CDEK
← All drugs Report issue

amiloride

Trade name: midamor

Small moleculeapproved

Approved

Oct 5, 1981

Amiloride, an antikaliuretic-diuretic agent, is a pyrazine-carbonyl-guanidine that is unrelated chemically to other known antikaliuretic or diuretic agents. It is an antihypertensive, potassium-sparing diuretic that was first approved for use in 1967 and helps to treat hypertension and congestive heart failure. The drug is often used in conjunction with thiazide or loop diuretics. Due to its potassium-sparing capacities, hyperkalemia (high blood potassium levels) are occasionally observed in patients taking amiloride. Amiloride works by inhibiting sodium reabsorption in the distal convoluted tubules and collecting ducts in the kidneys by binding to the amiloride-sensitive sodium channels. This promotes the loss of sodium and water from the body, but without depleting potassium. It is used for as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension. — NCATS

Clinical trial activity

51 trials · 65 clinical orgs · 17 marketing orgs

Phase 1
7
Phase 2
16
Phase 3
12
Phase 4
13

Earliest trial started Sep 1, 1996 (NCT00004705)

Timeline

1980s

  1. Oct 5, 1981

    Merck — Earliest FDA Approval

  2. Oct 5, 1981

    Paddock Laboratories — NDA Secondary Org

  3. Oct 5, 1981

    Merck — Marketing Organization

  4. Oct 5, 1981

    Merck — NDA Organization

  5. Oct 5, 1981

    Padagis Us — Marketing Organization

  6. Oct 5, 1981

    Padagis Us — NDA Secondary Org

  7. Jan 22, 1986

    Par Pharmaceuticals — Marketing Organization

  8. Jan 22, 1986

    Endo Pharmaceuticals — Marketing Organization

  9. Jan 22, 1986

    PH HEALTH — Marketing Organization

  10. Jul 15, 1987

    Teva — Marketing Organization

  11. May 10, 1988

    Barr Laboratories — Marketing Organization

1990s

  1. Jul 19, 1991

    Watson Pharmaceuticals — Marketing Organization

  2. Oct 31, 1991

    Rising Pharmaceuticals — Marketing Organization

  3. Oct 31, 1991

    Mylan — Marketing Organization

  4. Nov 27, 1991

    Fosun — Marketing Organization

  5. Nov 27, 1991

    Chartwell Pharmaceuticals — Marketing Organization

2000s

  1. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  3. Jan 30, 2009

    Sigmapharm Laboratories — Marketing Organization

2010s

  1. Jan 1, 2010

    Earliest Phase 3 Sponsor(trial)

  2. Aug 7, 2015

    ANDA Repository — Marketing Organization

  3. Aug 7, 2015

    Windlas Healthcare — Marketing Organization

  4. Aug 7, 2015

    US Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedOct 5, 1981

Chemistry & pharmacology

Loading structure…

SMILES

N=C(N)NC(=O)c1nc(Cl)c(N)nc1N
Mol. weight
229.63 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 3,5-diamino-n-carbamimidoyl-6-chloropyrazine-2-carboxamide
  • 3,5-diamino-n-carbamimidoyl-6-chloropyrazine-2-carboxamide
  • amilamont
  • amilorid
  • amilorid
  • amilorida
  • amilorida
  • amiloride
  • amiloride
  • amiloride
  • amiloride
  • amiloride
  • amiloride
  • amiloride
  • amiloride
  • amiloride
  • amiloride
  • amiloride chloride
  • amiloride chloride
  • amiloride hcl
  • amiloride hcl
  • amiloride hcl
  • amiloride hydrochloride
  • amiloride hydrochloride
  • amiloride hydrochloride
  • amiloride hydrochloride
  • amiloride hydrochloride
  • amiloride hydrochloride anhydrous
  • amiloride hydrochloride dihydrate
  • amiloride hydrochloride, hydrochlorothiazide 1:10
  • amiloride - hydrochlorothiazide
  • amiloride, hydrochlorothiazide drug combination
  • amiloride mixture with hydrochlorothiazide
  • amiloridum
  • amiloridum
  • amilospare 5
  • amipramidin
  • amipramidin
  • amipramidine
  • amipramidine
  • amipramidine
  • amoride
  • amyloride
  • amyloride
  • berkamil
  • co-amilozide
  • co-amilozide hydrochloride
  • hydro-ride
  • midamor
  • midamor
  • midamor
  • modamide
  • modamide
  • moduretic
  • moduretic
  • moduretic
  • n-amidino-3,5-diamino-6-chloropyrazinecarboxamide
  • n-amidino-3,5-diamino-6-chloropyrazinecarboxamide

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06923709Phase 2Oct 10, 2024University of Southern Denmark
NCT05044611Phase 4Apr 1, 2022Assistance Publique - Hôpitaux de Paris
NCT05228574Phase 4Mar 11, 2022Erasmus University Rotterdam
NCT05079789Phase 3Jun 8, 2020University of Tuebingen
NCT04331691Phase 4May 31, 2020Yonsei University
NCT04181008Early Phase 1 (Phase 1)Dec 31, 2019University of Toronto, University of Utah
NCT04063540Phase 2Nov 30, 2019University of Nice Sophia Antipolis
NCT03928145Phase 3Jun 30, 2019Federal University of Health Science of Porto Alegre, Federal University of Rio Grande do Sul
NCT03837626Phase 2/Phase 3 (Phase 3)Apr 30, 2019University of Missouri
NCT06416735Phase 3Sep 28, 2018Vita-Salute University of Milano. Italy
NCT02824718Phase 2Jun 6, 2017Government of France, University of Paris
NCT03170336Phase 4Jun 1, 2017Shantou University
NCT03031496Phase 1Mar 17, 2017GlaxoSmithKline
NCT03036748N/AFeb 1, 2017University of Southern Denmark
NCT02847338Phase 4Nov 1, 2016Medical Research Council, University of Cambridge
NCT02875886Phase 4Sep 1, 2016Erasmus University Rotterdam
NCT02525796Phase 2/Phase 3 (Phase 3)Jan 1, 2016Harvard University
NCT02832973Phase 4Sep 1, 2015Sao Jose do Rio Preto University
NCT02896621Phase 3Apr 1, 2015Federal University of Rio Grande do Sul
NCT02497300Phase 2Mar 1, 2015National Institutes of Health (NIH), University of Alabama, Birmingham
Showing 20 of 51 trials
Page 1 / 3

Organizations

Research & Development (65)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Aarhus UniversityAcademic/Hospital5432007
Federal University of Rio Grande do SulAcademic/Hospital5422005
University of Southern DenmarkAcademic/Hospital4332010
University of CambridgeAcademic/Hospital3322006
University of LondonAcademic/Hospital3232003
University of North Carolina at Chapel HillAcademic/Hospital3231996
Cystic Fibrosis Foundation TherapeuticsAcademic/Hospital2022001
Danish Heart FoundationAcademic/Hospital2012007
Department of Veteran AffairsGovernment2122008
Docent Institute of UrologyAcademic/Hospital2012009
Erasmus University RotterdamAcademic/Hospital2212016
Eurofarma Laboratorios S.A.For profit2212011
Government of BrazilGovernment2012010
Harvard UniversityAcademic/Hospital2222006
Medical Research CouncilGovernment2022014
University of CaraboboAcademic/Hospital2212009
University of EdinburghAcademic/Hospital2022009
University of UtahAcademic/Hospital2122008
Venezuelan Foundation of Heart FailureAcademic/Hospital2012009
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112022
65 organizations
Page 1 / 4

Marketing (20)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGAug 7, 2015
Barr LaboratoriesFor profitMKTGMay 10, 1988
Chartwell PharmaceuticalsFor profitMKTGNov 27, 1991
Endo PharmaceuticalsFor profitMKTGJan 22, 1986
FosunFor profitMKTGNov 27, 1991
MerckFor profitMKTGOct 5, 1981
MerckFor profitNDAOct 5, 1981
MylanFor profitMKTGOct 31, 1991
PH HEALTHFor profitMKTGJan 22, 1986
Padagis UsFor profitMKTGOct 5, 1981
Padagis UsFor profitNDA2Oct 5, 1981
Paddock LaboratoriesFor profitNDA2Oct 5, 1981
Par PharmaceuticalsFor profitMKTGJan 22, 1986
Rising PharmaceuticalsFor profitMKTGOct 31, 1991
Rising PharmaceuticalsFor profitSYNOct 31, 1991
Sigmapharm LaboratoriesFor profitMKTGJan 30, 2009
TevaFor profitMKTGJul 15, 1987
US PharmaFor profitMKTGAug 7, 2015
Watson PharmaceuticalsFor profitMKTGJul 19, 1991
Windlas HealthcareFor profitMKTGAug 7, 2015