tromethamine

Trade name: tham

Small moleculeapproved

Approved

Dec 16, 1965

Tromethamine is extensively used in biochemistry and molecular biology. Because tromethamine (in the form of R-NH2) is a proton acceptor with a pK of 7.8, it is an effective buffer that can be used to maintain the pH of body fluids. Tromethamine is indicated for the prevention and correction of metabolic acidosis. When administered intravenously as a 0.3 M solution, tromethamine acts as a proton acceptor and prevents or corrects acidosis by actively binding hydrogen ions (H+). It binds not only cations of fixed or metabolic acids, but also hydrogen ions of carbonic acid, thus increasing bicarbonate anion (HCO3‾). TromeThamine also acts as an osmotic diuretic, increasing urine flow, urinary pH, and excretion of fixed acids, carbon dioxide and electrolytes. A significant fraction of tromethamine (30% at pH 7.40) is not ionized and therefore is capable of reaching equilibrium in total body water. This portion may penetrate cells and may neutralize acidic ions of the intracellular fluid. — NCATS

Clinical trial activity

33 trials · 28 clinical orgs · 3 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jan 1, 2009 (NCT01339624)

Timeline

1960s

Dec 16, 1965
Hospira — Earliest FDA Approval
Dec 16, 1965
Hospira — NDA Secondary Org
Dec 16, 1965
Hospira — NDA Organization

2010s

Jan 1, 2011
Earliest Phase 2 Sponsor(trial)
Jan 1, 2013
Earliest Phase 3 Sponsor(trial)
Jan 1, 2014
Earliest Phase 1 Sponsor(trial)

2020s

Dec 9, 2024
B. Braun — Marketing Organization
Dec 31, 2024
Milla Pharms — Marketing Organization

Mechanism of action

Unspecified targetOTHER
Unknown

Combination products

tham-e
with potassium chloride, sodium chloride

Approval history

approvedPriority reviewDec 16, 1965

Chemistry & pharmacology

Loading structure…

SMILES

NC(CO)(CO)CO

Mol. weight: 121.135 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Prescription Only

Oral

Parenteral

Yes

Topical

Sources

Also known as

1,1,1-tris(hydroxymethyl)methanamine
1,1,1-tris(hydroxymethyl)methanamine
2-amino-2-(hydroxymethyl)-1,3-propanediol
2-amino-2-(hydroxymethyl)-1,3-propanediol
adolquir
aminotris(hydroxymethyl)methane
aminotris(hydroxymethyl)methane
badyket
dexketoprofen
dexketoprofen
dexketoprofen
dexketoprofen
dexketoprofen
dexketoprofen
dexketoprofen trometamol
dexketoprofen trometamol
dexketoprofen trometamol
dexketoprofen trometamol
dexketoprofen trometamol
dexketoprofen trometamol
dexketoprofen trometamol
enangel
enantyum
enantyum
enantyum
keral
keral
keral
ketesse
(+)-ketoprofen
quiralam
quirgel
(s)-ketoprofen
sympal
tham
tham
tham
tham-e
tham-e
tris
tris
trisamin
trisamine
trisaminol
tris(hydroxymethyl)aminomethane
tris(hydroxymethyl)aminomethane
trometamol
trometamol
trometamol
trometamol
trometamol
trometamol
tromethamine
tromethamine
tromethamine
tromethamine
tromethamine
tromethamine
tromethamine
tromethamine
tromethamine

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT04526132	Phase 3	Sep 14, 2020	Central South University, Yiling Pharmaceutical Inc.
NCT04200885	Phase 4	May 2, 2019	Gaziosmanpasa University
NCT03872830	Phase 2	Apr 30, 2019	Central South University, Yiling Pharmaceutical Inc.
NCT04178109	Phase 2	Jan 10, 2019	KAT General Hospital
NCT03830398	Phase 4	Nov 20, 2018	Mustafa Kemal University
NCT03697746	N/A	Oct 1, 2018	Pamukkale University
NCT03638999	Early Phase 1 (Phase 1)	Jul 31, 2018	Washington University in St. Louis
NCT03585036	Phase 3	Jul 31, 2018	Cairo University
NCT03617510	Phase 1	Jul 20, 2018	Jilin University, Yiling Pharmaceutical Inc.
NCT03768882	Phase 4	Dec 1, 2017	Pamukkale University
NCT03235778	Phase 1	Jul 17, 2017	Jilin University, Yiling Pharmaceutical Inc.
NCT03170726	N/A	May 15, 2017	Erzincan University
NCT03170713	N/A	May 15, 2017	Erzincan University
NCT02777970	Phase 4	Apr 1, 2016	Menarini Group
NCT03428503	Phase 4	Dec 31, 2015	Pamukkale University
NCT02527603	N/A	Aug 1, 2015	Corporacion Parc Tauli
NCT03122314	Phase 4	Aug 1, 2015	Pamukkale University
NCT02160236	Phase 4	Nov 1, 2014	Erciyes University
NCT02209454	Phase 1	Apr 1, 2014	Menarini Group, Simbec-Orion
NCT02092012	Phase 4	Mar 1, 2014	Erciyes University

Showing 20 of 33 trials

Page 1 / 2

Organizations

Research & Development (28)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Menarini Group	For profit	5	5	4	2011
Pamukkale University	Academic/Hospital	4	4	2	2015
Yiling Pharmaceutical Inc.	For profit	4	4	3	2017
Erciyes University	Academic/Hospital	3	2	2	2012
University of Oxford	Academic/Hospital	3	0	2	2011
Central South University	Academic/Hospital	2	0	2	2019
Erzincan University	Academic/Hospital	2	2	1	2017
Jilin University	Academic/Hospital	2	0	1	2017
Cairo University	Academic/Hospital	1	1	1	2018
Corporacion Parc Tauli	Academic/Hospital	1	1	1	2015
Derince Training and Research Hospital	Academic/Hospital	1	1	1	2013
Fundação Altino Ventura	Academic/Hospital	1	1	1	2012
Gaziosmanpasa University	Academic/Hospital	1	1	1	2019
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Government	1	1	1	2013
KAT General Hospital	Academic/Hospital	1	1	1	2019
Kavaklıdere Umut Hospital	Academic/Hospital	1	1	1	2012
Kayseri City Hospital	Academic/Hospital	1	1	1	2012
Mustafa Kemal University	Academic/Hospital	1	1	1	2018
Pharmaceutical Research Associates, Inc. (PRA)	For profit	1	0	1	2011
Simbec-Orion	For profit	1	0	1	2014

28 organizations