vitamin k
Approved
May 18, 2000
Vitamin K is a family of structurally similar, fat-soluble vitamers found in foods and marketed as dietary supplements. The human body requires vitamin K for post-synthesis modification of certain proteins that are required for blood coagulation and for controlling binding of calcium in bones and other tissues. The complete synthesis involves final modification of these so-called "Gla proteins" by the enzyme gamma-glutamyl carboxylase that uses vitamin K as a cofactor. — Wikipedia
Clinical trial activity
44 trials · 44 clinical orgs · 4 marketing orgs
Earliest trial started Oct 1, 2001 (NCT00183001)
Timeline
2000s
- May 18, 2000
Novartis — Earliest FDA Approval
- May 18, 2000
Sandoz — NDA Secondary Org
- May 18, 2000
Novartis — NDA Secondary Org
- May 18, 2000
Novartis — NDA Organization
- Jan 1, 2001
Earliest Phase 3 Sponsor(trial)
- Jan 30, 2004
Hospira — NDA Secondary Org
- Jan 1, 2005
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2006
Earliest Phase 1 Sponsor(trial)
2020s
- Apr 9, 2026
Apotex — Marketing Organization
Indications
Approved for
Studied for
- Arthritis, Rheumatoid · Phase 1
- Burns · Phase 4
- Cerebral Hemorrhage · Phase 2
- Dermatitis, Atopic · Early Phase 1
- Diabetes Mellitus, Type 2 · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Esophageal and Gastric Varices · Phase 4
- Fibrosis · Phase 4
- Healthy Volunteers · Phase 4
- Hepatitis B, Chronic · Phase 1
- Inflammation · Phase 3
- Melanoma · Phase 1
- Multiple Sclerosis, Relapsing-Remitting · Phase 4
- Neoplasm Metastasis · Phase 1
- Neoplasms · Phase 1
- Osteoporosis · Phase 3
- Prostatic Neoplasms, Castration-Resistant · Phase 1
- Psoriasis · Phase 1
- Vascular Calcification · Phase 3
- Venous Thrombosis · Phase 1
- Volunteers · Phase 1
Mechanism of action
GGCX activator
Combination products
infuvite
with vitamin d3, vitamin e, folic acid, cyanocobalamin, vitamin c, nicotinamide, thiamine, biotin, panthenol, pyridoxine, riboflavin, vitamin a
Also known as infuvite pediatric, infuvite pediatric (pharmacy bulk package)
m.v.i. adult (pharmacy bulk package)
with vitamin e, folic acid, cyanocobalamin, vitamin c, nicotinamide, thiamine, biotin, panthenol, pyridoxine, riboflavin, vitamin a, ergocalciferol
Approval history
- approvedMay 18, 2000
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaVitamin K ↗
- ChEMBLCHEMBL1201519 ↗
Also known as
- vitamin k
- vitamin k
- vitamin k
- vitamin k
- vitamin k
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07041645 | N/A | Jul 1, 2025 | Technical University of Denmark, University of Copenhagen |
| NCT06855953 | N/A | Mar 17, 2025 | University of Montreal |
| NCT06881628 | Phase 4 | Dec 2, 2024 | Tanta University |
| NCT05891119 | Early Phase 1 (Phase 1) | Jun 3, 2023 | Amgen |
| NCT05742295 | Phase 4 | Feb 25, 2023 | Helwan University |
| NCT05505552 | N/A | Jan 1, 2023 | Tufts University, University of North Carolina at Chapel Hill |
| NCT05392127 | Phase 1 | Jul 15, 2022 | Hengrui Therapeutics, Inc. |
| NCT05273775 | Phase 1 | Apr 29, 2022 | Hengrui Therapeutics, Inc. |
| NCT04984083 | N/A | Jul 30, 2021 | Minia University, National Research Center, Egypt |
| NCT04669782 | N/A | Nov 24, 2020 | University of Milano Bicocca |
| NCT04496921 | N/A | Aug 10, 2020 | McGill University, University of Montreal |
| NCT04285450 | Phase 4 | Jun 30, 2020 | Cairo University |
| NCT04676035 | Phase 1 | Jun 1, 2020 | Hengrui Therapeutics, Inc. |
| NCT04246762 | Phase 1 | Mar 1, 2020 | IQVIA, R-Pharm, Thermo Fisher Scientific |
| NCT03941535 | Phase 4 | Apr 29, 2019 | Joseph M. Still Research Foundation, Inc. |
| NCT03493087 | N/A | Feb 22, 2018 | University of Copenhagen |
| NCT03363815 | Phase 1 | Dec 4, 2017 | Celgene |
| NCT04450212 | N/A | Aug 25, 2017 | National Institute of General Medical Sciences (NIGMS), University of Washington |
| NCT03091569 | Phase 4 | Mar 10, 2017 | Biogen |
| NCT02993471 | Phase 1 | Dec 1, 2016 | Eli Lilly |
Organizations
Research & Development (44)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Johnson and Johnson | For profit | 5 | 2 | 2 | 2004 |
| Hengrui Therapeutics, Inc. | For profit | 3 | 3 | 1 | 2020 |
| Tufts University | Academic/Hospital | 3 | 2 | 2 | 2001 |
| University of North Carolina at Chapel Hill | Academic/Hospital | 3 | 2 | 1 | 2005 |
| Bayer | For profit | 2 | 1 | 1 | 2008 |
| Biogen | For profit | 2 | 2 | 2 | 2011 |
| Boehringer Ingelheim | For profit | 2 | 2 | 1 | 2006 |
| Eli Lilly | For profit | 2 | 2 | 1 | 2016 |
| Maastricht University | Academic/Hospital | 2 | 2 | 1 | 2007 |
| University of Copenhagen | Academic/Hospital | 2 | 2 | 1 | 2018 |
| University of Montreal | Academic/Hospital | 2 | 1 | 1 | 2020 |
| Amgen | For profit | 1 | 1 | 1 | 2023 |
| Aragon Pharmaceuticals | For profit | 1 | 1 | 1 | 2016 |
| Arthritis Foundation | Academic/Hospital | 1 | 0 | 1 | 2001 |
| Bassett Healthcare | Academic/Hospital | 1 | 1 | 1 | 2004 |
| Cairo University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Celgene | For profit | 1 | 1 | 1 | 2017 |
| Clovis Oncology | For profit | 1 | 1 | 1 | 2016 |
| Daiichi Sankyo | For profit | 1 | 1 | 1 | 2011 |
| Helwan University | Academic/Hospital | 1 | 1 | 1 | 2023 |