Summary
Nifedipine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hypertension would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hypertension. ClinicalTrials.gov lists 8 registered trials linking Nifedipine to Hypertension: 1 is currently recruiting; 1 is active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02641821). The largest enrolment is 1215 participants (NCT05947448). Registration activity spans 2011 to 2024. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2025 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Essential Hypertension ranks 376 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Not well-characterized as population baseline; routinely framed as irreversible in clinical culture despite contrary trial evidence.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 79.0 (trials 29.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 4 completed, 2 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT02499822 | REducing Blood Pressure Variability in Essential Hypertension With RAmipril vErsus Nifedipine GITS Trial 2015 | completed | Phase 4 | 168 |
| NCT06501651 | Sacubitril/Valsartan Treats Patients With Essential Hypertension and Type 2 Diabetic Nephropathy 2024 | not yet recruiting | Phase 4 | 297 |
| NCT02641821 | Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension 2015 | status unknown | Phase 4 | 700 |
| NCT01788358 | Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension 2013 | completed | Phase 3 | 508 |
| NCT01287260 | High Dose BAYA1040_Nifedipine: a Dose-comparative Study 2011 | completed | Phase 3 | 352 |
| NCT01294215 | High Dose BAYA1040_Nifedipine: a Long Term Combination Study 2011 | completed | Phase 3 | 72 |
| NCT04755764 | Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by ICG in Early Pregnancy 2021 | recruiting | Not applicable | 60 |
| NCT05947448 | Efficacy and Safety of Mexartan Potassium Tablets (AZL-M) and Calcium Channel Blockers (CCB) in the Treatment of Adults With Essential Hypertension in Chinese Population: a National Multicenter, Prospective, Observational Study 2024 | status unknown | Not applicable | 1,215 |
Published literature
- Clinical trial publication Patient-profiled treatment responses in a large hypertension trial: a posthoc analysis of the INSIGHT studyDe Leeuw PW, Mancia G, Palmer CR et al. · Journal of hypertension · 2026 · PMID 41860168
- Clinical trial publication Effect of nifedipine combined with magnesium sulfate on gestational hypertension and its impact on blood lipidsCheng H, Xing S, Fu A et al. · Blood pressure monitoring · 2026 · PMID 41321132
- Cochrane review Postpartum management of the hypertensive disorders of pregnancy: a systematic review and meta-analysisTol ID, Khalil A, Cairns AE et al. · American journal of obstetrics and gynecology · 2026 · PMID 41421750
- Meta-analysis Efficacy of pharmacological agents for management of post-partum hypertension: A systematic review and network meta-analysisSingh A, Singh MP, Thakur P et al. · Journal of human hypertension · 2026 · PMID 41663753
- Systematic review Prescribing patterns for hypertensive disorders of pregnancy in low- and middle-income countries: a systematic reviewIrshad HA, Khan MAA, Yaseen A et al. · BMC pregnancy and childbirth · 2026 · PMID 41896792
- Clinical trial publication Alcohol consumption and ambulatory blood pressure-lowering effect in male patients on clinic blood pressure-guided antihypertensive treatmentYe XF, Wang WY, Wang XY et al. · Hypertension research : official journal of the Japanese Society of Hypertension · 2025 · PMID 39814964
- Clinical trial publication Amlodipine versus nifedipine ER for the management of postpartum hypertension: a noninferiority randomized controlled trialPratt K, Lordo R, Self S et al. · American journal of obstetrics & gynecology MFM · 2025 · PMID 39662698
- Clinical trial publication A Randomized Controlled Trial on the Efficacy and Safety of a Calcium-Channel Blocker and an Angiotensin-Converting Enzyme Inhibitor in Chinese and European Patients with HypertensionZhang W, Liu CY, Bilo G et al. · American journal of hypertension · 2025 · PMID 39657776
- Cochrane review Targeted antihypertensive therapy after hypertensive pregnancy: Lactation-safe choices, treatment thresholds, and outcomes (2015-2025)Alhazmi AM, Albulushi A · Current problems in cardiology · 2025 · PMID 41077107
- Cochrane review Risk of postpartum readmission following discharge on nifedipine or labetalol for hypertensive disorders of pregnancy: A systematic review and meta-analysisKanninen T, Ortiz V, Alvarez-Perez J et al. · European journal of obstetrics, gynecology, and reproductive biology · 2025 · PMID 40914007
- Cochrane review Efficacy and Safety of Nifedipine Compared to Intravenous Hydralazine for Severe Hypertensive Disorders in Pregnancy: A Systematic Review and Meta-Analysis of Randmomized Controlled TrialsGovindasamy V, Kamel MA, Volucke G et al. · Medical sciences (Basel, Switzerland) · 2025 · PMID 40700120
- Cochrane review Oral antihypertensive treatment during pregnancy: a systematic review and network meta-analysisHup RJ, Damen JAA, Terstappen J et al. · American journal of obstetrics and gynecology · 2025 · PMID 40216176
- Meta-analysis Antihypertensive therapy for pregnancy hypertension and implications for fetal and neonatal heart rate monitoring: A systematic review of randomized trials and observational studiesGaneshamoorthy A, Duke OF, Mistry HD et al. · Acta obstetricia et gynecologica Scandinavica · 2025 · PMID 40836392
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Nifedipine approved for Hypertension?
Nifedipine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hypertension would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hypertension. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Nifedipine in clinical trials for Hypertension?
ClinicalTrials.gov lists 8 registered trials linking Nifedipine to Hypertension: 1 is currently recruiting; 1 is active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02641821). The largest enrolment is 1215 participants (NCT05947448). Registration activity spans 2011 to 2024.
What does the evidence show for Nifedipine in Hypertension?
Nifedipine has both completed registered trials and synthesis-level publications linked to Hypertension. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.