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Fimasartan + Indapamide
Fimasartan + Indapamide is a Angiotensin II receptor blocker + thiazide-like diuretic combination Small molecule drug developed by Boryung Pharmaceutical Co., Ltd. It is currently in Phase 3 development for Essential hypertension. Also known as: I : BR1015-3 + BR1015-2, II : BR1015-1 + BR1015-2, I : BR1015-3 + BR1015-4, II : BR1015-1 + BR1015-4.
Fimasartan blocks angiotensin II receptors to lower blood pressure, while indapamide acts as a thiazide-like diuretic to reduce fluid volume and further decrease blood pressure.
Fimasartan blocks angiotensin II receptors to lower blood pressure, while indapamide acts as a thiazide-like diuretic to reduce fluid volume and further decrease blood pressure. Used for Essential hypertension.
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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 | Fimasartan + Indapamide |
|---|---|
| Also known as | I : BR1015-3 + BR1015-2, II : BR1015-1 + BR1015-2, I : BR1015-3 + BR1015-4, II : BR1015-1 + BR1015-4 |
| Sponsor | Boryung Pharmaceutical Co., Ltd |
| Drug class | Angiotensin II receptor blocker + thiazide-like diuretic combination |
| Target | AT1 receptor (fimasartan); sodium-chloride cotransporter (indapamide) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Fimasartan is an angiotensin II receptor blocker (ARB) that prevents angiotensin II from binding to AT1 receptors on blood vessels and the heart, causing vasodilation and reduced blood pressure. Indapamide is a thiazide-like diuretic that inhibits sodium reabsorption in the distal convoluted tubule, promoting sodium and water excretion and reducing blood volume. The combination provides complementary antihypertensive effects through different mechanisms.
Approved indications
- Essential hypertension
Common side effects
- Dizziness
- Fatigue
- Hyperuricemia
- Hypokalemia
- Headache
Key clinical trials
- A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015-3 and BR1015-2 Under Fed Conditions (PHASE1)
- A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy (PHASE3)
- A Clinical Trial to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers (PHASE1)
- Fimasartan in the Senior Subjects (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:
- Fimasartan + Indapamide CI brief — competitive landscape report
- Fimasartan + Indapamide updates RSS · CI watch RSS
- Boryung Pharmaceutical Co., Ltd portfolio CI
Frequently asked questions about Fimasartan + Indapamide
What is Fimasartan + Indapamide?
How does Fimasartan + Indapamide work?
What is Fimasartan + Indapamide used for?
Who makes Fimasartan + Indapamide?
Is Fimasartan + Indapamide also known as anything else?
What drug class is Fimasartan + Indapamide in?
What development phase is Fimasartan + Indapamide in?
What are the side effects of Fimasartan + Indapamide?
What does Fimasartan + Indapamide target?
Related
- Drug class: All Angiotensin II receptor blocker + thiazide-like diuretic combination drugs
- Target: All drugs targeting AT1 receptor (fimasartan); sodium-chloride cotransporter (indapamide)
- Manufacturer: Boryung Pharmaceutical Co., Ltd — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Essential hypertension
- Also known as: I : BR1015-3 + BR1015-2, II : BR1015-1 + BR1015-2, I : BR1015-3 + BR1015-4, II : BR1015-1 + BR1015-4
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing