↗13“The study lock consisted of 15 or 30 μg/ml of nitroglycerin in combination with 4% sodium citrate and 22% ethanol.” PMID 28416559 ↗ Jun 2017 “Sodium Citrate 2.90 g per os” NCT04802785 ↗ |
| Action | Inhibit | “Citrate functions by binding free calcium, thereby inhibiting coagulation in both the intrinsic and extrinsic coagulation pathways.” NCT00968565 ↗ |
| Route | Other | “Sodium citrate will be infused as the blood enters the ECMO circuit” NCT00968565 ↗ |