TheraRadar
Data updated: May 26, 2026

POKONZA (potassium chloride)

Renal Approved 2014-12-22

Pokonza is a potassium salt used to help patients with low potassium levels, a condition known as hypokalemia. It treats or prevents this deficiency in cases where eating more potassium-rich foods or adjusting diuretic medications is not sufficient to fix the problem. This medication is also used when hypokalemia occurs alongside metabolic alkalosis.

Source: FDA Label • GENUS LIFESCIENCES

How POKONZA Works

This drug works by providing potassium ions, which are the primary positive ions found inside body tissues. These ions are essential for maintaining intracellular tonicity, sending nerve signals, and allowing cardiac, skeletal, and smooth muscles to contract properly. By restoring potassium levels, the drug helps maintain normal kidney function and the necessary electrical balance across cell membranes.

2
Indications
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2014-12-22
Patent Cliff
2039

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Routes
ORAL
Dosage Forms
SOLUTION, FOR SOLUTION

Companies

Active Ingredient: POTASSIUM CHLORIDE

POKONZA Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
11 FDA actions from 2014 to 2020
Mar 2020 SUPPL
Label · Labeling
Jul 2019 SUPPL
Label · Labeling
May 2019 SUPPL
Mfg · Manufacturing (CMC)

What POKONZA Treats

2 indications

POKONZA is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypokalemia
  • Metabolic Alkalosis
Source: FDA Label

POKONZA Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to POKONZA

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KLOR-CON M15
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KLOR-CON M20
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Clinical Trial Registry

8 trials
Trial Sponsor ID Phase Status Title
NCT07238400 CARDAMOM 2025P001799 R01HL181150 Ph 2 recruiting Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia
NCT04316611 POTACREH APHP180577 2019-002544-24 Ph 2 withdrawn Potassium Chloride in Out-of-hospital Cardiac Arrest Due to Refractory Ventricular Fibrillation
NCT02450773 201501157 Ph 2 withdrawn Prevention of Severe Postpartum Hypertension
NCT03627130 NITRATE-CIN 18/1 Ph 2 completed The Use of Inorganic Nitrate for the Prevention of Contrast-induced Nephropathy
NCT03483051 PULSE-AS results posted 828994 Ph 2 completed Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After Aortic Valve Replacement for Severe Aortic Stenosis (PULSE AS)
NCT01074918 012007-080 Ph 1, Ph 2 withdrawn Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients
NCT01818583 AK-01 Ph 4 completed Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter
NCT01085071 GRIP-COMPASS GRIP-COMPASS trial Ph 4 completed Comparison of Two Potassium Targets Within the Normal Range in Intensive Care Patients
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Active Pipeline

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

POKONZA FDA Label Details

Indications & Usage

FDA Label (PDF)

POKONZA is indicated for the treatment of Hypokalemia; Metabolic Alkalosis.

View full patent landscape →
1 OB patents · 1 families · 1 international docs across 1 countries

POKONZA Patents & Exclusivity

Latest Patent: Mar 2039

Patents (1 active)

US12539314 Expires Mar 7, 2039
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • Cliff: 2039
  • 2 active patents

Trial Analysis

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  • Development stage analysis

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.