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arginine

Small moleculeapproved

Approved

Feb 28, 1973

L-arginine is a nonessential amino acid that may play an important role in the treatment of cardiovascular disease due to its antiatherogenic, anti-ischemic, antiplatelet, and antithrombotic properties. It has been promoted as a growth stimulant and as a treatment for erectile dysfunction in men. L-arginine is a nonessential amino acid that may play an important role in the treatment of heart disease due to its block arterial plaque buildup, blood clots, platelet clumping, and to increase blood flow through the coronary artery. L-arginine is commonly sold as a health supplement claiming to improve vascular health and treat erectile dysfunction in men. L-arginine, which is promoted as a human growth stimulant, has also been used in bodybuilding. In the 1800s, it was first isolated from animal horn. — NCATS

Clinical trial activity

205 trials · 239 clinical orgs · 1 marketing orgs

Phase 1
31
Phase 2
64
Phase 3
31
Phase 4
24

Earliest trial started Dec 1, 1994 (NCT00006340)

Timeline

1970s

  1. Feb 28, 1973

    Pharmacia & Upjohn — Earliest FDA Approval

  2. Feb 28, 1973

    Evidence of US Marketing

  3. Feb 28, 1973

    Pharmacia & Upjohn — NDA Secondary Org

  4. Feb 28, 1973

    Pharmacia & Upjohn — NDA Organization

1990s

  1. Jan 1, 1994

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • glutamateSupplementation

    glutamate supplementation

  • L-arginineSupplementation

    L-arginine supplementation

Approval history

  • approvedPriority reviewFeb 28, 1973
  • approvedPriority reviewFeb 28, 1973

Chemistry & pharmacology

Loading structure…

SMILES

N[C@@H](CCCNC(N)=N)C(O)=O
Mol. weight
174.201 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

  • (2s)-2-amino-5-(carbamimidamido)pentanoic acid
  • (2s)-2-amino-5-(carbamimidamido)pentanoic acid
  • (2s)-2-amino-5-guanidinopentanoic acid
  • (2s)-2-amino-5-guanidinopentanoic acid
  • ac-083
  • ac-083
  • arg
  • arg
  • arg-glu
  • argimate
  • arginine
  • arginine
  • arginine
  • arginine
  • arginine
  • arginine butyrate
  • arginine butyrate
  • arginine glutamate
  • arginine glutamate
  • arginine glutamate
  • arginine glutamate
  • arginine glutamate
  • arginine hcl
  • arginine hcl
  • arginine hcl
  • arginine hydrochloride
  • arginine hydrochloride
  • arginine hydrochloride
  • arginine hydrochloride
  • arginine hydrochloride
  • arginine hydrochloride
  • arginine hydrochloride
  • arginine hydrochloride-r-gene 10
  • arginine sodium succinate
  • arginylglutamate
  • ginamate
  • glutargin
  • hqk-1004
  • hqk-1004
  • l-arg
  • l-arg
  • l-arg
  • l-arginin
  • l-arginin
  • l arginine
  • l arginine
  • l-arginine
  • l-arginine
  • l-arginine
  • l-arginine
  • l-arginine
  • l-arginine
  • l-arginine
  • l-(+)-arginine
  • l-(+)-arginine
  • l-arginine aspartate
  • l-arginine aspartate
  • l-arginine glutamate
  • l-arginine glutamate
  • l-arginine hydrochloride
  • l-arginine hydrochloride
  • l-glutamic acid, cpd with l-arginine (1:1)
  • modumate
  • modumate
  • polyarginine
  • polyarginine
  • polyarginine
  • polyarginine, (d)-isomer
  • polyarginine, (dl)-isomer
  • polyarginine hydrochloride
  • polyarginine sulfate
  • poly(l-arginine)
  • r
  • r
  • r-gene 10
  • r-gene 10
  • (s)-2-amino-5-guanidinopentanoic acid
  • (s)-2-amino-5-guanidinopentanoic acid
  • (s)-2-amino-5-guanidinovaleric acid
  • (s)-2-amino-5-guanidinovaleric acid

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07167693Phase 1/Phase 2 (Phase 2)Nov 1, 2025Wayne State University
NCT07257042Phase 3Jul 14, 2025Colgate Palmolive, Loma Linda University
NCT07020754Phase 2Apr 1, 2025Ain Shams University
NCT06728644N/ADec 20, 2024Huazhong University of Science and Technology
NCT06483737N/AOct 1, 2024People's Liberation Army of China
NCT06328686Early Phase 1 (Phase 1)Sep 5, 2024Emory University, National Cancer Institute (NCI)
NCT07135037Phase 2Sep 1, 2024Kafrelsheikh University
NCT06593054Phase 1Jul 29, 2024Pfizer
NCT06379217Phase 1Jul 29, 2024Novartis
NCT06405243Phase 3Jun 30, 2024Beni Suef University
NCT06475391N/AJun 14, 2024University of Manitoba
NCT06865261N/AMay 20, 2024Universita' Cattolica del Sacro Cuore
NCT06216262N/AMar 1, 2024Çanakkale Onsekiz Mart University
NCT06405477N/AFeb 15, 2024Sao Paulo State University
NCT06273930Phase 1Feb 1, 2024Government of Pakistan
NCT06947265Phase 4Jan 14, 2024Cairo University
NCT05855330Phase 2Dec 31, 2023Emory University
NCT06128434N/ANov 30, 2023Mansoura University
NCT06182267Phase 1Nov 27, 2023Colgate Palmolive
NCT06135792N/AOct 19, 2023Aarhus University
Showing 20 of 205 trials
Page 1 / 11

Organizations

Research & Development (239)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Heart, Lung, and Blood Institute (NHLBI)Government7241998
Boston UniversityAcademic/Hospital6431994
Cairo UniversityAcademic/Hospital5522017
Emory UniversityAcademic/Hospital5532015
Harvard UniversityAcademic/Hospital5352007
Maastricht UniversityAcademic/Hospital5542003
Texas A&M UniversityAcademic/Hospital5512009
Ain Shams UniversityAcademic/Hospital4432011
National Institutes of Health (NIH)Government4131997
NovartisFor profit4132003
Zhengzhou UniversityAcademic/Hospital4412017
Anyang Regional HospitalAcademic/Hospital3012017
Baylor UniversityAcademic/Hospital3332008
Colgate PalmoliveFor profit3332015
Duke UniversityAcademic/Hospital3232004
Government of FranceGovernment3222003
Luoyang Central HospitalAcademic/Hospital3012017
Menzies School of Health ResearchAcademic/Hospital3322005
Nanyang Central HospitalAcademic/Hospital3012017
National Cancer Institute (NCI)Government3032007
239 organizations
Page 1 / 12

Marketing (2)

OrganizationOrg typeRelationshipDate
Pharmacia & UpjohnFor profitNDA2Feb 28, 1973
Pharmacia & UpjohnFor profitNDAFeb 28, 1973