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Amlodipine 300
Amlodipine 300 is a Small molecule drug developed by Novartis. It is currently in Phase 3 development.
Amlodipine 300 is a small molecule that belongs to the drug class of blockers, specifically targeting the voltage-gated L-type calcium channel. It is used to treat conditions such as hypertension, abdominal aortic aneurysm, essential hypertension, and metabolic syndrome.
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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). -
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 | Amlodipine 300 |
|---|---|
| Sponsor | Novartis |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Exploring the Impact of Nephropathy Formula No. 1 on Chronic Kidney Disease Patients (EARLY_PHASE1)
- Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas (NA)
- A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension (PHASE3)
- Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension (PHASE4)
- Nephropathy In Type 2 Diabetes and Cardio-renal Events (PHASE4)
- Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance (NA)
- Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis (ANDORRA) (PHASE4)
- Direct Renin Inhibition Effects on Atherosclerotic Biomarkers (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:
- Amlodipine 300 CI brief — competitive landscape report
- Amlodipine 300 updates RSS · CI watch RSS
- Novartis portfolio CI
Frequently asked questions about Amlodipine 300
What is Amlodipine 300?
Who makes Amlodipine 300?
What development phase is Amlodipine 300 in?
Related
- Manufacturer: Novartis — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing