Drugs / Nicotinamide
Nicotinamide
also known as
niacinamide · NAM · Vitamin B3 · CICR-NAM · Nicotinamide, nicomide · Sirtuin Histone deacetylase inhibitor · vitamin PP
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 49 · a red edge is where a trial was stopped
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 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 | NCT05702398 | Apr 2023 → Jan 2028 expected | disease related to solid organ transplantation, skin cancer | Rhode Island Hospital | Recruiting | No outcome recorded |
| Phase 0 | NCT05362188 | Mar → Sep 2022 | discoid lupus erythematosus | Al-Azhar University | Completed | 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 18 trials | ||||||
| Phase 1 | NCT07585006 | May → Dec 2026 expected | cancer, substance dependence | Ohio State University Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT07258667 | Apr 2026 → Apr 2028 expected | Leber hereditary optic neuropathy | University Hospital, Angers | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05497323 | Aug → Nov 2022 | acne | Indonesia University | Unknown | No outcome recorded |
| Phase 1 | NCT05258474 | Dec 2020 → Mar 2022 | — | University Hospital Schleswig-Holstein | Completed | No outcome recorded |
| Phase 1 | NCT04055818 | Jan 2020 → Oct 2026 expected | sickle cell disease | EpiDestiny, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT02213094 | Jan 2014 → Dec 2015 | preeclampsia | University of North Carolina, Chapel Hill | Completed | 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 | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05083546 | Dec 2024 → Dec 2025 | obesity disorder | University of California, San Francisco | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT00580931 | Jan 2008 → Jul 2014 | Alzheimer disease | University of California, Irvine | Completed | No outcome recorded |
| Phase 1/2 | NCT00508885 | Oct 2006 → Jul 2007 | hyperphosphatemia | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT06805656 | Jul 2026 → Jan 2027 expected | HIV infectious disease | Federal University of São Paulo | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06465602 | May → Nov 2024 | — | University of Chile | Unknown | No outcome recorded |
| Phase 2 | NCT06640309 | Dec 2023 → Jun 2025 overdue | rheumatoid arthritis | Ain Shams University | Recruiting | No outcome recorded |
| Phase 2 | NCT04244630 | Nov 2023 → Dec 2025 overdue | amyotrophic lateral sclerosis | Dallas VA Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04844528 | Feb 2022 → Aug 2026 overdue | B-cell chronic lymphocytic leukemia, skin cancer | University of Utah | Recruiting | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT03769285 | Dec 2018 → Dec 2023 | basal cell carcinoma, skin cancer, squamous cell carcinoma | Women's College Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03419364 | Nov 2017 → Aug 2021 | preeclampsia | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT03260166 | Aug 2017 → Jan 2020 | cutaneous lupus erythematosus, systemic lupus erythematosus | Second Xiangya Hospital of Central South University | Unknown | No outcome recorded |
| Phase 2 | NCT03061474 | Jul 2017 → Aug 2022 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | University of California, Irvine | Completed | No outcome recorded |
| Phase 2 | NCT02258074 | Mar 2015 → Nov 2018 | chronic kidney disease | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 2 | NCT01589809 | Jun 2012 → Jun 2015 | neurodegenerative disease | Imperial College London | Unknown | No outcome recorded |
| Phase 2 | NCT01200784 | Aug 2010 → Jun 2011 | chronic kidney disease, hyperphosphatemia | Medice Arzneimittel Pütter GmbH & Co KG | Completed | No outcome recorded |
| Phase 2/36 trials | ||||||
| Phase 2/3 | NCT06488625 | Sep 2024 → Oct 2027 expected | ulcerative colitis | University Hospital Schleswig-Holstein | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06007391 | Jan 2024 → Sep 2026 expected | poisoning | University Hospital, Angers | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05695027 | Mar 2023 → Aug 2027 expected | open-angle glaucoma | Columbia University | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT03268902 | Sep 2017 → Feb 2020 | intestinal infectious disease, nutritional deficiency disease | Haydom Lutheran Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT02416739 | Mar 2015 → Mar 2020 | non-small cell lung carcinoma | Il Yeong Park, Ph.D. | Unknown | No outcome recorded |
| Phase 2/3 | NCT01763424 | Jul 2011 → Dec 2012 | psoriasis | Isfahan University of Medical Sciences | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT05405868 | Jan 2024 → Apr 2027 expected | open-angle glaucoma | University College, London | Recruiting | No outcome recorded |
| Phase 3 | NCT05955924 | Aug 2023 → Aug 2027 expected | basal cell carcinoma, epithelial skin neoplasm, skin cancer, squamous cell carcinoma | Women's College Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05513807 | Jan 2023 → Feb 2024 | — | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT04631484 | Nov 2020 → May 2024 | brain injury | POLYSAN Scientific & Technological Pharmaceutical Company | Completed | No outcome recorded |
| Phase 3 | NCT04589546 | Oct 2020 → Sep 2025 overdue | acute kidney injury, infectious disease with sepsis | Centre Hospitalier Universitaire, Amiens | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00116207 | Jan 2000 → Sep 2009 | diabetic autonomic neuropathy | University of Michigan | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT05446402 | Jun 2022 → May 2023 | acne | Northwestern University | Completed | No outcome recorded |
| Phase 4 | NCT03626298 | Aug → Dec 2016 | acne | Rumah Sakit Pusat Angkatan Darat Gatot Soebroto | Completed | No outcome recorded |
| Phase 4 | NCT00140166 | Jul 2005 → May 2008 | schizophrenia | Beersheva Mental Health Center | Completed | No outcome recorded |
| Phase not applicable5 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 |
| — | NCT04910230 | Mar → Apr 2020 | COVID-19, lymphopenia | Qiang Hu | Completed | No outcome recorded |
| — | NCT04012177 | Jul 2019 → Sep 2022 | protein-energy malnutrition | Vital Pakistan Trust | Unknown | No outcome recorded |
| — | NCT02961829 | Jul 2015 → Mar 2019 | HIV infectious disease | Federal University of São Paulo | Completed | No outcome recorded |
Also used as a comparator or background therapy in 19 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04843553 Comparator | Oct 2016 → Feb 2019 | actinic keratosis | Rhode Island Hospital | Completed | No outcome recorded |
| Phase 0 | NCT02701127 Comparator | Mar 2016 → Feb 2017 | acute kidney injury | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT06882096 Comparator | Apr 2025 → Dec 2026 expected | — | Metro International Biotech, LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT07049068 Comparator | Feb 2022 → Nov 2024 | actinic keratosis | Federal University of Rio Grande do Sul | Completed | No outcome recorded |
| Phase 1 | NCT03136705 Comparator | Feb 2016 → Dec 2017 | — | Northwestern University | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04708340 Comparator | Mar 2021 → Oct 2022 | COVID-19, acute respiratory distress syndrome | Reven Pharmaceuticals, Inc. | Unknown | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06599918 Comparator | Apr 2024 → Dec 2027 expected | NAFLD1, fibrotic liver disease, obesity disorder | Sant Pau Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT03761511 Comparator | Apr 2023 → Jun 2025 | Friedreich ataxia | RWTH Aachen University | Withdrawn | No outcome recorded |
| Phase 2 | NCT05790577 Comparator | Feb 2022 → Feb 2023 | hyperpigmentation of the skin | Ishtiaq Ahmed | Completed | No outcome recorded |
| Phase 2 | NCT01368887 Comparator | Apr → Nov 2013 | psoriasis | DermiPsor, Ltd. | Suspended | No outcome recorded |
| Phase 2/31 trial | ||||||
| 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 | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01295450 Comparator | Apr → Aug 2011 | eating disorder | MDCPharma Produtos Farmaceuticos LTDA | Unknown | No outcome recorded |
| Phase 3 | NCT01011699 Comparator | Jan 2010 → Jun 2013 | chronic renal failure syndrome | Centre Hospitalier Universitaire, Amiens | Terminated | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07655791 Comparator | Jul → Oct 2026 expected | infectious disease with sepsis | Ain Shams University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07296354 Comparator | Jan 2026 → Feb 2028 expected | neuropathy, painful | Egyptian International Pharmaceutical Industries Co | Not yet recruiting | No outcome recorded |
| 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 |
| Phase not applicable2 trials | ||||||
| — | NCT01085981 Comparator | Apr → Jun 2010 | sexual disorder | East Suburban Ob Gyn | Unknown | 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 11 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nicotinamide | “Apevinat BC presents in its formula the cyproheptadine hydrochloride (0,800 mg), tiamin hydrochloride(0,120 mg), Riboflavin sodium phosphate (0,200 mg), nicotinamide (1,334 mg,...” NCT01295450 ↗48“Mothers in the nicotinamide arm will be given nicotinamide 250 mg daily from delivery through 6 months post-partum in capsule form.” NCT03268902 ↗ “Over-the-counter anti-oxidants, namely vitamin E, NAc cysteine, L-cystine, Nicotinamide and Taurursodiol at defined doses” NCT04244630 ↗ “MGO cocktail containing a combination of alpha-lipoic acid, nicotinamide, thiamine, pyridoxamine, and piperine” NCT05083546 ↗ “antioxidant treatment with allopurinol, α-lipoic acid and nicotinamide, or placebo.” PMID 23740194 ↗ Jun 2013 “Nicotinamide (Vitamin B3) - 20 mg Vitamin B12 (Cyanocobalamin) - 500 mcg” NCT07296354 ↗ “Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM)” NCT06488625 ↗ “Nicotinamide tablets (750mg)” NCT05405868 ↗ “Nicotinamide” NCT06805656 ↗ |
| Known as | CICR-NAM | “Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM)” NCT06488625 ↗ |
| Known as | NAM | “lanthanum carbonate (LC; a phosphate binder) and/or nicotinamide (NAM; an inhibitor of active intestinal phosphate transport)” PMID 31085679 ↗ May 20196“Administration of the active compound, the amide form of vitamin B3, Nicotinamide (NAM).” NCT06599918 ↗ “We are testing oral nicotinamide (NAM)-a B-vitamin compound-for that purpose.” NCT04843553 ↗ “Nicotinamide (NAM), also known as vitamin PP or as a vitamin B3 analog” NCT05513807 ↗ “oral nicotinamide (NAM; a derivative of vitamin B3 \[niacin\])” NCT05702398 ↗ “Nicotinamide (NAM) is a form of Vitamin B3” NCT05405868 ↗ “Nicotinamide (NAM)” NCT06882096 ↗ |
| Known as | niacinamide | “Active drug comprised of: ascorbic acid, magnesium sulfate heptahydrate, cyanocobalamin, thiamine, riboflavin 5' phosphate, niacinamide, pyridoxine, calcium d-pantothenate, and...” NCT04708340 ↗19“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 ↗ “providing vitamin B3 as nicotinamide/niacinamide” NCT03268902 ↗ “Nicotinamide 1000 mg (Niacinamide)” NCT07655791 ↗ “Nature's Life Niacinamide 1000 mg” NCT03850886 ↗ “Niacinamide: 20 mg” NCT00064753 ↗ |
| Known as | Nicotinamide, nicomide | “Nicotinamide, nicomide” NCT01542138 ↗ |
| Known as | Sirtuin Histone deacetylase inhibitor | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02961829 ↗ |
| Known as | Vitamin B3 | “All participants receive nicotinamide (vitamin B3) at a dose of 2 grams per day for 12 months.” NCT07258667 ↗3“Oral nicotinamide (Vitamin B3) alone compared to THU Decitabine combination” NCT04055818 ↗ “Molecular Effects of Vitamin B3 (Niacinamide) in Acute Kidney Injury” NCT02701127 ↗ “Nicotinamide (Vitamin B3) - 20 mg” NCT07296354 ↗ |
| Known as | vitamin PP | “Nicotinamide (NAM), also known as vitamin PP or as a vitamin B3 analog” NCT05513807 ↗ |
| Action | Inhibit | “Niacinamide inhibits intestinal sodium/phosphorus transporters and reduces serum phosphorus in open-label studies.” PMID 18385391 ↗ Apr 2008 |
| Modality | Other / unclassified | “nicotinamide (NA), a B3 vitamin” NCT00580931 ↗ |
| Route | Oral | “The Effect of Oral Niacinamide on Serum Phosphorus Levels in Hemodialysis Patients” NCT00316472 ↗ |