Potassium
| Evidence Level: L1 | Predicted Indications: 5 |
Table of Contents
Potassium: From Electrolyte Supplementation to Hypertensive Disorder
One-Sentence Summary
Potassium (DrugBank DB14500) is an essential electrolyte; this dataset contains no approved indication or market presence for it in Taiwan. The TxGNN model predicts a strong association with Hypertensive Disorder, and while 50 clinical trials were screened, most are only tangentially related — the real weight of evidence comes from 20 publications, including a landmark RCT and multiple systematic reviews on potassium/salt-substitute intake and blood pressure.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not on file — Potassium has no registered indication or license in Taiwan; it functions as a physiological electrolyte rather than a marketed drug product in this dataset |
| Predicted New Indication | Hypertensive Disorder |
| TxGNN Prediction Score | 99.16% |
| Evidence Level | L1 |
| Taiwan Market Status | Not marketed (Not marketed) |
| Number of Registrations | 0 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data for this candidate is not available from DrugBank in this pack (flagged as a High-severity data gap). Based on established physiology, dietary/supplemental potassium acts on the renal distal convoluted tubule by suppressing the WNK–SPAK–NCC (Na⁺/Cl⁻ co-transporter) pathway, promoting natriuresis, reducing sympathetic tone, and improving vascular endothelial function — a well-characterized, consensus mechanism for blood-pressure lowering rather than a novel repurposing hypothesis.
This means the TxGNN score is essentially rediscovering long-established nutrition-physiology knowledge (low potassium intake / high sodium-to-potassium ratio raises blood pressure) rather than surfacing a truly new mechanistic link. The practical repurposing question is therefore not “does potassium lower blood pressure” (well established) but “can this specific DrugBank entity (elemental/ionic potassium) be positioned as a regulated therapeutic product” — since the record shows zero Taiwan licenses and no defined dosage form, formulation (e.g., potassium chloride, potassium-enriched salt substitute) and target population (especially renal function) would need to be defined before any regulatory pathway is pursued.
Clinical Trial Evidence
Note: the search for “Potassium” + “hypertensive disorder” returned 50 trials, but most are general antihypertensive-drug studies with no direct potassium intervention (graded C — not shown). The trials below are the ones with a direct thematic link to potassium/salt-substitute intervention or the potassium–aldosterone axis.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT07178964 | N/A | Not yet recruiting | 80 | Evaluates potassium-rich salt substitutes for blood pressure control in kidney transplant recipients — most directly on-topic trial in the set |
| NCT05638009 | N/A | Unknown | 2490 | EPIC trial: cluster-randomized, double-blind comparison of two potassium-enriched salt substitutes vs. regular salt on systolic BP (Argentina) |
| NCT05593055 | Phase 4 | Recruiting | 75 | Mineralocorticoid receptor antagonism vs. thiazide-like diuretic on coronary microvascular function in hypertensive LVH patients — relevant to the potassium–aldosterone axis but not a direct potassium intervention |
| NCT06569589 | N/A | Recruiting | 80 | Non-invasive tissue Na⁺/K⁺ quantification (23Na-MRI) in primary aldosteronism, analogous to HbA1c as a long-term metabolic marker |
| NCT06597630 | N/A | Recruiting | 100 | Pathology, genetics, and clinical phenotype of unilateral primary aldosteronism in Asians (K⁺/aldosterone axis, observational only) |
| NCT03326583 | Phase 2 | Completed | 27 | Patiromer (a potassium-binder) effects on serum K⁺ and gut microbiome in ESRD hyperkalemia — opposite therapeutic direction, included only as mechanistic context |
| NCT01318746 | N/A | Completed | 30 | Circadian rhythm and day-to-day variability of serum potassium and cystatin C in renal impairment |
| NCT04761354 | N/A | Completed | 514 | Multicenter analysis of blood-pressure reduction following adrenalectomy for primary aldosteronism |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 34459569 | 2021 | RCT | The New England Journal of Medicine | Salt substitution (reduced sodium, increased potassium) significantly reduced cardiovascular events and death in a large randomized trial |
| 32500831 | 2020 | Dose-response Meta-Analysis of RCTs | J Am Heart Assoc | Establishes a dose-response relationship between potassium supplementation and blood pressure across RCTs ≥4 weeks |
| 23558164 | 2013 | Systematic Review / Meta-Analysis | BMJ | Increased potassium intake associated with reduced blood pressure and lower stroke risk |
| 27455317 | 2016 | Review | Nutrients | Reviews potassium bioavailability and its role in blood pressure and glucose control |
| 29771736 | 2018 | Review | Current Opinion in Cardiology | Dietary approaches, including potassium intake, for prevention/management of hypertension |
| 30190007 | 2018 | Review | J Am Coll Cardiol | Identifies inadequate dietary potassium as a modifiable risk factor in hypertension prevention/control |
| 23674806 | 2013 | Review | Advances in Nutrition | Moderate evidence linking potassium intake to blood pressure reduction and downstream stroke/CHD risk |
| 31060074 | 2019 | Review | Annals of Internal Medicine | Contemporary hypertension management guideline review referencing dietary potassium |
| 37772757 | 2024 | Review | American Journal of Hypertension | State-of-the-art review on potassium and hypertension, contrasting emphasis on sodium restriction vs. potassium supplementation |
| 39472546 | 2025 | Review | Hypertension Research | Role of dietary potassium and salt substitution in prevention and management of hypertension |
Taiwan Market Information
No marketing authorizations are on file for this candidate — taiwan_regulatory.total_licenses = 0 and the license list is empty. Potassium (DB14500) is currently not marketed in Taiwan as a registered drug product under this record.
Safety Considerations
Please refer to the package insert for safety information — no key warnings, contraindications, or drug-interaction data are on file for this candidate, and the DDI lookup returned no results.
One point worth flagging independent of this data gap: because the candidate is elemental/ionic potassium itself, any therapeutic use for blood-pressure control carries an inherent, drug-class-level hyperkalemia risk — particularly in patients with renal impairment or those on RAAS-active agents (ACEi/ARB/MRA) — that should be assumed and verified once a specific TFDA label is obtained.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: The mechanistic and epidemiological/RCT evidence linking potassium intake to blood pressure reduction is strong and well-replicated (L1), including a large NEJM RCT on potassium-enriched salt substitutes. However, this specific DrugBank record has zero Taiwan market presence, no defined formulation, and — critically — a Blocking data gap on TFDA label warnings/contraindications, which by policy prevents this candidate from clearing even the initial (S1) safety screen. The guardrails therefore apply to regulatory and safety readiness, not to the underlying scientific plausibility.
To proceed, the following is needed:
- TFDA label/package-insert warnings and contraindications (Blocking gap DG001) — required before any S1 safety pre-assessment can be completed
- DrugBank mechanism-of-action data (High-severity gap DG002) to formally document the WNK–SPAK–NCC pathway link
- Definition of the specific product form to be repositioned (e.g., potassium chloride supplement vs. potassium-enriched salt substitute) and its intended route/dosage
- A renal-function-stratified safety plan addressing hyperkalemia risk, especially in combination with ACEi/ARB/MRA therapy
- Clarification of the regulatory pathway, since the product currently holds no Taiwan license to build on
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.