sodium polystyrene sulfonate

Trade name: kayexalate

Small moleculeapproved

Approved

Jun 5, 1958

Polystyrene sulfonates are a group of medications used to treat high blood potassium. Effects generally take hours to days. They are also used to remove potassium, calcium, and sodium from solutions in technical applications. — Wikipedia

Clinical trial activity

8 trials · 6 clinical orgs · 25 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Dec 1, 1992 (NCT00004328)

Timeline

1950s

Jun 5, 1958
Advanz Pharma — Earliest FDA Approval
Jun 5, 1958
Advanz Pharma — NDA Secondary Org
Jun 5, 1958
Advanz Pharma — Marketing Organization
Jun 5, 1958
Advanz Pharma — NDA Organization

1980s

Dec 8, 1982
CMP Therapeutics Ltd — Marketing Organization
Sep 11, 1984
Pharmaceutical Associates — Marketing Organization
Sep 11, 1984
Wockhardt — Marketing Organization
Nov 17, 1986
West-Ward Pharmaceutical — Marketing Organization
Nov 17, 1986
Hikma — Marketing Organization

1990s

Jan 1, 1992
Earliest Phase 2 Sponsor(trial)
Feb 6, 1998
Paddock Laboratories — Marketing Organization
Feb 6, 1998
Ani Pharmaceuticals — Marketing Organization

2000s

Jan 1, 2005
Earliest Phase 3 Sponsor(trial)
Dec 3, 2008
Citruspharma — Marketing Organization
Mar 30, 2009
Kvk Tech Inc — Marketing Organization

2010s

Dec 21, 2011
Aderis — Marketing Organization
Dec 21, 2011
Eci Pharmaceuticals Llc — Marketing Organization
Dec 21, 2011
TTY Biopharm — Marketing Organization
Dec 21, 2011
AiPing Pharm Inc — Marketing Organization
Dec 21, 2011
Upsher-Smith Laboratories — Marketing Organization
Mar 19, 2014
Epic Pharma Llc — Marketing Organization
Nov 28, 2014
Nuvo Research Inc. — Marketing Organization
Feb 18, 2016
Apnar Pharma — Marketing Organization
Feb 18, 2016
Chartwell Pharmaceuticals — Marketing Organization
Feb 18, 2016
Novelgenix Therapeutics — Marketing Organization
Feb 23, 2016
Belcher Pharmaceuticals — Marketing Organization
Feb 23, 2016
AJENAT PHARMS — Marketing Organization

2020s

Jun 10, 2025
Lyne Laboratories — Marketing Organization

Indications

Approved for

Hyperkalemia (approved 1958)

Studied for

Mechanism of action

PotassiumCHELATING AGENT
Potassium chelating agent
PotassiumSEQUESTERING AGENT
Potassium sequestering agent

Approval history

approvedPriority reviewJun 5, 1958

Chemistry & pharmacology

Chirality: Single Stereoisomer
Inorganic: No
Polymer: Yes
Delivery: Oral, Topical
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Yes

Sources

Also known as

calcium polystyrenesulfonate
calcium polystyrene sulfonate
calcium polystyrene sulfonate
calcium polystyrene sulfonate
calcium polystyrene sulfonate
calcium polystyrene sulfonate
calcium polystyrene sulfonate
calcium polystyrene sulphonate
calcium resonium
calc resonium
gt160-246
gt160-246
kalexate
kalimate
kalimate
kayexalate
kayexalate
kayexalate
kayexalate
kayexalate
kayexalate
kionex
poly(4-styrenesulfonic acid)
poly(p-styrenesulfonic acid)
poly(sodium-4-styrene sulfonate)
poly(sodium-4-styrenesulfonate)
polysodium 4-styrenesulfonate
poly(styrene-4-sulfonic acid)
poly(styrenesulfonate)
polystyrene sulfonate
polystyrene sulfonate
polystyrene sulfonate
polystyrene sulfonate
polystyrene sulfonate
polystyrene sulfonate
poly(styrene sulfonate sodium salt)
polystyrene sulfonic acid
polystyrene sulfonic acid
polystyrene sulfonic acid
polystyrenesulfonic acid
polystyrene sulfonic acid, homopolymer, calcium salt
polystyrene sulfonic acid, homopolymer, sodium salt
psso3
p-styrenesulfonic acid homopolymer
p-styrenesulfonic acid polymer
resonium a
resonium a
resonium-a
sodium polystyrene sulfonate
sodium polystyrene sulfonate
sodium polystyrene sulfonate
sodium polystyrene sulfonate
sodium polystyrene sulfonate
sodium polystyrene sulfonate
sodium polystyrene sulfonate
sodium p-styrenesulfonate homopolymer
sorbisterit
styrenesulfonic acid polymer
tolevamer
tolevamer
tolevamer
tolevamer

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT04585542	Phase 4	Oct 20, 2020	University of California, Irvine
NCT02065076	Phase 4	Feb 1, 2014	University of Montreal
NCT01866709	Phase 4	May 1, 2013	ZS Pharma, Inc.
NCT00382304	Phase 2	Sep 1, 2006	Genzyme
NCT00196794	Phase 3	Apr 1, 2005	Genzyme
NCT00106509	Phase 3	Mar 1, 2005	Genzyme
NCT00034294	Phase 2	Feb 1, 2002	Genzyme
NCT00004328	Phase 2	Dec 1, 1992	National Center for Research Resources (NCRR), The University of Texas, Dallas

Showing 8 of 8 trials

Page 1 / 1

Organizations

Research & Development (6)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Genzyme	For profit	4	4	2	2002
National Center for Research Resources (NCRR)	Government	1	1	1	1992
The University of Texas, Dallas	Academic/Hospital	1	0	1	1992
University of California, Irvine	Academic/Hospital	1	1	1	2020
University of Montreal	Academic/Hospital	1	1	1	2014
ZS Pharma, Inc.	For profit	1	1	1	2013

6 organizations

Page 1 / 1

Marketing (29)

Organization	Org type	Relationship	Date
AJENAT PHARMS	For profit	MKTG	Feb 23, 2016
Aderis	For profit	MKTG	Dec 21, 2011
Advanz Pharma	For profit	NDA2	Jun 5, 1958
Advanz Pharma	For profit	MKTG	Jun 5, 1958
Advanz Pharma	For profit	NDA	Jun 5, 1958
AiPing Pharm Inc	For profit	MKTG	Dec 21, 2011
Ani Pharmaceuticals	For profit	MKTG	Feb 6, 1998
Apnar Pharma	For profit	MKTG	Feb 18, 2016
Belcher Pharmaceuticals	For profit	SYN	Feb 23, 2016
Belcher Pharmaceuticals	For profit	MKTG	Feb 23, 2016
CMP Therapeutics Ltd	For profit	MKTG	Dec 8, 1982
Chartwell Pharmaceuticals	For profit	MKTG	Feb 18, 2016
Citruspharma	For profit	MKTG	Dec 3, 2008
Eci Pharmaceuticals Llc	For profit	MKTG	Dec 21, 2011
Epic Pharma Llc	For profit	MKTG	Mar 19, 2014
Hikma	For profit	MKTG	Nov 17, 1986
Hikma	For profit	SYN	Nov 17, 1986
Kvk Tech Inc	For profit	MKTG	Mar 30, 2009
Lyne Laboratories	For profit	MKTG	Jun 10, 2025
Morton Grove Pharmaceuticals	For profit	MKTG	—
Novelgenix Therapeutics	For profit	MKTG	Feb 18, 2016
Nuvo Research Inc.	For profit	MKTG	Nov 28, 2014
Paddock Laboratories	For profit	MKTG	Feb 6, 1998
Pharmaceutical Associates	For profit	MKTG	Sep 11, 1984
Roxane Laboratories	For profit	MKTG	—
TTY Biopharm	For profit	MKTG	Dec 21, 2011
Upsher-Smith Laboratories	For profit	MKTG	Dec 21, 2011
West-Ward Pharmaceutical	For profit	MKTG	Nov 17, 1986
Wockhardt	For profit	MKTG	Sep 11, 1984