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Amiloride 20 mg
Amiloride 20 mg is a Small molecule drug developed by Hospital de Clinicas de Porto Alegre. It is currently in Phase 3 development. Also known as: Amiloride.
Amiloride is a small molecule used in the treatment of various conditions, including Autosomal Dominant Polycystic Kidney Disease, Diabetic Nephropathies, and Hypertension, among others. It is available in a 20 mg dosage form, although the exact dosage used in clinical trials varies, with some trials using 5 mg tablets.
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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).
| 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 | Amiloride 20 mg |
|---|---|
| Also known as | Amiloride |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Treatment of Vascular Stiffness in ADPKD (PHASE4)
- Natriuretic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant (PHASE3)
- Recombinant Human rhPTH(1-34) VS Association Alfacalcidol/Hydrochlorothiazide in Severe Primary Hypoparathyroidism (PHASE2)
- MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial (PHASE2)
- Efficacy of Chlorthalidone and Hydrochlorothiazide Combined With Amiloride on Blood Pressure in Primary Hypertension. (PHASE3)
- Sequential Nephron Blockade vs. Dual Blockade Renin-angiotensin System + Bisoprolol in Resistant Arterial Hypertension (PHASE4)
- Epithelial Sodium Channel (ENaC) as a Novel Mechanism for Hypertension and Volume Expansion in Type 2 Diabetes (EARLY_PHASE1)
- Input of the Use of Indometacin in Gitelman Syndrome as Compared to Potassium Sparing Diuretics (PHASE1, PHASE2)
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:
- Amiloride 20 mg CI brief — competitive landscape report
- Amiloride 20 mg updates RSS · CI watch RSS
- Hospital de Clinicas de Porto Alegre portfolio CI
Frequently asked questions about Amiloride 20 mg
What is Amiloride 20 mg?
Who makes Amiloride 20 mg?
Is Amiloride 20 mg also known as anything else?
What development phase is Amiloride 20 mg in?
Related
- Manufacturer: Hospital de Clinicas de Porto Alegre — full pipeline
- Also known as: Amiloride
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing