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Chlorthalidone plus amiloride
Chlorthalidone plus amiloride is a Thiazide-like diuretic plus potassium-sparing diuretic combination Small molecule drug developed by Hospital de Clinicas de Porto Alegre. It is currently in Phase 3 development for Hypertension, Edema associated with congestive heart failure or renal disease. Also known as: Chlo+Ami, diuretics, diuretic.
Chlorthalidone is a thiazide-like diuretic that reduces sodium reabsorption in the distal convoluted tubule, while amiloride is a potassium-sparing diuretic that blocks sodium channels in the collecting duct, together lowering blood pressure and reducing fluid overload.
Chlorthalidone is a thiazide-like diuretic that reduces sodium reabsorption in the distal convoluted tubule, while amiloride is a potassium-sparing diuretic that blocks sodium channels in the collecting duct, together lowering blood pressure and reducing fluid overload. Used for Hypertension, Edema associated with congestive heart failure or renal disease.
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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.
| 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 | Chlorthalidone plus amiloride |
|---|---|
| Also known as | Chlo+Ami, diuretics, diuretic |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Drug class | Thiazide-like diuretic plus potassium-sparing diuretic combination |
| Target | Na-Cl cotransporter (chlorthalidone); epithelial sodium channel ENaC (amiloride) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Chlorthalidone inhibits the Na-Cl cotransporter in the distal convoluted tubule, promoting sodium and water excretion and reducing blood volume and vascular resistance. Amiloride blocks epithelial sodium channels in the collecting duct, preventing potassium loss and counteracting the hypokalemia caused by chlorthalidone. The combination provides synergistic antihypertensive and diuretic effects while maintaining electrolyte balance.
Approved indications
- Hypertension
- Edema associated with congestive heart failure or renal disease
Common side effects
- Hypokalemia
- Hyperkalemia
- Hyponatremia
- Hyperuricemia
- Hyperglycemia
- Dizziness
- Headache
- Fatigue
Key clinical trials
- Comparison of Optimal Hypertension Regimens (PHASE4)
- Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension (PHASE3)
- ACEI or ARB and COVID-19 Severity and Mortality in US Veterans
- Efficacy of Chlorthalidone and Hydrochlorothiazide Combined With Amiloride on Blood Pressure in Primary Hypertension. (PHASE3)
- Effect of Antihypertensive Agents on Diastolic Function in Patients With Sleep Apnea (PHASE3)
- Effect of Antihypertensive Agents Over Sleep Apnea (PHASE3)
- Diuretics and Angiotensin-Receptor Blocker Agents in Patients With Stage I Hypertension (PHASE3)
- Hypertension Prevention in Pre-Hypertensive Individuals (PHASE3)
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:
- Chlorthalidone plus amiloride CI brief — competitive landscape report
- Chlorthalidone plus amiloride updates RSS · CI watch RSS
- Hospital de Clinicas de Porto Alegre portfolio CI
Frequently asked questions about Chlorthalidone plus amiloride
What is Chlorthalidone plus amiloride?
How does Chlorthalidone plus amiloride work?
What is Chlorthalidone plus amiloride used for?
Who makes Chlorthalidone plus amiloride?
Is Chlorthalidone plus amiloride also known as anything else?
What drug class is Chlorthalidone plus amiloride in?
What development phase is Chlorthalidone plus amiloride in?
What are the side effects of Chlorthalidone plus amiloride?
What does Chlorthalidone plus amiloride target?
Related
- Drug class: All Thiazide-like diuretic plus potassium-sparing diuretic combination drugs
- Target: All drugs targeting Na-Cl cotransporter (chlorthalidone); epithelial sodium channel ENaC (amiloride)
- Manufacturer: Hospital de Clinicas de Porto Alegre — 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: Chlo+Ami, diuretics, diuretic
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing