triamterene
Trade name: dyrenium
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
Earliest trial started Jul 1, 1986 (NCT00000525)
Timeline
1960s
- Aug 10, 1964
Advanz Pharma — Earliest FDA Approval
- Aug 10, 1964
Advanz Pharma — NDA Secondary Org
- Aug 10, 1964
Advanz Pharma — Marketing Organization
- Aug 10, 1964
Advanz Pharma — NDA Organization
- Dec 2, 1965
GlaxoSmithKline — Marketing Organization
- Dec 2, 1965
GlaxoSmithKline — NDA Secondary Org
1980s
- Oct 22, 1984
Aurobindo Pharma — NDA Secondary Org
- Jan 1, 1986
Earliest Phase 3 Sponsor(trial)
- Dec 8, 1987
Apotex — Marketing Organization
- Jan 14, 1988
Watson Pharmaceuticals — Marketing Organization
- Jun 17, 1988
Sandoz — Marketing Organization
1990s
- Jul 31, 1991
CASI Pharmaceuticals, Inc. — Marketing Organization
- Jul 31, 1991
Chartwell Pharmaceuticals — Marketing Organization
- Mar 30, 1995
Teva — Marketing Organization
- Jan 31, 1996
Ani Pharmaceuticals — Marketing Organization
- Apr 26, 1996
Pliva — Marketing Organization
- Jun 7, 1996
Mylan — Marketing Organization
- Jun 5, 1997
Novartis — Marketing Organization
- Jun 18, 1999
Duramed Research — Marketing Organization
2010s
- Dec 9, 2011
Lannett Company, Inc. — Marketing Organization
- Jun 29, 2018
Zydus Discovery DMCC — Marketing Organization
- Feb 11, 2019
Cadila Healthcare — Marketing Organization
- Aug 19, 2019
Agnitio — Marketing Organization
2020s
- Feb 23, 2022
Rubicon Research — Marketing Organization
- Jul 6, 2022
Eywa Pharma — Marketing Organization
Indications
Approved for
Mechanism of action
Amiloride-sensitive sodium channel, ENaC blocker
Alpha subunit is binding site
Combination products
dyazide
with hydrochlorothiazide
Also known as maxzide
Approval history
- approvedPriority reviewAug 10, 1964
Chemistry & pharmacology
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
Sources
- WikipediaTriamterene ↗
- NCATSWS821Z52LQ ↗
- ChEMBLCHEMBL585 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02522650 | Phase 4 | Jul 1, 2013 | Georgetown University |
| NCT00000525 | Phase 3 | Jul 1, 1986 | National Heart, Lung, and Blood Institute (NHLBI), University of California, Berkeley, University of California, San Francisco |
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Georgetown University | Academic/Hospital | 1 | 1 | 1 | 2013 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 1 | 0 | 1 | 1986 |
| University of California, Berkeley | Academic/Hospital | 1 | 0 | 1 | 1986 |
| University of California, San Francisco | Academic/Hospital | 1 | 1 | 1 | 1986 |
Marketing (28)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Advanz Pharma | For profit | NDA2 | Aug 10, 1964 |
| Advanz Pharma | For profit | MKTG | Aug 10, 1964 |
| Advanz Pharma | For profit | NDA | Aug 10, 1964 |
| Agnitio | For profit | MKTG | Aug 19, 2019 |
| Am Therap | For profit | MKTG | — |
| Ani Pharmaceuticals | For profit | MKTG | Jan 31, 1996 |
| Ani Pharmaceuticals | For profit | SYN | Mar 30, 1995 |
| Apotex | For profit | MKTG | Dec 8, 1987 |
| Aurobindo Pharma | For profit | NDA2 | Oct 22, 1984 |
| CASI Pharmaceuticals, Inc. | For profit | MKTG | Jul 31, 1991 |
| Cadila Healthcare | For profit | MKTG | Feb 11, 2019 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jul 31, 1991 |
| Duramed Research | For profit | MKTG | Jun 18, 1999 |
| Eywa Pharma | For profit | MKTG | Jul 6, 2022 |
| GlaxoSmithKline | For profit | MKTG | Dec 2, 1965 |
| GlaxoSmithKline | For profit | NDA2 | Dec 2, 1965 |
| Lannett Company, Inc. | For profit | MKTG | Dec 9, 2011 |
| Mylan | For profit | MKTG | Jun 7, 1996 |
| Mylan | For profit | SYN | Oct 22, 1984 |
| Novartis | For profit | MKTG | Jun 5, 1997 |
| Pliva | For profit | MKTG | Apr 26, 1996 |
| Quantum Pharmaceutical | For profit | MKTG | — |
| Rubicon Research | For profit | MKTG | Feb 23, 2022 |
| Sandoz | For profit | MKTG | Jun 17, 1988 |
| Teva | For profit | MKTG | Mar 30, 1995 |
| Vitarine | For profit | MKTG | — |
| Watson Pharmaceuticals | For profit | MKTG | Jan 14, 1988 |
| Zydus Discovery DMCC | For profit | MKTG | Jun 29, 2018 |