Last reviewed 2026-05-31 · How we verify

GROUP C: Chlorthalidone

Farma de Colombia SA · Phase 3 active Small molecule ✓ Verified May 2026

GROUP C: Chlorthalidone is a Thiazide-like diuretic Small molecule drug developed by Farma de Colombia SA. It is currently in Phase 3 development for Hypertension, Edema associated with congestive heart failure or renal disease. Also known as: Sodium Chloride Symporter Inhibitors, Antihypertensive Agents, Diuretics.

Chlorthalidone is a thiazide-like diuretic that inhibits sodium and chloride reabsorption in the distal convoluted tubule of the kidney, promoting urinary excretion and reducing blood volume and blood pressure.

Chlorthalidone is used to treat hypertension and arterial hypertension. It is often used in combination with other medications, such as valsartan, but can also be used as a standalone treatment.

Likelihood of approval

56.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	GROUP C: Chlorthalidone
Also known as	Sodium Chloride Symporter Inhibitors, Antihypertensive Agents, Diuretics
Sponsor	Farma de Colombia SA
Drug class	Thiazide-like diuretic
Target	Sodium-chloride cotransporter (NCC)
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

Chlorthalidone blocks the sodium-chloride cotransporter (NCC) in the distal convoluted tubule, preventing electrolyte reabsorption and increasing urine output. This reduces circulating blood volume and total peripheral resistance, leading to decreased blood pressure. It also has mild vasodilatory properties that contribute to its antihypertensive effect.

Approved indications

Hypertension
Edema associated with congestive heart failure or renal disease

Common side effects

Hypokalemia
Hyperuricemia
Hyperglycemia
Hyponatremia
Dizziness
Headache

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

GROUP C: Chlorthalidone CI brief — competitive landscape report
GROUP C: Chlorthalidone updates RSS · CI watch RSS
Farma de Colombia SA portfolio CI

Frequently asked questions about GROUP C: Chlorthalidone

What is GROUP C: Chlorthalidone?

GROUP C: Chlorthalidone is a Thiazide-like diuretic drug developed by Farma de Colombia SA, indicated for Hypertension, Edema associated with congestive heart failure or renal disease.

How does GROUP C: Chlorthalidone work?

What is GROUP C: Chlorthalidone used for?

GROUP C: Chlorthalidone is indicated for Hypertension, Edema associated with congestive heart failure or renal disease.

Who makes GROUP C: Chlorthalidone?

GROUP C: Chlorthalidone is developed by Farma de Colombia SA (see full Farma de Colombia SA pipeline at /company/farma-de-colombia-sa).

Is GROUP C: Chlorthalidone also known as anything else?

GROUP C: Chlorthalidone is also known as Sodium Chloride Symporter Inhibitors, Antihypertensive Agents, Diuretics.

What drug class is GROUP C: Chlorthalidone in?

GROUP C: Chlorthalidone belongs to the Thiazide-like diuretic class. See all Thiazide-like diuretic drugs at /class/thiazide-like-diuretic.

What development phase is GROUP C: Chlorthalidone in?

GROUP C: Chlorthalidone is in Phase 3.

What are the side effects of GROUP C: Chlorthalidone?

Common side effects of GROUP C: Chlorthalidone include Hypokalemia, Hyperuricemia, Hyperglycemia, Hyponatremia, Dizziness, Headache.

What does GROUP C: Chlorthalidone target?

GROUP C: Chlorthalidone targets Sodium-chloride cotransporter (NCC) and is a Thiazide-like diuretic.

Drug class: All Thiazide-like diuretic drugs
Target: All drugs targeting Sodium-chloride cotransporter (NCC)
Manufacturer: Farma de Colombia SA — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Hypertension
Indication: Drugs for Edema associated with congestive heart failure or renal disease
Also known as: Sodium Chloride Symporter Inhibitors, Antihypertensive Agents, Diuretics

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing