Nisoldipine

證據等級: L5

預測適應症: 5 個

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

One-Sentence Summary

Nisoldipine is a dihydropyridine calcium channel blocker generally used for essential hypertension; detailed original-indication and mechanism-of-action records are currently missing from the evidence pack. The TxGNN model predicts possible efficacy in Pulmonary Hypertension owing to Lung Disease and/or Hypoxia (WHO Group 3 PH), but this is currently supported by 0 clinical trials and only 20 loosely-related mechanistic publications on hypoxia biology in general — none of which study nisoldipine or this indication directly.

Quick Overview

Item	Content
Original Indication	Hypertension (dihydropyridine calcium channel blocker class; no TFDA-approved label text available — drug not marketed in Taiwan)
Predicted New Indication	Pulmonary hypertension owing to lung disease and/or hypoxia
TxGNN Prediction Score	99.77%
Evidence Level	L5
Market Status	✗ Not marketed (未上市)
Number of Licenses	0
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available (flagged as a data gap, remediation pending via DrugBank API query). Based on general pharmacological class knowledge, nisoldipine is a dihydropyridine calcium channel blocker, a class whose members act primarily by inhibiting L-type calcium channels in vascular smooth muscle, producing vasodilation — the basis for its use in hypertension.

The predicted new indication, pulmonary hypertension owing to lung disease and/or hypoxia (WHO Group 3 PH), is mechanistically connected to nisoldipine’s original use only through a shared theme of vascular tone regulation: hypoxic pulmonary vasoconstriction raises pulmonary vascular resistance, and calcium-channel blockade could theoretically counteract this. However, it is important to note that this class-level rationale applies most strongly to vasoreactive Group 1 pulmonary arterial hypertension (where nifedipine and diltiazem have an established, guideline-supported role) — not to Group 3 PH, where calcium channel blockers are generally not recommended, since they can worsen ventilation-perfusion mismatch and systemic hypotension without proven benefit.

The literature evidence retrieved for this candidate does not actually study nisoldipine or calcium channel blockers in the context of pulmonary hypertension; it consists of general reviews on hypoxia biology (brain aging, cognitive impairment, cancer hypoxia signaling, altitude physiology, etc.). This means the current evidentiary basis is disease-mechanism background rather than drug-specific support, and the mechanistic plausibility should be treated as speculative pending direct data.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Note: none of the retrieved literature studies nisoldipine directly; these are general hypoxia-biology publications used by the model as contextual signal for the predicted indication.

PMID	Year	Type	Journal	Key Findings
11172576	2000	Review	Respiratory Care Clinics of North America	Reviews the four basic mechanisms of hypoxemia, including ventilation-perfusion mismatch relevant to lung-disease-related hypoxia
33862277	2021	Review	Ageing Research Reviews	Hypoxia’s role in neurodegeneration vs. neuroprotection; general hypoxia pathophysiology
34618295	2022	Review	Metabolic Brain Disease	Clinical and molecular mechanisms of cognitive impairment from acute/chronic hypoxia
21328446	2011	Review	Journal of Cellular Biochemistry	General overview of hypoxia-mediated biological control across organ systems
31706510	2019	Review	Trends in Cancer	Deubiquitinase regulation of HIF under hypoxia; cancer-focused, not PH-specific
34535359	2021	Review	Clinical Oncology	Therapeutic modification of tumor hypoxia; oncology-focused
40815459	2025	Review	Revista Médica del IMSS	High-altitude hypobaric hypoxia physiology and acclimatization
24557798	2014	Commentary	Journal of Applied Physiology	Brief commentary on hypoxia research translation
40347693	2025	Review	Redox Biology	Role of hypoxia in multiple sclerosis pathology
37328448	2023	Preclinical/Mechanistic	Advanced Science	ac4C/NAT10/HIF-1α feedback loop driving hypoxia tolerance in gastric cancer cells

US Market Information

Nisoldipine is currently not marketed in this jurisdiction (market status: 未上市, total licenses on file: 0). No authorization records are available to summarize.

Safety Considerations

Please refer to the package insert for safety information. (All safety fields — key warnings, contraindications, and drug-drug interactions — are currently marked as data gaps in the evidence pack; TFDA label retrieval is flagged as a Blocking severity gap.)

Conclusion and Next Steps

Decision: Hold

Rationale: There are no clinical trials and no drug-specific literature supporting nisoldipine’s use in this indication — the retrieved literature addresses general hypoxia biology, not the drug or disease pairing. Combined with missing MOA data, missing safety/label data (a blocking gap), and the drug’s current non-marketed status, the evidence is insufficient to advance beyond hypothesis generation.

To proceed, the following is needed:

TFDA-equivalent package insert (warnings, contraindications) — currently a blocking data gap (DG001)
Verified mechanism-of-action data via DrugBank API (DG002)
Direct pharmacological or clinical evidence linking nisoldipine (or the dihydropyridine class) specifically to WHO Group 3 pulmonary hypertension, rather than general hypoxia biology
Specialist clinical review of the known guideline caution against calcium channel blockers in Group 3 PH (risk of worsening V/Q mismatch and systemic hypotension) before any further development
Preclinical or clinical trial data in a hypoxic pulmonary hypertension model
Disclaimer

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