All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

sodium zirconium cyclosilicate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
	5225	242800-27-7

Description:

Molecule

Description

Synonyms: sodium zirconium cyclosilicate lokelma ZS-9 UXSi-9

Sodium zirconium cyclosilicate selectively binds potassium in exchange for hydrogen and sodium cations throughout the gastrointestinal (GI) tract and reduces the concentration of free potassium in the GI lumen. This lowers serum potassium levels by drawing potassium into the GI tract and increasing faecal potassium excretion to resolve hyperkalaemia. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
7.50	g	O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
March 25, 2020	PMDA	AstraZeneca K.K.
March 22, 2018	EMA	AstraZeneca AB
May 18, 2018	FDA	ASTRAZENECA PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	422.20	40.00	162	816	456389	90171080
Blood potassium increased	84.03	40.00	23	955	20726	90606743
End stage renal disease	61.54	40.00	15	963	8556	90618913
Hypokalaemia	54.37	40.00	27	951	131089	90496380

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	524.27	28.15	297	1653	470888	42148497
Blood potassium increased	96.36	28.15	35	1915	18501	42600884
Hyperkalaemia	54.69	28.15	38	1912	80420	42538965
End stage renal disease	49.63	28.15	21	1929	16537	42602848
Genital ulceration	39.64	28.15	9	1941	882	42618503
Oedema	36.31	28.15	25	1925	51976	42567409
Chronic kidney disease	31.31	28.15	22	1928	47219	42572166

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	493.72	31.87	259	2239	698610	109888191
Blood potassium increased	132.15	31.87	43	2455	33206	110553595
Hyperkalaemia	90.27	31.87	49	2449	135747	110451054
Hypokalaemia	62.26	31.87	43	2455	182405	110404396
Cardiac failure	47.63	31.87	37	2461	187589	110399212
Cardiac failure congestive	43.22	31.87	32	2466	150968	110435833
Genital ulceration	38.82	31.87	9	2489	1966	110584835
Chronic kidney disease	33.30	31.87	21	2477	76270	110510531
X-ray gastrointestinal tract abnormal	32.56	31.87	4	2494	15	110586786

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	V03AE10	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Drugs for treatment of hyperkalemia and hyperphosphatemia
MeSH PA	D007475	Ion Exchange Resins
CHEBI has role	CHEBI:35554	cardiovascular drug

Related Drugs by ATC class:

V03AE Drugs for treatment of hyperkalemia and hyperphosphatemia 10 drugs

calcium acetatecalcium acetate and magnesium carbonatecalcium polystyrene sulfonatecolestilanferric citratelanthanum carbonatepatiromer calciumsevelamersodium polystyrene sulfonatesucroferric oxyhydroxide

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Hyperkalemia	indication	14140009

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	10398730	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	8808750	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9844567	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9861658	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	10335432	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	10398730	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	8808750	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9844567	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9861658	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9913860	Oct. 22, 2033	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9913860	Oct. 22, 2033	TREATMENT OF HYPERKALEMIA IN ADULTS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	10300087	Oct. 14, 2035	TREATMENT OF HYPERKALEMIA IN ADULTS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	11738044	Oct. 14, 2035	TREATMENT OF HYPERKALEMIA IN ADULTS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9592253	Oct. 14, 2035	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	10300087	Oct. 14, 2035	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	11738044	Oct. 14, 2035	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9592253	Oct. 14, 2035	TREATMENT OF HYPERKALEMIA IN ADULTS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

ID	Source
D652ZWF066	UNII
4037731	VANDF
C4045824	UMLSCUI
CHEBI:755275	CHEBI
CHEMBL3301592	ChEMBL_ID
155804812	PUBCHEM_CID
DB14048	DRUGBANK_ID
D10727	KEGG_DRUG
C000597310	MESH_SUPPLEMENTAL_RECORD_UI
279467	MMSL
34257	MMSL
d08797	MMSL
017557	NDDF
17141-74-1	SECONDARY_CAS_RN
2047628	RXNORM

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
LOKELMA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-1105	POWDER, FOR SUSPENSION	5 g	ORAL	NDA	24 sections
LOKELMA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-1110	POWDER, FOR SUSPENSION	10 g	ORAL	NDA	24 sections
LOKELMA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-6501	POWDER, FOR SUSPENSION	10 g	ORAL	NDA	24 sections
LOKELMA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-6502	POWDER, FOR SUSPENSION	5 g	ORAL	NDA	25 sections