Drugs / Vitamin K
Vitamin K
also known as
vitamin K1 · phylloquinone · Phytonadione · phytomenadione · KA-Vit Tropfen (phylloquinone) · Konakion · Natto · Vit-K1
targets MGP via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MEPHYTON | — | 1955-09-30 | fda.gov ↗ |
Trials 30 · a red edge is where a trial was stopped
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| 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 18 trials | ||||||
| Phase 1 | NCT04254783 | May 2020 → Oct 2022 | Crohn disease, ulcerative colitis | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT03718884 | Oct 2018 → Oct 2019 | psoriasis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03358706 | Feb 2018 → Nov 2021 | Crohn disease, ulcerative colitis | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT02993471 | Dec 2016 → Nov 2017 | psoriasis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02592317 | Feb → Nov 2016 overdue | castration-resistant prostate carcinoma | Aragon Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01636557 | Oct 2012 → Oct 2013 | rheumatoid arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01001299 | Nov 2009 → Feb 2012 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT00726726 | Aug → Oct 2008 | Alzheimer disease | Bristol-Myers Squibb | Completed | 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 23 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 2 | NCT00290212 | Jan 2006 → Jun 2007 | — | University Hospital of North Norway | Completed | No outcome recorded |
| Phase 35 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 |
| Phase 3 | NCT00143715 | Sep 2004 → Oct 2006 | blood coagulation disease, hemorrhagic disease, thrombotic disease | St. Joseph's Healthcare Hamilton | Completed | No outcome recorded |
| Phase 3 | NCT00183001 | Oct 2001 → Oct 2006 | calcinosis, osteoporosis | National Institute on Aging (NIA) | Completed | No outcome recorded |
| Phase 3 | NCT00062595 | Sep 2000 → Oct 2004 | osteoporosis | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07515664 | Jul 2025 → Aug 2026 overdue | — | University of Michigan | Recruiting | No outcome recorded |
| Phase 4 | NCT06881628 | Dec 2024 → Dec 2025 overdue | cirrhosis of liver, varicose disease | Tanta University | Recruiting | No outcome recorded |
| Phase 4 | NCT05742295 | Feb → Oct 2023 | poisoning | Helwan University | Completed | No outcome recorded |
| Phase 4 | NCT03941535 | May 2019 → Oct 2022 | — | Joseph M. Still Research Foundation, Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT05060809 | Jan 2018 → Jul 2019 | calcinosis | Assiut University | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT05360342 | Mar 2020 → Jul 2021 | vitamin K deficiency hemorrhagic disease | RWTH Aachen University | Completed | No outcome recorded |
| — | NCT04247087 | Sep 2017 → Sep 2019 | calcinosis | Mexican Social Security Institute | Completed | No outcome recorded |
| — | NCT02259647 | Oct 2014 → Oct 2015 | hepatocellular carcinoma | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT00363038 | Jul → Aug 2006 | — | Northwestern University | Completed | No outcome recorded |
| — | NCT00336232 | May 2006 → Jul 2009 | osteoporosis | Tufts University | Completed | No outcome recorded |
| — | NCT00287313 | Oct 2005 → May 2006 | — | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| — | NCT00826254 | Aug 2003 → Apr 2007 | bone disorder, obesity disorder | Oslo University Hospital | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 23 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT07665723 Background | Jun 2026 → Jul 2027 expected | ulcerative colitis | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1 | NCT06975605 Background | May → Jul 2025 | isolated focal cortical dysplasia, tuberous sclerosis | GRIN Therapeutics, Inc. | Completed | No outcome recorded |
| 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 | NCT04246762 Background | Nov 2021 → Jun 2022 | rheumatoid arthritis | R-Pharm International, LLC | 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 | NCT04233437 Background | Feb → May 2020 | stroke disorder | Moleac Pte Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02740712 Background | Apr 2016 → Mar 2017 | neoplasm | pharmaand GmbH | Completed | No outcome recorded |
| Phase 1 | NCT02567682 Background | Sep 2015 → May 2016 | sickle cell disease | Global Blood Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01400646 Background | Oct 2011 → May 2012 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01507051 Background | Nov 2008 → Nov 2009 | venous thromboembolism | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02182336 Background | Jun → Sep 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02243553 Background | Jan → Jul 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02256813 Background | Sep → Dec 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01528800 Comparator | Nov 2012 → Dec 2019 | end stage renal failure | Dr. Rachel Holden | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04477811 Comparator | Jul → Nov 2020 | end stage renal failure | Ain Shams University | Completed | No outcome recorded |
| Phase 2/3 | NCT01232647 Comparator | Apr 2015 → Mar 2020 | postmenopausal osteoporosis | Guy's and St Thomas' NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00990158 Comparator | Jul 2010 → Apr 2014 | blood coagulation disease, hemorrhagic disease, thrombotic disease | St. Joseph's Healthcare Hamilton | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06839352 Comparator | Oct 2022 → Oct 2023 | varicose disease | Zagazig University | Completed | No outcome recorded |
| Phase 4 | NCT00164112 Background | Nov 2004 → Jun 2005 | — | Bassett Healthcare | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT03547895 Comparator | Jun 2015 → May 2016 | cirrhosis of liver | Zagazig University | Completed | No outcome recorded |
| — | NCT00905229 Comparator | May 2009 → Apr 2010 | hemorrhagic disease | HaEmek Medical Center, Israel | Withdrawn | No outcome recorded |
| — | NCT01034124 Comparator | Jan → Nov 2007 | — | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2019-03-17 | Bristol-Myers Squibb | AUGUSTUS Demonstrates Favorable Safety Results of Eliquis® Versus Vitamin K Antagonists in Non-Valvular Atrial Fibrillation Patients with Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention bms.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 55 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | vitamin K | “Drug cocktail comprise of midazolam (2 mg), warfarin (10 mg), vitamin K (10 mg), omeprazole (40 mg), and fexofenadine (30 mg) will be administered on Study Day 1 and 43.” NCT02592317 ↗28“Co-administered drugs include: - Warfarin - 10 mg tablets, midazolam 1 mg, digoxin 0.25 mg, rosuvastatin 10 mg, omeprazole 20 mg, Vitamin K - 10 mg.” NCT06975605 ↗ “Vitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol.” NCT07665723 ↗ “vitamin K (Phytomenadione) 10 mg+ furosemide and spironolactone (Lasilactone) 50 mg + milk thistle (Silymarin) 140 mg + Albumin infusion” NCT03547895 ↗ “Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally” NCT03718884 ↗ “Drug cocktail (caffeine, warfarin + vitamin K, omeprazole, dextromethorphan, midazolam) orally once daily, day 1 and day 20” NCT01001299 ↗ “Tablet: Oral; CYP Substrates: midazolam, caffeine, warfarin, vitamin K, omeprazole and metoprolol” NCT04254783 ↗ “GBT440 capsules followed by Caffeine, S-warfarin+vitamin K, Omeprazole, and Midazolam” NCT02567682 ↗ “Warfarin (10 mg + 10 mg vitamin K orally) with collection of plasma over 96 hours.” NCT00164112 ↗ “Caffeine + Warfarin (plus vitamin K) + Omeprazole + Dextromethorphan + Midazolam” NCT02993471 ↗ “warfarin 10 mg (with vitamin K)” NCT04233437 ↗ “Drug: Vitamin K” NCT01636557 ↗ |
| Known as | KA-Vit Tropfen (phylloquinone) | “KA-Vit Tropfen (phylloquinone)” NCT01742273 ↗ |
| Known as | Konakion | “Drug: Vitamin K (Konakion)” NCT01507051 ↗ |
| Known as | Natto | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00290212 ↗ |
| 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 ↗4“The objective was to determine the effect of phylloquinone (vitamin K1) supplementation on CAC progression in older men and women.” PMID 19386744 ↗ Apr 2009 “phylloquinone (vitamin K1) 500 mcg daily in third month” NCT00336232 ↗ |
| Known as | phytomenadione | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04247087 ↗ |
| Known as | Phytonadione | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00990158 ↗ |
| 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 ↗ |
| 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 ↗20“The objective was to determine the effect of phylloquinone (vitamin K1) supplementation on CAC progression in older men and women.” PMID 19386744 ↗ Apr 2009 “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 ↗ “phylloquinone (vitamin K1) 500 mcg daily in third month” NCT00336232 ↗ “followed by oral Vitamin K1 20mg twice daily for 3month” NCT02259647 ↗ “Phytonadione (Vitamin K1)” NCT00990158 ↗ “Phytonadione (Vitamin K1)” NCT00143715 ↗ |
| Action | Activate | “Vitamin K activates matrix Gla protein (MGP), a key inhibitor of vascular calcification.” PMID 35641194 ↗ Feb 2023 |
| Route | Oral | “1.25 mg given orally” NCT00143715 ↗ |
| Target | MGP | “Vitamin K activates matrix Gla protein (MGP), a key inhibitor of vascular calcification.” PMID 35641194 ↗ Feb 2023 |