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biotin

Small moleculeapproved

Approved

Jul 28, 1947

Biotin (also known as vitamin H and vitamin B7) is a water-soluble vitamin which is required for normal cellular functions, growth and development. Biotin is an important cofactor for many mitochondria and cytoplasm enzymes: acetyl-CoA carboxylase a (ACCa),7 ACCb, pyruvate carboxylase (PC), propionyl-CoA carboxylase (PCC), and methylcrotonyl-CoA carboxylase (MCC) and plays critical role in in the intermediate metabolism of gluconeogenesis, fatty acid synthesis, and amino acid catabolism. The vitamin cannot be synthesized by humans and must be obtained from diet. If there is a lack of biotin, an organism starts suffering from biotin deficiency, a condition which is very common among pregnant women, for example. The vitamin deficiency effects hair, nail growth and skin health. For preventing measures, biotin should be taken as a dietary supplement (in a form of vitamin complex or as a pure biotin) which are marketed worldwide under different names. Biotin is a part of many formulations which were approved by FDA. — NCATS

Clinical trial activity

31 trials · 36 clinical orgs · 8 marketing orgs

Phase 1
7
Phase 2
9
Phase 3
6
Phase 4
1

Earliest trial started Mar 1, 2003 (NCT00289354)

Timeline

1940s

  1. Jul 28, 1947

    Roche — Earliest FDA Approval

  2. Jul 28, 1947

    Roche — NDA Secondary Org

  3. Jul 28, 1947

    Roche — NDA Organization

1950s

  1. Feb 20, 1953

    Hospira — NDA Secondary Org

1980s

  1. Nov 6, 1981

    Abraxis — NDA Secondary Org

  2. Jul 13, 1982

    Watson Pharmaceuticals — NDA Secondary Org

2000s

  1. May 18, 2000

    Sandoz — NDA Secondary Org

  2. May 18, 2000

    Novartis — NDA Secondary Org

2010s

  1. Jan 1, 2013

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2014

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2016

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Apr 9, 2026

    Apotex — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • lysineBINDING AGENT

    lysine binding agent

Combination products

Approval history

  • approvedJul 28, 1947

Chemistry & pharmacology

Loading structure…

SMILES

OC(=O)CCCC[C@@H]1SC[C@@H]2NC(=O)N[C@H]12
Mol. weight
244.311 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • (3as,4s,6ar)-hexahydro-2-oxo-1h-thieno[3,4-d]imidazole-4-valeric acid
  • (3as,4s,6ar)-hexahydro-2-oxo-1h-thieno[3,4-d]imidazole-4-valeric acid
  • 5-(2-oxohexahydro-1h-thieno[3,4-d]imidazol-4-yl)pentanoic acid
  • 5-(2-oxohexahydro-1h-thieno[3,4-d]imidazol-4-yl)pentanoic acid
  • bioepiderm
  • bioepiderm
  • biotin
  • biotin
  • biotin
  • biotin
  • biotin
  • biotin
  • biotin
  • biotin
  • biotin
  • biotin
  • biotin 100
  • biotina
  • biotina
  • biotine
  • biotine
  • biotinum
  • biotinum
  • (+)-cis-hexahydro-2-oxo-1h-thieno[3,4]imidazole-4-valeric acid
  • (+)-cis-hexahydro-2-oxo-1h-thieno[3,4]imidazole-4-valeric acid
  • cis-hexahydro-2-oxo-1h-thieno(3,4)imidazole-4-valeric acid
  • cis-hexahydro-2-oxo-1h-thieno(3,4)imidazole-4-valeric acid
  • cis-tetrahydro-2-oxothieno(3,4-d)imidazoline-4-valeric acid
  • cis-tetrahydro-2-oxothieno(3,4-d)imidazoline-4-valeric acid
  • cis-(+)-tetrahydro-2-oxothieno[3,4]imidazoline-4-valeric acid
  • cis-(+)-tetrahydro-2-oxothieno[3,4]imidazoline-4-valeric acid
  • coenzyme r
  • coenzyme r
  • coenzyme r
  • d-biotin
  • d-biotin
  • d-biotin
  • d-(+)-biotin
  • d-(+)-biotin
  • d(+)-biotin
  • d(+)-biotin
  • vitamin b7
  • vitamin b7
  • vitamin b7
  • vitamin h
  • vitamin h
  • vitamin h

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06556056N/AJun 30, 2024NovoBliss Research Pvt Ltd
NCT06605768N/AFeb 19, 2024Nutra Harmony LLC
NCT06174441N/AJan 31, 2024Higher School of Applied Sciences (VIST), Slovenian Research Agency, Tosla d.o.o.
NCT06010745N/AAug 11, 2023Nutrition 21, Inc.
NCT05832190N/AApr 30, 2023Assistance Publique - Hôpitaux de Paris
NCT05800496N/AOct 31, 2022Innovaderm, NovoBliss Research Pvt Ltd
NCT05632549Phase 3Aug 8, 2022Tanta University
NCT05450900Early Phase 1 (Phase 1)Jul 5, 2022Sports Medicine Research and Testing Laboratory
NCT04478734Phase 2Jan 1, 2022Centro de Investigación Biomédica en Red (CIBER), Fundación Pública Andaluza, University of Seville, Virgen del Rocío University Hospital, Seville
NCT04476277Early Phase 1 (Phase 1)Apr 19, 2021National Heart, Lung, and Blood Institute (NHLBI)
NCT04223232Phase 1Dec 10, 2019MedDay Pharmaceuticals, Quotient
NCT04168723Phase 1Nov 11, 2019ERT Clinical, MedDay Pharmaceuticals, Parexel
NCT04252417Phase 1Oct 11, 2019Eurofins, MedDay Pharmaceuticals
NCT04252430Phase 1Oct 9, 2019Eurofins, MedDay Pharmaceuticals
NCT03995277Phase 4Jan 11, 2019University of Hamburg
NCT03746821N/ANov 7, 2018SPD Development Company Limited
NCT03427086Phase 2Jan 29, 2018American University of Beirut
NCT03300440N/AJun 21, 2017Medical University of Graz
NCT02936037Phase 3Dec 1, 2016MedDay Pharmaceuticals, University of California, San Francisco
NCT03052413N/ADec 1, 2016Sadick Research Group
Showing 20 of 31 trials
Page 1 / 2

Organizations

Research & Development (36)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MedDay PharmaceuticalsFor profit101032013
Nutrition 21, Inc.For profit3312003
EurofinsFor profit2012019
Hoosier Cancer Research NetworkAcademic/Hospital2112006
Hopital Maison BlancheAcademic/Hospital2012013
NovoBliss Research Pvt LtdFor profit2212022
Alpha Therapy CenterAcademic/Hospital1012003
American University of BeirutAcademic/Hospital1112018
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112023
Boston UniversityAcademic/Hospital1012016
Centro de Investigación Biomédica en Red (CIBER)Academic/Hospital1012022
ERT ClinicalFor profit1012019
Fundación Pública AndaluzaAcademic/Hospital1112022
Heidi Moretti, MS, RDAcademic/Hospital1112006
Higher School of Applied Sciences (VIST)Academic/Hospital1112024
InnovadermFor profit1012022
Johns Hopkins UniversityAcademic/Hospital1012016
Medical University of GrazAcademic/Hospital1112017
National Heart, Lung, and Blood Institute (NHLBI)Government1112021
Nutra Harmony LLCFor profit1112024
36 organizations
Page 1 / 2

Marketing (9)

OrganizationOrg typeRelationshipDate
AbraxisFor profitNDA2Nov 6, 1981
ApotexFor profitMKTGApr 9, 2026
HospiraFor profitNDA2Feb 20, 1953
NovartisFor profitNDA2May 18, 2000
RocheFor profitNDA2Jul 28, 1947
RocheFor profitNDAJul 28, 1947
SandozFor profitNDA2May 18, 2000
Teligent PharmaceuticalsFor profitNDA2—
Watson PharmaceuticalsFor profitNDA2Jul 13, 1982