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Last update 23 Oct 2026

Spironolactone

Last update 23 Oct 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummarySpironolactone, also known by the trade name ALDACTONE®, is a drug that works as a mineralocorticoid receptor (MR) antagonist. It was first approved by Pfizer Inc. in the United States in 1960. ALDACTONE oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, which is a specific pharmacologic antagonist of aldosterone. Spironolactone acts primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. This causes increased amounts of sodium and water to be excreted, while potassium is retained. Spironolactone is indicated for heart failure, hypertension, edema associated with hepatic cirrhosis or nephrotic syndrome, and primary hyperaldosteronism. It acts as a diuretic and an antihypertensive drug and may be given alone or with other diuretic agents that act more proximally in the renal tubule.

Drug Type

Small molecule drug

Synonyms

Spironolactone (JP17/USP/INN), Spironolattone, NSC-150399

+ [8]

Target

Action

antagonists

Mechanism

MR antagonists(Mineralocorticoid receptor antagonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesDigestive System Disorders+ [3]

Active Indication

Myocardial InfarctionStrokeNephrotic Syndrome+ [8]

Inactive Indication-

Originator Organization

G.D. Searle & Co., Inc.

Active Organization

Lipomed AG

Pfizer Japan, Inc.

Pfizer Inc.

+ [1]

Inactive Organization

CMP Pharma, Inc.

Sinopharm Wuhan ZhongLian SiYao Pharmaceutical Co., Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (21 Jan 1960),

AscitesEdemaEssential Hypertension+ [4]

RegulationOrphan Drug (United States), Orphan Drug (European Union)

Structure/Sequence

Molecular FormulaC24H32O4S

InChIKeyLXMSZDCAJNLERA-ZHYRCANASA-N

CAS Registry52-01-7

385

Clinical Trials associated with Spironolactone

NCT06021860

/ Not yet recruitingPhase 4

A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Single and Multiple Doses of Spironolactone Oral Suspension in Pediatric Patients With Edema Due to Heart Failure or Cirrhosis

This is a 2-part, 2 periods per part, open-label study with spironolactone oral suspension in pediatric patients with edema due to HF or hepatic cirrhosis. Both study parts will evaluate the safety, PK and PD of multiple doses of spironolactone in patients aged from birth to ≤17 years of age.

Start Date01 Jun 2027

Sponsor / Collaborator

CMP Development LLC

NCT07687160

/ Not yet recruitingPhase 4IIT

SPIRO-First: A Pragmatic Primary Care-Embedded Pilot Trial of Renin-Guided First-Line Antihypertensive Therapy

The goal of this clinical trial is to determine whether a renin-guided antihypertensive treatment strategy is feasible to implement in community primary care clinics and to explore whether spironolactone improves blood pressure control in adults with low-renin hypertension.
The main questions it aims to answer are:
Is it feasible to identify, recruit, randomize, and follow adults with low-renin hypertension in a pragmatic primary care-based clinical trial?
Does first-line treatment with spironolactone result in greater reductions in ambulatory blood pressure compared with standard first-line antihypertensive therapy among adults with low-renin hypertension?
Researchers will compare spironolactone 25 mg daily with standard first-line antihypertensive therapy (candesartan, hydrochlorothiazide, or amlodipine) to determine whether spironolactone provides better blood pressure control in adults with low-renin hypertension.
Participants will:
Undergo blood pressure assessments, blood tests, and ambulatory blood pressure monitoring (ABPM) to determine eligibility.
Be randomly assigned to receive either spironolactone or a standard first-line antihypertensive medication for 12 weeks.
Complete follow-up visits and laboratory testing to monitor blood pressure response, kidney function, electrolyte levels, medication adherence, and side effects.
Undergo repeat blood pressure measurements and ABPM at the end of the study.

Start Date01 Jan 2027

Sponsor / Collaborator

Ottawa Hospital Research Institute

[+1]

NCT07715318

/ Not yet recruitingPhase 2IIT

Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.

The goal of this clinical trial is to learn if Spironolactone drug works to treat anemia in hemodialysis pediatric patients. It will also learn about the safety of Spironolactone drug. The main questions it aims to answer are:
In pediatric patients with anemia undergoing maintenance hemodialysis, does treatment with spironolactone, compared with standard care alone, reduce erythropoietin dose requirements while maintaining an acceptable safety profile? Researchers will compare Spironolactone drug to a standard therapy ((IV iron according to serum iron deficiency and patient's weight, epoetin after each session of dialysis according to the patient's weight) to see if Spironolactone drug works to treat anemia.
Participants will:
* Take Spironolactone drug daily for 12 weeks in addition to standard care.
* Continue their scheduled maintenance hemodialysis sessions.
* Undergo regular monitoring during dialysis visits, including clinical assessment and laboratory tests (e.g., hemoglobin, potassium, renal profile)
* Record any symptoms or side effects during the study period.

Start Date01 Dec 2026

Sponsor / Collaborator

Ain Shams University

100 Clinical Results associated with Spironolactone

100 Translational Medicine associated with Spironolactone

100 Patents (Medical) associated with Spironolactone

8,492

Literatures (Medical) associated with Spironolactone

31 Dec 2026·ANNALS OF MEDICINE

Biochemical characteristics associated with spironolactone use in hospitalized patients with hypotonic hyponatraemia

Article

Author: Kojecký, Vladimír ; Fajkus, Martin ; Šálek, Tomáš ; Vodička, Martin ; Klhůfek, Josef ; Ryšavý, Ilja

BACKGROUND:

Spironolactone has been associated with hypotonic hyponatraemia. However, its accompanying biochemical pattern - especially with concomitant loop diuretics - remains underdescribed. We characterized biochemical and epidemiological profiles of hospitalized patients with established hypotonic hyponatraemia according to spironolactone exposure.

METHODS:

Single-centre retrospective cohort of non-thiazide patients admitted with hypotonic hyponatraemia. Biochemical parameters were compared between spironolactone users (n=107) and non-users (n=427). The spironolactone-alone subgroup (n=27) was compared between (i) the non-diuretic group (n=374) and (ii) the spironolactone+furosemide group (n=80). We performed correlations between (a) admission serum sodium (s-Na) and in-hospital mortality; (b) spironolactone dose and biochemical parameters, also adjusted for furosemide dose; (c) serum potassium (s-K) and relevant parameters. Multivariable regression analyses were performed for s-K, s-Na, fractional excretion (FE)-K, FE-Cl, FE-H₂O and serum urea (s-urea) as dependent variables to assess associations with spironolactone while accounting for potential confounders.

RESULTS:

After eGFR adjustment, spironolactone users showed higher s-K (p<0.001), s-urea (p<0.001) and s-uric acid (s-UA; p=0.01). The spironolactone-alone group showed higher s-K (p=0.003), and s-urea (p=0.001) compared to the non-diuretic group; lower dose (p=0.04), s-urea (p=0.04), serum creatinine (s-creatinine) (p<0.001), s-UA (p=0.02) and chronic heart failure prevalence (p<0.001); higher eGFR (p=0.002), and hypertension prevalence (p=0.048), compared to the spironolactone+furosemide group. Multivariable regression analyses identified independent associations of spironolactone with higher s-K (b=0.33, p=0.001) and with higher log-transformed s-urea (b=0.22, p<0.001), corresponding to a 24.5% increase in s-urea.

CONCLUSIONS:

Spironolactone was independently associated with higher s-K and with higher s-urea levels. This pattern was not reflected by reduced urinary potassium excretion. Importantly, no clear evidence that concomitant furosemide materially modified this biochemical pattern was observed in the present analyses. Awareness of this pattern may support the phenotypic characterization of hyponatraemic patients receiving spironolactone. However, prospective studies are warranted to evaluate the diagnostic utility of this biochemical pattern in hyponatraemic patients receiving spironolactone.

31 Dec 2026·Journal of Maternal-Fetal & Neonatal Medicine

Transient conductive hearing loss as a notable and rare manifestation of preeclampsia: a case report

Article

Author: Chen, Xiuying ; Jin, Linna ; Zhao, Baihui

OBJECTIVE:

To report a case of transient conductive hearing loss secondary to secretory otitis media (SOM) in a patient with preeclampsia, highlight its unique pathophysiological link, and emphasize the importance of recognizing this potential complication.

CASE PRESENTATION:

Preeclampsia is a severe, pregnancy-specific multisystem disorder characterized by new-onset hypertension and proteinuria after 20 weeks of gestation. While endothelial dysfunction and vasospasm are central to its pathophysiology, its clinical manifestations are diverse. Auditory dysfunction, particularly conductive hearing loss, is infrequently reported. We present a case of a 25-year-old gravida 2, para 0 woman diagnosed with preeclampsia at 33 weeks of gestation. She had persistent proteinuria (24-hour urinary protein 1244.7 mg), unstable hypertension (148-165/95-107mmHg) managed with labetalol (100 mg every 8 h, suboptimal adherence), and gestational diabetes. She had no prior history of ear disease, trauma, or ototoxic medication use.At 35w5d gestation, the patient developed sudden bilateral hearing loss, accompanied by mild chest tightness and an elevated brain natriuretic peptide (BNP) level (346.1 pg/ml). Otolaryngology consultation was performed, and otoendoscopic examination revealed bilateral intratympanic fluid. Pure tone audiometry confirmed bilateral conductive hearing loss with significant air-bone gaps (left 30 dB, right 13 dB). Bone conduction thresholds were within normal limits (left 15 dB, right 16 dB), ruling out sensorineural hearing loss. Acoustic immittance audiometry showed bilateral B-type tympanograms, indicative of middle ear effusion. Alternative causes of conductive hearing loss (e.g. upper respiratory infection-related eustachian tube dysfunction, barotrauma, tympanic membrane pathology, middle ear mass) were excluded through clinical evaluation, negative inflammatory markers (C-reactive protein: <0.5 mg/l, white blood cell count: 12.9 × 10^9), and absence of relevant symptoms. Given her deteriorating condition, an emergent Cesarean section was performed at 36 weeks of gestation, delivering a healthy male infant. Postoperatively, supportive management with combined diuretics (furosemide and spironolactone) led to rapid and complete resolution of her hearing deficits within three days. She was discharged on continued antihypertensive therapy and was well at one-month follow-up.

CONCLUSION:

Transient conductive hearing loss due to SOM is a rare manifestation of preeclampsia, likely driven by hypertension-induced increased vascular permeability and altered fluid dynamics. Severe proteinuria may exacerbate systemic fluid imbalance, contributing to middle ear effusion. Early recognition via audiometric and tympanometric evaluation, exclusion of alternative etiologies, and targeted management (e.g. fluid overload reduction) can ensure prompt recovery and improve maternal outcomes. Early recognition and management can improve maternal outcomes by addressing fluid dysregulation and potentially preventing further complications.

31 Dec 2026·BLOOD PRESSURE

Effect of fourth-line antihypertensive therapy on clinic systolic blood pressure in resistant hypertension: a systematic review and meta-analysis

Review

Author: Un Nisa, Noor ; Alam, Taha ; Jawed, Hira Arshad ; Rajdeep, Dhvanit ; Ibrahim, Taha ; Saad, Muhammad ; Jamshaid, Zainab ; Hussain, Muhammad ; Hassan, Muhammad ; Kamal, Sohaima ; Hotak, Rafiullah

INTRODUCTION/BACKGROUND:

Resistant hypertension (rHTN) is defined as uncontrolled blood pressure despite ≥3 antihypertensives, including a diuretic. While fourth-line-intensification is recommended, comparative evidence remains scattered.

RESEARCH QUESTIONS/HYPOTHESIS:

To evaluate the efficacy and safety of fourth-line antihypertensives in reducing clinic systolic blood pressure (SBP) in rHTN.

METHODS/APPROACH:

PubMed, Embase, Scopus, and Web of Science were searched (2015-2026) for randomized controlled trials (RCTs) with ≥4 weeks follow-up. Risk of bias was assessed using Cochrane RoB 2. A planned network meta-analysis was not performed because statistical inconsistency and transitivity violations rendered indirect comparisons unreliable. Therefore, pairwise meta-analyses were conducted using random-effects models, with results reported as mean differences (MD) or risk ratios (RR) with 95% confidence intervals (CIs).

RESULTS/DATA:

Eleven RCTs involving 3,931 adults with rHTN were included. Compared with placebo, the largest SBP reductions were observed with lorundrostat (MD -11.70 mmHg [95% CI -16.07, -7.33]) and baxdrostat 2 mg (MD -10.10 [-12.63, -7.58]). Baxdrostat 1 mg (MD -8.56 [-11.08, -6.04]) produced reductions similar to spironolactone (MD -7.95 [-10.10, -5.80]). Bisoprolol achieved a modest SBP reduction (MD -6.71 mmHg), whereas aprocitentan 12.5 mg reduced SBP by -3.80 mmHg [-6.65, -0.95]. No intervention significantly increased serious adverse events. Higher rates of any adverse events were observed with aprocitentan 25 mg (RR 1.89 [1.39, 2.57]) and doxazosin (RR 1.55 [1.09, 2.20]).

CONCLUSIONS:

Aldosterone-targeted therapies, including aldosterone-synthase inhibitors and spironolactone, provide clinically meaningful SBP reductions in rHTN without increasing serious adverse event risk. Future trials should clarify comparative efficacy and long-term outcomes.

News (Medical) associated with Spironolactone

20 Oct 2026

·www.prnewswire.com

First joint guidelines of care for hidradenitis suppurativa issued by American Academy of Dermatology and Hidradenitis Suppurativa Foundation

ROSEMONT, Ill., Oct. 20, 2026 /PRNewswire/ -- Over 3 million people have been diagnosed with hidradenitis suppurativa (HS) in the United States and today, the American Academy of Dermatology (AAD) and the Hidradenitis Suppurativa Foundation (HSF) have published the first-ever joint guidelines for the management and care of HS. HS is a skin condition that causes painful lumps deep in the skin, typically in areas of the body where skin rubs together like armpits, inner thighs, and the groin. Early diagnosis of HS is critical as it is often confused with acne or infection, causing people to go years without an accurate diagnosis. A board-certified dermatologist can both identify HS and screen for the medical and psychiatric conditions that often accompany it, giving patients access to comprehensive, individualized care sooner. "While hidradenitis suppurativa is a chronic condition, its painful symptoms are highly treatable," said AAD President and board-certified dermatologist Murad Alam, MD, MSCI, MBA, FAAD. "For millions of people with HS, dermatologists provide more than just a diagnosis. They provide expert, comprehensive care that allows patients to have a better quality of life." Compiled by a work group of 13 experts, including 12 board-certified dermatologists, the newly released guidelines, published in the Journal of the American Academy of Dermatology (JAAD), include 37 evidence-based recommendations designed to treat chronic HS disease and acute HS flares. "These guidelines establish an evidence-based standard of care for HS, giving patients, dermatologists, and payers a shared roadmap for what high-quality HS care looks like," said board-certified dermatologist Haley B. Naik, MD, FAAD, co-chair of the Hidradenitis Suppurativa Guideline Work Group and president of HSF. "Every person living with HS deserves care that meets this standard." The largest barrier to impactful HS care is step therapy, an insurance requirement for patients to try insurer-designated treatments before coverage is approved for the dermatologist-prescribed preferred medication. Evidence does not support the use of step therapy in HS care as it delays access to appropriate treatment. Strong recommendations of care Strong recommendations imply that treatment benefits clearly outweigh risks and burdens. These recommendations apply to most patients in most circumstances. Biologics (adalimumab, bimekizumab, infliximab, and secukinumab), injectable treatments that target the immune system, are strongly recommended for individuals with moderate-to-severe HS. These treatments are shown to reduce the number of abscesses and nodules by at least half, without any new abscess or tunnel development. Abscesses are painful lumps that grow, join together, and fill with fluid. Tunnels are hollow channels that form under the skin. Conditional recommendations of care Conditional recommendations imply that treatment benefits are closely balanced with risks and burdens. These recommendations apply to most patients, but the best course depends on what matters most to each individual, including their tolerance for side effects, treatment goals, and day-to-day circumstances. Topical therapies (clindamycin, resorcinol, and ruxolitinib) are applied to the skin to reduce abscesses and the severity of symptoms. Systemic antibiotics (doxycycline, tetracycline, clindamycin in combination with rifampin, and ertapenem) work throughout the body to decrease severity of symptoms and improve quality of life. Hormone therapy (spironolactone) is taken by mouth to decrease severity. Systemic therapies (upadacitinib and short-term systemic steroids) are taken by mouth and work throughout the body for individuals with moderate-to-severe HS to reduce disease activity and pain. Continuing injectable biologics (adalimumab) is recommended for individuals with moderate-to-severe HS undergoing surgery. In-office procedures can be especially helpful if abscesses and tunnels have formed in the skin, including: Deroofing, a minor treatment to open and flatten the tunnels under the skin. This treats recurrent or persistently bothersome HS lesions, or bumps, spots, or growths. Incision and drainage to treat painful abscesses. Surgical removal of an area of affected skin for abscesses or tunnels that persist or continue to come back. Laser hair removal for fewer flares. Botulinum toxin to reduce flares. Intralesional triamcinolone (a steroid injection) to treat painful, flaring bumps. Conditional recommendations were made against the use of oral retinoids (acitretin and isotretinoin), certain biologics (etanercept, guselkumab, risankizumab, and vilobelimab), systemic therapies (avacopan, and methotrexate and azathioprine as primary treatments), and radiotherapy for pediatric and adolescent HS patients. In addition, there is insufficient evidence to support oral contraceptive pills or finasteride (hair loss medication) for HS management. Supportive management While HS therapies may reduce pain, they don't always achieve adequate pain relief. Supportive pain management is a conditional recommendation that helps manage sudden pain, consistent pain, and pain that does not improve after treatment and pain relief therapies. Treatments to manage sudden pain include warm or cool compresses, topical lidocaine (a local anesthetic), acetaminophen (a pain reliever), nonsteroidal anti-inflammatory drugs like aspirin and ibuprofen, steroid injections, incision and drainage, and short-term steroids that work throughout the body. Opioids can be used if the pain doesn't decrease through other treatments. Long-lasting pain can be managed with serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, psychotherapy, proper wound care, and nerve pain medications such as gabapentin and pregabalin. There is insufficient evidence to support weight reduction and GLP-1 usage for HS treatment. There is also insufficient evidence that specific diet plans — intermittent fasting, the Mediterranean diet, the yeast exclusion diet, and the dairy-free diet — help manage HS. However, a heart-healthy diet of fruits and vegetables, whole grains, healthy fats, and lean proteins remains important for reducing heart and diabetes risk for individuals with HS. Complementary medicine Lifestyle changes and supplements can also help manage the pain and discomfort from HS. A conditional recommendation was made for quitting tobacco, which can improve an individual's response to treatments aimed at addressing the disease itself. Conditional recommendations were made for complementary and alternative medicine, including vitamin D supplements for individuals with deficiencies, and zinc supplements. These supplements, taken under a doctor's supervision, may reduce lumps and tunnels and relieve pain. "Untreated HS can have a serious impact on your health and well-being. It can cause scarring, wounds that limit your mobility, and intense pain. It also often happens in combination with other medical and psychiatric conditions, with this increasing its overall toll on patients," said Dr. Alam. "Whether you've been diagnosed with HS or suspect you may have it, please take the time to see a board-certified dermatologist to have it expertly assessed, consider your options, and find the best plan for you." To find a board-certified dermatologist in your area, visit aad.org/findaderm. Resources Hidradenitis Suppurativa: Overview (AAD) How to Treat HS (HSF) Find an HS Provider (HSF) About the AAD Headquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 21,500 physicians worldwide, the AAD is committed to advancing the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair, and nails; advocating high standards in clinical practice, education and research in dermatology; and supporting and enhancing patient care because skin, hair, and nail conditions can have a serious impact on your health and well-being. For more information, contact the AAD at (888) 462-DERM (3376) or aad.org. Follow @AADskin on Facebook, TikTok, Pinterest, and YouTube, and @AADskin1 on Instagram. About the Hidradenitis Suppurativa Foundation Since its founding in 2005, the Hidradenitis Suppurativa Foundation has fostered and encouraged worldwide research by developing and supporting an interdisciplinary family of scientists and physicians devoted to studying Hidradenitis Suppurativa, in order to deliver more effective forms of treatment and preventative measures to those with this common, debilitating, and eminently chronic disease. HSF is a 501(c)(3) dedicated to improving the lives of people affected by Hidradenitis Suppurativa (HS) through research, education, and advocacy. Explore their resources for patients, clinicians, and investigators at hs-foundation.org, and follow @hsforg on Instagram and YouTube, and @HidradenitisSuppurativaFoundation on Facebook and LinkedIn. SOURCE American Academy of Dermatology 21% more press release views with Request a Demo

01 Oct 2026

·www.biospace.com

Mineralys Therapeutics Announces Presentation of Lorundrostat Data at American Heart Association Hypertension Scientific Sessions 2026

RADNOR, Pa., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in comorbid conditions such as chronic kidney disease, obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that five abstracts will be presented at the American Heart Association (AHA) Hypertension Scientific Sessions 2026, taking place October 7-11 in Arlington, VA. Oral Presentation Details: Title: Efficacy and Safety of the Selective Aldosterone Synthase Inhibitor Lorundrostat in Moderate-to-Severe Obstructive Sleep Apnea and Hypertension: Explore-OSA Randomized Crossover Trial Presenter: Reena Mehra, MD, MS, Professor of Medicine and Division Head, Pulmonary, Critical Care and Sleep Medicine, University of Washington Session Time: Thursday, October 8, 11:45 am ET Session Title: Clinical Trials and Care Delivery Innovation in Hypertension Session Location: Potomac Room Poster Presentation Details: Title: Blood Pressure Responder Analysis in the Global Launch-HTN Trial of Lorundrostat in Uncontrolled and Resistant Hypertension Presenter: Manish Saxena, MBBS, Deputy Clinical Co-Director of Queen Mary University of London’s William Harvey Heart Centre, and Hypertension Specialist at Barts Health NHS Trust Session Time: Friday, October 9, 9:00-10:30 am ET Session Title: Poster Session 2: Clinical Trials in Hypertension and Related Morbidities Poster Board: FR461 Title: Lorundrostat Mitigates Cardiorenal Injury Independent of Blood Pressure Reduction in an L-NAME/Angiotensin II Rat Model Presenter: Jose Romero, PhD, Assistant Professor of Medicine at Harvard Medical School, and Associate Physiologist Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Brigham and Women's Hospital Session Time: Friday, October 9, 9:00-10:30 am ET Session Title: Poster Session 2: Aldosterone, Receptors and Signal Transduction Poster Board: FR401 Title: Real-World Utilization and Treatment Patterns of Spironolactone in Patients with Hypertension Presenter: Kay Sadik, PharmD, PhD, Director, Health Economics & Outcomes Research/Real-World Evidence (HEOR/RWE), Mineralys Therapeutics Session Time: Friday, October 9, 9:00-10:30 am ET Session Title: Poster Session 2: Resistant Hypertension Poster Board: FR568 Title: Adherence to Mineralocorticoid Receptor Antagonists for Uncontrolled and Treatment-Resistant Hypertension: A Targeted Literature Review and Meta-Analysis Presenter: Kay Sadik, PharmD, PhD, Director, Health Economics & Outcomes Research/Real-World Evidence (HEOR/RWE), Mineralys Therapeutics Session Time: Friday, October 9, 9:00-10:30 am ET Session Title: Poster Session 2: BP Control and Adherence to Treatment Poster Board: FR447 About Launch-HTN The Launch-HTN trial ( NCT06153693 ) was a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial of adults whose blood pressure remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: lorundrostat 50 mg once daily; lorundrostat 50 mg once daily with the option to increase to 100 mg at week six based on prespecified criteria; or placebo. The primary endpoint was change from baseline in systolic blood pressure at six weeks versus placebo, measured by automated office blood pressure monitoring. About Explore-OSA The Explore-OSA trial ( NCT06785454 ) was a randomized, double-blind, placebo-controlled, crossover Phase 2 clinical trial. This proof-of-concept trial was designed to evaluate the efficacy, safety and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension. Participants in Explore-OSA received lorundrostat 50 mg once daily and placebo in sequential treatment periods, with continuous monitoring of blood pressure during overnight polysomnography. The primary efficacy endpoint of the trial was absolute change from baseline in apnea-hypopnea index after four weeks of active treatment compared to placebo. The first secondary endpoint was automated office blood pressure, and additional endpoints were nighttime blood pressure and sleep and cardiovascular health measures. About Hypertension Having sustained, elevated blood pressure (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019. Less than 50% of hypertensive patients achieve their blood pressure goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients. About Lorundrostat Lorundrostat is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as related comorbidities, such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, has an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in participants with hypertension. Mineralys has completed six late-stage clinical trials of lorundrostat supporting its efficacy and safety pro also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The clinical program includes two pivotal, registrational trials, the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic blood pressure by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. About Mineralys Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit . Follow Mineralys on LinkedIn , X and Bluesky . Forward-Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on Mineralys’ current beliefs and expectations and include, but are not limited to, statements regarding the potential therapeutic benefits of lorundrostat. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Mineralys’ business, including, without limitation: any delays in the Food and Drug Administration’s (FDA) review of Mineralys’ accepted new drug application (NDA), including as a result of a government shutdown or reductions in agency funding or personnel; the results of Mineralys’ clinical trials, including the Launch-HTN and Advance-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following the FDA’s review of Mineralys’ NDA submission; the risk that future funding under the secured debt facility may not be available on the timeframe Mineralys expects, or at all, including as a result of its failure to meet the conditions required for such funding or failure to comply with the affirmative and negative covenants under the debt facility; Mineralys may not be able to reach agreement on the proposed termination of its license agreement with Tanabe on its expected timeframe, or at all; Mineralys’ future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; Mineralys’ dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; Mineralys’ ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; Mineralys’ reliance on its exclusive license with Tanabe to provide Mineralys with intellectual property rights to develop and commercialize lorundrostat; and other risks described in Mineralys’ filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in its annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Mineralys undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Investor Relations investorrelations@mineralystx.com Media Relations Melyssa Weible Elixir Health Public Relations Email: mweible@elixirhealthpr.com

Phase 2Clinical ResultPhase 3NDAAHA

22 Sep 2026

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Lantern Pharma Secures USPTO Notice of Allowance for LP‑284 Treatment Patent in Aggressive B‑Cell Lymphomas

Newly allowed claims provide LP‑284 patent protection into 2042 for the treatment of mantle cell lymphoma and double-hit lymphoma, two blood cancers with high-unmet-needs The U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 18/500,032, "Method for Treating Blood Cancers," with claims directed to the use of LP‑284 (hydroxyureamethyl acylfulvene) to treat mantle cell lymphoma (MCL) and double‑hit lymphoma (DHL) Allowed claims include methods of treatment as a monotherapy and in combination with a second anti‑cancer agent — including DNA damage agents, glucocorticoids, immunomodulatory drugs (IMiDs), BCL2 inhibitors, BTK inhibitors, spironolactone, PARP inhibitors, and proteasome inhibitors Once issued, the patent is expected to extend Lantern's LP‑284 patent protection into 2042, complementing the existing composition‑of‑matter estate that provides protection into 2039 across major markets LP‑284 holds three FDA Orphan Drug Designations — in MCL, high‑grade B‑cell lymphoma (HGBL) with MYC and BCL2 rearrangements, and soft tissue sarcomas — and is being evaluated in an ongoing Phase 1 clinical trial (NCT06132503) DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), an AI‑driven precision oncology company transforming the cost, pace, and timeline of oncology drug discovery and development, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 18/500,032, titled "Method for Treating Blood Cancers," with claims directed to the use of the company's drug candidate LP‑284 to treat patients with mantle cell lymphoma (MCL), double‑hit lymphoma (DHL), and other blood cancers. The allowed claims cover methods of treating a subject diagnosed with blood cancer by administering an effective amount of LP‑284, when the cancer is mantle cell lymphoma or double‑hit lymphoma. Additional allowed claims cover the co‑administration of LP‑284 with a second anti‑cancer agent selected from: DNA damaging agents, glucocorticoids, immunomodulatory drugs (IMiDs), BCL2 inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, spironolactone, PARP inhibitors, and proteasome inhibitors. Additional claims also cover routes of administration including intravenous and intraperitoneal delivery. A Notice of Allowance is issued after the USPTO determines that prosecution on the merits of a patent application has concluded, and the patent grants upon payment of the required issuance fee. "This Notice of Allowance marks an important step in building a durable, layered intellectual-property portfolio around LP‑284,” said Panna Sharma, President and Chief Executive Officer of Lantern Pharma. “The anticipated patent claims cover the use of LP‑284 as a monotherapy and in combination with other therapeutic agent classes for mantle cell lymphoma and double-hit lymphoma, two aggressive B-cell lymphomas with significant unmet needs globally. Together with our composition-of-matter patent estate, this patent is expected to provide LP‑284 protection into 2042 and strengthen the program’s long-term commercial potential. Advancing LP‑284 from AI-generated insights through our RADR® platform to a first-in-human clinical trial in less than three years demonstrates the potential of our precision approach to efficient, data-driven drug development for novel therapies.” Strengthening a Global LP‑284 Patent Estate The newly allowed method‑of‑treatment patent builds on Lantern's existing LP‑284 composition‑of‑matter estate, which provides protection into 2039 across major medicine markets, including the United States, European Union, Japan, China, India, Mexico, Korea, and Australia. Lantern received its first U.S. composition‑of‑matter Notice of Allowance for LP‑284 in April 2023, followed by a Certificate of Patent from the Japan Patent Office in June 2024 and a European Patent Office allowance in July 2025. Once issued, the "Method for Treating Blood Cancers" patent is expected to extend Lantern's LP‑284 protection into 2042, adding a distinct layer of method‑of‑use protection on top of the underlying composition‑of‑matter rights. Lantern intends to continue prosecuting additional patent applications directed to further indications, combination regimens, and formulations of LP‑284 to further strengthen its intellectual property portfolio. LP‑284 — An AI‑Optimized, Next‑Generation Acylfulvene for Aggressive B‑Cell Cancers LP‑284 is an investigational, next‑generation acylfulvene and the stereoisomer (enantiomer) of Lantern's drug candidate LP‑184. It was optimized using Lantern's proprietary RADR® artificial intelligence platform, which identified its synthetically lethal mechanism targeting cancer cells with DNA damage repair (DDR) deficiencies. Unlike LP‑184, whose activity depends on the enzyme PTGR1, LP‑284's cytotoxic activity is independent of PTGR1 expression, making it well suited to hematologic malignancies. LP‑284 induces DNA lesions that are primarily repaired by the transcription‑coupled nucleotide excision repair (TC‑NER) pathway, and its activity is retained in tumors deficient in ATM — a gene inactivated in an estimated 40%–50% of MCL patients — as well as regardless of TP53 mutation status or lymphoma surface antigen expression. In preclinical studies, LP‑284 has demonstrated nanomolar potency across a panel of B‑cell non‑Hodgkin's lymphoma models, with the highest potency observed in MCL cell lines, including lines resistant to standard‑of‑care agents. In data presented at the 2022 Society of Hematologic Oncology (SOHO) Annual Meeting, LP‑284 showed its lowest IC50 of 88 nM in the bortezomib‑resistant MINO MCL cell line and 193 nM in the ibrutinib/venetoclax‑resistant MAVER‑1 line, demonstrating activity even in models resistant to ibrutinib, bortezomib, venetoclax, and zanubrutinib. LP‑284 has also shown preclinical synergy with rituximab in high‑grade B‑cell lymphoma models, and combination with spironolactone enhanced sensitivity to LP‑284 by 2.4‑fold in a multiple myeloma cell line. LP‑284 holds three FDA Orphan Drug Designations: for mantle cell lymphoma (granted January 2023), for high‑grade B‑cell lymphoma with MYC and BCL2 rearrangements (granted November 2023), and for soft tissue sarcomas (granted January 2026). These represent three of the six total Orphan Drug Designations granted across Lantern's clinical pipeline. Clinical Program LP‑284 is currently being evaluated in an ongoing Phase 1a dose‑escalation clinical trial (NCT06132503) in patients with relapsed or refractory B‑cell non‑Hodgkin's lymphomas and solid tumors. In 2025, Lantern reported that a heavily pretreated 41‑year‑old patient with aggressive Grade 3 non‑germinal center B‑cell diffuse large B‑cell lymphoma (DLBCL) — who had failed three prior state‑of‑the‑art treatment regimens, including CAR‑T cell therapy and a CD3xCD20 bispecific antibody — achieved a confirmed complete metabolic response after just two 28‑day cycles of LP‑284. To date, LP‑284 has been well tolerated, with primarily Grade 1–2 adverse events reported. Market Opportunity and Unmet Need MCL and DHL are aggressive B‑cell lymphomas characterized by high relapse rates and poor prognoses. Nearly all MCL patients acquire resistance to and relapse from standard‑of‑care therapies, and patients with double‑hit lymphoma face particularly poor outcomes following relapse. Lantern estimates that LP‑284 targets a global market estimated at $4 billion annually for blood cancers, driven by the rising incidence of non‑Hodgkin's lymphoma globally, and has potential to address an estimated market that could improve outcomes for 40,000 to 80,000 blood cancer patients annually. About LP‑284 LP‑284 is an investigational next‑generation acylfulvene designed to exploit synthetic lethal interactions in cancer cells with DNA damage repair deficiencies. Developed through Lantern's RADR® AI platform, LP‑284 induces DNA lesions primarily repaired by transcription‑coupled nucleotide excision repair (TC‑NER), creating a distinct anti‑tumor profile. The compound's efficacy remains unaffected by TP53 mutation or lymphoma surface antigen expression, and preclinical studies demonstrate synergistic activity with rituximab and the ability to overcome ibrutinib resistance. LP‑284 is currently in Phase 1 evaluation (NCT06132503) and has received multiple FDA Orphan Drug Designations, including for mantle cell lymphoma, high‑grade B‑cell lymphomas, and soft tissue sarcomas. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI‑driven precision oncology company transforming the cost, pace, and timeline of oncology drug discovery and development. Its proprietary RADR® platform leverages machine learning and large‑scale genomic and clinical data — more than 200 billion oncology‑focused data points and a library of 200+ advanced machine learning algorithms — to identify biomarker signatures and guide the development of targeted therapies for patients with significant unmet need. Lantern's clinical‑stage pipeline includes LP-184 (zirdafulven), LP-300, and LP-284, along with Lantern’s central-nervous-system focused subsidiary, Starlight Therapeutics, and its AI subsidiary, Open Medicine AI. For more information, visit . Forward‑Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; our patents and intellectual property profile; expectations and estimates regarding patent terms and coverage relating to LP-284; our clinical development plans, expectations and estimates regarding clinical trial timing and patient enrollment; estimates regarding patient populations, potential markets and potential market sizes; and our plans to discover and develop drug candidates and to maximize their commercial potential. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “model,” “objective,” “aim,” “upcoming,” “should,” “will,” “would,” or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that a patent may not issue from an allowed application on the expected timeline or with the expected term, (iii) the risk that actual patent terms and coverage may differ from expectations, (iv) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (v) the risk that our research and the research of our collaborators may not be successful, (vi) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (vii) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (viii) the risk that no drug product based on our proprietary AI platforms has received FDA marketing approval or otherwise been incorporated into a commercial product, and (ix) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026. You may access our Annual Report on Form 10-K for the year ended December 31, 2025 under the investor SEC filings tab of our website at or on the SEC’s website at . Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. Contacts Investor & Media Relations Email: IR@lanternpharma.com Phone: (972) 277‑1136

Phase 1Clinical ResultOrphan DrugCell TherapyASH

100 Deals associated with Spironolactone

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KEGG	Wiki	ATC	Drug Bank
D00443	Spironolactone	C03DA01	DB00421

R&D Status

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Indication	Country/Location	Organization	Date
Myocardial Infarction	United States	CMP Development LLC	04 Aug 2017
Stroke	United States	CMP Development LLC	04 Aug 2017
Nephrotic Syndrome	United States	Pfizer Inc.	30 Jun 1981
Hypertension	Japan	Pfizer Japan, Inc.	30 Mar 1965
Ascites	United States	Pfizer Inc.	21 Jan 1960
Edema	United States	Pfizer Inc.	21 Jan 1960
Essential Hypertension	United States	Pfizer Inc.	21 Jan 1960
Heart Failure	United States	Pfizer Inc.	21 Jan 1960
Hyperaldosteronism	United States	Pfizer Inc.	21 Jan 1960
Hypokalemia	United States	Pfizer Inc.	21 Jan 1960
Liver Cirrhosis	United States	Pfizer Inc.	21 Jan 1960

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2026	Not Applicable	Heart failure with normal ejection fraction \| Chronic Kidney Diseases	888	Finerenone	fqkcesjcdl(dkjwoznsfk) = edozwyntbe iypbwfitnl (yeyrgxjrpg ) View more	Positive	30 Aug 2026
				Spironolactone	fqkcesjcdl(dkjwoznsfk) = rmxwjplbrf iypbwfitnl (yeyrgxjrpg ) View more
ENDO2026	Not Applicable	Hyperaldosteronism	1,292	Targeted medical therapy	sitorbkcxz(zvflmsjevy) = Blood pressure reduction in the complete and partial clinical response groups was comparable at 19 mmHg and 22 mmHg for systolic, and 11 mmHg for diastolic blood pressures. gjgtszdveh (aatgxvpcjf )	Positive	14 Jun 2026
ENDO2026	Not Applicable	Hyperaldosteronism	456	Spironolactone	linyurjmjh(juoljlyuug) = dkbzjcotnq jrknaqoasj (johukyfkvv ) View more	Positive	14 Jun 2026
NCT00094302 (TOPCAT, Pubmed \| JACC Asia)	Phase 3	-	975	Spironolactone	zokmepyhxh(zjuqkaidhb): HR = 1.26 (95.0% CI, 0.64 - 2.5), P-Value = 0.506 View more	Negative	01 Jun 2026
				Placebo
NCT00094302 (TOPCAT, Pubmed \| Eur J Heart Fail)	Phase 3	Heart failure with normal ejection fraction	1,648	Spironolactone	igckiultys(girjbtdiea) = twrusecaeu zdhzfphtwr (dbbudpgsot )	Positive	08 Apr 2026
				Placebo	igckiultys(girjbtdiea) = uxmixfymoc zdhzfphtwr (dbbudpgsot )
NCT05676684 (SOGALDI-PEF, Pubmed \| J Am Coll Cardiol)	Phase 2/3	Heart failure with normal ejection fraction	108	Dapagliflozin/Spironolactone combination	ysddoyldjc(sjcypslcyz): OR = 2.27 (95.0% CI, 1.16 - 4.44), P-Value = 0.016 View more	Positive	01 Aug 2025
				Dapagliflozin
ENDO2025	Phase 2	Polyendocrine Metabolic Ovarian Syndrome	36	Cyclic Progesterone + Spironolactone (Androgenic PCOS)	ryzvfglfsg(btxdgjmnyl) = nncjlgdirv kioppwfkmt (lajkbgilba, -7.4 to -13.7, -7.0 to -12.4)	Positive	12 Jul 2025
NCT04676646 (REALIZE-K, CTgov)	Phase 4	Heart failure with reduced ejection fraction \| Hyperkalemia	366	Placebo+Spironolactone+Sodium zirconium cyclosilicate	ftqbgesezq(ekxblzyuag) = amsuspzlri lpqwrjtwng (qkvjgeeszd, sbdljmbxqg - ggesdsglqy) View more	-	09 Jul 2025
NCT00094302 (TOPCAT, Pubmed \| Open Heart)	Phase 3	Heart failure with normal ejection fraction	1,767	Spironolactone	whbcudqpah(gvqdeqqprh): OR = 0.85 (95.0% CI, 0.67 - 1.09) View more	Positive	01 Jul 2025
				Placebo
NCT00094302 \| NCT02556450 \| NCT04435626 (HOMAGE, Pubmed \| J Card Fail)	Not Applicable	Heart Failure natriuretic peptide	500	Spironolactone	rrxonogkhk(zofhreebaw) = lkgvbbtoyc vvbvmmttac (ihulyqvpik ) View more	Positive	01 May 2025
				Placebo	bkfdwppkjj(vxhmwauwqx) = reeonxbjht gkczqbgiqw (uinmyqfoop )

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