Drugs / Vitamin K
Vitamin K
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 17
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 32 trials · 1 missed | ||||||
| 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 | Missed primary |
| Phase 44 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 not applicable3 trials | ||||||
| — | NCT00363038 | Jul → Aug 2006 | — | Northwestern 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 |
| Comparator or background therapy14 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 | NCT04246762 Background | Nov 2021 → Jun 2022 | rheumatoid arthritis | R-Pharm International, LLC | 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 | Met primary |
| 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 3 | NCT00990158 Comparator | Jul 2010 → Apr 2014 | blood coagulation disease, hemorrhagic disease, thrombotic disease | St. Joseph's Healthcare Hamilton | Completed | No outcome recorded |
| Phase 4 | NCT00164112 Background | Nov 2004 → Jun 2005 | — | Bassett Healthcare | Completed | No outcome recorded |
| — | NCT00905229 Comparator | May 2009 → Apr 2010 | hemorrhagic disease | HaEmek Medical Center, Israel | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT01034124 Comparator | Jan → Nov 2007 | — | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-10-09 | Lupin Limited | Regulatory Lupin Receives U.S. FDA Approval for Phytonadione Injectable Emulsion, USP lupin.com ↗
today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe. |
| 2025-09-01 | Alembic Pharmaceuticals Ltd. | Regulatory 9th September, 2025 Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe. |
| 2019-09-01 | Bristol-Myers Squibb | Results Findings Released from NAXOS, a French Real-World Data Analysis and the Largest Real-World Data Analysis on Oral Anticoagulant Effectiveness and Safety in Europe Among Patients with Non-Valvular Atrial Fibrillation bms.com ↗
Eliquis ® (apixaban) was associated with a lower rate of major bleeding, stroke and systemic thromboembolic events compared to a vitamin K antagonist |
| 2019-02-21 | Zydus Lifesciences Limited | Regulatory Zydus receives final approvals from the USFDA for Phytonadione Tablets and Colchicine Tablets zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Phytonadione Tablets USP (US RLD – Mephyton), 5 mg. |
| 2015-05-14 | Janssen Research & Development, LLC | Results New Data on XARELTO® Versus Vitamin K Antagonists in Atrial Fibrillation Patients Undergoing Catheter Ablation Presented at Heart Rhythm 2015 jnj.com ↗ |
| 2015-03-16 | Boehringer Ingelheim | Results New Data from Boehringer Ingelheim's GLORIA™-AF Registry Show Non-Valvular Atrial Fibrillation (NVAF) Patients at High Risk of Stroke May Be Undertreated prnewswire.com ↗
The most frequently prescribed oral anticoagulants in patients with a CHA 2 DS 2 -VASc score of 2 or higher were vitamin K antagonists (VKAs, e.g., warfarin) |
All press releases naming this drug 9 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 32 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 ↗27“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 ↗ “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 | Konakion | “Drug: Vitamin K (Konakion)” NCT01507051 ↗ |
| Known as | phylloquinone | “The objective was to determine the effect of phylloquinone (vitamin K1) supplementation on CAC progression in older men and women.” PMID 19386744 ↗ Apr 2009 |
| Known as | Phytonadione | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00990158 ↗ |
| Known as | Vitamin K1 | “The objective was to determine the effect of phylloquinone (vitamin K1) supplementation on CAC progression in older men and women.” PMID 19386744 ↗ Apr 2009 |
| Route | Oral | “1.25 mg given orally” NCT00143715 ↗ |