PRM Pharma Announces Nationwide Availability of HemiClor® (Chlorthalidone) 12.5 mg: The First FDA-Approved Low-Dose Chlorthalidone Tablet Aligned With Hypertension Guidelines

WEST CONSHOHOCKEN, Pa., Nov. 7, 2025 /PRNewswire/ -- PRM Pharma, LLC announces the nationwide availability of HemiClor^® (chlorthalidone) 12.5 mg tablets, the first and only FDA-approved 12.5 mg formulation of chlorthalidone for the treatment of hypertension in adults (www.HemiClor.com).¹

This milestone comes as the newly released 2025 AHA/ACC Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults reemphasizes chlorthalidone's role as a long-acting, thiazide-like diuretic and recommends to "Maximize Diuretic Therapy" by replacing hydrochlorothiazide (HCTZ) with chlorthalidone 12.5 mg or 25 mg in patients with resistant hypertension. ²

Regarding resistant hypertension the 2025 AHA/ACC Guideline states:

• "Based on the current BP goal of <130/80 mmHg, the prevalence of resistant hypertension is approximately 8.5% to 20% among hypertensive U.S. adults." ²
  
  
• "Patients with resistant hypertension are known to have at least a 50% higher risk of MI, stroke, end-stage kidney disease, and cardiovascular death than adults with hypertension without resistance to treatment." ²
  
  
• "Antihypertensive drug therapy should start with a combination of an ACEi or ARB, a CCB, and a diuretic. Replacing thiazide-type diuretics (eg, HCTZ or bendroflumethiazide) with thiazide-like diuretics (eg, chlorthalidone and indapamide) may offer additional BP reduction and cardiovascular protection among patients with previous MI or stroke." ²

Chlorthalidone's long half-life and extensive cardiovascular outcome data have made it a cornerstone of hypertension management for more than 50 years. Landmark trials such as ALLHAT and SHEP (sponsored by the National Heart, Lung and Blood Institute) demonstrated that treatment regimens based on stepped-care therapy starting with once-daily 12.5 mg chlorthalidone significantly reduced cardiovascular events.^3,4 Further, previous and current guidelines recommend initiating therapy with chlorthalidone at doses of 12.5 to 25 mg, once daily.^2,5

"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."

"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."

HemiClor^® was approved by the FDA on March 17, 2025, and is now available in pharmacies nationwide. Pharmacy Savings Programs, such as SaveHealth, GoodRx, SingleCare, and WellRx, may help provide important savings to eligible patients. Using SaveHealth, for example, patients may be able to purchase a 30-day supply of HemiClor^® for as little as $12.15 (price subject to change; restrictions apply; see www.savehealth.com for details). Links to external sites are provided for patient convenience only; PRM Pharma does not control or endorse their content.

Indication and Usage
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: Most common adverse reactions include electrolyte imbalance (particularly hypokalemia), dizziness, and gastrointestinal discomfort.
Monitoring: Periodic monitoring of serum electrolytes is recommended.
Drug Interactions: Chlorthalidone may potentiate the effects of other antihypertensive agents and may interact with lithium, antidiabetics, or NSAIDs.

Please see Full Prescribing Information available at www.HemiClor.com for complete efficacy and important safety information.¹ 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. HEMICLOR^® Prescribing Information. PRM Pharma, LLC. 2025. 
2. Jones OW, Ferdinand KC, Toler SJ, Johnson HM, et al. 2025 AHA/ ACC/ AANP/ AAPA/ABC/ ACCP/ ACPM/ AGS/ AMA/ ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. https://doi.org/10.1016/j.jacc.2025.05.007.
3. Prevention of Stroke by Antihypertensive Drug Treatment in Older Patients with Isolated Systolic Hypertension Final Results at the Systolic Hypertension in the Elderly Program (SHEP). SHEP Cooperative Research Group. JAMA. 1991;265(1):3255-3264.
4. 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.
5. 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.

*Abbreviations: BP (Blood Pressure), HCTZ (hydrochlorothiazide), ACEi (Angiotensin-Converting Enzyme Inhibitor), ARB (Angiotensin Receptor Blocker), CCB (Calcium Channel Blocker), MI (Myocardial Infarction)

About PRM Pharma, LLC
PRM Pharma, LLC is a privately held specialty pharmaceutical company focused on developing low-dose therapies that align with clinical practice guidelines and advance patient care. www.prmpharma.com

Media Inquiries:
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Email: [email protected]

SOURCE PRM Pharma, LLC