Potassium

Evidence Level: L1

Predicted Indications: 5

Potassium

Pharmacist Assessment Report

Potassium: From an Essential Electrolyte to Hypertensive Disorder

One-Sentence Summary

Potassium is an essential mineral and electrolyte supplement, marketed in India in oral solution and tablet products. The TxGNN model predicts it may be useful for hypertensive disorder, with 23 registered clinical trials and 20 publications compiled for this direction. Only a few of these trials test potassium itself, and the best-supported evidence comes from meta-analyses of potassium intake and blood pressure.

Quick Overview

Item	Content
Original Indication	Not stated in the Indian licence records compiled for this report
Predicted New Indication	Hypertensive disorder
TxGNN Prediction Score	0.9916
Evidence Level	L1 (see note below)
India Market Status	Listed in a compiled Indian medicine price dataset (3 of 3) – CDSCO approval status is not included in this data
Number of Listed Products	3 (valid: 3)
Recommended Decision	Proceed with Guardrails

Note on evidence level: The L1 grade is the one assigned in the data compiled for this report. It rests largely on meta-analyses of randomized trials and on one older Phase 3 trial of potassium and sodium. Many of the registered Phase 3 trials involve other drugs (for example losartan potassium), where potassium is only the salt counter-ion. A strict reading of the rules (at least two completed Phase 3 RCTs of potassium itself) would be more conservative.

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the drug record. Potassium is, however, a well-characterised essential cation. Higher potassium intake is thought to lower blood pressure through several routes:

It promotes sodium excretion in the urine (natriuresis).
It relaxes blood vessels, through hyperpolarisation of the endothelium via Kir channels and activation of the Na⁺/K⁺-ATPase pump.
It reduces sympathetic nervous tone.

The effect appears greater in people who eat a lot of sodium and in people who already have hypertension. A 2022 study in hypertensive postmenopausal women also characterised potassium-induced natriuresis directly.

No original indication is recorded in the Indian licence data, so the link between the old and new use is based on physiology rather than on a shared disease category. Potassium is already used to correct low potassium, including the loss caused by thiazide diuretics, which are themselves common blood pressure drugs.

Clinical Trial Evidence

Most registered trials are only loosely related. Many test other antihypertensive drugs in which potassium is just part of the salt name. The trials below are the most relevant to potassium as an intervention, followed by examples of those that are not.

Trial Number	Phase	Status	Enrollment	Key Findings
NCT00000509	Phase 3	Completed	Not reported	Sodium reduction with and without potassium supplementation for blood pressure control in hypertensive men
NCT03809884	Phase 3	Completed	7	Diet versus supplement to raise potassium intake; too small for efficacy conclusions
NCT02959931	N/A	Completed	33	Acute vascular effects of a high-potassium meal in hypertensive patients
NCT00949585	N/A	Completed	29	Two levels of potassium intake in chronic kidney disease; mainly informs hyperkalaemia safety
NCT02697708	Phase 1/2	Unknown	40	Potatoes versus supplement as potassium sources: uptake, retention and blood pressure
NCT00000501	Phase 2	Completed	Not reported	Feasibility of nutritional interventions (weight loss, less sodium, with or without more potassium) to prevent hypertension
NCT01074918	Phase 1/2	Withdrawn	0	Potassium-magnesium citrate versus potassium chloride on blood pressure; never enrolled
NCT01302691	Phase 3	Completed	327	Losartan potassium/HCTZ/amlodipine combination; potassium is only the counter-ion, not evidence for potassium therapy
NCT00480805	Phase 3	Completed	312	Losartan potassium/HCTZ versus ramipril in diabetic hypertension; potassium is only the counter-ion
NCT07700875	Phase 2	Completed	391	Compound tablet versus its single component (a potassium salt) and valsartan in moderate to severe hypertension

Further registered trials (for example NCT00949884, NCT01216878, NCT05947448 and several losartan studies) are not shown because they involve potassium only as a salt counter-ion.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
32500831	2020	Meta-analysis of RCTs	J Am Heart Assoc	Dose-response relationship between potassium supplementation and blood pressure in trials lasting at least 4 weeks
23558164	2013	Systematic review and meta-analysis	BMJ	Effect of increased potassium intake on cardiovascular risk factors and disease
28024910	2017	Systematic review and meta-analysis	Int J Cardiol	Effect of potassium supplementation on blood pressure in hypertensive subjects
37772757	2024	Review	Am J Hypertens	State-of-the-art review of potassium and hypertension
35045721	2022	Clinical study	Hypertension	Potassium-induced natriuresis compared with hydrochlorothiazide in 19 hypertensive postmenopausal women
41263071	2026	Secondary analysis	Hypertension	Consistency of blood pressure response to potassium-enriched salt in the China Salt Substitute Study
10979053	2000	Guideline/Review	Arch Intern Med	National Council guidelines for potassium replacement in clinical practice
9624886	1998	Review	Nutr Rev	Increased potassium intake may help prevent and treat hypertension
25398734	2014	Review	Adv Nutr	Sodium-to-potassium ratio and blood pressure, hypertension and related factors
39543422	2025	Commentary	Hypertens Res	How antihypertensive combinations affect potassium balance

India Market Information

Authorization Number	Product Name	Dosage Form	Approved Indication
136906	Mpot B6 Oral Solution Natural Mango Sugar Free	Bottle of 200 ml oral solution	Not stated
94750	Gushout Tablet	Strip of 10 tablets	Not stated
150897	Noculi Tablet	Strip of 10 tablets	Not stated

All three are valid registrations.

Review correction (2026-11-06): Originally stated: “All three are valid single-ingredient registrations.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.

Safety Considerations

Hyperkalaemia risk: Extra potassium is a concern in chronic kidney disease, in people with impaired renal potassium excretion, and in those taking ACE inhibitors, ARBs or potassium-sparing diuretics. One small trial (NCT00949585) specifically examined potassium intake in kidney disease.
Drug interactions: No interaction records were found in the data compiled for this report. The combinations listed above are known physiological concerns rather than recorded entries.

Please refer to the package insert for full warnings and contraindications.

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: Meta-analyses of randomized trials consistently link higher potassium intake with lower blood pressure, especially in hypertensive people. Direct trials of potassium as a drug are few, small or old, and the hyperkalaemia risk requires careful patient selection.

To proceed, the following is needed:

Package insert warnings and contraindications from the Indian product labels (currently a blocking gap for safety screening)
Approved indication text for the three Indian registrations
Mechanism of action data from DrugBank
A defined patient-selection and monitoring plan (serum potassium, renal function, concomitant ACE inhibitor/ARB/potassium-sparing diuretic use)
Confirmation of the dose, formulation and route to be studied (oral products only are currently registered)

Other predicted indications (not recommended at this time): Pulmonary hypertension owing to lung disease and/or hypoxia, pulmonary hypertension of unclear multifactorial mechanism, malignant renovascular hypertension and malignant hypertensive renal disease were all rated Hold. They have no supporting clinical trials, only indirect or diagnostic literature, and in renal disease supplementation carries a hyperkalaemia risk.

Review Log

Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.

Review date	Item	Action	Source
2026-11-06	Removed: “single-ingredient”	Corrected	Indian Medicine Dataset

Disclaimer

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