Last reviewed · How we verify
Norvasc Tablets 5mg
Norvasc Tablets 5mg is a Small molecule drug developed by Shanghai Haini Pharmaceutical Co., Ltd.. It is currently in Phase 1 development. Also known as: Amlodipine Tablet 5mg.
Norvasc Tablets 5mg is a small molecule medication used to treat conditions such as hypertension, essential hypertension, and primary hypertension. Its mechanism of action is currently unknown.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Norvasc Tablets 5mg |
|---|---|
| Also known as | Amlodipine Tablet 5mg |
| Sponsor | Shanghai Haini Pharmaceutical Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets (PHASE1)
- Triple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure Control (NA)
- Study of Efficacy and Safety of LCZ696/Amlodipine in Grade 1 and 2 Hypertension Patients Uncontrolled by LCZ696 Monotherapy (PHASE3)
- Antihypertensive Drug Selection Based on Hemodynamic Phenotypes (PHASE4)
- Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia
- Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension (PHASE3)
- Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy (PHASE2)
- Evaluation of the Clinical Efficacy and Safety of Amlodipine 5mg/ Bisoprolol Fumarate 5mg /Perindopril Arginine 5mg Fixed-dose Combination in Capsule and Free Monotherapy at the Same Dose in Patients With Uncontrolled Essential Hypertension. (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:
- Norvasc Tablets 5mg CI brief — competitive landscape report
- Norvasc Tablets 5mg updates RSS · CI watch RSS
- Shanghai Haini Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Norvasc Tablets 5mg
What is Norvasc Tablets 5mg?
Who makes Norvasc Tablets 5mg?
Is Norvasc Tablets 5mg also known as anything else?
What development phase is Norvasc Tablets 5mg in?
Related
- Manufacturer: Shanghai Haini Pharmaceutical Co., Ltd. — full pipeline
- Also known as: Amlodipine Tablet 5mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing