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Aliskiren 150
Aliskiren 150 is a Direct renin inhibitor Small molecule drug developed by Novartis. It is currently in Phase 3 development for Hypertension, Diabetic nephropathy (in combination with losartan).
Aliskiren is a direct renin inhibitor that blocks the first step of the renin-angiotensin-aldosterone system (RAAS) by preventing renin from converting angiotensinogen to angiotensin I.
Aliskiren 150 is a medication used to treat conditions such as Heart Failure, Hypertension, End Stage Renal Disease, and Stage 2 Hypertension. It is a direct renin inhibitor, which means it works by blocking the action of renin, an enzyme involved in the regulation of blood pressure.
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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. -
Big-pharma sponsor
+3.0pp
Novartis is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Aliskiren 150 |
|---|---|
| Sponsor | Novartis |
| Drug class | Direct renin inhibitor |
| Target | Renin |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
By inhibiting renin directly at the top of the RAAS cascade, aliskiren reduces the formation of angiotensin II, a potent vasoconstrictor and aldosterone stimulator. This leads to vasodilation, reduced sodium retention, and lower blood pressure. Unlike ACE inhibitors or ARBs that block downstream steps, direct renin inhibition provides a more complete blockade of the RAAS.
Approved indications
- Hypertension
- Diabetic nephropathy (in combination with losartan)
Common side effects
- Diarrhea
- Headache
- Dizziness
- Fatigue
- Hyperkalemia
- Cough
Key clinical trials
- Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy (PHASE2)
- Pharmacokinetic and Pharmacodynamic Profiles of Aliskiren in Japanese Patients With Mild to Moderate Essential Hypertension (PHASE1)
- Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension (PHASE4)
- Effect of Aliskiren and Hydrochlorothiazide on Kidney Oxygenation in Patients With Hypertension (PHASE4)
- Aldosterone and the Metabolic Syndrome (PHASE1)
- Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation (PHASE4)
- Vitamin D Deficiency in Patients With Hypertension (PHASE4)
- Shiga Microalbuminuria Reduction Trial-2 (PHASE4)
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:
- Aliskiren 150 CI brief — competitive landscape report
- Aliskiren 150 updates RSS · CI watch RSS
- Novartis portfolio CI
Frequently asked questions about Aliskiren 150
What is Aliskiren 150?
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Related
- Drug class: All Direct renin inhibitor drugs
- Target: All drugs targeting Renin
- Manufacturer: Novartis — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertension
- Indication: Drugs for Diabetic nephropathy (in combination with losartan)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing