Drugs / Biotin
Biotin
also known as
MD1003 · d-biotin · Bioepiderm · Biotin 100 · Biotin component of vitaped · Biotina · Biotine · hdPB · +6 more
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 15 · a red edge is where a trial was stopped
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07513532 | Apr → Aug 2026 overdue | — | Bloodworks | Recruiting | No outcome recorded |
| Phase 1 | NCT04223232 | Dec 2019 → Jan 2020 | — | MedDay Pharmaceuticals SA | Completed | No outcome recorded |
| Phase 1 | NCT04168723 | Nov 2019 → Mar 2020 | — | MedDay Pharmaceuticals SA | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03269045 | Aug 2013 → Jan 2018 | biotinidase deficiency | Orpha Labs | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04478734 | Apr 2023 → Jun 2025 overdue | Huntington disease | Andalusian Public Foundation for Health Research in Seville | Recruiting | No outcome recorded |
| Phase 2 | NCT02967679 | Dec 2016 → Mar 2019 | Charcot-Marie-Tooth disease type 1A, Charcot-Marie-Tooth disease type 1B, polyneuropathy associated with IgM monoclonal gammapathy with anti-MAG, polyneuropathy, inflammatory demyelinating, chronic | MedDay Pharmaceuticals SA | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02961803 | Oct 2014 → Jun 2016 | adrenomyeloneuropathy | MedDay Pharmaceuticals SA | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05632549 | Aug 2022 → Aug 2024 | asthma | Tanta University | Unknown | No outcome recorded |
| Phase 3 | NCT02936037 | Dec 2016 → Nov 2019 | multiple sclerosis | MedDay Pharmaceuticals SA | Terminated | No outcome recorded |
| Phase 3 | NCT02220244 | Oct 2013 → Dec 2015 | multiple sclerosis | MedDay Pharmaceuticals SA | Unknown | No outcome recorded |
| Phase 3 | NCT02220933 | Oct 2013 → Jan 2016 | multiple sclerosis | MedDay Pharmaceuticals SA | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07592897 | Jun → Nov 2026 expected | — | University of Sao Paulo | Not yet recruiting | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT01474486 | Apr 2010 → Feb 2016 | cardiomyopathy, congestive heart failure | Phoenix VA Health Care System | Completed | No outcome recorded |
| — | NCT00308451 | Nov 2003 → Apr 2004 | type 2 diabetes mellitus | Nutrition 21, Inc. | Completed | No outcome recorded |
| — | NCT00289354 | Mar 2003 → Nov 2005 | type 2 diabetes mellitus | Nutrition 21, Inc. | Completed | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04252417 Comparator | Oct 2019 → Mar 2020 | — | MedDay Pharmaceuticals SA | Terminated | No outcome recorded |
| Phase 1 | NCT04252430 Comparator | Oct 2019 → Mar 2020 | impaired renal function disease | MedDay Pharmaceuticals SA | Terminated | No outcome recorded |
| Phase 1 | NCT01572506 Comparator | Mar 2012 → Jul 2015 | anemia | National Institute on Aging (NIA) | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03427086 Comparator | Jan 2018 → May 2021 | amyotrophic lateral sclerosis | American University of Beirut Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03114215 Comparator | Jun 2016 → Jun 2017 | amyotrophic lateral sclerosis | MedDay Pharmaceuticals SA | Completed | 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 |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | biotin | “The investigational product was high-dose pharmaceutical-grade biotin (100 mg taken orally three times a day over a maximum of 52 weeks.” PMID 37899433 ↗ Oct 20239“50 mcg cyanocobalamin (B12) and biotin” NCT01474486 ↗ “Biotin (as d-biotin) - 45 mcg” NCT07592897 ↗ |
| Known as | Bioepiderm | ChEMBL registry synonym — accepted as the source's own label CHEMBL857 ↗ |
| Known as | Biotin 100 | ChEMBL registry synonym — accepted as the source's own label CHEMBL857 ↗ |
| Known as | Biotin component of vitaped | ChEMBL registry synonym — accepted as the source's own label CHEMBL857 ↗ |
| Known as | Biotina | ChEMBL registry synonym — accepted as the source's own label CHEMBL857 ↗ |
| Known as | Biotine | ChEMBL registry synonym — accepted as the source's own label CHEMBL857 ↗ |
| Known as | d-biotin | “Biotin (as d-biotin) - 45 mcg” NCT07592897 ↗1“d-Biotin: 300 mcg” NCT00064753 ↗ |
| Known as | hdPB | “It was recently shown that MD1003 (high-dose pharmaceutical-grade biotin or hdPB) may improve disability in patients with progressive MS.” PMID 29808469 ↗ Jul 2018 |
| Known as | high-dose biotin | “Safety and efficacy of MD1003 (high-dose biotin)” PMID 33222767 ↗ Oct 2020 |
| Known as | high-dose pharmaceutical-grade biotin | “It was recently shown that MD1003 (high-dose pharmaceutical-grade biotin or hdPB) may improve disability in patients with progressive MS.” PMID 29808469 ↗ Jul 2018 |
| Known as | MD1003 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04252430 ↗ |
| Known as | NSC-63865 | ChEMBL registry synonym — accepted as the source's own label CHEMBL857 ↗ |
| Known as | ORL-1B | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03269045 ↗ |
| Known as | Ritatin | ChEMBL registry synonym — accepted as the source's own label CHEMBL857 ↗ |
| Known as | Vitamin b7 | ChEMBL registry synonym — accepted as the source's own label CHEMBL857 ↗ |
| Action | Activate | “biotin activates acetylCoA carboxylase” PMID 25787192 ↗ Jan 2015 |
| Modality | Small molecule | — CHEMBL857 ↗ |
| Route | Oral | “Adult patients with MS-related chronic visual loss of at least one eye [visual acuity (VA) below 0.5 decimal chart] were randomized 2:1 to oral MD1003 300 mg/day or placebo.” PMID 29808469 ↗ Jul 2018 |