Chlorthalidone - PharmaKB

Chlorthalidone

/ Chlorthalidone, Chlorthalidone, Clorpres, Combipres, Demi-regroton, Edarbyclor, Hemiclor, Kerledex, Lopressidone, Regroton, Tenoretic, Thalitone (chlorthalidone) is a small molecule pharmaceutical. Chlorthalidone was first approved as Hygroton on 1982-01-01. It is used to treat edema, glomerulonephritis, heart failure, hypertension, and liver cirrhosis amongst others in the USA. The pharmaceutical is active against carbonic anhydrase 7. In addition, it is known to target carbonic anhydrase 14, carbonic anhydrase 1, carbonic anhydrase 12, and carbonic anhydrase 4.

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Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
digestive system diseases	D004066
urogenital diseases	D000091642
cardiovascular diseases	D002318
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Chlorthalidone, Thalitone (discontinued: Chlorthalidone, Hygroton, Thalitone)

Combinations

Atenolol chlorthalidone, Azilsartan medoxomil chlorthalidone, Edarbyclor, Tenoretic (discontinued: Atenolol chlorthalidone, Clonidine chlorthalidone, Clorpres, Combipres, Demi-regroton, Kerledex, Lopressidone)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Chlorthalidone

Clonidine hydrochloride

Tradename	Company	Number	Date	Products
COMBIPRES	Boehringer Ingelheim	N-017503 DISCN	1982-01-01	3 products, RLD

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Chlorthalidone

Metoprolol tartrate

Tradename	Company	Number	Date	Products
LOPRESSIDONE	Novartis	N-019451 DISCN	1987-12-31	2 products

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Chlorthalidone

Reserpine

Tradename	Company	Number	Date	Products
REGROTON	Sanofi	N-015103 DISCN	1982-01-01	1 products
DEMI-REGROTON	Sanofi	N-015103 DISCN	1982-01-01	1 products

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Chlorthalidone

Tradename	Company	Number	Date	Products
THALITONE	Casper Pharma	N-019574 RX	1988-12-20	2 products, RLD

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Betaxolol hydrochloride

Chlorthalidone

Tradename	Company	Number	Date	Products
KERLEDEX	Sanofi	N-019807 DISCN	1992-10-30	2 products

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Atenolol

Chlorthalidone

Tradename	Company	Number	Date	Products
TENORETIC 100	TWi Pharmaceuticals	N-018760 RX	1984-06-08	1 products, RLD, RS
TENORETIC 50	TWi Pharmaceuticals	N-018760 RX	1984-06-08	1 products, RLD

Azilsartan kamedoxomil

Chlorthalidone

Tradename	Company	Number	Date	Products
EDARBYCLOR	Azurity	N-202331 RX	2011-12-20	2 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
atenolol and chlorthalidone	ANDA	2026-08-27
chlorthalidone	ANDA	2026-09-21
edarbyclor	New Drug Application	2023-03-29
hemiclor	New Drug Application	2025-03-27
thalitone	New Drug Application	2026-06-25

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
heart failure	EFO_0003144	D006333	I50
hypertension	EFO_0000537	D006973	I10
glomerulonephritis	—	D005921	N05
liver cirrhosis	EFO_0001422	D008103	K74.0
nephrotic syndrome	EFO_0004255	D009404	N04
edema	—	D004487	R60.9
substance withdrawal syndrome	EFO_0005800	D013375	—
diarrhea	—	D003967	R19.7
muscle spasticity	—	D009128	—
glaucoma	EFO_0000516	D005901	H40

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Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Azilsartan Kamedoxomil / Chlorthalidone, Edarbyclor, Azurity
9387249	2031-07-01		U-3
9169238	2030-02-04	DP
9066936	2028-03-26	DP
7157584	2025-05-22	DP
7572920	2025-01-07	DP	U-3

ATC Codes

C: Cardiovascular system drugs

— C03: Diuretics

— C03B: Low-ceiling diuretics, excl. thiazides

— C03BA: Sulfonamides, low-ceiling diuretics, plain

— C03BA04: Chlortalidone

— C03BB: Sulfonamides and potassium in combination, low-ceiling diruetics, excluding thiazides

— C03BB04: Chlortalidone and potassium

— C03E: Diuretics and potassium-sparing agents in combination

— C03EA: Low-ceiling diuretics and potassium-sparing agents

— C03EA06: Chlortalidone and potassium-sparing agents

HCPCS

No data

Clinical

Clinical Trials

109 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypertension	D006973	EFO_0000537	I10	7	9	34	17	18	85
Essential hypertension	D000075222	—	I10	1	1	16	2	4	24
Chronic renal insufficiency	D051436	—	N18	—	4	—	4	1	9
Kidney diseases	D007674	EFO_0003086	N08	—	—	1	2	1	4
Heart failure	D006333	EFO_0003144	I50	—	1	2	2	—	4
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	—	2	1	—	3
Nephrolithiasis	D053040	—	N20.0	—	1	—	1	1	3
Kidney calculi	D007669	EFO_0004253	N20	—	1	—	1	1	3
Cardio-renal syndrome	D059347	—	—	—	1	—	2	—	3
Covid-19	D000086382	—	U07.1	—	—	—	1	1	2

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cardiovascular diseases	D002318	EFO_0000319	I98	—	2	10	—	1	13
Heart diseases	D006331	EFO_0003777	I51.9	—	3	6	—	2	10
Vascular diseases	D014652	EFO_0004264	I77	—	2	3	—	—	5
Coronary disease	D003327	—	—	—	—	2	—	2	4
Healthy volunteers/patients	—	—	—	2	—	1	—	—	3
Hypercholesterolemia	D006937	—	—	—	—	2	—	—	2
Sleep apnea syndromes	D012891	EFO_0003877	G47.3	—	—	2	—	—	2
Myocardial infarction	D009203	EFO_0000612	I21	—	—	1	—	1	2
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	—	—	1	—	—	1
Atherosclerosis	D050197	EFO_0003914	I25.1	—	—	1	—	—	1

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypercalciuria	D053565	—	R82.994	—	1	—	—	1	2
Inflammation	D007249	MP_0001845	—	—	1	—	—	—	1
Water intoxication	D014869	—	—	—	1	—	—	—	1
Type 1 diabetes mellitus	D003922	EFO_0001359	E10	—	1	—	—	—	1
Renal insufficiency	D051437	—	N19	—	1	—	—	—	1
Pre-eclampsia	D011225	EFO_0000668	O14	—	1	—	—	—	1

Indications Phases 1

No data

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Vascular stiffness	D059289	—	—	—	—	—	—	2	2
Ambulatory blood pressure monitoring	D018660	—	—	—	—	—	—	1	1
Stroke	D020521	EFO_0000712	I63.9	—	—	—	—	1	1
Infarction	D007238	EFO_0009463	—	—	—	—	—	1	1
Calculi	D002137	—	—	—	—	—	—	1	1
Insulin resistance	D007333	EFO_0002614	E88.819	—	—	—	—	1	1
Hypokalemia	D007008	—	E87.6	—	—	—	—	1	1
Fatty liver	D005234	EFO_0003934	—	—	—	—	—	1	1
Patient participation	D010358	—	—	—	—	—	—	1	1
Self care	D012648	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Chlorthalidone
INN	chlortalidone
Description	Chlorthalidone is a sulfonamide, a member of isoindoles and a member of monochlorobenzenes.
Classification	Small molecule
Drug class	Thiazide-like diuretic
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	NS(=O)(=O)c1cc(C2(O)NC(=O)c3ccccc32)ccc1Cl

Identifiers

PDB	—
CAS-ID	77-36-1
RxCUI	—
ChEMBL ID	CHEMBL1055
ChEBI ID	3654
PubChem CID	2732
DrugBank	DB00310
UNII ID	Q0MQD1073Q (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

CA2

Organism

Homo sapiens

Gene name

CA2

Gene synonyms

NCBI Gene ID

760

Protein name

carbonic anhydrase 2

Protein synonyms

CA-II, CAC, Carbonate dehydratase II, carbonic anhydrase B, Carbonic anhydrase C, Carbonic anhydrase II, carbonic dehydratase, Cyanamide hydratase CA2, epididymis luminal protein 76, epididymis secretory protein Li 282

Uniprot ID

Q96ET9

Mouse ortholog

Car2 (12349)

carbonic anhydrase 2 (Q9DCY9)

Variants

No data

Financial

Revenue by drug

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Estimated US medical usage

Chlorthalidone

Atenolol

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Chlorthalidone

Azilsartan

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Chlorthalidone

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Chlorthalidone

Clonidine

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Trends

PubMed Central

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Safety

Black-box Warning

Black-box warning for: Edarbyclor

Adverse Events

Top Adverse Reactions

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4,398 adverse events reported

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