Amlodipine clinical trials
Amlodipine is named as an intervention in 10 current clinical trials in our China, Norway, Canada and Brazil registers. 5 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Shenzhen Ausa Pharmed Co.,Ltd (2). The most-studied condition is Hypertension.
Where Amlodipine is approved
All regulators →Of the three regulators tracked here, the first to approve Amlodipine was the US, on 31 Jul 1992. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Amlodipine patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Amlodipine, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 6 listed patents; the last listed expires 24 Feb 2041 (US 12226528).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Amlodipine
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Amlodipine works
All drug targets →- Voltage-gated L-type calcium channel blocker BlockerTarget: Voltage-gated L-type calcium channel✓ In ChEMBL and the Guide to Pharmacology
- CADASILPhase 3
- HypercholesterolemiaPhase 3
- Hypertension resistant to conventional therapyPhase 3
- Blood pressure traitPhase 3
- Chronic kidney diseasePhase 3
- Coronary artery disorderPhase 3
- Depressive disorderPhase 3
- Essential hypertensionPhase 3
- HyperlipidemiaPhase 3
- Impaired renal function diseasePhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1491, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6981, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Amlodipine
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 34 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Amlodipine
- ATC code
- C08CA01
- ChEMBL
- CHEMBL1491
- DrugBank
- DB00381
- PubChem CID
- 2162
- CAS number
- 88150-42-9
- FDA UNII
- 1J444QC288
- Wikidata
- Q411347
- Wikipedia
- Amlodipine
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Amlodipine
10 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Amlodipine across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
34 single-substance products containing Amlodipine on the HPRA medicines list.
- Amlode 10 mg TabletsRowex Limited, · PA0711/138/002 · Marketed
- Amlode 5 mg tabletsRowex Limited, · PA0711/138/001 · Marketed
- Amlodipine 10 mg tabletsAccord Healthcare Ireland Ltd. · PA2315/075/002 · Marketed
- Amlodipine 5 mg tabletsAccord Healthcare Ireland Ltd. · PA2315/075/001 · Marketed
- Amlodipine Clonmel 10 mg tabletsClonmel Healthcare Ltd · PA0126/258/002 · Marketed
Supply shortages
- Perindopril/Amlodipin Denk 4 mg/10 mg TablettenGermany (BfArM) · Other reason · 16 Jul 2025 to 15 Dec 2026
Recent approvals
- Telmisartan And AmlodipineFDA · 17 Nov 2016 · Generic (ANDA) · Alembic
Conditions studied with Amlodipine
14 conditionsAll 14 conditions
| Condition (as registered) | Trials |
|---|---|
| Hypertension | 5 |
| Stroke | 2 |
| Diabetes Mellitus, Type 2 | 1 |
| Adverse Event | 1 |
| Blood Pressure | 1 |
| Prehypertension | 1 |
| MTHFR 677 CC or CT Genotype | 1 |
| Elevated Plasma Homocysteine (Hcy≥10µmol/L) | 1 |
| Insufficient Plasma Folate Levels (<12ng/mL) | 1 |
| Cerebral Small Vessel Diseases | 1 |
| Endometrial Cancer | 1 |
| MTHFR 677 TT Genotype | 1 |
| Obesity, Morbid | 1 |
| Cognitive Decline | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Shenzhen Ausa Pharmed Co.,Ltd | 2 |
| Jing Liu | 2 |
| XueQing Yu | 1 |
| Beijing Tiantan Hospital | 1 |
| Peking University People's Hospital | 1 |
| Norwegian University of Science and Technology | 1 |
| Ottawa Hospital Research Institute | 1 |
| Hospital Moinhos de Vento | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 7 | 3 |
| Clinical trials in Norway | 1 | 1 |
| Clinical trials in Canada | 1 | 0 |
| Clinical trials in Brazil | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Amlodipine trials
How many clinical trials are testing Amlodipine?
10 current trials in our China, Norway, Canada and Brazil registers name Amlodipine as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Amlodipine trials recruiting patients?
Yes. 5 of the 10 trials are recruiting: 3 with sites in China, 1 with sites in Norway and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Amlodipine clinical trials?
Shenzhen Ausa Pharmed Co.,Ltd (2), Jing Liu (2), XueQing Yu (1) and Beijing Tiantan Hospital (1), among 8 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Amlodipine licensed in Ireland?
Yes. The HPRA medicines list includes 34 single-substance products containing Amlodipine, for example Amlode 10 mg Tablets (Rowex Limited,). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Amlodipine shortage?
The registers we track list 1 entry for Amlodipine: 1 German notice. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Amlodipine works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Amlodipine works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Amlodipine (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.