Drugs / Niacinamide
Niacinamide
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BEROCCA PN | — | 1947-07-28 | fda.gov ↗ |
Trials 12
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07286318 | May 2026 → May 2027 expected | actinic keratosis, disease related to solid organ transplantation, skin squamous cell carcinoma | Marissa Lobl | Recruiting | No outcome recorded |
| Phase 0 | NCT03392623 | Jan 2015 → Jan 2016 | hyperpigmentation of the skin | Autonomous University of San Luis Potosí | Completed | No outcome recorded |
| Phase 13 trials · 1 met primary | ||||||
| Phase 1 | NCT05497323 | Aug → Nov 2022 | acne | Indonesia University | Unknown | No outcome recorded |
| Phase 1 | NCT00691210 | Jun 2008 → Feb 2014 | Hodgkins lymphoma, non-Hodgkin lymphoma | Columbia University | Completed | No outcome recorded |
| Phase 1 | NCT00316472 | Apr 2006 → Apr 2007 | hyperphosphatemia | Washington University School of Medicine | Completed | Met primary |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT00508885 | Oct 2006 → Jul 2007 | hyperphosphatemia | Washington University School of Medicine | Completed | Met primary |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT04750616 | Sep 2021 → Apr 2025 overdue | acute kidney injury, ischemic disease | Kaiser Permanente | Recruiting | No outcome recorded |
| Phase 2 | NCT03850886 | Jan → Aug 2019 | NAFLD1 | Ain Shams University | Completed | Missed primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT05446402 | Jun 2022 → May 2023 | acne | Northwestern University | Completed | No outcome recorded |
| Phase 4 | NCT00140166 | Jul 2005 → May 2008 | schizophrenia | Beersheva Mental Health Center | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07618572 | Mar → Oct 2026 expected | hyperpigmentation of the skin | Hospital Israelita Albert Einstein | Recruiting | No outcome recorded |
| — | NCT07121439 | Sep → Nov 2025 overdue | hyperpigmentation of the skin | Indonesia University | Not yet recruiting | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 0 | NCT02701127 Comparator | Mar 2016 → Feb 2017 | acute kidney injury | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT04708340 Comparator | Mar 2021 → Oct 2022 | COVID-19, acute respiratory distress syndrome | Reven Pharmaceuticals, Inc. | Unknown | No outcome recorded |
| Phase 2/3 | NCT00064753 Background | May 2002 → Oct 2011 | cardiovascular disorder, chronic kidney disease | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | Missed primary |
| Phase 4 | NCT01542138 Comparator | Jul 2011 → Nov 2012 | hyperpigmentation of the skin | Autonomous University of San Luis Potosí | Completed | No outcome recorded |
| Phase 4 | NCT02620345 Background | Jan 2010 → Oct 2015 | benign neoplasm of corpus uteri | Trieu, Nguyen Thi, M.D. | Completed | No outcome recorded |
| — | NCT00893724 Comparator | Jun 2009 → Aug 2011 | diabetic macular edema, wet macular degeneration | Mid-Atlantic Retina Consultations, Inc. | Unknown | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | niacinamide | “Active drug comprised of: ascorbic acid, magnesium sulfate heptahydrate, cyanocobalamin, thiamine, riboflavin 5' phosphate, niacinamide, pyridoxine, calcium d-pantothenate, and...” NCT04708340 ↗17“The combination cream consists of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA, were applied every morning by group 2 and group 3.” NCT05497323 ↗ “Brightening Day Cream - SPF 15 (5% Azelaic Acid, 2% Hyaluronic Acid, 1%Niacinamide)” NCT05446402 ↗ “Riboflavin 1.7 mg/day Niacinamide 18 mg/day Pyridoxine Hydrochloride 2.6 mg/day” NCT02620345 ↗ “Nature's Life Niacinamide 1000 mg” NCT03850886 ↗ “Niacinamide: 20 mg” NCT00064753 ↗ |
| Known as | Nicotinamide, nicomide | “Nicotinamide, nicomide” NCT01542138 ↗ |
| Known as | Vitamin B3 | “Molecular Effects of Vitamin B3 (Niacinamide) in Acute Kidney Injury” NCT02701127 ↗ |
| Action | Inhibit | “Niacinamide inhibits intestinal sodium/phosphorus transporters and reduces serum phosphorus in open-label studies.” PMID 18385391 ↗ Apr 2008 |
| Route | Oral | “The Effect of Oral Niacinamide on Serum Phosphorus Levels in Hemodialysis Patients” NCT00316472 ↗ |