Last update 27 Sep 2024

Spironolactone

Last update 27 Sep 2024

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

Mechanism

MR antagonists(Mineralocorticoid receptor antagonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesDigestive System Disorders+ [3]

Active Indication

Malignant ascitesMyocardial InfarctionStroke+ [9]

Inactive Indication-

Originator Organization

G.D. Searle & Co., Inc.

Active Organization

Sinopharm Wuhan ZhongLian SiYao Pharmaceutical Co., Ltd.Nova Laboratories Ireland Ltd.

Pfizer Inc.

+ [2]

Inactive Organization

CMP Pharma, Inc.

Drug Highest PhaseApproved

First Approval Date

(01 Jan 1959),

EdemaHeart FailureHyperaldosteronism+ [2]

RegulationOrphan Drug (US)

Structure

Molecular FormulaC24H32O4S

InChIKeyLXMSZDCAJNLERA-ZHYRCANASA-N

CAS Registry52-01-7

309

Clinical Trials associated with Spironolactone

CTR20242134 / Active, not recruitingNot Applicable

螺内酯片在健康受试者中空腹/餐后单次口服给药、随机、开放、两制剂、两周期、交叉生物等效性试验

[Translation] A randomized, open-label, two-dose, two-period, crossover bioequivalence study of spironolactone tablets in healthy subjects after single oral administration on an empty stomach or after a meal

主要目的：以药代动力学参数为主要终点评价指标，通过比较空腹/高脂餐后口服螺内酯片受试制剂（生产厂家：江苏正大丰海制药有限公司，规格：25mg/片）与参比制剂（生产厂家：GD Searle by Division of Pfizer Inc，商品名：Aldactone，规格：25mg/片）后健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：评价螺内酯片的临床安全性。

[Translation]

Main purpose: Taking pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation of spironolactone tablets (manufacturer: Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd., specification: 25 mg/tablet) and the reference preparation (manufacturer: GD Searle by Division of Pfizer Inc, trade name: Aldactone, specification: 25 mg/tablet) in healthy subjects after oral administration on an empty stomach/high-fat meal was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: To evaluate the clinical safety of spironolactone tablets.

Start Date16 Jul 2024

Sponsor / Collaborator

Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

ChiCTR2400084977 / SuspendedNot ApplicableIIT

A multi-centre, randomised, double-blind, placebo-controlled clinical study of the clinical efficacy and safety of spironolactone in the treatment of female pattern hair loss

Start Date30 Jun 2024

Sponsor / Collaborator

Xiangya Hospital Central South University

IRCT20120524009844N12 / RecruitingPhase 2IIT

Comparison of the efficacy of spironolactone 5% solution with clindamycin 2% solution in patients with mild to moderate acne vulgaris

Start Date21 Jun 2024

Sponsor / Collaborator

Tabriz University of Medical Sciences

100 Clinical Results associated with Spironolactone

100 Translational Medicine associated with Spironolactone

100 Patents (Medical) associated with Spironolactone

7,225

Literatures (Medical) associated with Spironolactone

01 Jan 2025·JOURNAL OF ETHNOPHARMACOLOGY

Novel detoxifier of spironolactone against triptolide-induced hepatotoxicity through inhibition of RPB1 degradation

Article

31 Dec 2024·The Journal of dermatological treatment

The primary role of sebum in the pathophysiology of acne vulgaris and its therapeutic relevance in acne management

Review

Author: Del Rosso, James Q ; Kircik, Leon

BACKGROUND:

Sebum physiology and its contributions to acne vulgaris (AV) pathophysiology have been long debated. Within the pilosebaceous unit, androgens drive sebocyte production of sebum, comprising mono-, di-, and triglycerides (the latter converted to fatty acids); squalene; cholesterol; cholesterol esters; and wax esters. Upon release to the skin surface, human sebum has important roles in epidermal water retention, antimicrobial defenses, and innate immune responses.

AIMS:

Alterations in sebum alone and with other pathogenic factors (inflammation, follicular hyperkeratinization, and Cutibacterium acnes [C. acnes] proliferation) contribute to AV pathophysiology. Androgen-driven sebum production, mandatory for AV development, propagates C. acnes proliferation and upregulates inflammatory and comedogenic cascades.

RESULTS:

Some sebum lipids have comedogenic effects in isolation, and sebum content alterations (including elevations in specific fatty acids) contribute to AV pathogenesis. Regional differences in facial sebum production, coupled with patient characteristics (including sex and age), help exemplify this link between sebum alterations and AV lesion formation.

CONCLUSIONS:

To date, only combined oral contraceptives and oral spironolactone (both limited to female patients), oral isotretinoin and topical clascoterone (cortexolone 17α-propionate) modulate sebum production in patients with AV. A better understanding of mechanisms underlying sebaceous gland changes driving AV development is needed to expand the AV treatment armamentarium.

31 Dec 2024·RENAL FAILURE

Identification of kidney-related medications using AI from self-captured pill images

Article

Author: Cheungpasitporn, Wisit ; Barreto, Erin F. ; Sheikh, Mohammad S. ; Suppadungsuk, Supawadee ; Qureshi, Fawad ; Miao, Jing ; Thongprayoon, Charat ; Kashani, Kianoush B. ; Mao, Michael A. ; Pham, Justin H. ; Dreesman, Benjamin ; Craici, Iasmina M.

INTRODUCTION:

ChatGPT, a state-of-the-art large language model, has shown potential in analyzing images and providing accurate information. This study aimed to explore ChatGPT-4 as a tool for identifying commonly prescribed nephrology medications across different versions and testing dates.

METHODS:

25 nephrology medications were obtained from an institutional pharmacy. High-quality images of each medication were captured using an iPhone 13 Pro Max and uploaded to ChatGPT-4 with the query, 'What is this medication?' The accuracy of ChatGPT-4's responses was assessed for medication name, dosage, and imprint. The process was repeated after 2 weeks to evaluate consistency across different versions, including GPT-4, GPT-4 Legacy, and GPT-4.Ø.

RESULTS:

ChatGPT-4 correctly identified 22 out of 25 (88%) medications across all versions. However, it misidentified Hydrochlorothiazide, Nifedipine, and Spironolactone due to misreading imprints. For instance, Nifedipine ER 90 mg was mistaken for Metformin Hydrochloride ER 500 mg because 'NF 06' was misread as 'NF 05'. Hydrochlorothiazide 50 mg was confused with the 25 mg version due to imprint errors, and Spironolactone 25 mg was misidentified as Naproxen Sodium or Diclofenac Sodium. Despite these errors, ChatGPT-4 showed 100% consistency when retested, correcting misidentifications after receiving feedback on the correct imprints.

CONCLUSION:

ChatGPT-4 shows strong potential in identifying nephrology medications from self-captured images, though challenges with difficult-to-read imprints remain. Providing feedback improved accuracy, suggesting ChatGPT-4 could be a valuable tool in digital health for medication identification. Future research should enhance the model's ability to distinguish similar imprints and explore broader integration into digital health platforms.

News (Medical) associated with Spironolactone

20 Jun 2024

·www.prnewswire.com

Polycystic Ovarian Syndrome Market to Advance at Moderate CAGR During the Study Period (2020-2034) | DelveInsight

According to DelveInsight's estimates, the increasing prevalence of diabetes, obesity, hormonal disorders, socioeconomic factors, changes in sedentary lifestyle, and growing consumption of unhealthy diets among women, is expected to fuel the polycystic ovary syndrome market. LAS VEGAS, June 20, 2024 /PRNewswire/ -- DelveInsight's Polycystic Ovarian Syndrome Market Insights report includes a comprehensive understanding of current treatment practices, polycystic ovarian syndrome emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Polycystic Ovarian Syndrome Market Report According to DelveInsight's analysis, the market size for polycystic ovarian syndrome is expected to grow significantly by 2034. According to the data provided by the Centers for Disease Control and Prevention (CDC), PCOS is one of the most common causes of female infertility, affecting 6% to 12% of US women of reproductive age. According to the data published by NHS, PCOS is thought to be very common, affecting about 1 in every 10 women in the UK. Leading polycystic ovarian syndrome companies such as Spruce Biosciences, and others are developing novel polycystic ovarian syndrome drugs that can be available in the polycystic ovarian syndrome market in the coming years. The promising polycystic ovarian syndrome therapies in the pipeline include Tildacerfont, among others. Discover which therapies are expected to grab the major polycystic ovarian syndrome market share @ Polycystic Ovarian Syndrome Market Report Polycystic Ovarian Syndrome Overview Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in women, presenting a variety of signs, symptoms, and phenotypes. These can include reproductive, endocrine, and metabolic changes. PCOS is marked by dysfunction of the hypothalamic–pituitary–ovary axis and anovulation. Unlike other ovulatory failures characterized by inadequate ovarian follicle growth or suppressed gonadotropin secretion, PCOS usually involves androgen excess and subtle changes in serum levels of gonadotropins and estrogens that routine tests may not detect. The exact cause of PCOS remains unclear, but many women with the condition exhibit insulin resistance. Elevated insulin levels can lead to increased androgen production. Obesity can also raise insulin levels, exacerbating PCOS symptoms. PCOS often runs in families. Symptoms of PCOS may include missed or irregular periods, very light periods, enlarged ovaries or those with many cysts, excessive body hair (hirsutism) on the chest, stomach, and back, weight gain, particularly around the abdomen, acne or oily skin, and infertility. Polycystic Ovarian Syndrome Epidemiology Segmentation The polycystic ovarian syndrome epidemiology section provides insights into the historical and current polycystic ovarian syndrome patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The polycystic ovarian syndrome market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Polycystic Ovarian Syndrome Diagnosed Prevalent cases of Polycystic Ovarian Syndrome Treatable Cases of Polycystic Ovarian Syndrome Polycystic Ovarian Syndrome Treatment Market The primary goal of treating polycystic ovarian syndrome is to manage symptoms and lower the risk of long-term complications. Presently, most treatments target the patient's main concern. The focus of treatment is on alleviating symptoms of hyperandrogenism, regulating menstrual cycles, and facilitating conception. Maintaining a healthy weight by following a balanced diet and engaging in regular exercise can enhance insulin sensitivity and help regulate menstrual cycles in individuals with PCOS who are overweight or obese. Incorporating complex carbohydrates, lean proteins, and plenty of vegetables into the diet can be advantageous. Some women with PCOS might find a low-carbohydrate or low-glycemic index diet particularly beneficial. Physical activity also aids in improving insulin resistance and managing weight. Spironolactone and flutamide can help decrease excess hair growth and acne by inhibiting the effects of male hormones (androgens). While Metformin is not approved for PCOS treatment in the UK, it can be prescribed "off-label" due to its benefits for many women with PCOS who have insulin resistance. Metformin can aid in improving fertility, regulating menstrual cycles, and lowering miscarriage risks. Additionally, it offers long-term health benefits like reducing high cholesterol levels and decreasing the risk of heart disease. To know more about polycystic ovarian syndrome treatment guidelines, visit @ Polycystic Ovarian Syndrome Management Polycystic Ovarian Syndrome Pipeline Therapies and Key Companies The pipeline for PCOS is bleak with only a few companies working diligently. Of all the major market players, Spruce Biosciences is developing Tildacerfont. Tildacerfont is a CRF1 receptor antagonist developed to potentially provide significantly better disease management and reduce steroid use in patients with classic congenital adrenal hyperplasia and other conditions with elevated adrenocorticotropic hormone (ACTH) levels. It works by binding to CRF1 receptors in the pituitary gland, thereby inhibiting the overproduction of ACTH and reducing the production of adrenal androgens like androstenedione, a precursor to testosterone. Tildacerfont is typically well-tolerated in both healthy individuals and those with rare endocrine disorders. Spruce is carrying out the P.O.W.E.R. study, a randomized, placebo-controlled, dose-escalation trial to assess the safety and efficacy of tildacerfont titrated to 200 mg once daily compared to a placebo over 12 weeks in subjects with PCOS and elevated adrenal androgens, measured by baseline dehydroepiandrosterone sulfate (DHEAS) levels. PCOS is a common hormonal disorder in women of reproductive age, characterized by hirsutism, irregular menstrual cycles, infertility, and ovarian cysts. If approved, Tildacerfont could be beneficial for women with a rare form of PCOS resulting from hyperresponsiveness to adrenal androgens. Discover more about polycystic ovarian syndrome drugs in development @ Polycystic Ovarian Syndrome Clinical Trials Polycystic Ovarian Syndrome Market Dynamics The dynamics of the polycystic ovarian syndrome market are expected to change in the coming years. Rising awareness about PCOS and its associated complications, such as infertility, metabolic syndrome, and diabetes, has heightened the demand for effective diagnostic and treatment options. Advances in medical technology and diagnostics have also played a significant role, with improved imaging techniques and blood tests enabling earlier and more accurate detection of PCOS. Additionally, the growing emphasis on personalized medicine and tailored treatment regimens is fueling the market, as healthcare providers seek to offer more specific and effective therapies for managing PCOS symptoms. Furthermore, potential therapies are being investigated for the treatment of polycystic ovarian syndrome, and it is safe to predict that the treatment space will significantly impact the polycystic ovarian syndrome market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the polycystic ovarian syndrome market in the 7MM. However several factors may impede the growth of the polycystic ovarian syndrome market. One of the major challenges is the lack of standardized diagnostic criteria, which can lead to underdiagnosis or misdiagnosis, thus limiting the potential market size. Treatment adherence is another concern, as the chronic nature of PCOS often requires long-term management strategies that patients may find difficult to maintain. Furthermore, there is a need for more comprehensive and effective treatment options; current therapies primarily focus on symptom management rather than addressing the underlying causes of PCOS. Moreover, polycystic ovarian syndrome treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the polycystic ovarian syndrome market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the polycystic ovarian syndrome market growth. Scope of the Polycystic Ovarian Syndrome Market Report Therapeutic Assessment: Polycystic Ovarian Syndrome current marketed and emerging therapies Polycystic Ovarian Syndrome Market Dynamics: Key Market Forecast Assumptions of Emerging Polycystic Ovarian Syndrome Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Polycystic Ovarian Syndrome Market Access and Reimbursement Download the report to understand which factors are driving polycystic ovarian syndrome market trends @ Polycystic Ovarian Syndrome Market Trends Table of Contents Related Reports Polycystic Ovarian Syndrome Pipeline Polycystic Ovarian Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key polycystic ovarian syndrome companies, including Spruce Biosciences, Zydus Therapeutics, AbbVie, among others. Polycystic Ovarian Syndrome Epidemiology Forecast Polycystic Ovarian Syndrome Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted polycystic ovarian syndrome epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Type 2 Diabetes Pipeline Type 2 Diabetes Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key type 2 diabetes companies, including Sanofi, Eli Lilly and Company, Novartis, among others. Type 2 Diabetes Market Type 2 Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 2 diabetes companies, including Eli Lilly and Company, Regor Pharmaceuticals Inc., AstraZeneca, Eccogene, Pfizer, Sciwind Biosciences USA Co., Ltd., MediciNova, Sparrow Pharmaceuticals, HighTide Biopharma Pty Ltd, Novo Nordisk A/S, Biomea Fusion Inc., Altimmune, Inc., Novartis, Amgen, Neuraly, Inc., Carmot Therapeutics, Inc., Inventiva Pharma, Inversago Pharma Inc, Applied Therapeutics, Inc. , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Drug Approval

31 Jan 2024

·www.prnewswire.com

AMERICAN ACADEMY OF DERMATOLOGY ISSUES UPDATED GUIDELINES FOR THE MANAGEMENT OF ACNE

Both newly approved and well-established treatments recommended ROSEMONT, Ill., Jan. 31, 2024 /PRNewswire/ -- Acne is the most common skin condition in the United States, affecting nearly 50 million Americans each year, with symptoms usually beginning in puberty. Acne affects 85% of adolescents and can also often begin or continue in adulthood, especially in women. To help ensure that people with acne get the best possible treatment, the American Academy of Dermatology (AAD) has published updated guidelines of care for the management of acne in adults, adolescents, and children over the age of 9 in the Journal of the American Academy of Dermatology. Continue Reading "These guidelines provide important updates to the 2016 AAD acne guidelines, including discussion of new topical medications, which are directly applied to the skin, and systemic treatments, which are taken by mouth," said board-certified dermatologist John S. Barbieri, MD, MBA, FAAD, co-chair of the AAD's Acne Guideline Workgroup. "This update provides evidence-based recommendations for dermatologists and other clinicians caring for patients with acne." Acne affects 85% of adolescents and can also often begin or continue in adulthood, especially in women. Post this Updates to the management of acne vulgaris provides 18 evidence-based recommendations for topical, systemic, and physical treatment methods, including newly approved therapeutic options, and 5 good practice statements. Strong recommendations were made for the use of the following: Topical benzoyl peroxide to reduce the amount of acne-causing bacteria on the skin. Topical retinoids (e.g. adapalene, tretinoin, tazarotene, trifarotene) to help unclog pores and reduce inflammation. Oral antibiotics, such as oral doxycycline, and topical antibiotics to reduce the amount of acne-causing bacteria on the skin and lessen inflammation. Combinations of topical benzoyl peroxide, retinoids, or the above antibiotics. Employing best practices in guideline development, the multidisciplinary workgroup also issued 5 good practice statements. When managing acne with topical medications, the guidelines recommend combining multiple different treatment types, as this can lead to better results. The guidelines recommend limiting use of oral antibiotics when possible to reduce the development of antibiotic resistance and other antibiotic-associated complications. It is recommended that topical and oral antibiotics are used simultaneously with benzoyl peroxide to prevent the development of antibiotic resistance. For patients with larger acne bumps, the guidelines recommend injectable corticosteroids as a potential option for more rapid relief of inflammation and pain. For patients with severe acne or for patients who have failed standard treatment with oral or topical therapy, the guidelines recommend isotretinoin. Additionally, the guidelines provide conditional recommendations. Conditional recommendations apply to most patients, but the most appropriate action may differ depending on individual patient factors. Topical clascoterone, which addresses hormonal causes of acne. Topical salicylic acid to unclog pores and exfoliate the skin. Topical azelaic acid to unclog pores, kill bacteria, and fade dark spots that may continue when an acne spot clears. Oral minocycline or sarecycline to reduce the amount of acne-causing bacteria on the skin and lessen inflammation. Hormonal therapies such as combined oral contraceptives or spironolactone to address hormonal causes of acne. Available evidence was insufficient to develop recommendations for procedures such as chemical peels, laser and light-based devices, microneedling, as well as for dietary changes, or alternative therapies such as vitamins or plant-based products. Additionally, a conditional recommendation against adding broadband light, intense pulsed light, to adapalene 0.3% gel. "Board-certified dermatologists are on the forefront of new and exciting advances in the treatment of acne," said Dr. Barbieri. "We are able to offer our patients with acne more options than ever before as we work to address their concerns and determine the most effective treatment plan possible. Just as important, dermatologists must have access to all available therapeutic options." Since there are a variety of treatment options for acne and treatment plans are not one-size-fits-all, it is important to partner with a board-certified dermatologist to decide which options work best for you. To find a board-certified dermatologist in your area, visit aad.org/findaderm. More Information Acne resource center Acne treatment AAD B-Roll Library 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 20,800 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. SOURCE American Academy of Dermatology

04 Jan 2024

·www.biospace.com

Amneal Launched Record Number of 39 New Retail and Injectable Products in 2023, Including 13 in Q4 2023

More new product innovations in 2023, as compared to 26 in 2022 13 new products launched in the fourth quarter of 2023 BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal”) today announces that it has launched 39 new retail and injectable medicines in 2023, as compared to 26 new launches in 2022. In the fourth quarter of 2023, Amneal launched 13 new products, including 5 injectables. New injectable products added include potassium phosphate vials, tranexamic acid and esmolol intravenous bags. These launches provide a strong foundation for higher injectable revenues going forward. In addition, Amneal launched several key new retail products in the fourth quarter, including spironolactone suspension with 180-day exclusivity, valsartan and hydrochlorothiazide tablets, and icosapent capsules. “We are pleased to have brought an impressive number of new products to market in 2023,” said Dr. Srinivas Kone, Senior Vice President, Generics R&D. “Our R&D portfolio prioritizes complex and high-value products that provide better access to affordable medicines for providers and patients.” About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit . Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations, including international expansion; expected or estimated operating results and financial performance; the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our ability to manage our growth through acquisitions and otherwise; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our ability to complete the proposed holding company reorganization on the anticipated timeline or at all and to realize the expected benefits of such reorganization; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our ability to secure satisfactory terms when negotiating a refinancing or other new indebtedness; our dependence on third-party agreements for a portion of our product offerings; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our ability to attract, hire and retain highly skilled personnel; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. View source version on businesswire.com: Contacts Investors: Anthony DiMeo Head of Investor Relations anthony.dimeo@amneal.com Source: Amneal Pharmaceuticals, Inc. View this news release online at:

100 Deals associated with Spironolactone

External Link

KEGG	Wiki	ATC	Drug Bank
D00443	Spironolactone	C03DA01	DB00421

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Malignant ascites	EU	Nova Laboratories Ireland Ltd.	26 May 2023
Malignant ascites	IS	Nova Laboratories Ireland Ltd.	26 May 2023
Malignant ascites	LI	Nova Laboratories Ireland Ltd.	26 May 2023
Malignant ascites	NO	Nova Laboratories Ireland Ltd.	26 May 2023
Myocardial Infarction	US	CMP Development LLC	04 Aug 2017
Stroke	US	CMP Development LLC	04 Aug 2017
Nephrotic Syndrome	US	Pfizer Inc.	30 Jun 1981
Ascites	US	Pfizer Inc.	21 Jan 1960
Essential Hypertension	US	Pfizer Inc.	21 Jan 1960
Liver Cirrhosis	US	Pfizer Inc.	21 Jan 1960
Edema	-	Pfizer Inc.	01 Jan 1959
Heart Failure	-	Pfizer Inc.	01 Jan 1959
Hyperaldosteronism	-	Pfizer Inc.	01 Jan 1959
Hypertension	-	Pfizer Inc.	01 Jan 1959
Hypokalemia	-	Pfizer Inc.	01 Jan 1959

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02169089 (MAGMA, Pubmed \| Circulation) Manual	Phase 4	Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	79	Spironolactone 25 mg	acqzgmmfii(esozqdujwn) = nrgsewsppd edhwqhdazo (pvjoxstnvf, 10.0) View more	Positive	27 Aug 2024
				Placebo	acqzgmmfii(esozqdujwn) = mysulfkxtn edhwqhdazo (pvjoxstnvf, 10.7) View more
NCT02556450 (HOMAGE, Pubmed) Manual	Phase 2	Heart Failure carboxyterminal propeptide of procollagen I (PICP) \| carboxyterminal telopeptide of collagen I (CITP)	290	usual therapy + Spironolactone 25-50 mg/day	tobpdqeymt(uahyldhfue) = wmbccawfvh aotscqvriu (ukzkcxrpib )	Positive	09 May 2024
				Usual therapy	tobpdqeymt(uahyldhfue) = wvjurvxqrt aotscqvriu (ukzkcxrpib )
ISRCTN12892056 (Pubmed)	Phase 3	Acne Vulgaris	-	Spironolactone 50 mg/day	vmpstmuqwb(ujjuzlgcjb) = azklcdbnas hrhagzfzwp (fybkqsvaqa )	-	01 Dec 2023
AASLD2023	Not Applicable	-	9,635	Spironolactone therapy	inbftzvkjq(mdpmenrlzh) = xgnmbcpgau iwpcivkogo (thzrenpbmy )	-	10 Nov 2023
				No spironolactone therapy	inbftzvkjq(mdpmenrlzh) = wwfxqmbxcp iwpcivkogo (thzrenpbmy )
NCT03777319 (CTgov)	Phase 1	Muscular Dystrophy, Duchenne	2	Spironolactone (Spironolactone)	axybnrwiqo(rpsfdblvve) = nlbbymdqbf mjewhaqimp (ovugrxqrrs, qfjrfxgdku - dbdjjpuobq) View more	-	23 Oct 2023
				Prednisolone (Prednisolone)	axybnrwiqo(rpsfdblvve) = hdnisvrsho mjewhaqimp (ovugrxqrrs, lqjudgstgw - faeecrqlcf) View more
NCT02169089 (MAGMA, CTgov)	Phase 4	Atherosclerosis	79	Spironolactone (Spironolactone)	dwuphebjzp(irwdykpelu) = plkubolywo uyvwsgmgmt (rhcdtfbilq, prmaeehqfo - egfuwpjupf) View more	-	01 Aug 2023
				Placebo (Placebo)	dwuphebjzp(irwdykpelu) = apwzgnbyjg uyvwsgmgmt (rhcdtfbilq, ewbfdadrmf - zmhaohkcmu) View more
#3068 (ERA2023)	Not Applicable	Chronic Kidney Diseases	-	Spironolactone 25 mg	dcehhurxas(sulghtierb) = Seventeen patients developed severe HK with a P-K > 5.5mmol/l and four were briefly admitted with a P-K > 6.2mmol/l gtumaobxow (uwttjjfaws )	Positive	14 Jun 2023
				Spironolactone 50 mg
NCT03909529 (CTgov)	Phase 1	Medication interactions	28	Carospir+digoxin (Drug-Drug Interaction Study)	sgvymmsumq(alrxcicvns) = exvwfhfekg bbholumkyu (frjvvjqhsx, obwjjwquoo - jkgtadmyvy) View more	-	01 May 2023
				Digoxin (LANOXIN) (Treatment-A- Single Dose of Digoxin (LANOXIN))	lcmekwmqsz(odvaelhevg) = erihdeyfya mjphgojbgh (xohoieshzn, ikhqhbhihb - wekcqutwft) View more
NCT02497300 (VEMAKD, CTgov)	Phase 2	Proteinuria \| Chronic Kidney Diseases	21	Spironolactone (Spironolactone)	dtziocwowg(zivqvctfvk) = mrhgwoudjh eotkkzijtw (fvtbckplyl, tylvbieluf - mdcauqszkt) View more	-	21 Dec 2022
				Amiloride (Amiloride)	dtziocwowg(zivqvctfvk) = opizqcbozq eotkkzijtw (fvtbckplyl, jeprfnuqlz - zvbgchzorm) View more
AFTER-PRIORITY (ASN2022)	Not Applicable	Albuminuria urinary proteomic risk classifier - CKD273	115	Spironolactone	xysmesitjt(zxbnnsbnqu) = zfseyfdokh icgslgmjni (fhqdadgaer, 33% - -37;104) View more	Negative	05 Nov 2022
				Placebo	xysmesitjt(zxbnnsbnqu) = gyvrwbltmj icgslgmjni (fhqdadgaer, 9% - -27;81) View more

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