triamterene

Trade name: dyrenium

Small moleculeapproved

Approved

Aug 10, 1964

Triamterene, a relatively weak, potassium-sparing diuretic and antihypertensive, is used in the management of hypokalemia. Triamterene inhibits the epithelial sodium channels on principal cells in the late distal convoluted tubule and collecting tubule, which are responsible for 1-2% of total sodium reabsorption. As sodium reabsorption is inhibited, this increases the osmolarity in the nephron lumen and decreases the osmolarity of the interstitium. Since sodium concentration is the main driving force for water reabsorption, triamterene can achieve a modest amount of diuresis by decreasing the osmotic gradient necessary for water reabsorption from lumen to interstitium. Triamterene also has a potassium-sparing effect. Normally, the process of potassium excretion is driven by the electrochemical gradient produced by sodium reabsorption. As sodium is reabsorbed, it leaves a negative potential in the lumen, while producing a positive potential in the principal cell. This potential promotes potassium excretion through apical potassium channels. By inhibiting sodium reabsorption, triamterene also inhibits potassium excretion.Triamterene is used for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and the nephrotic syndrome; also in steroid-induced edema, idiopathic edema, and edema due to secondary hyperaldosteronism. Triamterene is maeketed under the trade name Dyrenium. — NCATS

Clinical trial activity

2 trials · 4 clinical orgs · 23 marketing orgs

Phase 1
0
Phase 2
1
Phase 3
1
Phase 4
1

Earliest trial started Jul 1, 1986 (NCT00000525)

Timeline

1960s

  1. Aug 10, 1964

    Advanz Pharma — Earliest FDA Approval

  2. Aug 10, 1964

    Advanz Pharma — NDA Secondary Org

  3. Aug 10, 1964

    Advanz Pharma — Marketing Organization

  4. Aug 10, 1964

    Advanz Pharma — NDA Organization

  5. Dec 2, 1965

    GlaxoSmithKline — Marketing Organization

  6. Dec 2, 1965

    GlaxoSmithKline — NDA Secondary Org

1980s

  1. Oct 22, 1984

    Aurobindo Pharma — NDA Secondary Org

  2. Jan 1, 1986

    Earliest Phase 3 Sponsor(trial)

  3. Dec 8, 1987

    Apotex — Marketing Organization

  4. Jan 14, 1988

    Watson Pharmaceuticals — Marketing Organization

  5. Jun 17, 1988

    Sandoz — Marketing Organization

1990s

  1. Jul 31, 1991

    CASI Pharmaceuticals, Inc. — Marketing Organization

  2. Jul 31, 1991

    Chartwell Pharmaceuticals — Marketing Organization

  3. Mar 30, 1995

    Teva — Marketing Organization

  4. Jan 31, 1996

    Ani Pharmaceuticals — Marketing Organization

  5. Apr 26, 1996

    Pliva — Marketing Organization

  6. Jun 7, 1996

    Mylan — Marketing Organization

  7. Jun 5, 1997

    Novartis — Marketing Organization

  8. Jun 18, 1999

    Duramed Research — Marketing Organization

2010s

  1. Dec 9, 2011

    Lannett Company, Inc. — Marketing Organization

  2. Jun 29, 2018

    Zydus Discovery DMCC — Marketing Organization

  3. Feb 11, 2019

    Cadila Healthcare — Marketing Organization

  4. Aug 19, 2019

    Agnitio — Marketing Organization

2020s

  1. Feb 23, 2022

    Rubicon Research — Marketing Organization

  2. Jul 6, 2022

    Eywa Pharma — Marketing Organization

Indications

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewAug 10, 1964

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC2=C(N=C(C3=CC=CC=C3)C(N)=N2)C(N)=N1
Mol. weight
253.2626 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

  • 6-phenylpteridine-2,4,7-triamine
  • 6-phenylpteridine-2,4,7-triamine
  • diurene
  • dyrenium
  • dyrenium
  • dyrenium
  • dytac
  • dytac
  • pterofen
  • pterophene
  • sk-8542
  • sk-8542
  • sk&f-8542
  • sk&f-8542
  • teridin
  • teridin
  • triamteren
  • triamteren
  • triamteren
  • triamterene
  • triamterene
  • triamterene
  • triamterene
  • triamterene
  • triamterene
  • triamterene
  • triamterene
  • triamterene
  • triamterene
  • triamterene
  • triamtérène
  • triamtérène
  • triamtereno
  • triamtereno
  • triamterenum
  • triamterenum
  • triamteril
  • triteren

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02522650Phase 4Jul 1, 2013Georgetown University
NCT00000525Phase 3Jul 1, 1986National Heart, Lung, and Blood Institute (NHLBI), University of California, Berkeley, University of California, San Francisco
Showing 2 of 2 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Georgetown UniversityAcademic/Hospital1112013
National Heart, Lung, and Blood Institute (NHLBI)Government1011986
University of California, BerkeleyAcademic/Hospital1011986
University of California, San FranciscoAcademic/Hospital1111986
4 organizations
Page 1 / 1

Marketing (28)

OrganizationOrg typeRelationshipDate
Advanz PharmaFor profitNDA2Aug 10, 1964
Advanz PharmaFor profitMKTGAug 10, 1964
Advanz PharmaFor profitNDAAug 10, 1964
AgnitioFor profitMKTGAug 19, 2019
Am TherapFor profitMKTG
Ani PharmaceuticalsFor profitMKTGJan 31, 1996
Ani PharmaceuticalsFor profitSYNMar 30, 1995
ApotexFor profitMKTGDec 8, 1987
Aurobindo PharmaFor profitNDA2Oct 22, 1984
CASI Pharmaceuticals, Inc.For profitMKTGJul 31, 1991
Cadila HealthcareFor profitMKTGFeb 11, 2019
Chartwell PharmaceuticalsFor profitMKTGJul 31, 1991
Duramed ResearchFor profitMKTGJun 18, 1999
Eywa PharmaFor profitMKTGJul 6, 2022
GlaxoSmithKlineFor profitMKTGDec 2, 1965
GlaxoSmithKlineFor profitNDA2Dec 2, 1965
Lannett Company, Inc.For profitMKTGDec 9, 2011
MylanFor profitMKTGJun 7, 1996
MylanFor profitSYNOct 22, 1984
NovartisFor profitMKTGJun 5, 1997
PlivaFor profitMKTGApr 26, 1996
Quantum PharmaceuticalFor profitMKTG
Rubicon ResearchFor profitMKTGFeb 23, 2022
SandozFor profitMKTGJun 17, 1988
TevaFor profitMKTGMar 30, 1995
VitarineFor profitMKTG
Watson PharmaceuticalsFor profitMKTGJan 14, 1988
Zydus Discovery DMCCFor profitMKTGJun 29, 2018