A New Chapter in the Story of Chlorthalidone: Low-Dose HEMICLOR® Now Available in Pharmacies Nationwide
Preferred diuretic option now accessible in guideline-recommended 12.5 mg dose for U.S. patients.
WEST CONSHOHOCKEN, Pa., June 24, 2025 /PRNewswire/ -- PRM Pharma, LLC today announced that HEMICLOR® (12.5 mg chlorthalidone tablets) — the first FDA-approved low-dose formulation of chlorthalidone — for the treatment of hypertension in adults — is now available in pharmacies across the United States and third party discount coupon programs are available to assist with patient access (see below).
Chlorthalidone, a thiazide-like diuretic, has played a central role in hypertension management for decades, with extensive data supporting its cardiovascular outcome benefits. Until now, however, U.S. clinicians and patients lacked access to an approved 12.5 mg formulation — the starting dose consistently used in landmark hypertension trials such as ALLHAT and SHEP and recommended in current guidelines.1-4
"The evidence for the benefit of low-dose chlorthalidone spans over 30 years, but unfortunately we've lacked a commercially available product that enabled widespread use of the drug effectively in practice," said Michael Ernst, PharmD, AHSCP-CHC, Clinical Professor, Department of Pharmacy Practice and Science, College of Pharmacy; and Department of Family and Community Medicine, Carver College of Medicine, The University of Iowa, Iowa City, IA. "The availability of a low dose formulation aligns with our contemporary understanding of how to optimize the benefit-risk when using the drug, and I'm excited for this new chapter in chlorthalidone's storied history."
The 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults recognizes chlorthalidone as the preferred diuretic based on its long half-life and extensive outcome evidence.1 However, until the approval of HEMICLOR, only 25 mg and 50 mg chlorthalidone tablets were available in the U.S. The availability of an FDA-approved 12.5 mg tablet now enables guideline-consistent dosing and may help reduce the risk of dose-related side effects.5
"Chlorthalidone has played a key role in hypertension treatment strategies for decades," said William B. White, MD, Professor Emeritus at the University of Connecticut School of Medicine and past president of the American Society of Hypertension. "Having access to a 12.5 mg dose in the U.S. may offer clinicians additional flexibility when initiating therapy and aligns with current treatment recommendations for many adult patients with stage 1 or stage 2 hypertension."
Joseph T. McDevitt, President and CEO of PRM Pharma, LLC, added, "We are proud to introduce HEMICLOR as a new treatment option for adults with hypertension. Our mission is to address unmet clinical needs by developing low-dose pharmaceutical products that support evidence-based care. Lower effective doses may offer a more individualized approach to initiating therapies, particularly for elderly patients who are more susceptible to dose-related adverse effects."
HEMICLOR (chlorthalidone) 12.5 mg tablets is now available in pharmacies nationwide, and third party pharmacy HemiClor coupon programs are available to assist in patient access.
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Indication and Usage5
HEMICLOR (chlorthalidone) is indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been demonstrated in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including chlorthalidone.
Important Safety Information
- Contraindications: HEMICLOR is contraindicated in patients with anuria or known hypersensitivity to chlorthalidone or sulfonamide-derived drugs.
- Adverse Reactions: The most common adverse reactions observed with chlorthalidone include electrolyte imbalance (particularly hypokalemia), dizziness, and gastrointestinal discomfort.
- Monitoring: Periodic monitoring of serum electrolytes is recommended.
- Chlorthalidone may increase blood sugar levels, affect diabetes control, and cause changes in the need for diabetes medication.
- Drug Interactions: Chlorthalidone may potentiate the effects of other antihypertensive agents and may interact with lithium, antidiabetics, or NSAIDs.
These are not all the possible side effects of chlorthalidone. Please see the Full Prescribing Information, available at www.prmpharma.com , for complete efficacy and important safety information.5
About PRM Pharma, LLC
PRM Pharma, LLC is a privately held specialty pharmaceutical company based in Pennsylvania, focused on developing low-dose therapies to support clinical practice guidelines and improve patient care.
www.prmpharma.com
Media Inquiries:
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Email: info@prmpharma.com
To report suspected adverse reactions, contact PRM Pharma at 1-877-748-1970 or the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.
References
1. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary. Hypertension. 2018;71(6):1269-1324.
2. ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to ACE inhibitor or calcium channel blocker vs diuretic. JAMA. 2002;288(23):2981-2997. doi:10.1001/jama.288.23.2981
3. SHEP Cooperative Research Group. Prevention of Stroke by Antihypertensive Drug Treatment in Older Patients with Isolated Systolic Hypertension. JAMA. 1991;265(24):3255-3264.
4. James PA, Oparil S, Carter BL, et al. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults. JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427
5. HEMICLOR™ Prescribing Information. PRM Pharma, LLC. 2025.
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