Lercanidipine

證據等級: L5 預測適應症: 10

目錄

  1. Lercanidipine
  2. Lercanidipine: From Hypertension to Pulmonary Hypertension Owing to Lung Disease and/or Hypoxia
    1. One-Sentence Summary
    2. Quick Overview
    3. Why is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. Safety Considerations
    7. Conclusion and Next Steps
    8. Disclaimer

## 藥師評估報告

Lercanidipine: From Hypertension to Pulmonary Hypertension Owing to Lung Disease and/or Hypoxia

One-Sentence Summary

Lercanidipine is a third-generation dihydropyridine calcium channel blocker used to treat hypertension. The TxGNN model predicts it may be effective for pulmonary hypertension owing to lung disease and/or hypoxia (WHO Group 3 PH), with a high prediction score of 98.79%, but there are currently no clinical trials and no drug-specific literature supporting this direction — the 20 associated publications describe general hypoxia biology (HIF-1α signalling, altitude physiology, oncology), none mentioning lercanidipine or any calcium channel blocker in this context.


Quick Overview

Item Content
Original Indication Hypertension (lercanidipine is a marketed dihydropyridine calcium channel blocker; no formal TFDA/TGA indication text is available in this evidence pack)
Predicted New Indication Pulmonary hypertension owing to lung disease and/or hypoxia
TxGNN Prediction Score 98.79%
Evidence Level L5
Australia Market Status Not marketed
Number of ARTG Entries 0
Recommended Decision Hold

Why is This Prediction Reasonable?

Detailed structured mechanism-of-action data is not available for this drug (data gap DG002). Based on the notes accompanying this evidence pack, lercanidipine is a third-generation, highly lipophilic dihydropyridine L-type calcium channel blocker with long-acting, vascular-smooth-muscle-selective activity — it lowers systemic blood pressure by relaxing peripheral arteriolar smooth muscle.

The predicted new indication, Group 3 pulmonary hypertension (secondary to chronic lung disease and/or hypoxia), is pathophysiologically distinct from systemic hypertension: it involves hypoxic pulmonary vasoconstriction and pulmonary vascular remodelling, not systemic arteriolar tone. There is no known pharmacological rationale for a peripherally-selective dihydropyridine CCB to act on the pulmonary vasculature, and systemic vasodilation could theoretically worsen ventilation-perfusion mismatch in hypoxic lung disease rather than help it.

This prediction score is driven by embedding similarity in the TxGNN knowledge graph rather than by any drug-specific mechanistic or clinical signal — the underlying literature set is about hypoxia biology broadly, not about this drug. This should be treated as a hypothesis-generating signal only, not a mechanistically supported candidate.


Clinical Trial Evidence

Currently no related clinical trials registered.


Literature Evidence

Note: none of the publications below mention lercanidipine or calcium channel blockers directly — they describe general hypoxia biology and are surfaced only because of TxGNN embedding similarity.

PMID Year Type Journal Key Findings
39841808 2025 Review Science Translational Medicine Chronic controlled hypoxia may be therapeutically beneficial in mitochondrial disease, autoimmunity, ischaemia and aging models
28972206 2017 Review Nature Reviews Immunology Hypoxia regulates innate and adaptive immunity differently across physiological and pathological niches
34618295 2022 Review Metabolic Brain Disease Reviews clinical evidence and molecular mechanisms of cognitive impairment caused by acute/chronic hypoxia
21328446 2011 Review Journal of Cellular Biochemistry Overview of hypoxia-mediated control of growth, metabolism and disease including vascular disease and cancer
34535359 2021 Review Clinical Oncology Reviews therapeutic modification of tumour hypoxia and its impact on treatment resistance
33862277 2021 Not classified Ageing Research Reviews Discusses hypoxia’s role in neurodegeneration vs. neuroprotection in brain aging
37328448 2023 Not classified Advanced Science Describes an ac4C/NAT10/HIF-1α feedback loop driving glycolysis in gastric cancer under hypoxia
8817697 1996 Not classified Progress in Neurobiology Reviews effects of fetal/perinatal hypoxia on brain development and later cognitive decline
31706510 2019 Not classified Trends in Cancer Reviews deubiquitinase regulation of HIF stability in cancer
40963621 2025 Not classified Frontiers in Immunology Discusses HIF-1α as a shared mechanistic link between tumour hypoxia and autoimmune disease

Safety Considerations

Lercanidipine is not currently marketed in Australia (0 ARTG entries), and no TGA-approved Product Information is available. Structured safety data in this evidence pack (key warnings, contraindications, drug-drug interactions) is also missing (data gap DG001, flagged as Blocking — TFDA label warnings/contraindications could not be retrieved). Any safety assessment should reference the manufacturer’s international product information (e.g. EU/UK SmPC) pending confirmation of an Australian PI, should this product be registered.


Conclusion and Next Steps

Decision: Hold

Rationale: The TxGNN score is high, but there is no drug-specific clinical or preclinical evidence, no plausible pharmacological rationale for a peripherally-selective dihydropyridine CCB in hypoxic pulmonary hypertension, and a theoretical risk that systemic vasodilation could worsen ventilation-perfusion mismatch. Combined with a blocking data gap on TFDA/PI safety information, this candidate does not support further progression at this time.

To proceed, the following is needed:

  • Drug-specific preclinical or clinical evidence for lercanidipine in Group 3 pulmonary hypertension
  • Confirmed mechanism-of-action data via DrugBank API (DG002)
  • TFDA product label / warnings and contraindications (DG001 — blocking; required before any S1 safety review)
  • Pharmacological assessment of pulmonary vascular selectivity vs. systemic vasodilation risk

Additional note: among the 10 TxGNN-predicted indications in this evidence pack, cerebrovascular disorder (rank 9, score 69.6%) shows materially stronger support — evidence level L3 with a completed Phase 4 cohort study (NCT00741585) and 12 relevant publications including neuroprotection data in stroke models and a retrospective comparison to amlodipine in hypertensive stroke patients. This is likely a more promising candidate for further evaluation than the top-ranked indication above.

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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