Drugs / Vitamin K1
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | VITAMIN K1 | — | 1983-07-25 | fda.gov ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03388970 | Aug 2017 → Oct 2018 | intracerebral hemorrhage | HUANG XIANJIAN | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06385275 | Jun 2025 → Dec 2026 expected | osteoarthritis, knee | Boston University | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02324686 | Jan 2014 → Dec 2017 | atrial fibrillation, end stage renal failure | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2 | NCT01763307 | Jan 2013 → Jan 2014 | toxic dermatosis | Hadassah Medical Organization | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05018221 | Aug 2021 → Dec 2029 expected | calciphylaxis cutis | University of Sydney | Recruiting | No outcome recorded |
| Phase 3 | NCT01742273 | Oct 2013 → Jul 2020 | cardiovascular disorder | RWTH Aachen University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 41 trial | ||||||
| Phase 4 | NCT05060809 | Jan 2018 → Jul 2019 | calcinosis | Assiut University | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05360342 | Mar 2020 → Jul 2021 | vitamin K deficiency hemorrhagic disease | RWTH Aachen University | Completed | No outcome recorded |
| — | NCT02259647 | Oct 2014 → Oct 2015 | hepatocellular carcinoma | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT05392127 Background | Jul → Aug 2022 | rheumatoid arthritis | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05273775 Background | Apr → Jun 2022 | chronic hepatitis B virus infection | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04676035 Background | Jun 2020 → Jan 2022 | prostate cancer | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02256813 Background | Sep → Dec 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01528800 Comparator | Nov 2012 → Dec 2019 | end stage renal failure | Dr. Rachel Holden | Completed | No outcome recorded |
| Phase 2/3 | NCT04477811 Comparator | Jul → Nov 2020 | end stage renal failure | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT06839352 Comparator | Oct 2022 → Oct 2023 | varicose disease | Zagazig University | Completed | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | vitamin K1 | “Patients in the experimental group was treated with intravenous injection of vitamin K1 20mg once a day for 2 days after admission” NCT03388970 ↗16“The vitamin K supplement contains 3 subforms of vitamin K: vitamin K1 (1000µg), menaquinone-4 (1000µg) and menaquinone-7 (200µg).” NCT05360342 ↗ “Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic colorectal cancer patients.” NCT01763307 ↗ “followed by oral Vitamin K1 20mg twice daily for 3month” NCT02259647 ↗ |
| Known as | KA-Vit Tropfen (phylloquinone) | “KA-Vit Tropfen (phylloquinone)” NCT01742273 ↗ |
| Known as | phylloquinone | “The enrolled patients received 5 mg of oral vitamin K1 (phylloquinone) three times /week for 6 months at the end of HD session to ensure compliance.” NCT05060809 ↗ |
| Known as | Vit-K1 | “The administration of Vitamin K1 (Vit-K1) injection is frequently utilized in clinical practice for managing upper gastrointestinal bleeding (UGIB) associated with liver...” NCT06839352 ↗ |
| Action | Activate | “Vitamin K activates matrix Gla protein (MGP), a key inhibitor of vascular calcification.” PMID 35641194 ↗ Feb 2023 |
| Route | Oral | “10mg orally three times a week for 12 months” NCT01528800 ↗ |
| Target | MGP | “Vitamin K activates matrix Gla protein (MGP), a key inhibitor of vascular calcification.” PMID 35641194 ↗ Feb 2023 |