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amino acids

Trade name: Freamine

Small moleculeapproved

Approved

Sep 24, 1971

An essential amino acid, or indispensable amino acid, is an amino acid that cannot be synthesized from scratch by the organism fast enough to supply its demand, and must therefore come from the diet. Of the 21 amino acids common to all life forms, the nine amino acids humans cannot synthesize are valine, isoleucine, leucine, methionine, phenylalanine, tryptophan, threonine, histidine, and lysine. — Wikipedia

Clinical trial activity

234 trials · 226 clinical orgs · 8 marketing orgs

Phase 1
20
Phase 2
45
Phase 3
22
Phase 4
24

Earliest trial started Oct 1, 1999 (NCT00005889)

Timeline

1970s

  1. Sep 24, 1971

    Braun Beteiligungs GmbH — Earliest FDA Approval

  2. Sep 24, 1971

    B. Braun — NDA Secondary Org

  3. Sep 24, 1971

    Braun Beteiligungs GmbH — NDA Organization

  4. Dec 3, 1975

    ICU Medical Inc — NDA Secondary Org

  5. Mar 24, 1976

    Baxalta — NDA Secondary Org

  6. Mar 24, 1976

    Baxter — NDA Secondary Org

1980s

  1. Jan 17, 1984

    Hospira — NDA Secondary Org

  2. Dec 16, 1986

    Abbott — Marketing Organization

  3. Dec 16, 1986

    Abbott — NDA Secondary Org

1990s

  1. Apr 4, 1996

    ICU Medical Inc — Marketing Organization

  2. Apr 4, 1996

    Baxter — Marketing Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2006

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Apr 13, 2012

    B. Braun — Marketing Organization

  2. Aug 25, 2014

    Fresenius — Marketing Organization

  3. Aug 25, 2014

    Fresenius — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetSupplementation

    Supplementation

Combination products

Approval history

  • approvedPriority reviewSep 24, 1971

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • aminess
  • amino acid
  • amino acid chelated iron
  • amino acides
  • amino-acid, glucose, and electrolyte solution
  • amino acids
  • amino acids
  • amino acids
  • aminosteril
  • aminosyn
  • aminosyn
  • aminosyn
  • aminosyn-hbc
  • aminosyn-hf
  • aminosyn ii
  • aminosyn ii
  • aminosyn-pf
  • aminosyn-rf
  • ami-u--ii
  • aspatofort
  • branchamin
  • branchamin
  • branchamin
  • branch chain amino acid
  • branched chain amino acids
  • branched chain amino acids
  • branched-chain amino acids
  • branched-chain amino acids
  • combiflex
  • combiflex
  • combiflexomega
  • essential amino acid
  • essential amino acids
  • essential amino acids
  • freamine
  • freamine
  • freamine
  • freamine
  • freamine hbc
  • freamine ii
  • freamine iii
  • freamine iii
  • freamine iii
  • hepatamine
  • hepatasol
  • isonitrogenous vaminolact
  • mixed amino acids
  • neopham
  • nephramine
  • novamine
  • novamine
  • novamine
  • renamin w/o electrolytes
  • smofkabiven
  • sulfur amino acids
  • synthamin
  • synthamin 17
  • travasol
  • travasol
  • travasol
  • trophamine
  • trophamine
  • trophamine
  • vamin
  • vamin n
  • vaminolac
  • zinc amino acid chelate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07199023N/AJan 1, 2026Capital Medical University, Chongqing Medical University, Guangzhou Medical University, Guiyang Maternity and Child Health Care Hospital, Jiao Tong University, Peking University, Shantou University
NCT07256028N/ADec 10, 2025AgroParisTech, Morocco's National Centre for Energy, Sciences and Nuclear Techniques
NCT06991738Phase 1/Phase 2 (Phase 2)Dec 2, 2025National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT07303738Phase 4Dec 1, 2025Harvard University
NCT07212595Phase 2Nov 30, 2025University of Cincinnati
NCT07030933Phase 4Nov 1, 2025Pennsylvania State University
NCT07115563N/AOct 31, 2025United States Department of Agriculture, University of Connecticut
NCT07001098Phase 2Sep 30, 2025Stanford University
NCT07132697N/AAug 25, 2025Institute of Liver and Biliary Sciences, India
NCT06604065Phase 1Jul 31, 2025University of Arkansas
NCT06878664Phase 3Jun 12, 2025Grupo Espanol de Tumores Neuroendocrinos (GETNE), Institut Gustave Roussy, Universidad Complutense de Madrid
NCT07004387N/AMay 27, 2025Hospital Sotero del Rio
NCT06954662Early Phase 1 (Phase 1)May 22, 2025University of Connecticut
NCT06721026N/AMar 1, 2025Maastricht University
NCT06835816N/AFeb 3, 2025Karolinska Institute
NCT06652698N/AJan 31, 2025Government of Poland, Medical University of Warsaw
NCT06785428N/AJan 31, 2025McGill University
NCT06687343N/ANov 30, 2024Maastricht University
NCT06654986N/ANov 1, 2024University of Copenhagen
NCT06483737N/AOct 1, 2024People's Liberation Army of China
Showing 20 of 234 trials
Page 1 / 12

Organizations

Research & Development (226)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of TorontoAcademic/Hospital151422008
AjinomotoFor profit9022010
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government9252003
FreseniusFor profit7632017
Harvard UniversityAcademic/Hospital7652006
McGill UniversityAcademic/Hospital7722004
National Institutes of Health (NIH)Government7142008
Hoosier Cancer Research NetworkAcademic/Hospital6222002
University of ArkansasAcademic/Hospital6532007
Axcella Health Inc.For profit5422017
Capital Medical UniversityAcademic/Hospital5222018
Maastricht UniversityAcademic/Hospital5512002
Mayo ClinicAcademic/Hospital5432005
National Cancer Institute (NCI)Government5112015
University of British ColumbiaAcademic/Hospital5512017
University of VermontAcademic/Hospital5422011
Aarhus UniversityAcademic/Hospital4312007
Canadian Institutes of Health Research (CIHR)Academic/Hospital4022013
National Institute on Aging (NIA)Government4032003
University of CopenhagenAcademic/Hospital4422014
226 organizations
Page 1 / 12

Marketing (14)

OrganizationOrg typeRelationshipDate
AbbottFor profitMKTGDec 16, 1986
AbbottFor profitNDA2Dec 16, 1986
B. BraunFor profitNDA2Sep 24, 1971
B. BraunFor profitMKTGApr 13, 2012
BaxaltaFor profitNDA2Mar 24, 1976
BaxterFor profitNDA2Mar 24, 1976
BaxterFor profitMKTGApr 4, 1996
Braun Beteiligungs GmbHFor profitNDASep 24, 1971
FreseniusFor profitMKTGAug 25, 2014
FreseniusFor profitNDA2Aug 25, 2014
HospiraFor profitNDA2Jan 17, 1984
HospiraFor profitSYNJan 3, 1978
ICU Medical IncFor profitNDA2Dec 3, 1975
ICU Medical IncFor profitMKTGApr 4, 1996