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nifedipine (Darbelan 10)

✓ Approved

Teva Pharmaceutical Industries Ltd. · CACNA1C · Small Molecule

What is nifedipine?

nifedipine is a small molecule developed by Teva Pharmaceutical Industries Ltd.. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesDarbelan 10
CompanyTeva Pharmaceutical Industries Ltd.
Drug ClassSmall Molecule
Molecular TargetCACNA1C
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Teva Pharmaceutical Industries Ltd.

Mechanism of Action

Molecular Targets

nifedipine acts on 1 molecular target:

CACNA1Ccalcium voltage-gated channel subunit alpha1 C (CACNL1A1, CACNA1C-IT2)
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Therapeutic Indications

nifedipine is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Cardiac disordersAngina pectoris✓ Approved
Vascular disordersHypertension✓ Approved

Related Research Articles

PubMedEuropean journal of obstetrics, gynecology, and reproductive biology2026-07-17

The association between oral antihypertensive agents and perinatal outcomes in early-onset fetal growth restriction: A post-hoc analysis of the Dutch OPTICORE study.

Hup Rosalie J RJ, van de Meent Mette M, Ganzevoort Wessel W, Gordijn Sanne J SJ et al.

Early-onset fetal growth restriction (FGR) and hypertensive disorders of pregnancy frequently co-occur, reflecting shared underlying placental pathology. We evaluated whether the type of oral antihypertensive agent (OAA) (i.e. methyldopa, labetalol, nifedipine, or a combination) is associated with birthweight or adverse perinatal outcomes in pregnancies complicated by early-onset FGR. A post-hoc analysis of the OPtimal TIming of antenatal COrticosteroid administration in early-onset fetal growth REstriction (OPTICORE) study was performed, including women treated with methyldopa, labetalol, nifedipine, or a combination. The primary outcome was birthweight. Secondary outcomes included gestational age (GA) and adverse perinatal outcome measures as defined by the Core Outcome Set for FGR (COSGROVE). Outcomes were compared separately in monotherapy and combination therapy groups. Adjusted multilevel linear or logistic regression analyses were performed. Of the 1,453 women included in the OPTICORE study, 849 (58.4%) received OAAs during pregnancy, with exposure groups ranging from 14 to 230 patients. No significant differences were found in absolute birthweight, GA, or adverse perinatal outcomes between monotherapy groups nor between combination therapy groups. Among early-onset FGR pregnancies, we found no differences in birthweight, GA, or adverse perinatal outcomes between the commonly used OAAs methyldopa, labetalol, and nifedipine when compared head-to-head, nor between different combination therapies. These findings suggest that OAA treatment in this context should not be guided by concerns regarding fetal growth or adverse perinatal outcomes. However, since some exposure groups included a limited number of patients and possible bias by indication, results should be interpreted with caution.

PMID 42462570
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PubMedEuropean journal of hospital pharmacy : science and practice2026-07-11

The optimisation of extemporaneous compounding of low-dose nifedipine capsules.

Pajula Katja K, Sunnarborg Rasmus R, Ramon Carla Riera CR, Lehtonen Marko M et al.

Extemporaneous compounding is often necessary when a suitable drug product is not on the market (eg, when the patient is a child). The medication of children often differs from adults as there are several excipients which are generally recognised as safe but which nevertheless are unsuitable ingredients for paediatric medication. Extemporaneous compounding is the only manufacturing method to tailor the final drug product with specific needs. However, the disadvantage is the lack of standardised instructions. The situation is even more difficult if the active pharmaceutical ingredient is light sensitive. The aim of the study was to optimise the extemporaneous compounding of low-dose nifedipine (NIF) capsules size 3 (0.3 mL) and 4 (0.21 mL) by comparing the volumetric and gravimetric methods. The suitability of several fillers-lactose (LAC), mannitol (MAN) and microcrystalline cellulose (MCC)-for capsule compounding was evaluated. The powder properties of NIF, LAC, MAN and MCC were characterised. The volumetric and gravimetric methods (12 batches) were evaluated by the European Pharmacopoeia (Ph. Eur.). The light degradation of NIF was studied with a UV-Vis spectrophotometer. All manufactured capsules met the Ph. Eur. requirements on uniformity of mass (2.9.5.). With regard to uniformity of content (2.9.6.), nine of the 12 batches met the Ph. Eur. However, deviation from the average content was greater with LAC than with MAN and MCC. According to the uniformity of dosage units (Ph. Eur. 2.9.40.), eight of the 12 batches met the requirements, with LAC being slightly poorer than MAN and MCC. Both volumetric and gravimetric methods were suitable for low-dose NIF capsule compounding. The powder loss during preparation was greater with the gravimetric method, even though it produced better quality capsules. MAN and MCC were slightly better than LAC as capsule fillers. Solid NIF degraded slowly when exposed to artificial light whereas dissolved NIF degraded in less than an hour.

PMID 42431730
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PubMedToxicology reports2026-07-11

VA-ECMO and HIET for toxic cardiogenic shock in an elderly patient following severe poly-intoxication: A case report.

Ouwerkerk J J J JJJ, Poublon N A NA, Westra A F AF, Kraaijvanger N N

This case report presents the successful use of high-dose insulin euglycemic therapy (HIET) and venous arterial extracorporeal membrane oxygenation (VA-ECMO) in managing severe toxic cardiogenic shock following poly-intoxication in an elderly patient. A 67-year-old woman, with a history of depression, previous suicide attempts and chronic renal failure, overdosed on multiple cardiovascular active agents including metoprolol (β-blocker), nifedipine (calcium channel blocker), nortriptyline (tricyclic antidepressant), venlafaxine (serotonin-noradrenaline reuptake inhibitor), and temazepam (benzodiazepine) were reported. Initial treatment with vasopressors, HIET and supportive measures stabilized her condition temporarily. Despite these interventions, the patient developed catecholamine-refractory shock with progressive multiorgan failure, requiring escalation to VA-ECMO as a bridge to recovery. VA-ECMO resulted in hemodynamic stabilization, enabling vasopressor withdrawal and decannulation after three days. The patient survived the acute toxic phase without irreversible neurological injury. However, the course was complicated by vascular complications, prolonged mechanical ventilation, renal replacement therapy, severe functional decline and eventually death eight months later. This case illustrates that VA-ECMO may provide effective temporary circulatory support in severe reversible toxic cardiogenic shock, even in elderly patients with significant comorbidity. However, the substantial burden of long-term morbidity and prolonged recovery should be carefully weighed during multidisciplinary decision-making.

PMID 42434173
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PubMedRevista peruana de medicina experimental y salud publica2026-07-09

Adherence to antihypertensive treatment in patients at a tertiary hospital in Lima, Peru.

Aguilar-Lizarme Angy A, Amado-Tineo José J

In Peru, there are few reports on pharmacological adherence in patients with arterial hypertension. In this context, the present study aimed to determine adherence to antihypertensive treatment in patients treated at a tertiary-level social security hospital in Lima. A cross-sectional study was conducted in 250 hospitalized patients, over 18 years of age, with a diagnosis of primary arterial hypertension on pharmacological treatment. Adherence was evaluated using the Morisky questionnaire (MMAS-8), and variables such as prescribed medication, age, sex, marital status, and educational level were collected. 56.4% of the participants were male and 86.4% were over 60 years old. It was observed that 42% presented low pharmacological adherence and 58% medium adherence, with no cases of high adherence recorded. Monotherapy was the most frequent regimen (48%), with losartan, nifedipine, and enalapril being the most prescribed drugs. Finally, significant differences were identified between adherence to antihypertensive treatment and educational level and the number of drugs.

PMID 42424289
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PubMedInternational journal of developmental neuroscience : the official journal of the International Society for Developmental Neuroscience2026-07-08

Abscisic Acid Enhances Hippocampal Neuroplasticity and Rescues Learning and Memory Deficits in a Valproate-Induced Rat Model of Autism.

Doustdar Sanaye Nikta N, Abbasnejad Mehdi M, Kooshki Razieh R, Esmaeili Mahani Saeed S et al.

This study investigated the possible protective effects of abscisic acid (ABA), a naturally occurring phytohormone with incipient neuromodulatory properties, to alleviate cognitive and neurological alterations in a valproate (VPA)-induced rat model of autism. ABA was injected intra-CA1 hippocampal (0.5, 1, 1.5 μg/rat) in both VPA-exposed and control rats. Spatial learning and memory retention was validated by Morris water maze (MWM). Additionally, hippocampal levels of oxidative stress biomarkers-hydrogen peroxide (H2O2) and malondialdehyde (MDA)-were quantified. The expression of key neuroplasticity-related genes (BDNF, TrkB, PI3K and AKT) was also evaluated via real-time PCR. VPA-exposed rats exhibited significant deficits in learning and memory, alongside elevated hippocampal oxidative stress and downregulation of BDNF/TrkB and PI3K/AKT signalling. ABA treatment dose-dependently reversed learning and memory impairments. Moreover, ABA (1.5 μg/rat) significantly reduced H2O2 and MDA levels and restored the gene expression of BDNF, TrkB, PI3K and AKT in the hippocampus, indicating coordinated enhancement of antioxidant defences and neurotrophic transcriptional activity. However, ABA's efficiency in improving these responses was completely blocked by nifedipine, a calcium channel blocker, and chelerythrine, a PKC inhibitor. Overall, our results highlight the promising potential of ABA as a treatment for ASD while emphasising the necessity for more research to entirely elucidate its underlying mechanisms.

PMID 42413917
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PubMedJCEM case reports2026-07-02

PASNA syndrome with overlapping CACNA1D and MED12L variants: expanding the spectrum.

Nalluri Bhanu Teja BT, Kudugunti Neelaveni N, Sahay Rakesh Kumar RK, Santhoju Venkatesh V

Hypertension in infancy is rare and usually secondary to renal, cardiovascular, or endocrine disorders. PASNA syndrome (primary aldosteronism, seizures, and neurological abnormalities) (OMIM #615474) caused by activating CACNA1D mutations, has been increasingly recognized with wider availability of genetic testing. We report a 5-month-old male infant with incidentally detected severe hypertension (>99th percentile), neonatal jitteriness, and global developmental delay. Laboratory evaluation showed markedly elevated aldosterone (824 ng/dL) (SI: 22.9 nmol/L) (reference range, 5-150 ng/dL [SI: 0.14-4.2 nmol/L]) with low-normal renin and normal renal and cardiac imaging. Genetic analysis revealed a heterozygous CACNA1D missense variant (c.2241C > G; p.Phe747Leu) likely pathogenic and a heterozygous MED12L variant, classified as variants of unknown significance. The mother was an asymptomatic carrier of the CACNA1D variant. Blood pressure improved with nifedipine followed by spironolactone (2.5 mg/kg/day). Neurological symptoms partially improved, though motor delay persisted. This case expands the phenotypic spectrum of PASNA syndrome and highlights the need for early genetic evaluation in infants with unexplained hypertension and neurological abnormalities. The concurrent MED12L variant may contribute to the neurodevelopmental phenotype, underscoring the complexity of dual-gene involvement.

PMID 42388386
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