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Levamlodipine, Amlodipine
Levamlodipine, Amlodipine is a Small molecule drug developed by Conjupro Biotherapeutics, Inc.. It is currently in Phase 1 development. Also known as: Xuanning®, NORVASC®.
Levamlodipine is a small molecule used to treat conditions such as hypertension, essential hypertension, and hyperlipidemia. It is a variant of the medication amlodipine, which is also known by other names including amlodipine and levamlodipine.
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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 | Levamlodipine, Amlodipine |
|---|---|
| Also known as | Xuanning®, NORVASC® |
| Sponsor | Conjupro Biotherapeutics, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets In Hypertensive Patients (PHASE3)
- Drug-Drug Interaction Study Between HUC2-565-A and HUC2-565-B (PHASE1)
- An Observation Study on the Identification of Prescription Patterns of Lodient Tab(Telmisartan/S-amlodipine)
- S-amlodipine in Essential HypertensIon and Assessment of Blood Pressure Targets Achievement
- A Clinical Trial to Evaluate the Blood Pressure Control of Telmisartan or Losartan in Essential Hypertensive Patients With Metabolic Syndrome (PHASE4)
- Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects (PHASE1)
- Anti Inflammatory Treatment of Hypertension (PHASE2, PHASE3)
- Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With 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:
- Levamlodipine, Amlodipine CI brief — competitive landscape report
- Levamlodipine, Amlodipine updates RSS · CI watch RSS
- Conjupro Biotherapeutics, Inc. portfolio CI
Frequently asked questions about Levamlodipine, Amlodipine
What is Levamlodipine, Amlodipine?
Who makes Levamlodipine, Amlodipine?
Is Levamlodipine, Amlodipine also known as anything else?
What development phase is Levamlodipine, Amlodipine in?
Related
- Manufacturer: Conjupro Biotherapeutics, Inc. — full pipeline
- Also known as: Xuanning®, NORVASC®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing