FDA Approves HemiClor™ for Adult Hypertension Treatment

WEST CONSHOHOCKEN, Pa., May 6, 2025 -- PRM Pharma, LLC has announced that the U.S. Food and Drug Administration (FDA) has approved HemiClor, a 12.5 mg chlorthalidone tablet, for managing hypertension in adults. The approval marks a significant addition to available options for treating high blood pressure.

Chlorthalidone is a thiazide-like diuretic extensively researched over the years for its effectiveness in hypertension management. Recognized in the 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, chlorthalidone is favored for its long half-life and positive cardiovascular outcomes. Landmark studies, such as the ALLHAT and SHEP trials sponsored by the National Heart, Lung, and Blood Institute, have validated the use of chlorthalidone in reducing cardiovascular events. These studies have led to the recommendation of the 12.5 mg dosage as a starting point for anti-hypertensive therapy.

HemiClor is introducing a new 12.5 mg formulation in the U.S., which aligns with guideline recommendations and offers a lower-dose alternative to the previously available higher doses of 25 mg and 50 mg. This lower dosage may help healthcare providers tailor treatment plans more effectively and potentially minimize dose-related side effects, such as metabolic issues like hypokalemia and hyperuricemia. The lower dose is designed to mitigate these risks while initiating treatment.

Dr. William B. White, Professor Emeritus at the University of Connecticut School of Medicine and former president of the American Society of Hypertension, emphasized the importance of chlorthalidone in hypertension strategies over the decades. He remarked that the availability of a 12.5 mg dose in the U.S. provides clinicians with more flexibility in beginning treatment, consistent with current recommendations for patients with stage 1 or stage 2 hypertension.

Joseph T. McDevitt, President and CEO of PRM Pharma, LLC, expressed pride in launching HemiClor as a new option for adults dealing with hypertension. He highlighted the company's commitment to addressing unmet clinical needs by developing low-dose pharmaceutical products that support evidence-based care. McDevitt emphasized that lower effective doses might offer a more personalized approach to therapy initiation, particularly for older patients who are more susceptible to dose-related side effects.

HemiClor is expected to be available in pharmacies throughout the nation starting in May 2025. The primary indication for HemiClor is the treatment of hypertension to lower blood pressure, an important measure to reduce the risk of fatal and nonfatal cardiovascular events, including strokes and myocardial infarctions. These benefits have been proven in controlled antihypertensive drug trials across various pharmacologic classes, including chlorthalidone.

Regarding safety, HemiClor is contraindicated for patients with anuria or known hypersensitivity to chlorthalidone or sulfonamide-derived drugs. Common adverse reactions include electrolyte imbalance, dizziness, and gastrointestinal discomfort. It is advised to monitor serum electrolytes periodically, as chlorthalidone may increase blood sugar levels and affect diabetes management. Additionally, it may enhance the effects of other antihypertensive agents and interact with lithium, antidiabetics, or NSAIDs.

PRM Pharma, LLC, based in Pennsylvania, is a privately-held specialty pharmaceutical company focusing on developing low-dose therapies to support clinical practice guidelines and improve patient care.