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
194619471948194919501951195219531954195519561957195819591960196119621963196419651966196719681969197019711972197319741975197619771978197919801981198219831984198519861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029
| 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 · 1 missed | ||||||
| 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 | Missed primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02961803 | Oct 2014 → Jun 2016 | adrenomyeloneuropathy | MedDay Pharmaceuticals SA | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary · 2 missed | ||||||
| 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 | Missed primary Stop: Business |
| Phase 3 | NCT02220933 | Oct 2013 → Jan 2016 | multiple sclerosis | MedDay Pharmaceuticals SA | Unknown | Met primary |
| Phase 3 | NCT02220244 | Oct 2013 → Dec 2015 | multiple sclerosis | MedDay Pharmaceuticals SA | Unknown | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT07592897 | Jun → Nov 2026 expected | — | University of Sao Paulo | Not yet recruiting | No outcome recorded |
| Phase not applicable3 trials · 1 met primary | ||||||
| — | 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 | Met primary |
| Comparator or background therapy6 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 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 2/3 | NCT00064753 Background | May 2002 → Oct 2011 | cardiovascular disorder, chronic kidney disease | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2023-05-17 | MedDay Pharmaceuticals SA | Results MedDay reports additional positive data of its pivotal Phase III study with MD1003 in patients with Progressive Multiple Sclerosis medday-pharma.com ↗
MedDay reports additional positive data of its pivotal Phase III study with MD1003 in patients with Progressive Multiple Sclerosis |
| 2020-03-10 | MedDay Pharmaceuticals SA | Results MedDay Reports Top-Line Data from Phase III Trial “SPI2” for Treatment of Progressive Forms of Multiple Sclerosis medday-pharma.com ↗
MedDay Pharmaceuticals announced today that the second pivotal Phase III trial (SPI2) of its investigational product MD1003 has not met its primary and secondary endpoints. |
| 2016-09-14 | MedDay Pharmaceuticals SA | Results Positive Preclinical Data with MD1003 (high dose pharmaceutical grade biotin) in X-Linked Adrenoleukodystrophy to be presented at European Committee for Treatment and Research in Multiple Sclerosis 2016 medday-pharma.com ↗
The results show both preclinical safety and efficacy in two mouse models of X-ALD and reveal that MD1003 halted the late-onset axonopathy, which are the main contributors to disability in progressive neurodegenerative diseases such as X-ALD. |
| 2016-09-02 | MedDay Pharmaceuticals SA | Results MedDay Announces Publication of MD1003 Phase IIb/III Study in the Multiple Sclerosis Journal medday-pharma.com ↗
According to the key findings published in the journal,a total of 13 (12.6%) MD1003-treated patients achieved the primary endpoint versus none of the placebo-treated patients (p=0.005). |
| 2016-04-21 | MedDay Pharmaceuticals SA | Results MedDay reports full data from pivotal Phase IIb/III MS-SPI / MS-ON studies with MD1003 in Multiple Sclerosis at AAN medday-pharma.com ↗
Overall these data show the best effect size ever observed to date and confirm the good safety profile of MD1003. |
| 2015-12-01 | MedDay Pharmaceuticals SA | Results MedDay provides update on MS-ON study of MD-1003 medday-pharma.com ↗
Patients who received MD1003 tended to improve slightly more than patients who received the placebo (3 letters mean improvement in the MD1003 arm versus 1.8 letters in the placebo arm) however the difference did not reach statistical significance and overall the study did not meet its primary endpoint. |
| 2015-10-07 | MedDay Pharmaceuticals SA | Results MedDay reports additional positive analyses of its pivotal study with MD1003 in patients with primary and secondary Progressive Multiple Sclerosis medday-pharma.com ↗ |
| 2015-04-24 | MedDay Pharmaceuticals SA | Results MedDay reports positive pivotal Phase III study results with MD1003 in patients with Progressive Multiple Sclerosis medday-pharma.com ↗
MedDay, a biotechnology company focused on the treatment of nervous system disorders, today announced positive results from the pivotal Phase III clinical trial, MS-SPI. |
| 2015-04-24 | MedDay Pharmaceuticals SA | Results MedDay annonce que son étude pivot de phase III sur le MD1003 chez des patients atteints de sclérose en plaques progressive a donné des résultats positifs medday-pharma.com ↗
MedDay, une société biotechnologique axée sur le traitement des troubles du système nerveux, annonce aujourd’hui que les résultats de son étude clinique pivot de phase III, MS-SPI, sont positifs. |
| 2015-04-24 | MedDay Pharmaceuticals SA | Results MedDay annonce avoir atteint le critère principal de son étude pivot de phase III sur le MD1003 chez des patients présentant une sclérose en plaques progressive medday-pharma.com ↗
Paris, France, April 17 2015 – MedDay, une société biotechnologique axée sur le traitement des troubles du système nerveux, annonce aujourd’hui que le critère principal de son essai clinique pivot MS-SPI a été atteint. |
| 2015-04-17 | MedDay Pharmaceuticals SA | Results MedDay announces its pivotal Phase III study of MD1003 in patients with Progressive Multiple Sclerosis meets primary endpoint medday-pharma.com ↗ |
| 2015-01-29 | MedDay Pharmaceuticals SA | Results MedDay Notes Acceptance of Manuscript into Journal of Multiple Sclerosis and Related Disorders medday-pharma.com ↗
The conclusions were that the preliminary data suggest that high doses of biotin may impact disease’s progression and improve clinical sequelae in primary and secondary progressive MS. |
All press releases naming this drug 18 releases
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 NCT02220244 ↗ |
| 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 |