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folic acid

Small moleculeapproved

Approved

Aug 13, 1946

Folic Acid is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of Folic Acid are present in a wide variety of foods, particularly liver, kidneys, yeast and leafy green vegetables. Commercially available Folic Acid is prepared synthetically. Folic Acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Aqueous solutions of Folic Acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. Folic Acid is effective in the treatment of megaloblastic anemias due to a deficiency of Folic Acid (as may be seen in tropical or nontropical sprue) and in anemia of nutritional origin, pregnancy, infancy, or childhood. Folic Acid is relatively nontoxic in man. Rare instances of allergic responses to Folic Acid preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. Endocyte is developing an intravenous (IV) formulation of folic acid, called Neocepri®, which is intended for the diagnosis of positive folate receptor-positive status in patients with ovarian cancer when administered prior to the radioactive medicine, technetium Tc99m Etarfolatide. The benefits of Neocepri® are its ability to reduce the background activity observed on single photon emission computed tomography (SPECT) imaging in most normal, nontarget tissues (e.g. intestines, liver, kidney, spleen), thereby improving the image quality of the scans. The product had been granted orphan drug designation in the EU. Endocyte had filed a conditional marketing authorization application (CMA) with the European Medicines Agency (EMA) for Neocepri®. — NCATS

Clinical trial activity

382 trials · 450 clinical orgs · 52 marketing orgs

Phase 1
37
Phase 2
136
Phase 3
75
Phase 4
63

Earliest trial started Feb 1, 1992 (NCT00272324)

Timeline

1940s

  1. Aug 13, 1946

    Earliest FDA Approval

  2. Aug 13, 1946

    Lederle — Marketing Organization

  3. Aug 13, 1946

    American Cyanamid — NDA Secondary Org

  4. Jun 2, 1947

    Eli Lilly — NDA Secondary Org

  5. Jun 5, 1947

    Wyeth — NDA Secondary Org

  6. Jun 5, 1947

    American Home Products — NDA Secondary Org

  7. Jul 28, 1947

    Roche — Marketing Organization

  8. Jul 28, 1947

    Roche — NDA Secondary Org

1950s

  1. Feb 20, 1953

    Hospira — Marketing Organization

  2. Feb 20, 1953

    Hospira — NDA Secondary Org

1970s

  1. Dec 23, 1971

    Watson Pharmaceuticals — Marketing Organization

  2. Mar 31, 1972

    Hikma — Marketing Organization

  3. Oct 2, 1972

    Teva — Marketing Organization

  4. Nov 2, 1972

    Puracap Pharmaceutical — Marketing Organization

  5. Mar 20, 1973

    Everylife Foundation for Rare Diseases — Marketing Organization

  6. Apr 24, 1973

    Tablicaps — Marketing Organization

  7. Jul 20, 1973

    Impax Laboratories — Marketing Organization

  8. Jul 31, 1973

    Whiteworth Towne Paulsen — Marketing Organization

  9. Nov 13, 1973

    MK Labs — Marketing Organization

  10. May 8, 1974

    Lannett Company, Inc. — Marketing Organization

  11. Feb 4, 1976

    Nexgen Pharma, Inc — Marketing Organization

  12. Jun 16, 1976

    Sandoz — Marketing Organization

  13. Jul 29, 1976

    Contract Pharmacal — Marketing Organization

1980s

  1. Jul 30, 1981

    Mission Pharmacal — Marketing Organization

  2. Nov 6, 1981

    Abraxis — Marketing Organization

  3. Nov 6, 1981

    Abraxis — NDA Secondary Org

  4. May 13, 1982

    Upsher-Smith Laboratories — Marketing Organization

  5. Jul 13, 1982

    Watson Pharmaceuticals — NDA Secondary Org

  6. Mar 29, 1983

    UDL Laboratories — Marketing Organization

  7. Mar 23, 1984

    Vanguard — Marketing Organization

  8. Jan 8, 1986

    Barr Laboratories — Marketing Organization

  9. Feb 18, 1986

    Fresenius — Marketing Organization

1990s

  1. Jan 1, 1992

    Earliest Phase 2 Sponsor(trial)

  2. Dec 29, 1993

    Boehringer Ingelheim — Marketing Organization

  3. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

2000s

  1. May 18, 2000

    Sandoz — NDA Secondary Org

  2. May 18, 2000

    Novartis — NDA Secondary Org

  3. Jan 1, 2001

    Earliest Phase 1 Sponsor(trial)

  4. Jun 14, 2005

    Jubilant Innovation Ltd. — Marketing Organization

  5. Jul 18, 2005

    Sun Pharmaceuticals — Marketing Organization

  6. Jul 21, 2005

    Amneal Pharmaceuticals — Marketing Organization

  7. Jan 12, 2009

    Leading Pharma Llc — Marketing Organization

  8. Jun 9, 2009

    Chartwell Pharmaceuticals — Marketing Organization

2010s

  1. Jun 4, 2010

    Vintage — Marketing Organization

  2. Jun 4, 2010

    Endo Pharmaceuticals — Marketing Organization

  3. Jun 4, 2010

    Apax Partners — Marketing Organization

  4. Jun 4, 2010

    PH HEALTH — Marketing Organization

  5. Jul 12, 2013

    Anbison Lab — Marketing Organization

  6. Jul 12, 2013

    Baheal Pharmaceutical — Marketing Organization

  7. Jul 12, 2013

    AiPing Pharm Inc — Marketing Organization

  8. Jan 27, 2014

    Cadila Healthcare — Marketing Organization

  9. Jul 28, 2015

    Nuvo Research Inc. — Marketing Organization

  10. Mar 8, 2019

    Invatech — Marketing Organization

  11. Mar 8, 2019

    Athem — Marketing Organization

  12. Mar 8, 2019

    Rising Pharmaceuticals — Marketing Organization

  13. Nov 6, 2019

    X Gen Pharmaceuticals — Marketing Organization

  14. Nov 6, 2019

    Exela Pharma Sciences, LLC. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedAug 13, 1946

Chemistry & pharmacology

Loading structure…

SMILES

Nc1nc(=O)c2nc(CNc3ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc3)cnc2[nH]1
Mol. weight
441.4 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • acifolic
  • aspol
  • bio science
  • cytofol
  • folacid
  • folacin
  • folacin
  • folacin
  • folate
  • folate
  • folate
  • folate sodium
  • folic aci
  • folic acid
  • folic acid
  • folic acid
  • folic acid
  • folic acid
  • folic acid
  • folic acid
  • folic acid
  • folic acid
  • folic acid
  • folic acid
  • folicare
  • folicet
  • folicet
  • folsaeure
  • folsaeure
  • folsan
  • folsan
  • folvite
  • folvite
  • folvron
  • folvron
  • lexpec
  • n-[(4-{[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino}phenyl)carbonyl]-l-glutamic acid
  • n-[(4-{[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino}phenyl)carbonyl]-l-glutamic acid
  • natur flow
  • n-pteroyl-l-glutamic acid
  • n-pteroyl-l-glutamic acid
  • pga
  • pga
  • pga
  • preconceive
  • pteglu
  • pteglu
  • pteroylglutamic acid
  • pteroylglutamic acid
  • pteroylglutamic acid
  • pteroylglutamic acid
  • pteroyl-l-glutamate
  • pteroyl-l-glutamate
  • pteroyl-l-glutamic acid
  • pteroyl-l-glutamic acid
  • pteroyl-l-monoglutamic acid
  • pteroyl-l-monoglutamic acid
  • roche
  • roche
  • vitamin b9
  • vitamin b9
  • vitamin b9
  • vitamin bc
  • vitamin bc
  • vitamin bc
  • vitamin m
  • vitamin m
  • vitamin m

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07113158Phase 3Nov 30, 2025Assistance Publique - Hôpitaux de Paris
NCT07241221N/ANov 30, 2025National University of Singapore
NCT07013136Early Phase 1 (Phase 1)Oct 1, 2025The University of Hong Kong
NCT06069856Phase 3Sep 30, 2025Africa Academy for Public Health, Columbia University, George Washington University, Harvard University, Ifakara Health Institute, Muhimbili University
NCT07048860N/AJul 9, 2025University of Toulouse
NCT06943482Phase 4Jul 1, 2025National University of Singapore
NCT06930144N/AApr 30, 2025Second Military Medical University
NCT07029698Phase 4Apr 16, 2025Medice Arzneimittel Pütter GmbH & Co KG
NCT06734611N/AMar 1, 2025Baylor University, Centre for Infectious Disease Research in Zambia (CIDRZ), University of Alabama, Birmingham
NCT06774885Phase 3Feb 9, 2025Future University in Egypt
NCT06641245N/AJan 31, 2025University of British Columbia, University of Saskatchewan
NCT06768294Phase 2Jan 31, 2025I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
NCT06935630N/AJan 1, 2025Dr. Soetomo General Hospital, Prodia Diacro Laboratories P.T.
NCT06610266Phase 4Nov 1, 2024People's Liberation Army of China
NCT06235294N/ASep 30, 2024University of Coimbra
NCT06590805N/ASep 1, 2024Kafrelsheikh University
NCT06622551N/AAug 1, 2024Airlangga University, Griffith University
NCT06661083N/AAug 1, 2024AGUNCO Obstetrics and Gynecology Centre
NCT06847139N/AJul 1, 2024Chittagong Medical College
NCT06405204Phase 3Jun 30, 2024Beni Suef University
Showing 20 of 382 trials
Page 1 / 20

Organizations

Research & Development (450)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Harvard UniversityAcademic/Hospital181651993
National Cancer Institute (NCI)Government11151992
Peking UniversityAcademic/Hospital11242005
RocheFor profit11542002
Eli LillyFor profit10532002
GenentechFor profit10632002
National Institutes of Health (NIH)Government10542001
Spectrum PharmaceuticalsFor profit8822007
AGUNCO Obstetrics and Gynecology CentreAcademic/Hospital7732011
Centers for Disease Control and Prevention (CDC)Government7432003
Jiao Tong UniversityAcademic/Hospital7532005
Johns Hopkins UniversityAcademic/Hospital7521996
University of TorontoAcademic/Hospital7541995
Bill and Melinda Gates FoundationAcademic/Hospital6032001
Johnson and JohnsonFor profit6622004
Lo.Li. Pharma, Ltd.For profit6422011
Aga Khan UniversityAcademic/Hospital5322004
Ain Shams UniversityAcademic/Hospital5442014
Emory UniversityAcademic/Hospital5322011
MerckFor profit5231998
450 organizations
Page 1 / 23

Marketing (63)

OrganizationOrg typeRelationshipDate
AbraxisFor profitMKTGNov 6, 1981
AbraxisFor profitNDA2Nov 6, 1981
AiPing Pharm IncFor profitMKTGJul 12, 2013
American CyanamidFor profitNDA2Aug 13, 1946
American Home ProductsFor profitNDA2Jun 5, 1947
Amneal PharmaceuticalsFor profitMKTGJul 21, 2005
Anbison LabFor profitMKTGJul 12, 2013
Apax PartnersFor profitMKTGJun 4, 2010
AthemFor profitMKTGMar 8, 2019
Baheal PharmaceuticalFor profitMKTGJul 12, 2013
Barr LaboratoriesFor profitMKTGJan 8, 1986
Bausch Health CompaniesFor profitMKTG—
Boehringer IngelheimFor profitMKTGDec 29, 1993
Cadila HealthcareFor profitMKTGJan 27, 2014
Chartwell PharmaceuticalsFor profitMKTGJun 9, 2009
Contract PharmacalFor profitMKTGJul 29, 1976
Dow ChemicalFor profitMKTG—
Eli LillyFor profitNDA2Jun 2, 1947
Endo PharmaceuticalsFor profitMKTGJun 4, 2010
Everylife Foundation for Rare DiseasesAcademic/HospitalMKTGMar 20, 1973
Exela Pharma Sciences, LLC.For profitMKTGNov 6, 2019
FreseniusFor profitMKTGFeb 18, 1986
HalseyFor profitMKTG—
HikmaFor profitMKTGMar 31, 1972
HikmaFor profitSYNMar 31, 1972
HospiraFor profitMKTGFeb 20, 1953
HospiraFor profitNDA2Feb 20, 1953
Impax LaboratoriesFor profitMKTGJul 20, 1973
InvatechFor profitMKTGMar 8, 2019
Jubilant Innovation Ltd.For profitMKTGJun 14, 2005
Lannett Company, Inc.For profitMKTGMay 8, 1974
Lannett Company, Inc.For profitSYNMay 6, 1974
Leading Pharma LlcFor profitMKTGJan 12, 2009
Leading Pharma LlcFor profitSYNJan 12, 2009
LederleFor profitMKTGAug 13, 1946
LederleFor profitNDA—
MK LabsFor profitMKTGNov 13, 1973
Mission PharmacalFor profitMKTGJul 30, 1981
Nexgen Pharma, IncFor profitMKTGFeb 4, 1976
NovartisFor profitNDA2May 18, 2000
Nuvo Research Inc.For profitMKTGJul 28, 2015
PH HEALTHFor profitMKTGJun 4, 2010
Puracap PharmaceuticalFor profitMKTGNov 2, 1972
Rising PharmaceuticalsFor profitMKTGMar 8, 2019
RocheFor profitMKTGJul 28, 1947
RocheFor profitNDA2Jul 28, 1947
SandozFor profitMKTGJun 16, 1976
SandozFor profitSYNMay 18, 2000
SandozFor profitNDA2May 18, 2000
Sun PharmaceuticalsFor profitMKTGJul 18, 2005
TablicapsFor profitMKTGApr 24, 1973
Teligent PharmaceuticalsFor profitNDA2—
TevaFor profitMKTGOct 2, 1972
UDL LaboratoriesFor profitMKTGMar 29, 1983
Upsher-Smith LaboratoriesFor profitMKTGMay 13, 1982
VanguardFor profitMKTGMar 23, 1984
VintageFor profitMKTGJun 4, 2010
Watson PharmaceuticalsFor profitMKTGDec 23, 1971
Watson PharmaceuticalsFor profitNDA2Jul 13, 1982
Whiteworth Towne PaulsenFor profitMKTGJul 31, 1973
WyethFor profitNDA2Jun 5, 1947
X Gen PharmaceuticalsFor profitMKTGNov 6, 2019
X Gen PharmaceuticalsFor profitSYNNov 6, 2019