CDEK
← All drugs Report issue

beta carotene

Trade name: solatene

Small moleculeapproved

Approved

Jan 1, 1964

Beta-carotene is found in many foods and is sold as a dietary supplement. Beta-carotene is a carotenoid, weak antioxidant; precursor of vitamin A, which is essential for vision and growth. Used to reduce the severity of photosensitivity reactions in patients with erythropoietic protoporphyria (EPP). Has been used in high-dose antioxidant supplements containing ascorbic acid and vitamin E with zinc in high-risk patients with age-related macular degeneration. Beta-carotene is also used to decrease asthma symptoms caused by exercise; to prevent certain cancers, heart disease, cataracts; and to treat AIDS, alcoholism, Alzheimer’s disease, depression, epilepsy, headache, heartburn, high blood pressure, infertility, Parkinson’s disease, rheumatoid arthritis, schizophrenia, and skin disorders including psoriasis and vitiligo. — NCATS

Clinical trial activity

31 trials · 61 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
12
Phase 3
11
Phase 4
3

Earliest trial started Apr 1, 1982 (NCT00000152)

Timeline

1960s

  1. Jan 1, 1964

    Evidence of US Marketing

  2. Jan 1, 1964

    Earliest FDA Approval

1970s

  1. Jun 1, 1975

    Roche — First NDA Organization

  2. Jun 1, 1975

    Roche — NDA Organization

1980s

  1. Jan 1, 1982

    Earliest Phase 3 Sponsor(trial)

1990s

  1. Jan 1, 1993

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJan 1, 1964
  • approvedJan 1, 1964

Chemistry & pharmacology

Loading structure…

SMILES

CC(\C=C\C=C(C)\C=C\C1=C(C)CCCC1(C)C)=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C2=C(C)CCCC2(C)C
Mol. weight
536.8726 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • b-carotene
  • b-carotene
  • betacarotene
  • betacarotene
  • betacarotene
  • betacarotene
  • betacarotene
  • betacarotene
  • betacarotene
  • beta carotene
  • beta carotene
  • beta carotene
  • beta carotene
  • beta carotene
  • beta carotene
  • beta carotene
  • beta carotene
  • beta-carotene
  • beta-carotene
  • beta-carotene
  • beta-carotene
  • beta-carotene
  • beta-carotene
  • betavit
  • betavit
  • eldon
  • gerard
  • gerard
  • golden rose
  • lucaratin
  • lucaratin
  • lumitene
  • nature's plus
  • optimum
  • optimun
  • provatene
  • solatene
  • solatene
  • solatene

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04974450N/AJun 1, 2021University of Hasanuddin
NCT04697355N/AApr 19, 2021Pennington Biomedical Research Center
NCT02422368Phase 2/Phase 3 (Phase 3)Sep 1, 2017Isfahan University
NCT02393183Phase 2/Phase 3 (Phase 3)Sep 1, 2017Isfahan University
NCT03366584Phase 4Jan 31, 2017Persahabatan General Hospital, University of Indonesia
NCT03005496Phase 4Dec 1, 2016University of Indonesia
NCT02421887Phase 2Dec 1, 2015Augusta University, National Institutes of Health (NIH), Pennsylvania State University, University of California, San Francisco, University of Colorado, Denver, University of North Carolina at Chapel Hill, University of Oklahoma, University of Pennsylvania, Yale University
NCT03492593N/ASep 30, 2014Aix-University of Marseille, Government of France, University of Avignon
NCT02714543Phase 3Nov 1, 2013The Oxford Dental College, Hospital and Research Center, Bangalore, India
NCT01803659N/AJan 1, 2013Helen Keller International, University of California, Davis
NCT01666587N/AAug 1, 2012Thompson Rivers University, University of Essex
NCT01695148Phase 3Aug 1, 2012Canadian International Development Agency, HarvestPlus, Johns Hopkins University, National Food and Nutrition Commission, Zambia, Tropical Diseases Research Centre, Zambia, Zambia Agriculture Research Institute
NCT02276014N/AApr 1, 2012DSM, Newcastle University
NCT01469936N/ANov 1, 2011Lescuyer Laboratory, University of Lyon
NCT01381276Phase 2Jun 30, 2011HarvestPlus, United States Department of Agriculture, University of California, Davis
NCT01321268N/AMay 1, 2011DSM, Pontifical Catholic University of Rio Grande do Sul
NCT01477112N/AJan 1, 2010Instituto Venezolano de Investigaciones Cientificas, Seguros Caracas Foundation
NCT00864188Phase 1Feb 1, 2009Nestle
NCT00808470Phase 2Oct 1, 2008Hearing Health Science, Inc., National Institute on Deafness and Other Communication Disorders (NIDCD), Southern Illinois University, University of Florida, University of Michigan
NCT00858273N/AMar 1, 2008Juvenile Diabetes Research Foundation, Thomas Jefferson University
Showing 20 of 31 trials
Page 1 / 2

Organizations

Research & Development (61)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Harvard UniversityAcademic/Hospital3331993
National Cancer Institute (NCI)Government3031985
DSMFor profit2112011
HarvestPlusAcademic/Hospital2022011
Isfahan UniversityAcademic/Hospital2212017
National Eye Institute (NEI)Government2211982
National Heart, Lung, and Blood Institute (NHLBI)Government2121992
University of California, DavisAcademic/Hospital2122011
University of IndonesiaAcademic/Hospital2212016
Aix-University of MarseilleAcademic/Hospital1012014
Augusta UniversityAcademic/Hospital1012015
Bnai Zion Medical CenterAcademic/Hospital1112002
Canadian Cancer Trials GroupAcademic/Hospital1011994
Canadian International Development AgencyAcademic/Hospital1012012
Ernst Moritz Arndt UniversityAcademic/Hospital1012004
Government of FranceGovernment1112014
Hearing Health Science, Inc.For profit1012008
Helen Keller InternationalAcademic/Hospital1012013
Instituto Venezolano de Investigaciones CientificasAcademic/Hospital1112010
Johns Hopkins UniversityAcademic/Hospital1112012
61 organizations
Page 1 / 4

Marketing (1)

OrganizationOrg typeRelationshipDate
RocheFor profitNDAJun 1, 1975